Preamble

 

Social anthropologists carry out their professional research in many places around the world; some where they are 'at home' and others where they are in some way 'foreign'. Anthropological scholarship occurs within a variety of economic, cultural, legal and political settings. As professionals and as citizens, they need to consider the effects of their involvement with, and consequences of their work for the following: the individuals and groups among whom they do their fieldwork (their research participants or 'subjects'); their colleagues and the discipline; collaborating researchers; sponsors, funders, employers and gatekeepers; their own and host governments; and other interest groups and the wider society in the countries in which they work.

 

Anthropologists, like other social researchers, are faced increasingly with competing duties, obligations and conflicts of interest, with the need to make implicit or explicit choices between their own values and between the interests of different individuals and groups. Ethical and legal dilemmas occur at all stages of research: in the selection of topic, area or population, choice of sponsor and source of funding, in negotiating access, making 'research bargains' and during the research itself while conducting fieldwork, including the interpretation and analysis of results, the publication of findings and the disposal of data. Anthropologists have a responsibility to anticipate problems and insofar as is possible to resolve them without harming either the research participants or the scholarly community. They should do their utmost to ensure that they leave a research field in a state which permits future access by other researchers. As members of a discipline committed to the pursuit of knowledge and the public disclosure of findings, they should strive to maintain integrity in the conduct of anthropological research. This ethics code applies to anthropological work whether studying 'up' and/or 'down', with persons and/or animals, within and outside the UK as well as in cyberspace.

 

The ethnographic method – the process through which theory is developed on the basis of empirical data collected – is the dominant mode through which anthropology is practised. Ethnographic methods cover a range of research practices and methods often including long/short-term/multi-sited/repeated fieldwork/visits. These ethical guidelines address the stages of preparation, the process of fieldwork and the writing procedure. Within fieldwork, participant observation has been considered by anthropologists as one of the core methods. This is a holistic method of research which is usually carried out over a period of time and can be conducted with a wide variety of communities and groups. The contexts for research can include economic, political, legal, medical settings and concerns as well as religious, gender, and kinship dimensions, among many others. The range of participants is also, as a result, varied. Participant observation is inductive and has the potential for uncovering unexpected links between different domains of social life. Accordingly, a degree of flexibility in research design that allows modification of topic focus - following the initial formulation of a research question - is required. Participant observation includes engagement with and observation of various forms of participatory activities specific to the group being studied, usually in both public and private settings. Fieldwork is also carried out by means of casual conversations (with a wide range of participants, some of whom are wellknown and seen regularly, others during fleeting encounters), interviews (usually open-ended, qualitative and in-depth), surveys, audio and video recording, sometimes supplemented by subsequent co-viewing with participants. The methods can vary from the informal and unstructured (such as participant observation, conversations) through to structured methods (such as interviews, surveys, audio-visual recordings).

 

Participant observation involves certain key ethical principles:

 

1.  Participants should be made aware of the presence and purpose of the researcher whenever reasonably practicable. Researchers should inform participants of their research in the most appropriate way depending on the context of the research.
2.  Fieldnotes (and other forms of personal data) are predominantly private barring legal exceptions. This is the most important way in which confidentiality and the anonymity of subjects is ensured. Anthropologists have a duty to protect all original records of their research from unauthorised access. They also have a duty to ensure that nothing that they publish or otherwise make public, through textual or audio-visual media, would permit identification of individuals that would put their welfare or security at risk.

 

 

 

1.  Given the methods used during fieldwork, and depending on the nature of the project, the researcher may be able to provide only rough approximations in advance (for example, to various institutional Ethics committees including those to do with the university, National Health Service etc.) of some of the likely participants an anthropologist will observe or converse with during fieldwork and some of the likely scenarios in which consent will be sought. As a result, it may be difficult and/or artificial to prepare distinct data collection instruments for approval in advance. Given the open-ended and often long-term nature of fieldwork, ethical decision-making has to be undertaken repeatedly throughout the research and in response to specific circumstances. 
2. Many of those participating in public events observed by the anthropologist will not be known to him or her. This is particularly the case for strangers visiting the community (a term that could also include employees of government agencies, multinational corporations, schools, hospitals among others) being studied; or in research on mobile groups (which could involve pastoral and nomadic groups, refugees or expatriate and corporate elites) who move around for various reasons (such as subsistence, ritual celebrations, pilgrimage, corporate meetings, wartime displacements) to other places; or in studies of large institutions. In such situations, the anthropologists should take all practicable steps to be introduced by local participants and identify him/herself as a researcher. Not everyone observed or photographed, especially in large crowds, will be known. Large-scale events (such as religious festivals, political rallies or mass protests) are clearly legitimate and necessary foci of anthropological study, but should be subject to various ethical considerations. Hence due sensitivity to those involved in large-scale events and necessary observation of ethical standards with regard to the sensibilities and security of the participants needs to be kept in mind depending on the nature of the event. 
3.  Many of the communities studied by anthropologists are highly suspicious of formal bureaucratic procedures and often of their state or local forms of the state. Under these circumstances, requests for signatures on printed forms are liable to arouse suspicion and therefore standard procedures for obtaining written consent can be problematic. It is possible and appropriate, however, to obtain informed verbal consent. In working with informants with limited literacy or with learning difficulties that might render informed consent as commonly understood problematic, it may be appropriate to give people the chance to discuss their consent to an interview with friends, family or other trusted acquaintances. Repeated checking with informants during the research process, can ensure that the continuity of consent is maintained. 
4.  In some cases, consent will initially need to be sought from individual gatekeepers such as community leaders and officials: chiefs, local councillors, headmen, hospital consultants, trade union leaders, etc or from collective decision-making bodies such as community or neighbourhood assemblies. In addition to needing to negotiate access to the field through such "gatekeepers", it will often be desirable to supplement the informed consent of collective bodies with that of individuals, particularly where substantial sectors of the local society are excluded from collective decision-making but are also subjects of the research.  By the same token, in all settings further consent may need to be negotiated as the research advances and new fields of inquiry open up. 
5. Photography (both stills and film) is a very important tool of anthropological inquiry. Filming should always be overt. Moreover, in the case of large public events it is likely that not everyone photographed/filmed will have the chance to give verbal consent. In such cases the researchers should do all that is possible in his/her powers to not compromise people's identities or security in public presentations of the material.

 

In light of these considerations, the weight of responsibility for adherence to good ethical conduct is on the anthropological researcher. Ethics Committees need to recognise the diversity of methods of ethnographic research. For anthropology, once the research is completed the ethics of representations are a major issue. The principles outlined below are intended to guide anthropologists not only in the way they conduct fieldwork but in the way they represent and publish their results to wider audiences.

 

To these ends the Association has adopted the following set of ethical guidelines to which individual members, other anthropologists should subscribe. They follow the educational model for professional codes, aiming to alert researchers to issues that raise ethical concerns or to potential problems and conflicts of interests that might arise in the research process. They are intended to provide a practical framework for anthropologists to make informed decisions about their own behaviour and involvement, and to help them communicate their professional positions more clearly to the other parties involved in or affected by their research activities. Anthropologists requiring permission from local bureaucracies for the purpose of their research (particularly on sensitive topics like research on children) might, however, need to adhere to the ethics procedure of the institution from which permission is being sought. The ASA does not adjudicate claims regarding unethical behaviour. Rather than intervening, the ASA can act as a forum for discussion among parties to a disagreement over ethics. Anthropological researchers should expect to encounter ethical dilemmas at every stage of their work, and should make good-faith efforts to identify potential ethical claims and conflicts in advance when preparing proposals and as projects proceed. Persons using the ASA guidelines to help them make ethical choices or for teaching are encouraged to seek out illustrative examples and appropriate case studies to enrich their knowledge base.

 

I. Relations with and responsibilities towards research participants

 

The close and often lengthy association of anthropologists with the communities/cultures/societies among whom they carry out research entails personal and moral relationships, trust and reciprocity between the researcher and research participants; it also entails recognition of power differentials between them.

 

1) Protecting research participants and honouring trust: Anthropologists should endeavour to protect the physical, social and psychological well-being of those with whom they conduct their study and to respect their rights, interests, sensitivities and privacy, other than in the most exceptional of circumstances. It would also be important to keep in mind the ethical responsibilities to non-human research subjects.

 

a) The ASA maintains that their paramount obligation is to their research participants and that when there is conflict, the interests and rights of those studied should come first. This means that anthropologists must reflect particularly deeply on the likely impacts on the communities/cultures/societies they are studying; of any research, consultancy or other services that they might offer or be asked to provide to national/supra-national or foreign states or to non-state entities (such as transnational corporations, law enforcement agencies, NGOs or charities) that intervene or are seeking to intervene in the lives of those communities/cultures/societies. Work for state or non-state organisations that is covert, and therefore breaches relations of trust and openness, is especially problematic. Overt work that is only possible because the participants are subject to coercion is also likely to breach basic ethical standards.

 

 b) Under some research conditions, particularly those involving contracted research, it may not be possible to fully guarantee research participants' interests. In such cases anthropologists would be well-advised to consider in advance whether they should pursue such research.

 

2) Anticipating harms: Anthropologists should be sensitive to the possible consequences of their work and should endeavour to guard against predictably harmful effects. Consent from subjects does not absolve anthropologists from their obligation to protect research participants as far as possible against any potential harmful effects of research:

 

a) The researcher should try to minimise disturbances both to subjects themselves and to the subjects' relationships with their environment. Even though research participants may be immediately protected by the device of anonymity, the researcher should try to anticipate the long-term effects on individuals or groups as a result of the research;

 

b) Anthropologists may sometimes be better placed than (at the least, some of) their informants to anticipate the possible repercussions of their research both for the immediate participants and for other members of the research population or the wider society. In certain political contexts, some groups, for example, religious or ethnic minorities, may be particularly vulnerable and it may be necessary to withhold data from publication or even to refrain from studying them at all.

 

3) Avoiding undue intrusion: Anthropologists should be aware of the intrusive potential of some of their enquiries and methods:

 

a) Like other social researchers, they have no special entitlement to study all phenomena; and the advancement of knowledge and the pursuit of information are not in themselves sufficient justifications for overriding the values and ignoring the interests of those studied;

 

b) They should be aware that for research participants becoming the subject of anthropological description and interpretations can be a welcome experience, but it can also be a disturbing one. In many of the social scientific enquiries that have caused controversy, problems have not arisen because participants have suffered directly or indirectly any actual harm. Rather, concerns have resulted from participants' feelings of having suffered an intrusion into private and personal domains, or of having been wronged (for example, by acquiring self-knowledge which they did not seek or want). Where feasible, participants should also be made aware that they can withdraw from the research at any time.

 

4) Negotiating informed consent: Inquiries involving human subjects should be based on the freely given informed consent of subjects. The principle of informed consent expresses the belief in the need for truthful and respectful exchanges between social researchers and the people with whom they study.

 

a) Negotiating consent entails communicating information likely to be material to a person's willingness to participate, such as: the purpose(s) of the study and the anticipated consequences of the research; the identity of funders and sponsors; the anticipated uses of the data; possible benefits of the study and harm or discomfort that might affect participants; issues relating to data storage and security; and including limits to the degree of anonymity and confidentiality which may be afforded to informants and subjects. These can be communicated verbally, particularly to those participants with whom the anthropologist has close and continuing relations.

 

b) Conditions which constitute an absence of consent: consent made after the research is completed and publicly made available is not meaningful consent at all. Where subjects are legally compelled (e.g., by their employer or government) to participate in a piece of research, consent cannot be said to have been meaningfully given by subjects, and anthropologists are advised not to pursue that piece of work. However, as has been noted above, in the case of exceptional circumstances such as large public events - especially where photographs are taken - consent sometimes might be sought after the event as it is often not possible to seek advance consent. Although it will not always be possible to obtain formal consent, reasonably practicable steps to do so should be taken.

 

c) Consent in ethnographic research is a process, not a one-off event, due to its long-term and open-ended qualities. Consent may require renegotiation over time; it is an issue to which the anthropologist should return periodically. Depending on the research project, researchers may only be able to provide a rough approximation of some of the likely scenarios in which consent might be sought. Thus continuous reflection on ethical issues and conduct is necessary.

 

d) When audio-visual media is to be used, be it merely for data-gathering or for broader representational purposes such as producing ethnographic films or photographic essays, the principal research subjects should be made aware of the technical capacities of these media and should be free to reject their use. These conditions should generally apply in public spaces as well as in private spaces where there is a reasonable expectation of privacy. And anthropologists must take steps at the beginning of fieldwork to sensitise themselves to local norms that may embody different ideas about the private and public from those of the anthropologist's' own society.

 

e) Anthropologists engaged in cyber ethnography or other forms of research that involve the use of electronic texts, images and/or audio-recordings already in the public domain and/or available through fora such as blogs, chatrooms, social media sites etc., should remain sensitive to the possible implications of re-using those electronic texts, images and sounds, not only in terms of ethical responsibilities to the subjects but also in relation to the Intellectual Property Rights held either by the subjects themselves or by those who created the images or recordings in the first place. It is important to note that the very notion of public domain (given the issue of membership for some sites and corporate ownership in social networking sites) is an evolving, shifting phenomenon and hence so is cyber ethnography and its ethical implications.

 

f) When information is being collected from proxies, care should be taken not to infringe the 'private space' of the subject or the relationship between subject and proxy; and if there are indications that the person concerned would object to certain information being disclosed, such information should not be sought by proxy.

 

g) The long period over which anthropologists make use of their data and the possibility that unforeseen uses or theoretical interests may arise in the future may need to be conveyed to participants, as should any likelihood that the data may be shared (in some form) with other colleagues or be made available to sponsors, funders or other interested parties, or deposited in archives.

 

5) Rights to confidentiality and anonymity: informants and other research participants should have the right to remain anonymous and to have their rights to privacy and confidentiality respected. However, privacy and confidentiality present anthropologists with particularly difficult problems given the cultural and legal variations between societies and the various ways in which the real interests or research role of the ethnographer may not fully be realised by some or all of participants or may even become invisible over time.

 

a) Care should be taken not to infringe uninvited upon the 'private space' (as locally defined) of an individual or group;

 

b) As far as is possible researchers should anticipate potential threats to confidentiality and anonymity. They should consider whether it is necessary even as a matter of propriety to record certain information at all; take appropriate measures relating to the storage and security of records during and after fieldwork; and use where appropriate such means as the removal of identifiers, the use of pseudonyms and other technical solutions to the problems of privacy in field records and in oral and written forms of data dissemination (whether or not this is enjoined by law or administrative regulation); 

 

c) Researchers should endeavour to anticipate problems likely to compromise anonymity; but they should make clear to participants that it may not be possible in field notes and other records or publications totally to conceal identities, and that the anonymity afforded or promised to individuals, families or other groups may also be unintentionally compromised. A particular configuration of attributes can frequently identify an individual beyond reasonable doubt; and it is particularly difficult to disguise, say, office-holders, organizations, public agencies, ethnic groups, religious denominations or other collectivities without so distorting the data as to compromise scholarly accuracy and integrity;

 

d) If guarantees of privacy and confidentiality are made, they should be honoured unless there are clear and overriding ethical reasons not to do so. Confidential information should be treated as such by the anthropologist even when it enjoys no legal protection or privilege, and other people who have access to the data should likewise be made aware of their obligations; but conversely participants should be made aware that it is rarely, if at all, legally possible to ensure total confidentiality or to completely protect the privacy of records. Fieldnotes and other data should not be archived in raw form if this infringes either the promise of confidentiality and anonymity made to participants, or the stated reasons for the research on which informed consent was agreed. Extended embargo periods may provide a way of securing the material for future researchers, including those from source communities, while honouring present commitments. In the longer term, it might be proper to make available fieldnotes and other research material for use by other researchers e.g. by including them in relevant archives. Anthropologists should make this clear when securing informed consent. Anthropologists should be cognisant that they might not be able to protect their fieldnotes to the fullest extent and hence care must be taken as to how data is recorded.

 

e) Anthropologists should similarly respect the measures taken by other researchers to maintain the anonymity of their research field and participants.

 

6) Fair return for assistance: There should be no economic exploitation of individual informants, translators, groups, animals and research participants or cultural or biological materials; fair return should be made for their help and services.

 

7) Participants' intellectual property rights: It should be recognised that research participants have contractual and/or legal interests and rights in data, recordings and publications, although rights will vary according to agreements and legal jurisdiction.

 

a) It is the obligation of the interviewer to inform the interviewee of their rights under any copyright or data protection laws of the country where research takes place, and the interviewer should indicate beforehand any uses to which the anthropological use of interview methods is likely to be put (e.g., research, educational use, publication, broadcasting etc).

 

b) Under the UK Copyright, Designs and Patents Act (1988), researchers making audio or video recordings should obtain 'copyright clearance' from interviewees if recordings are to be publicly broadcast or deposited in public archives. Any restrictions on use (e.g. time period) or other conditions (e.g. preservation of anonymity) which the interviewee requires should be recorded in writing or can also be done audio-visually as a record of oral consent. This is best done at the time of the interview (the anthropological use of this method), using a standard form. Retrospective clearance is often time-consuming or impossible where the interviewee is deceased or has moved away.

 

c) Interviewers should clarify before interviewing the extent to which subjects are allowed to see transcripts of interviews, and field notes and to alter the content, withdraw statements, provide additional information or to add glosses on interpretations.

 

d) Clarification should also be given to subjects regarding the degree to which they will be consulted prior to publication.

 

 8) Participants' involvement in research: As far as is possible anthropologists should try and involve the people from the communities/cultures/societies being studied in the planning and execution of research projects. They should recognise that their obligations to the participants or the host community may not end (indeed should not end, many would argue) with the completion of their fieldwork or research project.

 

II. Relations with and responsibilities towards sponsors, funders and employers

 

Anthropologists should attempt to ensure that sponsors, funders and employers appreciate the obligations that they have not only to them, but also to research participants and to professional colleagues.

 

1) Clarifying roles, rights and obligations: Anthropologists should clarify in advance the respective roles, rights and obligations of sponsor, funder, employer and researcher:

 

a) They should be careful not to promise or imply acceptance of conditions which would be contrary to professional ethics or competing commitments. Where conflicts seem likely, they should refer sponsors or other interested parties to the relevant portions of the professional guidelines;

 

b) Anthropologists who work in non-academic settings should be particularly aware of likely constraints on research and publication and of the potentiality for conflict between the aims of the employer, funder or sponsor and the interests of the communities/cultures/societies studied;

 

c) Where some or all of the research participants are also acting as sponsors and/or funders of the research the potential for conflict between their different roles and interests should be made clear to them.

 

2) Obligations to sponsors, funders and employers: Anthropologists should recognise their general and specific obligations to sponsors, funders and employers whether these are contractually defined or are only the subject of informal, and often unwritten, agreements. In particular:

 

a) They should be honest about their qualifications and expertise, about the limitations, advantages and disadvantages of their methods and data, and they should acknowledge the necessity for discretion with confidential information provided by sponsors and employers;

 

b) They should not conceal personal or other factors which might affect the satisfactory conduct or completion of the proposed research project or contract.

 

3) Negotiating 'research space': Anthropologists should be careful to clarify, preferably in advance of signing contracts or starting their research, matters relating to their professional domain and to their control over the research project and its products:

 

a) They are entitled to full disclosure of the sources of funds, personnel and aims of the institution for the purpose(s) of the research project and the disposition of research results;

 

b) They are entitled to expect from a sponsor, funder or employer a respect for their professional expertise and for the integrity of the data, whether or not these obligations are incorporated in formal contracts. Even when contractual obligations may necessitate the guarding of privileged information, the methods and procedures that have been utilised to produce the published data should not be kept confidential;

 

c) They should pay particular attention to matters such as: their ability to protect the rights and interests of research participants; their ability to make all ethical decisions in their research; and their own and other parties' rights in data collected, in publications, copyright and royalties.

 

4) Relations with gatekeepers: Where access to subjects is controlled by a national or local 'gatekeeper', researchers should not devolve their responsibilities onto the gatekeeper. Whilst respecting gatekeepers' legitimate interests, researchers should adhere to the principle of obtaining informed consent directly from subjects once access has been gained. They should be wary of inadvertently disturbing the relationship between subjects and gatekeepers since that will continue long after the researcher has left the field.

 

III. Relations with, and responsibilities towards, colleagues and the discipline

 

Anthropologists derive their status and certain privileges of access to research participants and to data not only by virtue of their personal standing but also by virtue of their professional citizenship. In acknowledging membership of a wider anthropological community anthropologists owe various obligations to that community and can expect consideration from it.

 

1) Individual responsibility: Anthropologists bear responsibility for the good reputation of the discipline and its practitioners. In considering the methods, procedures, content and reporting of their enquiries, their behaviour in the field and relations with research participants and field assistant, they should therefore try to ensure that their activities will not jeopardize future research. Thus, anthropological researchers are subject to the general moral rules of scientific and scholarly conduct: they should not deceive or knowingly misrepresent (e.g. fabricate evidence, falsify, or plagiarise), or attempt to prevent reporting of misconduct, or obstruct the scientific/scholarly research of others.

 

2) Conflicts of interest and consideration for colleagues: It should be recognised that there may be conflicts of interest (professional and political) between anthropologists, particularly between visiting and local researchers, and especially when cross-national research is involved:

 

a) Consideration for and consultation with anthropologists who have already worked or are currently working in the proposed research setting is advisable and is also a professional courtesy. In particular, the vulnerability of long-term research projects to academic intrusion should be recognised;

 

b) In cross-national research, consideration should be given to the interests of local scholars and researchers, to the problems that may result from matters such as the disparities in resources available to visiting researchers, and to problems of equity in collaboration. As far as is possible and practicable, visiting anthropologists should try and involve local anthropologists and scholars in their research activities but should be alert to the potential for harm that such collaboration might entail in some contexts.

 

3) Sharing research materials: Anthropologists should give consideration to ways in which research data and findings can be shared with colleagues and with research participants. However in certain instances this can prove to be difficult where political leaders, invading armies, military, multi-national corporations and the state are being criticised on various matters of injustice.

 

a) Research findings, publications and, where feasible, data should be made available in the country where the research took place. If necessary, it should be translated into the national or local language. Researchers should be alert, though, to the harm to research participants, collaborators and local colleagues that might arise from total or even partial disclosure of raw or processed data or from revelations of their involvement in the research project. Anthropologists should weigh up the intended and potential uses of their work and the impact of its distribution in determining whether limited availability of results is warranted and ethical in any given instance.

 

b) Where the sharing with colleagues of raw, or even processed data or their (voluntary or obligatory) deposition in data archives or libraries is envisaged, care should be taken not to breach privacy and guarantees of confidentiality and anonymity, and appropriate safeguards should be devised.

 

4) Collaborative and team research: In some cases anthropologists will need to collaborate with researchers in other disciplines, as well as with research and field assistants, clerical staff, students etc. In such cases they should make clear their own ethical and professional obligations and similarly take account of the ethical principles of their collaborators. Care ASA Ethical Guidelines 2011 www.theasa.org 9 should be taken to clarify roles, rights and obligations of team members in relation to matters such as the division of labour, responsibilities, access to and rights in data and fieldnotes, publication, co-authorship, professional liability, etc.

 

5) Responsibilities towards research students and field assistants: Academic supervisors and project directors should ensure that students and assistants are aware of the ethical guidelines and should discuss with them potential (as well as actual) problems which may arise during the stages/periods of fieldwork or writing-up. Teachers/mentors should publicly acknowledge student/trainee assistance in research and preparation of their work; give appropriate credit for co-authorship to students/trainees; encourage publication of worthy student/trainee papers; and compensate students/trainees justly for their participation in all professional activities. It should also be a duty to acknowledge the support and intellectual input of colleagues in the field.

 

IV. Relations with own and host governments

 

Anthropologists should be honest and candid in their relations with their own and host governments.

 

1) Conditions of access: Researchers should seek assurance that they will not be required to compromise their professional and scholarly responsibilities as a condition of being granted research access.

 

2) Cross-national research: Research conducted outside one's own country raises special ethical and political issues relating to personal and national disparities in wealth, power, the legal status of the researcher, political interest and his or her national political systems:

 

a) Anthropologists should bear in mind the differences between the civil and legal, and often the financial position of national and foreign researchers and scholars;

 

b) They should be aware that irresponsible actions by a researcher or research team may jeopardise access to a research setting or even to a whole country for other researchers, both anthropologist and non-anthropologist. Being cognisant of the consequence of one's research activities is particularly relevant when anthropologists consulting for governments, multi-national corporations, invading armies and the military do not prioritise the rights and interests of the local population and in cases where the ostensible aims of the intervention might reasonably be questioned by critical and reflective social scientists.

 

3) Open research: Anthropologists owe a responsibility to their colleagues around the world and to the discipline as a whole not to use their anthropological role as a cover for clandestine research or activities.

 

4) Legal and administrative constraints: Anthropologists should note that there may be a number of national laws or administrative regulations which may affect the conduct of their research, matters pertaining to data dissemination and storage, publication and rights of research subjects, sponsors and employers, etc They should also remember that, save in a very few exceptional circumstances, social research data are not privileged under law and may be subject to legal subpoena. Such laws vary by jurisdiction. Some which may have consequences for research and publication in the U.K. are, for example, the Data Protection Act, law of confidence, Race Relations Act, defamation laws, copyright law, law of contract, and the Official Secrets Act.

 

V. Responsibilities to the wider society

 

Anthropologists also have responsibilities towards other members of the public and wider society. They depend upon the confidence of the public and they should in their work attempt to promote and preserve such confidence without exaggerating the accuracy or explanatory power of their findings.

 

 1) Widening the scope of social research: Anthropologists should use the possibilities open to them to extend the scope of social inquiry and to communicate their findings for the benefit of the widest possible community. Anthropologists are most likely to avoid restrictions being placed on their work when they are able to stipulate in advance the issues over which they should maintain control; the greatest problems seem to emerge when such issues remain unresolved until the data are collected or the findings emerge.

 

2) Considering conflicting interests: Social inquiry is predicated on the belief that greater access to well-founded information will serve rather than threaten the interests of society/ies:

 

a) Nonetheless, in planning all phases of an inquiry, from design to presentation of findings, anthropologists should also consider the likely consequences for the wider society, groups within it, and possible future research, as well as for members of the research population not directly involved in the study as well as the immediate research participants;

 

b) That information can be misconstrued or misused is not in itself a convincing argument against its collection and dissemination. All information is subject to misuse and no information is devoid of possible harm to one interest or another. Individuals may be harmed by their participation in social inquiries, or group interests may be harmed by certain findings. Researchers are usually not in a position to prevent action based on their findings; but they should, attempt to pre-empt likely misinterpretations and to counteract them when they occur.

 

3) Maintaining professional and scholarly integrity: Research can never be entirely objective - the selection of topics may reflect a bias in favour of certain cultural or personal values, the employment base of the researcher, the source of funding and any of these other factors may impose certain priorities, obligations and prohibitions. But anthropologists should strive for impartiality and fair representation and be open about known barriers to its achievement:

 

a) Anthropologists should not engage or collude in selecting methods designed to produce misleading results or in misrepresenting findings, either by commission or omission;

 

b) When it is likely that research findings will bear upon public policy and opinion anthropologists should be careful to state any significant limitations on their findings and interpretations.

 

VI. Epilogue

 

The reputation of anthropological research will inevitably depend less on what professional bodies assert about their ethical norms than on the conduct of individual researchers. We recognise that ethical views and conclusions may legitimately differ, even when there is agreement about the facts of the case. The researcher thereby needs to reflect on their own position in the research and their research practices at all stages. These guidelines are aimed at helping anthropologists to reach an equitable and satisfactory resolution of their (potential) dilemmas. This statement of ideals does not impose a rigid set of rules backed by institutional sanctions, given the variations in both individuals' moral precepts and the conditions under which they work. Guidelines cannot resolve difficulties in a vacuum nor allocate greater priority to one of the principles than another. Instead, they are aimed at educating anthropologists, sensitizing them to the potential sources of ethical conflict and dilemmas that may arise in research, scholarship and professional practice, and at being informative and descriptive rather than authoritarian or prescriptive. They aim to ensure that where a departure from the principles is contemplated or where the privileging of one group or interested party or parties is deemed situationally or legally necessary, the researcher's decisions should be based on foresight and informed deliberation.

 

Just as the current document has been immeasurably enriched by comments and contributions from ASA members, we very much hope that ASA membership will continue to call attention to issues and resources relating to the ethical guidelines of anthropology for the purpose of debate and deliberation.

 

 VII. Acknowledgments

 

The amendments to the ASA Ethics Guidelines were drafted by the ASA Executive Committee Members during the period July 2010 – November 2011. The Committee members were James Fairhead, Raminder Kaur, Nayanika Mookherjee, James Staples, Catherine Degnen and Garry Marvin. The ASA Ethics Guidelines were last updated in 1999 and on receiving considerable feedback from the ASA members the need was felt to update and amend the Guidelines in the light of the changing disciplinary nature of anthropology. The first version of this draft amended Guidelines were sent to all ASA Members in February 2011. A large number of ASA members responded with comments and thanks to all for contributing to this process. At the ASA AGM held on 4th March 2011 it was decided that the recent amendments would be incorporated into the Ethics Guidelines and this second version of the draft guidelines will be finalised in due course in June 2011. Thereafter that version of the document was sent out to all ASA members for a final consultation process and all subsequent responses were received by end of July 2011 for them to be incorporated into the document. This version of the ASA Ethics Guidelines was proposed at an extraordinary AGM at the ASA 2011 conference in Lampeter, Wales on 15th September 2011. On 12th October 2011, the Executive committee approved this version of the Ethics Guidelines. The Committee considered all comments from the membership in formulating the final draft in October 2011. The Committee also gratefully acknowledges the use of some language from the codes of ethics of the American Anthropological Association. We hope to publish this version of the Ethics Guidelines on the ASA web site (http://www.theasa.org). Members are urged to bring to the attention of the ASA ethics officer (ethics(at)asa.org) any amendments that they would like to make to the ethics guidelines and suggested amendments can be added annually to the Guidelines as Addenda, on approval at the ASA AGM.

 The Y2004 Final Code

 

Developed and Drafted by the AACC Law and Ethics Committee

 

George Ohlschlager, Chairman

 

CONTENTS

PREFACE TO THE Y2004 FINAL CODE

 APPLICABILITY OF THE CODE

 INTRODUCTION AND MISSION

 BIBLICAL—ETHICAL FOUNDATIONS

ETHICAL STANDARDS

 I. Ethical Standards for Christian Counselors

II. Ethical Standards for Supervisors, Educators, Researchers, & Writers

 III. Standards and Exemptions for Ordained Ministers and Pastoral Counselors

 IV. Standards and Exemptions for Lay Helpers and Other Ministers

 V. Standards for Resolving Legal-Ethical Conflicts

 PROCEDURAL RULES

 VI. Authority, Jurisdiction, and Operation of the Law & Ethics Committee (LEC)

 VII. Procedures for the Adjudication of Complaints Against AACC Members

 VIII. Procedures Following Action by Churches, Courts, and Other Bodies

 FINAL ENCOURAGEMENT

 

 PREFACE TO THE Y2004 FINAL CODE

 

Welcome to the Y2004 final revision of the AACC Christian Counseling Code of Ethics (Code). This edition of the Code revises the 1998, 2000, 2001, and 2003 Provisional Codes, and supercedes those versions of the Code in their entirety. This is the Final Code version—the Code, with ‘Procedural Rules,’ in its completed form—which was first presented to the AACC membership at the 2003 AACC World Conference in Nashville, Tennessee.

 

With the publication of this Code on our web-site—www.aacc.net—we publicly present our ethics to our over 50,000 members in all 50 states and 50 other nations (as of Summer 2003). We also respectfully submit this document to the church and the helping professions, to the courts, legislatures, and licensure boards of America, to mental health and health-care organizations everywhere, and to the world-at-large.

 

This Code has already been adopted, in whole or in part, in nearly two dozen countries on every continent. It has been translated into Spanish, German, French, and Dutch languages. We at the AACC anticipate this Code becoming the basis of a worldwide statement of Christian counseling ethics and, as it spreads further internationally, the foundation of a 21st-century, global standard of Christian counseling care.

 

Work on this Code has been continuous for 10 years—since AACC created the Law and Ethics Committee in 1993. The primary mission given this group a decade ago was to construct and manage a new, Christ-centered, interdisciplinary code of ethics for Christian counseling as it matures into the 21st- century. This code begins to fulfill this mission.

 

Committee members, AACC leaders, and other colleagues who helped me develop, draft, and survive this project through 18 evolving drafts over ten years included: AACC President Tim Clinton, EdD; former president Gary Collins, PhD; Mark McMinn, PhD; Rosemarie Hughes, PhD; the late David Gatewood, MS; Peter Mosgofian, MA; W.L. Ryder, MD; Elizabeth York, MEd; Siang-Yang Tan, PhD; Chris Thurman, PhD; Ev Worthington, PhD; Tom Whiteman, PhD; Norm Wright, MA; Leigh Bishop, MD; Freda Crews, DMin, PhD; Gary Oliver, PhD; Bill Secor, PhD; Ron Hawkins, DMin, EdD; Diane Langberg, PhD; Michael Lyles, MD; and Archibald Hart, PhD.

 

The Holy Scriptures and the AACC Doctrinal Statement are foundational to this Code. Other ethics codes, in alphabetical order, that were consulted as we drafted this statement included those from the:

•  American Association of Marriage and Family Therapists (AAMFT), including portions of the California Association of Marriage and Family Therapists (CAMFT) 
•  American Association of Pastoral Counselors (AAPC) 
•  American Counseling Association (ACA), including the Association for Counselor Education and Supervision (ACES—ACA related), and the Association for Spiritual, Ethical, and Religious Values in Counseling (ASERVIC—also ACA related) 
• American Psychiatric Association (APiA) 
• American Psychological Association (APoA), including APoA General Guidelines for Providers of Psychological Services 
•  Christian Association for Psychological Studies (CAPS) 
• National Association of Social Workers (NASW), including NASW Standards for the Private Practice of Clinical Social Work 
• The Society of Professionals in Dispute Resolution (SPDR)

 

Furthermore, many writings influenced this Code, especially by Alister McGrath, on “Doctrine and Ethics,” and Alan Tjeltveit, on “Psychotherapy and Christian Ethics.” Some rules for procedure, for resolution of conflicted values, and the detail in this document was suggested by the legal profession’s Code of Professional Responsibility, and by selected court cases, mental health license statutes, and licensure board administrative rules from California, Virginia, Texas, Colorado, Florida, Minnesota, Washington, and New York.

 

This Code may be downloaded from the AACC web site, or purchased in paper form from AACC at a nominal cost. We continue to invite your feedback about this code (to George@AACC.net)—ideas and suggestions that will be considered for inclusion into future Code revisions. Also, we are developing a new section on the ethics of remote counseling—using the phone, the Internet, and doing in-home counseling—and a code specifically for lay helping ministry in the church. Your thoughts and comments here are also welcome. Thank you and may God bless your study and use of this new Code of Ethics

 

Sincerely,

George Ohlschlager, JD, LCSW

Chairman, AACC Law & Ethics Committee

 

APPLICABILITY OF THE CODE

 

All members of the AACC, the IACC (International Association of Christian Counselors), and Christian counselors everywhere are invited to fully adopt this AACC Code of Ethics (Code) in their work as Christian counselors, ministers, and helpers as soon as they are able. This Code may inform and enlighten all Christian counselors and ministers, but is not strictly enforceable toward non-AACC persons, nor upon AACC members in their private lives apart from professional-ministerial roles.

 

The Code will become a mandatory ethic for all AACC/IACC members who elect to become credential holders or members of either the American Board of Christian Counselors (ABCC) or the Christian Care Network (CCN).*

 

INTRODUCTION AND MISSION

 

The Code is designed to assist AACC members to better serve their clients and congregants and to improve the work of Christian counseling worldwide. It will help achieve the primary goals of the AACC—to bring honor to Jesus Christ and his church, promote excellence in Christian counseling, and bring unity to Christian counselors.

 

A New Code for an Emerging Profession

 

The Code is a comprehensive, detailed, and integrative synthesis of biblical, clinical, systemic, ethical, and legal information. It was created this way because vaguely worded, content limited, and overly generalized codes are insufficient for the complexities of the modern, 21st-century counseling environment. A more comprehensive and behavior-specific ethical code is needed for Christian counselors (and all mental health and ministerial professions, we believe) because of:

 

(1) the mounting evidence of questionable and incompetent practices among Christian counselors, including increasing complaints of client-parishioner harm;

 

(2) the largely unprotected legal status of Christian counseling, including the increasing state scrutiny, excessive litigation, and unrelenting legalization of professional ethics; and more positively

 

(3) the vitality and growing maturity of Christian counseling—including its many theories and controversies—indicating the need for an overarching ethical-legal template to guide the development of biblical and empirically sound Christian counseling models.

 

This Code—beyond defining the boundaries of unethical practice—affirmatively educates counselors in the direction of becoming helpers of ethical excellence, capable of more consistently securing the best counseling outcomes. This Code shows four streams of influence. These include (1) the Bible (both Old and New Testaments) and historic orthodox Christian theology;** (2) accepted standards of counseling and clinical practice from Christian counseling and the established mental health disciplines; (3) codes of ethics from other Christian and mental health professions; and (4) current and developing standards derived from mental health and ministry-related law. ____________________________________________

 

*NOTE 1. This code is adopted in its entirety by AACC affiliate organizations, the ABCC and the CCN. All ABCC and CCN members will be required to mandatory adherence to this code.

 

** NOTE 2. Although rooted primarily in an orthodox evangelical biblical theology, this Code is also influenced (according to the paradigm offered by Richard Foster) by the social justice, charismatic-pentecostal, pietistic-holiness, liturgical, and contemplative traditions of Christian theology and church history.

 

Mission, Uses, and Limits of the Code

 

The mission of this Code is to

 

(1) help advance the central mission of the AACC—to bring honor to Jesus Christ and promote excellence and unity in Christian counseling;

 

(2) promote the welfare and protect the dignity and fundamental rights of all individuals, families, groups, churches, schools, agencies, ministries, and other organizations with whom Christian counselors work;

 

(3) provide standards of ethical conduct in Christian counseling that are to be advocated and applied by the AACC (and ABCC and CCN) and that can be respected by other professionals and institutions.

 

This Code defines biblically based values and universal behavioral standards for ethical Christian counseling. We intend this Code to become a core document by which Christian counselors, clients, and the church oversee and evaluate Christian counselors and counseling values, goals, process, and effectiveness. Furthermore, the Code asserts a Christian counseling standard of care that invites respect and application by the courts, the regulatory bodies of church and state, insurance and managed care groups, other professions, and by society.

 

This Code should be seen as normative but non-exhaustive. It provides a common definition of practice, but does not presume to be a complete picture of Christian counseling nor does it necessarily cover all ethical issues. This Code outlines a foundation of preferred values and agreed professional behavior upon which Christian counselors can shape their identity and build their work. It defines standards upon which practice diversity is acknowledged and encouraged as well as the limits beyond which practice deviance is not allowed.

 

The Code is aspirational throughout the AACC and enforceable in ABCC and CCN. It consists of four major parts—Introduction and Mission, Biblical-Ethical Foundations, Ethical Standards, and Procedural Rules (which are being developed). It aspires to define, in the mission and the biblical-ethical foundations statements, the best ideals and goals of Christian counseling. The ethical standards and procedural rules are the codes of individual practice and organizational behavior that are to guide the membership of the AACC. The mission and foundations statements are to be consulted in working out the problems and dilemmas of ethics application and procedural rules interpretation.

 

Concerning language, we have endeavored to avoid pedantic, legalese, and sexist language, but we also avoid a radical inclusivism that de-sexes the name of God. Unless denoted, we use the term "client" to refer to clients, patients, congregants, parishioners, or helpees. "Counseling" is usually a generic reference to clinical, psychiatric, pastoral, and lay helping.

 

Grace for the Task Ahead

 

This is a dynamic Code, one that will anchor the mission of the AACC and retain some elements without change, but one that will also live and grow with the life and growth of the Association and its membership. The Code calls us to a life-long commitment to ethical and excellent service; it challenges us to encourage ethical behavior in our colleagues, churches, organizations, and communities. May God give us the grace to own it professionally, the strength to live it honorably, and the hope to see it as a foundation of common identity and corporate unity.

 

BIBLICAL-ETHICAL FOUNDATIONS OF THE AACC ETHICS CODE+

 

1st FOUNDATION: Jesus Christ—and His revelation in the Old and New Testaments of the Bible—is the pre-eminent model for Christian counseling practice, ethics, and caregiving activities.

 

2nd FOUNDATION: Christian counseling maintains a committed, intimate, and dedicated relationship with the worldwide church, and individual counselors with a local body of believers.

 

3rd FOUNDATION: Christian counseling, at its best, is a Spirit-led process of change and growth, geared to help others mature in Christ by the skillful synthesis of counselor-assisted spiritual, psycho-social, familial, bio-medical, and environmental interventions.

 

4th FOUNDATION: Christian counselors are dedicated to Jesus Christ as their ‘first love,’ to excellence in client service, to ethical integrity in practice, and to respect for everyone encountered.

 

5th FOUNDATION: Christian counselors accord the highest respect to the Biblical revelation regarding the defense of human life, the dignity of human personhood, and the sanctity of marriage and family life.

 

6th FOUNDATION: The biblical and constitutional rights to Religious Freedom, Free Speech, and Free Association protects Christian counselor public identity, and the explicit incorporation of spiritual practices into all forms of counseling and intervention.

 

7th FOUNDATION: Christian counselors are mindful of their representation of Christ and his church and are dedicated to honor their commitments and obligations in all social and professional relations.

____________________________________________

 

+ NOTE 4. This statement of “biblical-ethical foundations” is not a doctrinal statement, nor is it intended to substitute for one. The AACC Doctrinal Statement is a separate standard that reflects the baseline religious beliefs and biblical commitments of AACC members. However, it is true that these seven foundation statements are implicitly rooted in the AACC doctrinal statement. Furthermore, combined with the Scriptures, the AACC doctrinal statement, and the statement of “Introduction and Mission” to this code, this section stands as the baseline ethics policy that will ground this code, assist the search for clear meaning and common interpretation, and guide the resolution of disputed applications of ethical standards and procedural rules.

 

ETHICAL STANDARDS

 

I. ETHICAL STANDARDS FOR CHRISTIAN COUNSELORS

 

ES1-100 First, Do No Harm

 

Christian counselors acknowledge that the first rule of professional-ministerial ethical conduct is: do no harm to those served.

 

1-101 Affirming the God-given Dignity of All Persons

Affirmatively, Christian counselors recognize and uphold the inherent, God-given dignity of every human person, from the pre-born to those on death’s bed. Human beings are God’s creation—in fact, the crown of His creation—and are therefore due all the rights and respect and ordered logic that this fact of creation entails.

Therefore, regardless of how we respond to and challenge harmful attitudes and actions, Christian counselors will express a loving care to any client, service-inquiring person, or anyone encountered in the course of practice or ministry, without regard to race, ethnicity, gender, sexual behavior or orientation, socio-economic status, education, denomination, belief system, values, or political affiliation. God’s love is unconditional and, at this level of concern, so must that of the Christian counselor.

 

1-102 No Harm or Exploitation Allowed

Prohibitively, then, Christian counselors avoid every manner of harm, exploitation, and unjust discrimination in all client-congregant relations. Christian counselors are also aware of their psychosocial and spiritual influence and the inherent power imbalance of helping relationships—power dynamics that can harm others even without harmful intent.

 

1-110 Avoidance of Client Harm, Intended or Not

Christian counselors strictly avoid all behavior or suggestion of practice that harms or reasonably could harm clients, client families, client social systems and representatives, students, trainees, supervisees, employees, colleagues, and third-party payors and authorizers.

 

1-111 Managing Client Conflicts

Christian counselors acknowledge that client conflicts are unavoidable. In fact, conflict and resistance are often a central dynamic of the helping process. We will attempt to resolve all counseling conflicts in the client's best interest. Counselors tempted to respond in harmful ways to clients shall seek out consultative and restorative help. If self-control is not accomplished—and client harm is not avoided—counselors shall terminate counseling relations and make referral in the client's best interest.

 

1-112 Action Regarding Clients Harmed by Other Helpers

Christian counselors take proper action against the harmful behavior of other counselors and pastors. We will act assertively to challenge or expose those who exploit others, and protect clients against harm wherever it is found, taking care to honor and support client decision-making regarding curative action against violators.

 

1-113 Managing Problems with Managed Care

Managed care has greatly expanded its influence in health and mental health service delivery. Widespread problems in client-provider-managed care relations are now being reported: breach of confidentiality, client abandonment, failure to maintain continuity of care, incompetent care, restriction of therapist choice and access, and even infliction of emotional distress. Christian counselors acknowledge these legal-ethical problems, and will avoid and work to correct any unethical entanglement and unintended client harm due to managed care relations.

 

1-120 Refusal to Participate in the Harmful Actions of Clients

Christian counselors refuse to condone, advocate for, or assist the harmful actions of clients, especially those that imperil human life from conception to death. We agree that the protection of human life is always a priority value in any professional or ministerial intervention. We will not abandon clients who do or intend harm, will terminate helping relations only in the most compelling circumstances, and will continue to serve clients in these troubles so far as it is humanly possible.

 

1-121 Application to Deadly and Threatening Behavior

Christian counselors refuse to condone, advocate for, or assist the suicidal, homicidal, or assaultive/abusive harm done to self or others by clients, including that which is threatened by verbal or other means. In fact, we are under an affirmative ethical duty to prudently intervene for the sake of protecting life, and under certain conditions, to report deadly threats to the proper authorities and those threatened by clients (see Code sections 1-430ff).

 

1-122 Application to Substance Abuse and Other Addictions

Christian counselors refuse to condone, advocate for, or assist substance abuse or other addictions and addictive behaviors by clients. We recognize and accept the distinction between drug dependence and addiction, and may support or assist clients in the use of necessary drugs—even those from which dependencies may develop for limited periods of time—when medically justified and under a physician’s supervision.

 

1-123 Application to Abortion

Christian counselors refuse to condone or advocate for abortion and the abortion-related activities of clients. All counselors will consider and inform clients of alternative means to abortion and, as far as it is possible, will continue to serve clients and work compassionately with them through the abortion crisis.

 

1-124 Application to Divorce

Christian counselors refuse to assume the decision for client divorce. We may assist clients in analyzing and making the decision to divorce, insofar as it is biblically permissible, as God does allow for divorce in some cases. Therefore, we may assist clients through the divorce process without being a divorce advocate, as that divorce decision must always reside in and be owned by the client. Christian counselors working in divorce mediation will be careful to communicate that such work is not an endorsement of divorce, but rather a decision to offer a better choice than adversarial litigation and its destructive family impact when divorce is inevitable.

 

1-125 Application to Premarital and Extramarital Sexual Behavior

Christian counselors refuse to condone or advocate for the pursuit of or active involvement in pre-marital and extra-marital sexual behavior by clients—promoting an affair is never proper counsel as a solution to marital problems. We acknowledge that sex is God’s good creation and a delightful gift when confined to one man and one woman in marriage. We may agree to and support the wish to work out issues of sexual behavior, identity, and attractions, but will encourage sexual celibacy or biblically proscribed sexual behavior while such issues are being addressed.

 

1-126 Application to Homosexual and Transgendered Behavior

Christian counselors refuse to condone or advocate for the pursuit of or active involvement in homosexual, transgendered, and cross-dressing behavior, and in the adoption gay & lesbian & transgendered lifestyles by clients. We may agree to and support the wish to work out issues of homosexual and transgendered identity and attractions, but will refuse to describe or reduce human identity and nature to sexual reference or orientation, and will encourage sexual celibacy or biblically proscribed sexual behavior while such issues are being addressed.

Christian counselors differ, on biblical, ethical, and legal grounds, with groups who abhor and condemn reparative therapy, willingly offering it to those who come into counseling with a genuine desire to be set free of homosexual attractions and leave homosexual behavior and lifestyles behind. Either goal of heterosexual relations and marriage or lifelong sexual celibacy is legitimate and a function of client choice in reparative therapy. It is acknowledged that some persons engaged in same-sex change or reparative therapy will be able to change and become free of all homo-erotic behavior and attraction, some will change but will still struggle with homosexual attraction from time to time, and some will not change away from homosexual practices.

 

1-127 Application to Euthanasia and Assisted Suicide

Christian counselors refuse to condone or advocate for active forms of euthanasia and assisted suicide. We may agree to and support the wish not to prolong life by artificial means, and will often advocate for hospice care, more effective application of medicine, and other reasonable means to reduce pain and suffering.

Regarding patients or clients who wish to die, we will not deliver, nor advocate for, nor support the use of drugs or devices to be utilized for the purpose of ending a patient’s life. We recognize that the death of a patient may occur as the unintended and secondary result of aggressive action to alleviate a terminally ill patient’s extreme pain and suffering.

So long as there are no other reasonable methods to alleviate such pain and suffering, the Christian counselor is free to support, advocate for, and participate in such aggressive pain management in accordance with sound medical practice, and with the informed consent of the patient or the patient’s authorized representative.

 

1-130 Sexual Misconduct Forbidden

All forms of sexual misconduct in pastoral, professional, or lay relationships are unethical. This includes every kind of sexual exploitation, deception, manipulation, abuse, harassment, relations where the sexual involvement is invited, and relations where informed consent presumably exists. Due to the inherent power imbalance of helping relationships and the immoral nature of sexual behavior outside of marriage, such apparent consent is illusory and illegitimate.

Forbidden sexual activities and deceptions include, but are not limited to, direct sexual touch or contact; seductive sexual speech or non-verbal behavior; solicitation of sexual or romantic relations; erotic contact or behavior as a response to the sexual invitation or seductive behavior of clients; unnecessary questioning and/or excessive probing into the client's sexual history and practices; inappropriate counselor disclosures of client attractiveness, sexual opinions, or sexual humor; advocacy of the healing value of counselor-client sexual relations; secretive sexual communications and anonymous virtual interaction via the Internet or other electronic and informational means; sexual harassment by comments, touch, or promises/threats of special action; and sexual misconduct as defined by all applicable laws, ethics, and church, organizational, or practice policies.

 

1-131 Sexual Relations with Former Clients Forbidden

All sexual relations as defined in 1-130 above with former clients are unethical. Furthermore, we do not terminate and refer clients or parishioners, even at first contact, in order to pursue sexual or romantic relations.

 

1-132 Counseling with Marital/Sexual Partners

Christian counselors do not counsel, but make appropriate referral, with current or former sexual and/or marital partners.

 

1-133 Marriage with Former Clients/Patients

Since marriage is honorable before God, the lone exception to this rule against marriage to a former client, is a case anticipating marriage, so long as (1) counseling relations were properly terminated, and not for the purpose of pursuing marriage or romantic relations, (2) the client is fully informed that any further counseling must be done by another, (3) there is no harm or exploitation of the client or the client’s family as a result of different relations with the counselor, and (4) the marriage takes place two years or more after the conclusion of a counseling or helping relationship.

 

 

1-140 Dual and Multiple Relationships

Dual relationships involve the breakdown of proper professional or ministerial boundaries. A dual relationship is where two or more roles are mixed in a manner that can harm the counseling relationship. Examples include counseling plus personal, fraternal, business, financial, or sexual and romantic relations. Some dual relationships are not unethical—it is client exploitation that is wrong, not the dual relationship itself. Based on an absolute application that harms membership bonds in the Body of Christ, we oppose the ethical-legal view that all dual relationships are per se harmful and therefore invalid on their face. Many dual relations are wrong and indefensible, but some dual relationships are worthwhile and defensible (per section 1-142 below).

 

1-141 The Rule of Dual Relationships

While in therapy, or when counseling relations are imminent, or for an appropriate time after termination of counseling, Christian counselors do not engage in dual relations with counselees. Some dual relationships are always avoided—sexual or romantic relations, and counseling close friends, family members, employees, or supervisees. Other dual relationships should be presumed troublesome and avoided wherever possible. 1-142 Proving an Exception to the Rule The Christian counselor has the burden of proving a justified dual relationship by showing (1) informed consent, including discussion of how the counseling relationship might be harmed as other relations proceed, and (2) lack of harm or exploitation to the client. As a general rule, all close relations are unethical if they become counselor-client or formal lay helping relations. Dual relations may be allowable, requiring justification by the foregoing rule, if the client is an arms-length acquaintance—if the relationship is not a close one. This distinction is crucial in the applications below.

 

1-143 Counseling with Family, Friends, and Acquaintances

Christian counselors do not provide counseling to close family or friends. We presume that dual relations with other family members, acquaintances, and fraternal, club, association, or group members are potentially troublesome and best avoided, otherwise requiring justification.

 

1-144 Business and Economic Relations

Christian counselors avoid partnerships, employment relations, and close business associations with clients. Barter relations are normally avoided as potentially troublesome, and require justification; therefore if done, barter is a rare and not a common occurrence. Unless justified by compelling necessity, customer relations with clients are normally avoided.

 

1-145 Counseling with Fellow Church Members

Christian counselors do not provide counseling to fellow church members with whom they have close personal, business, or shared ministry relations. We presume that dual relations with any other church members who are clients are potentially troublesome and best avoided, otherwise requiring justification. Pastors and church staff helpers will take all reasonable precautions to limit the adverse impact of any dual relationships.

 

1-146 Termination to Engage in Dual Relations Prohibited

Christian counselors do not terminate counseling to engage in dual relationships of any kind. Some counselors and their former clients will agree that any future counseling will be done by someone else if, after legitimate termination, they decide to pursue another form of relationship.

 

ES1-200 Competence in Christian Counseling

 

1-210 Honoring the Call to Competent Christian Counseling

Christian counselors maintain the highest standards of competence with integrity. We know and respect the boundaries of competence in ourselves and others, especially those under our supervision. We make only truthful, realistic statements about our identity, education, experience, credentials, and about counseling goals and process, avoiding exaggerated and sensational claims. We do not offer services or work beyond the limits of our competence and do not aid or abet the work of Christian counseling by untrained, unqualified, or unethical helpers.

 

1-220 Duties to Consult and/or Refer

Christian counselors consult with and/or refer to more competent colleagues or supervisors when these limits of counseling competence are reached: (1) when facing issues not dealt with before or not experienced in handling, (2) when clients need further help outside the scope of our training and practice, (3) when either counselor or clients are feeling stuck or confused about counseling and neither is clear what to do about it, or (4) when counselees are deteriorating or making no realistic gain over a number of sessions. Christian counselors shall honor the client's goals and confidential privacy interests in all consultations and referrals.

 

1-221 Consultation Practice

When counseling help is needed, and with client consent, consultation may be attempted first, when in the client's best interest and to improve helper's knowledge and skill where some competence exists. Counselors shall take all reasonable action to apply consultative help to the case in order to gain/maintain ground toward client objectives. The consultant shall maintain a balanced concern for the client discussed and the practice/education needs of the consultee, directing the counselor-consultee to further training or special resources, if needed.

 

1-222 Referral Practice

Referral shall be made in situations where client need is beyond the counselor's ability or scope of practice or when consultation is inappropriate, unavailable, or unsuccessful. Referrals should be done only after the client is provided with informed choices among referral sources. As much as possible, counselors referred to shall honor prior commitments between client and referring counselor or church.

 

1-223 Seek Christian Help,

If Available When consulting or referring, Christian counselors seek out the best Christian help at a higher level of knowledge, skill, and expertise. If Christian help is not available, or when professional skill is more important than the professional's beliefs, Christian counselors shall use the entire network of professional services available.

 

1-224 Avoid Counsel Against Professional Treatment

Christian counselors do not counsel or advice against professional counseling, medical or psychiatric treatment, the use of medications, legal counsel, or other forms of professional service merely because we believe such practice is per se wrong or because the provider may not be a Christian.

 

1-230 Duties to Study and Maintain Expertise

Christian counselors keep abreast of and, whenever possible, contribute to new knowledge, issues, and resources in Christian counseling and our respective fields. We maintain an active program of study, continuing education, and personal/professional growth to improve helping effectiveness and ethical practice. We seek out specialized training, supervision, and/or advanced certification if we choose to gain expertise and before we practice and advertise in recognized specialty areas of counseling and clinical practice.

 

1-240 Maintaining Integrity in Work, Reports, and Relationships

Christian counselors maintain the highest standards of integrity in all their work, in professional reports, and in all professional relationships. We delegate to employees, supervisees, and other subordinates only that work these persons can competently perform, meeting the client's best interest and done with appropriate supervision.

 

1-250 Protective Action When Personal Problems Interfere

Christian counselors acknowledge that sin, illnesses, mental disorders, interpersonal crises, distress, and self-deception still influence us personally—and that these problems can adversely affect our clients and parishioners. When personal problems flare to a level that harm to one's clients is realized or is highly likely, the Christian counselor will refrain from or reduce those particular professional-ministerial activities that are or could be harmful. During such times, the counselor will seek out and use those reparative resources that will allow for problem resolution and a return to a fully functioning ministry, if possible.

 

ES1-300 Informed Consent in Christian Counseling

 

1-310 Securing Informed Consent

Christian counselors secure client consent for all counseling and related services. This includes the video/audio-taping of client sessions, the use of supervisory and consultative help, the application of special procedures and evaluations, and the communication of client data with other professionals and institutions. Christian counselors take care that (1) the client has the capacity to give consent; (2) we have discussed counseling together and the client reasonably understands the nature and process of counseling; the costs, time, and work required; the limits of counseling; and any appropriate alternatives; and (3) the client freely gives consent to counseling, without coercion or undue influence.

 

1-320 Consent for the Structure and Process of Counseling

Christian counselors respect the need for informed consent regarding the structure and process of counseling. Early in counseling, counselor and client should discuss and agree upon these issues: the nature of and course of therapy; client issues and goals; potential problems and reasonable alternatives to counseling; counselor status and credentials; confidentiality and its limits; fees and financial procedures; limitations about time and access to the counselor, including directions in emergency situations; and procedures for resolution of disputes and misunderstandings. If the counselor is supervised, that fact shall be disclosed and the supervisor's name and role indicated to the client.

 

1-321 Consent from Parent or Client Representative

Christian counselors obtain consent from parents or the client's legally authorized representative when clients are minors or adults who are legally incapable of giving consent.

 

1-322 Documentation of Consent

Christian counselors will document client consent in writing by professional service contract or consent form, the standard now required in most professional therapy relations, or by case note at the very least. 1-330 Consent for Biblical-Spiritual Practices in Counseling Christian counselors do not presume that all clients want or will be receptive to explicit spiritual interventions in counseling. We obtain consent that honors client choice, receptivity to these practices, and the timing and manner in which these things are introduced: prayer for and with clients, Bible reading and reference, spiritual meditation, the use of biblical and religious imagery, assistance with spiritual formation and discipline, and other common spiritual practices.

 

1-331 Special Consent for More Difficult Interventions

Close or special consent is obtained for more difficult and controversial practices. These include, but are not limited to: deliverance and spiritual warfare activities; cult de-programming work; recovering memories and treatment of past abuse or trauma; use of hypnosis and any kind of induction of altered states; authorizing (by MDs) medications, electro-convulsive therapy, or patient restraints; use of aversive, involuntary, or experimental therapies; engaging in reparative therapy with homosexual persons; and counseling around abortion and end-of-life issues. These interventions require a more detailed discussion with patient-clients or client representatives of the procedures, risks, and treatment alternatives, and we secure detailed written agreement for the procedure.

 

ES1-400 Confidentiality, Privacy, and Privileged Communication

 

1-410 Maintaining Client Confidentiality

Christian counselors maintain client confidentiality to the fullest extent allowed by law, professional ethics, and church or organizational rules. Confidential client communications include all verbal, written, telephonic, audio or videotaped, or electronic communications arising within the helping relationship. Apart from the exceptions below, Christian counselors shall not disclose confidential client communications without first discussing the intended disclosure and securing written consent from the client or client representative.

 

1-411 Discussing the Limits of Confidentiality and Privilege

Clients should be informed about both the counselor's commitment to confidentiality and its limits before engaging in counseling. Christian counselors avoid stating or implying that confidentiality is guaranteed or absolute. We will discuss the limits of confidentiality and privacy with clients at the outset of counseling.

 

1-420 Asserting Confidentiality or Privilege Following Demands for Disclosure

Protecting confidential communications, including the assertion of privilege in the face of legal or court demands, shall be the first response of counselors to demands or requests for client communications and records.

 

1-421 Disclosure of Confidential Client Communications

Christian counselors disclose only that client information they have written permission from the client to disclose or that which is required by legal or ethical mandates. The counselor shall maintain confidentiality of client information outside the bounds of that narrowly required to fulfill the disclosure and shall limit disclosures only to those people having a direct professional interest in the case. In the face of a subpoena, counselors shall neither deny nor immediately comply with disclosure demands, but will assert privilege in order to give the client time to consult with a lawyer to direct disclosures.

 

1-430 Protecting Persons from Deadly Harm: The Rule of Mandatory Disclosure

Christian counselors accept the limits of confidentiality when human life is imperiled or abused. We will take appropriate action, including necessary disclosures of confidential information, to protect life in the face of client threats of suicide, homicide, and/or the abuse of children, elders, and dependent persons.

 

1-431 The Duty to Protect Others

The duty to take protective action is triggered when the counselor (1) has reasonable suspicion, as stated in your state statute, that a minor child (under 18 years), elder person (65 years and older), or dependent adult (regardless of age) has been harmed by the client; or (2) has direct client admissions of serious and imminent suicidal threats; or (3) has direct client admissions of harmful acts or threatened action that is serious, imminent, and attainable against a clearly identified third person or group of persons.

 

1-432 Guidelines to Ethical Disclosure and Protective Action

Action to protect life, whether you’re a client or a third-person, shall be that which is reasonably necessary to stop or forestall deadly or harmful action in the present situation. This could involve hospitalizing the client, intensifying clinical intervention to the degree necessary to reasonably protect against harmful action, consultation and referral with other professionals, or disclosure of harm or threats to law enforcement, protective services, identifiable third-persons, and/or family members able to help with protective action.

 

1-433 Special Guidelines When Violence is Threatened Against Others

Action to protect third persons from client violence may involve or, in states that have a third-person protection (Tarasoff) duty, require disclosure of imminent harm to the intended victim, to their family or close friends, and to law enforcement. When child abuse or elder abuse or abuse of dependent adults exists, as defined by state law, Christian counselors shall report to child or elder protective services, or to any designated agency established for protective services. We shall also attempt to defuse the situation and/or take preventive action by whatever means are available and appropriate.

When clients threaten serious and imminent homicide or violence against an identifiable third-person, the Christian counselor shall inform appropriate law enforcement, and/or medical-crisis personnel, and the at-risk person or close family member of the threat, except when precluded by compelling circumstances or by state law.

When the client threat is serious but not imminent, the Christian counselor shall take preventive clinical action that seeks to forestall any further escalation of threat toward violent behavior.

 

1-440 Disclosures in Cases of Third-party Payment and Managed Care

Christian counselors are diligent to protect client confidences in relations with insurance and third party payors, employee assistance programs, and managed care groups. We are cautious about demands for confidential client information that exceed the need for validation of services rendered or continued care. We do not disclose or submit session notes and details of client admissions solely on demand of third-party payors. We will narrowly disclose information that the client has given written authorization only after we have discussed and are assured that the client understands the full implications of authorizations signed or contemplated to sign.

 

1-450 Disclosures for Supervision, Consultation, Teaching, Preaching, and Publication

Christian counselors do not disclose confidential client communications in any supervisory, consultation, teaching, preaching, publishing, or other activity without written or other legal authorization by the client. Counselors under supervision will disclose that fact to their clients. We will adequately disguise client identifiers by various means when presenting cases in group or in public forums. We will not presume that disguise alone is sufficient client protection, but will consider seeking client authorization when client identity is hard to conceal.

 

1-460 Maintaining Privacy and Preserving Written Records

Christian counselors will preserve, store, and transfer written records of client communications in a way that protects client confidentiality and privacy rights. This requires, at minimum, keeping records files in locked storage with access given only to those persons with a direct professional interest in the materials.

 

1-461 Maintaining Privacy in Electronic Databases

Christian counselors take special precautions to protect client privacy rights with records stored and transferred by electronic means. This requires, at minimum, use of password entry into all electronic client files and/or coded files that do not use client names or easy identifiers. Client information transferred electronically—FAX, E-mail, or other computerized network transfer—shall be done only after the counselor determines that the process of transmission and reception of data is reasonably protected from interception and unauthorized disclosures.

 

1-470 Advocacy for Privacy Rights Against Intrusive Powers

Christian counselors hear the most private and sensitive details of client lives—information that must be zealously guarded from public disclosure. Rapidly expanding and interlocking electronic information networks are increasingly threatening client privacy rights. Though federal and state laws exist to protect client privacy, these laws are weak, are routinely violated at many levels, and the record of privacy right enforcement is dismal. Accordingly, Christian counselors are called to wisely protect and assertively advocate for privacy protection on behalf of our clients against the pervasive intrusion of personal, corporate, governmental, even religious powers.

 

ES1-500 Ethical Practice in Christian Counseling and Evaluation

 

1-510 Fees and Financial Relationships in Christian Counseling

Professional Christian counselors will set fees for services that are fair and reasonable, according to the services contracted and time performed, and with due regard for the client's ability to pay. We avoid all deception, confusion, and misrepresentation about fees and in our financial relationships with clients and client systems.

 

1-511 Disclosure of Fees and Payment History

Fee schedules and rules for payment shall be outlined clearly for client review at the outset of counseling. Moreover, agreement about fees and payment schedules will be made as early as possible in the course of professional relations. We will provide clients or their representatives with a full and accurate account of previous and current charges upon request.

 

1-512 Sliding Fee Scales Encouraged

Christian counselors are free, within the bounds of biblical, professional, and community standards, to set their own fees. Clinicians are encouraged, however, to use sliding fee schedules, scaled to client's ability to pay, and other reduced payment methods to increase counseling accessibility to those of lesser financial means.

 

1-513 Pro Bono Work

Christian counselors are encouraged, beyond their fee schedule, to make a portion of their time and services available without cost or at a greatly reduced fee to those unable to pay.

 

1-514 Avoiding Self-serving Financial Relations

Christian counselors avoid financial practices that result or appear to result in greedy and self-serving outcomes. We do not select clients or prolong therapy based on their ability to pay high fees, nor do we quickly terminate counseling with low-fee clients. When making referrals, we do not divide fees with other professionals nor accept or give anything of value for making the referral. We do not exaggerate problems nor refer exclusively for specialized services to get clients into special programs or institutions in which we have a proprietary interest.

 

1-515 Financial Integrity with Insurance and Third-party Payors

Christian counselors maintain financial integrity with client insurers and other third-party payors. We do not charge third-party payors for services not rendered, nor for missed or cancelled appointments, unless specially authorized to do so. We do not distort or change diagnoses to fit restricted reimbursement categories. Any special benefits or reductions in client fees must also be extended in full to third-party payors.

 

1-520 Case notes and Proper Record-keeping

Christian counselors maintain appropriate documentation of their counseling activities, adequate for competent recall of prior sessions and the provision of later services by oneself or others. Records used in legal and other official capacities will show the quality, detail, objectivity, and timeliness of production expected by professionals who practice in these arenas.

 

1-521 Records Maintenance and Ownership

Records of professional activities will be created, maintained, stored, and disposed of in accordance with the law and the ethical duties of the counselor, especially maintaining client confidentiality. Ordinarily, client records belong to the employing organization or to the therapist in a private or group practice. However, in view of the expanding right of client record access and the ethic of continuity of care, clients’ records should follow the client. Therefore, in any dispute about record access or ownership at the termination of professional employment, the records will stay with the employer if the therapist is leaving the area and his or her clients, or they should go with the therapist if he or she is staying in the area and the clients are staying with the therapist.

 

1-530 Ethics in Testing, Assessment, and Clinical Evaluation

Christian counselors do clinical evaluations of clients only in the context of professional relations, in the best interests of clients, and with the proper training and supervision. Christian counselors avoid (1) incompetent and inaccurate evaluations, (2) clinically unnecessary and excessively expensive testing, and (3) unauthorized practice of testing and evaluation that is the province of another clinical or counseling discipline. Referral and consultation are used when evaluation is desired or necessary beyond the competence and/or role of the counselor.

 

1-531 Use of Appropriate Assessments

Christian counselors use tests and assessment techniques that are appropriate to the needs, resources, capabilities, and understanding of the client. We apply tests skillfully and administer tests properly and safely. We substantiate our findings, with knowledge of the reliability, validity, outcome results, and limits of the tests used. We avoid both the misuse of testing procedures and the creation of confusion or misunderstanding by clients about testing purposes, procedures, and findings.

 

1-532 Reporting and Interpreting Assessment Results

Christian counselors report testing results in a fair, understandable, and objective manner. We avoid undue testing bias and honor the limits of test results, ensuring verifiable means to substantiate conclusions and recommendations. We recognize the limits of test interpretation, and avoid exaggeration and absolute statements about the certainty of client diagnoses, behavior predictions, clinical judgments, and recommendations. Due regard is given to the unique history, values, family dynamics, sociocultural influences, economic realities, and spiritual maturity of the client. Christian counselors will state any and all reservations about the validity of test results and present reports and recommendations in tentative language and with alternative possibilities.

 

1-540 Working with Couples, Families, and Groups

Christian counselors often work with multiple persons in session—marriage couples, families or parts of families, and small groups—and should know when these forms of counseling are preferred over or used as an adjunct to individual counseling. In these relationships we will identify a primary client—the group as a unit or the individual members—and will discuss with our client(s) how our differing roles, counseling goals, and confidentiality and consent issues are affected by these dynamics.

 

1-541 Safety and Integrity in Family and Group Counseling

Christian counselors will maintain their role as fair, unbiased, and effective helpers in all marital, family, and group work. We will remain accessible to all persons, avoiding enmeshed alliances and taking sides unjustly. As group or family counseling leaders, Christian counselors respect the boundary between constructive confrontation and verbal abuse, and will take reasonable precautions to protect client members from any physical, psychological, or verbal abuse from other members of a family or group.

 

1-542 Confidentiality in Family and Group Counseling (see also ES1-400)

Christian counselors do not promise or guarantee confidentiality in family and group counseling, but rather explain the problems and limits of keeping confidences in these modes of therapy. We communicate the importance of confidentiality and encourage family or group members to honor it, including discussion of consequences for its breach. Christian counselors do not share confidences by one family or group member to others without permission or prior agreement, unless maintaining the secret will likely lead to grave and serious harm to a family member or someone else.

 

1-543 Avoiding and Resolving Role Conflicts

If/when Christian counselors are asked to perform conflicting roles with possible unethical consequences (i.e.: pressure to keep "secrets" or called to testify as an adverse witness in a client's divorce), we will clarify our therapeutic, neutral, and mediative role and/or decline to serve in a conflicted capacity, if possible. Some counselors will contract for professional neutrality at the beginning of professional relations, securing client agreement not to have oneself or one's records subpoenaed or deposed in any legal proceeding.

 

1-550 Working with Persons of Different Faiths, Religions, and Values

Christian counselors do not withhold services to anyone of a different faith, religion, denomination, or value system. We work to understand the client's belief system and always maintain respect for the client. We strive to understand when faith and values issues are important to the client and foster values-informed client decision-making in counseling. We share our own faith only as a function of legitimate self-disclosure and when appropriate to client need, always maintaining a humility that exposes and never imposes the way of Christ.

 

1-551 Action if Value Differences Interfere with Counseling

Christian counselor work to resolve problems—always in the client's best interest—when differences between counselor and client values becomes too great, adversely affecting counseling. This may include discussion of the issue as a therapeutic matter, renegotiation of the counseling agreement, consultation with a supervisor or trusted colleague or, as a last resort, referral to another counselor if the differences cannot be reduced or bridged.

 

1-560 Continuity of Care and Service Interruption

Christian counselors maintain continuity of care for all patients and clients. We avoid interruptions in service to clients that are too lengthy or disruptive. Care is taken to refer clients and network to provide emergency services when faced with counselor vacations, illnesses, job changes, financial hardships, or any other reason services are interrupted or limited. 1-570 Avoiding Abandonment and Improper Counseling Termination Christian counselors do not abandon clients. To the extent the counselor is able, client services are never abruptly cut-off or ended without giving notice and adequately preparing the client for termination or referral.

 

1-571 Ethical Termination of Counseling

Discussion and action toward counseling termination and/or referral is indicated when (1) counseling goals have been achieved; (2) when the client no longer wants or does not return to counseling; (3) when the client is no longer benefiting from counseling; or (4) when counseling is harmful to the client. Christian counselors shall discuss termination and/or referral with clients, offer referral if wanted or appropriate, and facilitate termination in the client's best interest. If crisis events alter, even end counseling prematurely the counselor, if it is safe and proper, should follow-through with the client to ensure proper termination and referral.

 

ES1-600 Ethical Relations in the Professional Workplace

 

1-610 Honorable Relations Between Professional and Ministerial Colleagues

Christian counselors respect professional and ministerial colleagues, both within and outside the church. We strive to understand and, wherever able, respect differing approaches to counseling. We strive to maintain collaborative and constructive relations with other professionals serving our client, in the client's best interest.

 

1-611 Solicitation of Clients Under Another’s Care

Christian counselors do not solicit clients nor do we knowingly offer professional services to those under the care of another mental health professional or pastor, except with that provider's knowledge, or when someone is in crisis. When approached by clients being served by other counselors, due regard will be given that relationship with a commitment to encourage client resolution with the other counselor before starting professional relations.

 

1-612 Maintaining Honor Toward Others When in Conflict

If a counselor learns that a current client is receiving therapy from another pastor or mental health professional, reasonable steps will be taken to inform the other helper and resolve the situation. Professional relations in this case are to be maintained, as much as is possible, with a priority of Christian love and peace.

Any action to challenge or confront the wrongdoing of other service providers will be done with accuracy, humility, and protecting the dignity and reputation of others. Behavior that slanders, libels, or gossips about colleagues, or uncritically accepts these things from others about other service providers, will be strictly avoided.

 

1-620 Maintaining Honorable Professional and Employment Relations

Christian counselors create and preserve honorable relations in the professional workplace, whether church, counseling agency, or other setting. We maintain the utmost honesty, respect, and integrity in all employment and collegial relations. We shall contract relations that balance the best interests of clients, colleagues, and our organizations, and will honor all contractual obligations, even if it is costly for us to do so. We will avoid all actions and appearances of greed, fraud, manipulation, and self-serving action in all collegial and employment relations, and will disclose and discuss all reasonably foreseen problems to our colleagues before they enter into relations with us.

 

1-621 Toward Clear Role Boundaries and Work Definitions

All professional/employment relations should be mutually understood and described in sufficient detail by work agreement. Administrators and staff should reasonably understand (1) required work behavior, expectations, and limits; (2) lines of authority and responsibility; (3) bases for and boundaries of accountability; and (4) procedures for voicing and curing disagreements and substandard work performance. When such guidelines do not exist, Christian counselors encourage development of sound collegial and employer-employee rules and relations.

 

1-630 Christian Counselors as Employers

Employers of Christian counselors shall provide a personnel program that honors the dignity and promotes the welfare of employees. Information will be given about the mission, goals, programs, policies, and procedures of the employing person or organization. Employers should deliver regular programs of in-service training, supervision of staff, and evaluation and review of employee work performance. Employers do not coerce, manipulate, threaten, or exploit employees or colleagues.

 

1-631 Employers Avoid Discrimination and Promote Meritoriously

Employers hire, evaluate, and promote staff meritoriously—based on staff training, experience, credentials, competence, responsibility, integrity, and ethical excellence. We do not discriminate in hiring or promotion practices on the basis of age, race, ethnicity, gender, disability, medical status, socioeconomic status, or special relationship with employer or other staff.

 

1-640 Christian Counselors as Employees

Counselors accept employment only when they are qualified for the position—by education, supervised training, credentials, skill, and experience. We will honor and advance the mission, goals, and policies of employing organizations. Employees have duties to both employers and clients and, in the event of conflict between these duties, shall strive to resolve them in ways that harmonize the best interests of both.

 

1-641 Employees Serve with Integrity and Dedication

Employees serve with dedication, diligence, and honesty, maintaining high professional and ethical standards. We do not abuse our employment positions, nor presume excessive demands or rights against an employer.

 

1-642 Moving From An Agency to Private Practice

While employed in a counseling agency, and for a reasonable time after employment, we do not take clients from an employing organization to develop a private or group practice of a competing kind. Any part-time practice while employed must be kept strictly separate from the clients and resources of the employing agency. If we develop a full-time private practice with intent to resign employment and take current clients, each client shall be apprised of their right to choose to stay with the employing organization or go with the therapist.

 

ES1-700 Ethics in Advertising and Public Relations

All advertising and public communications by Christian counselors shall be done with accuracy and humility, with a primary goal of assisting clients to make informed choices about counseling services.

 

1-710 Unethical Statements in Public Communications

Christian counselors make only factual and straightforward public communications and avoid statements that: (1) are false, inaccurate, exaggerated or sensational; (2) are likely to deceive or mislead others because it is partial or taken out of context; (3) are testimonials by current clients; (4) exploit other's fears or distressing emotions; (5) note the inferiority or negative characteristics of another counselor; and (6) express unique or unusual helping abilities outside the range of accepted Christian counseling practices. 1-720 Communication of Association with the AACC and Other Groups Public communication of AACC or other professional membership should adhere to all the requirements of this section and should not express or imply that such membership confers special status, expertise, or extraordinary competence in counseling.

 

1-721 Communication About Professional Status and Credentials

Christian counselors do not state that professional credentials—state licenses, graduate degrees, specialized training, church, professional, or governmental certifications, or any other credentials—confer greater status or power than the credentials actually represent. Advanced credentials shall be communicated with accuracy and humility, adhering to the guidelines of the credential itself.

 

1-722 Communication of Unaccredited and Unrelated Credentials

Christian counselors avoid public communication of degrees or credentials received from schools and organizations (1) not holding or maintaining a reputable and widely-known national stature, (2) not accredited by state, regional, or national authorities, or that (3) are not substantially related to counseling, pastoral counseling, or mental health services. Holders of a religious license or credential for church ministry only shall not state or imply that they are counseling professionals, or that they hold a mental health practice license.

 

1-730 Communication of Work Products and Training Materials

Christian counselors ensure that advertisements about work products and training events adhere to these ethics. We take care to avoid undue influence and respect informed consumer choice in promoting our work to anyone under our professional influence or authority.

 

1-740 Ethical Guidelines in Public Statements by Others

Christian counselors ensure adherence to these ethics by third parties we engage to create and make public statements about our work—employers, publishers, producers, sponsors, marketers, organizational clients, and representatives of the media. We do not pay for or compensate the news media for news items about our work. We are responsible to correct, in timely fashion, any misinformation by third parties regarding our work.

 

ES1-800 Ethical Relations with the State and Other Social Systems

 

Christian counselors, as individual members and as an Association, will strive to maintain ethical relations with the world-wide and the local church, with the state in its various forms, with the mental health professions and associations to which some of us belong, with other professions and organizations, and with society-at-large.

 

1-810 Ethical Relations to Other Professions and Institutions

Christian counselors recognize and respect that we are part of larger networks of Christian ministry and of mental health care. To borrow a metaphor, we envision church-based ministry and professional mental health care as the two tracks on which runs the Christian counseling train—tracks with different rather than opposing objectives. Within the AACC are representatives of many different mental health and ministerial disciplines—we invite and welcome them all in the name of Christ. We will honor and preserve these relations, will challenge value differences with respect, and will build the best relations we can with all these professions and institutions that intersect with us as Christian counselors.

 

1-820 Working for a Caring Church, a Just Government, and a Better Society

Christian counselors are dedicated to build a more caring church, a more just government, and a better society in which to live. We will honor the laws and customs of our culture, and will challenge them when they threaten or abuse our freedoms, dishonor our God, or deny the rights of those most powerless. When critical, we will strive to offer a better alternative—model programs to govern our ecclesiastical, socio-cultural, and governmental life.

We will support the cause of Christ and advocate for Christian counseling in the church, in our ministries and professions, and in society. We will work to shape laws and policies that encourage the acceptance and growth of Christian ministry generally and Christian counseling in particular. We will facilitate harmonious relations between church and state and will serve and advocate the best interests of our clients in church, community, and governmental relations.

 

1-830 Being Salt and Light in a Post-Christian Culture

Christian counselors acknowledge that we live in a post-Christian and pluralistic culture that no longer shares a common Judeo-Christian value base. We are called by Christ to be "salt and light" throughout our culture, a call of engagement with our culture and the world-at-large. Hence, the AACC will be and our members are encouraged to engage in active and honorable relations with the world around us—relations in which the world can see the light and taste the salt of Christ.

 

1-831 Christ and Culture: Diversity over Conformity

We accept that there are differing views within our Association on the proper relationship of the Christian life to a modern culture that no longer substantially honors Christ. Our association includes those who are largely apolitical—acknowledging a receding religious-cultural status as Christians but dedicated to building up the church and our profession. There are also those who believe it is necessary to retain a vibrant Christian value base in society and seek to return our culture to these roots, including by political and legal action. We wish to support this diversity and encourage this ongoing debate, respecting the validity of these different views as the healthy evidence of a living church and a vibrant and growing profession.

 

II. ETHICAL STANDARDS FOR SUPERVISORS, EDUCATORS, RESEARCHERS, AND WRITERS

 

The Ministry of Christian Counseling Leaders Some Christian counselors serve in senior professional roles—as administrators, supervisors, teachers, consultants, researchers, and writers. They are recognized for their counseling expertise, their dedication to Christ and the ministry or profession to which they belong, and for their exemplary ethics. These leaders are responsible for the development and maturation of the Christian counseling profession, for serving as active and ethical role models, and for raising up the next generation of Christian counselors and leaders. ES2-100 Base Standards for Supervisors and Educators

 

2-110 Ethics and Excellence in Supervision and Teaching

Christian counseling supervisors and educators maintain the highest levels of clinical knowledge, professional skill, and ethical excellence in all supervision and teaching. They are knowledgeable about the latest professional and ministerial developments and responsibly transmit this knowledge to students and supervisees.

 

2-111 Preparation for Teaching and Supervision

Christian counseling supervisors and educators have received adequate training and experience in teaching and supervision methods before they deliver these services. Supervisors and educators are encouraged to maintain and enhance their skills through continued clinical practice, advanced training, and continuing education.

 

2-120 Supervisors and Educators Do Not Exploit Students and Trainees

Christian counseling supervisors and educators avoid exploitation, appearances of exploitation, and harmful dual relations with students and trainees. Students and trainees are taught by example and by explanation, with the mentor responsible to define and maintain clear, proper, and ethical professional and social boundaries.

 

2-121 Sexual and Romantic Relations Forbidden with Students and Supervisees

Christian counseling supervisors and educators (1) shall not engage in any form of sexual or romantic relations with their students and trainees, (2) nor subject them, by relations with others, to any form of sexual exploitation, abuse, or harassment, (3) nor pressure them to engage in any questionable social relationships. The standards of sections 1-130ff, "Sexual Misconduct Forbidden," shall apply fully here.

 

2-122 Dual Relationships Cautioned

Integrity and caution shall be the hallmark of dual relationships between supervisors and supervisees and between teacher and student. Those relations that harm or are likely to harm students and trainees, or that impair or are likely to distort the professional judgment of supervisors and teachers shall be avoided. The standards of sections 1-140ff, "Dual and Multiple Relationships," and those stated below shall apply here.

 

2-123 Supervisors and Educators Do Not Provide Psychotherapy

Christian counseling supervisors and educators do not engage in psychotherapeutic relations with supervisees or students. Personal issues can be addressed in supervision and teaching only insofar as they adversely impact counselor supervision and training. Students and supervisees needing or wanting counseling or psychotherapy shall be referred to appropriate resources.

 

2-124 Acknowledgement of Professional Contributions

Christian counseling supervisors and educators shall fully acknowledge the contributions of students and trainees in any creative professional activity, scholarly work, research, or published material. This shall be done by coauthorship, assistance in speaking or project presentation, or other accepted forms of public acknowledgement.

 

ES2-200 Ethical Standards for Christian Counseling Supervisors

 

2-210 Counselor Supervision Programs

Christian counseling supervisors ensure that supervision programs integrate theory and practice and train counselors to respect client rights, promote client welfare, and assist clients in the acquisition of mutually agreed goals in the counseling process. Supervision programs in Christian counseling shall adhere to these ethics, to those of other applicable professional groups, and to all applicable state and federal laws.

 

2-211 Baseline Program Standards

Counseling programs shall only accept supervisees who are capable of professional practice, are fully informed about the program, and are committed to engage in counselor training following (1) mutual agreement that the supervisee meets base standards of education and experience; (2) disclosure of the training goals, supervisory site policies and procedures, and theoretical orientations to be used; (3) understanding of program relationship to national accreditation and credentialing organizations; (4) understanding of the standards, procedures, and time of evaluations of supervisee skill, professional-ethical awareness, and clinical effectiveness; and (5) disclosure of the manner and expectations regarding remediation of professional deficiencies and substandard performance.

 

2-220 Supervisors to Provide a Varied Experience

Christian counseling supervisors will provide a varied counseling experience, exposing the trainee to different client populations, clinical activities, and theoretical approaches to counseling. Supervisees should gain experience in direct counseling practice, clinical evaluation, treatment planning, record keeping, case management and consultative presentation, legal and ethical decision-making, and the development of professional identity.

 

2-221 Supervisors Are Responsible for Services to Clients

Christian counselor supervisors ensure that supervisee work with clients maintains accepted professional and ministerial standards. Supervisors do not allow supervisees to work with clients or in situations where they are not adequately prepared. Supervisors retain full professional-clinical responsibility for all supervisee cases.

 

2-230 Supervision Evaluation and Feedback Christian counseling supervisors meet frequently and regularly with supervisees and give timely, informative feedback about counselor performance and effectiveness. These evaluations shall minimally require supervisor review of case notes and discussion or brief check of each client case. Evaluative feedback is given in both verbal and written forms, covering counseling content, process, and ethical-legal issues of counselor training.

 

2-231 Supervisors Are Aware of Licensure and Certification Requirements Christian counseling supervisors are aware of and honor the legal, ethical, and professional requirements of supervisees who are pursuing state licensure and specialized certification standards. ES2-300 Ethical Standards for Christian Counseling Educators 2-310 Counselor Education and Training Programs Counselor education programs are dedicated to train students as competent practitioners using current theories, techniques, and ethical-legal knowledge. Christian counseling educators ensure that prospective students and trainees are fully informed, able to make responsible decisions about program involvement. 2-311 Baseline Program Standards Christian counseling educators accept students on the basis of their educational background, professional promise, ethical integrity, and ability to reasonably complete the program. Program information should clearly disclose (1) the subject matter and coursework to be covered; (2) program relationship to national accreditation and credentialing organizations; (3) the kinds and level of counseling skills necessary to learn; (4) personal and professional growth requirements and opportunities; (5) the requirements and kinds of supervised clinical practicums and field placements offered; (6) the kinds and quality of research opportunities, including thesis/dissertation possibilities and requirements; (7) the basis for student evaluation, including appeal and dismissal policies and procedures; and (8) the latest employment prospects and program placement figures.

 

2-312 Student and Faculty Diversity

Christian counseling educators ensure that their programs seek and attempt to retain students and faculty of a diverse background, including representation by women, minorities, and people with special needs.

 

2-320 Student and Trainee Evaluation

Christian counseling educators provide students and trainees with periodic and ongoing evaluation of their progress in classroom, practice, and experimental learning settings. Policies and procedures for student evaluation, remedial training requirements, and program dismissal and appeal shall be clearly stated and delivered to student-trainees. Both the method and timing of evaluations are disclosed to students in advance of program involvement.

 

2-321 Overcoming Student Limitations

Educators help students overcome limitations and deficiencies that might impede performance as Christian counselors. Student-trainees will be assisted and encouraged to secure remedial help to improve substandard professional development. Honoring student due process, supervisors and educators will retain and fairly exercise their duty to dismiss from programs student-trainees who are unable to overcome substandard performance.

 

2-322 Student-Trainee Endorsement

Educators and field supervisors endorse the competence of student-trainees for graduation, admission to other degree programs, employment, certification, or licensure only when they have adequate knowledge to judge that the student-trainee is qualified. 2-330 Integration Study and Training Christian counseling educators ensure that programs include both academic and practice dimensions in counselor training and integrate biblical-theological study with learning in the bio-psycho-social sciences, however these are emphasized. Students, if not producing research, should learn to be effective research consumers.

 

2-331 Exposure to Various Counseling Theories Encouraged

Educators develop programs that expose students to various accepted theoretical models for counseling, including data on their relative efficacy, and will give students opportunities to develop their own practice orientations. If a program adheres to or emphasizes one particular theoretical model, that fact should be clearly stated in all public communications without asserting that the model is superior to all others.

 

2-332 Teaching Law, Ethics, and the Business of Practice

Training programs should give teach students about the legal, ethical, and business dimensions of Christian counseling. This includes study of these issues throughout didactic and clinical training. Students should be able to make competent ethical judgments and assess their own practice limitations, learning how to analyze and resolve ethical-legal conflicts and do consultation and referral competently.

 

2-340 Field Placement, Practicum, and Intern Training

Educators develop clear policies and procedures for all field experience, practicum, and intern training experiences. Roles and responsibilities are clearly delineated for student-trainees, site supervisors, and academic supervisors. Training sites shall meet required training standards, including national accreditation standards if applicable. Field supervisors shall be competent and ethical in their clinical and supervisory work. Educators do not solicit and will not accept any form of fee, service, or remuneration for the field placement of a student-trainee.

 

2-341 Clients of Student-Trainees

Academic and field supervisors ensure that clients of student-trainees are fully informed of trainee status, and the trainees' duty to honor all professional obligations. Trainees shall secure client permission to use, within the bounds of confidential duties, information from the counseling work to advance their counseling education.

 

ES2-400 Ethical Standards for Christian Counseling Researchers

2-410 Respecting Standards of Science and Research Christian counseling researchers honor accepted scientific standards and research protocol in all research activities. Research is ethically planned and competently conducted. Researchers do not undertake nor do they let subordinates conduct research activities they are not adequately trained for or prepared to conduct.

 

2-420 Protecting Human Research Participants and Human Rights

Researchers maintain the highest care for human participants and respect human rights in all bio-psycho-social-spiritual research activities. Researchers plan, design, conduct, and report research projects according to all applicable state and federal laws, ethical mandates, and institutional regulations regarding human participants.

 

2-421 Special Precautions to Protect Persons

Researchers take special precautions and observe stringent standards when (1) a research design suggests deviation from accepted protocol, or (2) when there is any risk of pain or injury to participants, whether of a physical, psychosocial, spiritual, reputational, or financial nature. In all such cases, we will obtain appropriate consultation that apprises participants of these risks and secures informed consent.

 

2-422 Minimizing Undesirable Consequences

Researchers reasonably anticipate and diligently work to minimize any adverse or undesirable consequences of the research on human participants. This includes a commitment to minimize any possible long-term research effects, including those on the participants' person, family and family life, spiritual beliefs, moral values, reputation, relationships, vocation, finances, or cultural system.

 

2-430 Informed Consent and Confidentiality in Research

Researchers obtain informed consent from research participants using language that the participant can understand. This consent shall disclose (1) a clear explanation of research purposes and procedures, (2) any risk of harm, injury, or discomfort that the participant might experience, (3) any benefits that the participant might experience, (4) any limitations on confidentiality, (5) a commitment to discuss all concerns of the participant about the research, and (6) instructions on the right and the way to honorably withdraw from the research project. Researchers shall honor all commitments made to research participants. Data and results shall be explained to participants in ways that are understandable and that clarify any confusion or misconceptions.

 

2-431 Consent from Those Legally Incapable

Researchers obtain consent from parents or a participant's legal representative when the research participants are minors or adults incapable of giving consent. Researchers inform all participants about the research in understandable language, seeking the participant's understanding and assent.

 

2-432 Concealment and Deception in Research

When a research design requires concealment or deception, the researcher shall apply these methods most narrowly and will inform participants as soon as possible after the procedure. The research value of a deceptive practice must clearly outweigh any reasonably foreseen consequences, especially how such deception may reflect adversely on Christ and the church. Normally, we do not use methods of deception and concealment when alternative research procedures are available to accomplish the project objectives.

 

2-433 Protecting Confidentiality and Voluntary Participation

Researchers ensure participant confidentiality and privacy, and that subjects are participating voluntarily in the project. Any deviation from these ethics shall (1) be necessary to the project and justifiable upon panel review, (2) shall not harm the participants, and (3) shall be disclosed to the participants, ensuring their consent.

 

2-440 Reporting Research Results

Researchers report research results fully, accurately, and without alteration or distortion of data. Data and conclusions are reported clearly and simply, with any problems with the research design fully discussed. Researchers do not conduct fraudulent research, distort or misrepresent data, manipulate results, or bias conclusions to conform to preferred agendas or desired outcomes.

 

2-441 Protecting Participant Identity

Researchers are diligent to protect the identity of research participants in all research reports. Due care will be taken to disguise participant identity in the absence of consent by participants.

 

2-442 Reporting Challenging or Unfavorable Data

Outcomes that challenge accepted policies, programs, donor/sponsor priorities, and prevailing theory shall be reported and all variables known to have affected the outcomes shall be disclosed. Upon formal request, researchers shall provide sufficient original data to qualified others who wish to replicate the study.

 

ES2-500 Writing and Publication Ethics in Christian Counseling

 

2-510 Integrity in Writing and Publication

Christian counselors maintain honesty and integrity in all writing and publication ventures, giving full credit to whom credit is due. Christian counselors recognize the work of others on all projects, avoid plagiarism of other's work, share credit by joint authorship or acknowledgement with others who have directly and substantially contributed to the work published, and honor all copyright and other laws applicable to the work.

 

2-520 Submission of Manuscripts

Christian counselors honor all publication deadlines, rules of submission of manuscripts, and rules of format when submitting manuscripts or agreeing to write invited works. Articles published whole or in major part in other works shall be done only with the acknowledgement and the permission of the previous publisher.

 

2-521 Review of Manuscripts

Christian counselors and editors who review manuscripts for publication shall consider the work strictly on its merits, avoiding prejudice for or against a particular author. Reviewers will diligently protect the confidential, reputational, and proprietary rights of all persons submitting materials for publication.

 

2-522 Encouragement to New Authors

Christian counseling editors and publishers will be diligent to call forth, encourage, and help develop new writers and materials from among the growing community of Christian counselors.

 

2-530 Avoiding Ghost Writers

Christian counselors shall resist use of ghostwriters, where the name of a prominent leader-author is attached to work substantially or wholly written by someone else. Instead, in accordance with section 2-510 above, Christian counseling authors will give due authorship credit to anyone who has substantially contributed to the published text. Order of authorship should reflect the level of substantive contribution to a work.

 

III. STANDARDS & EXEMPTIONS FOR ORDAINED PASTORS AND PASTORAL COUNSELORS

 

ES3-100 Definitions and Roles of Pastors and Pastoral Counselor

 

3-110 The Pastor and Pastoral Counselor: Ordained Ministers of the Gospel Pastors and pastoral counselors have central roles in the counseling and care ministry of the church. They are normally ordained ministers, recognized by a reputable church denomination as called of God, set apart for special church ministry, and have fulfilled the education and preparatory tasks the church requires for that ministry.

 

3-111 The Specialized Pastoral Counselor Pastoral counselors and psychotherapists have received advanced training in counseling and psychotherapy and often counsel in a church or a specialized counseling setting. Pastoral counselors often have advanced degrees in counseling, have undergone counseling practicum training under supervision, and may be certified by national associations as a pastoral counselor or pastoral psychotherapist. ES3-200 Rules of Ethics Code Application and Exemption

 

3-210 General Rule of Ethical Code Application and Exemption Pastors and pastoral counselors shall honor this Code in it entirety, except for those code sections (1) not applicable due to their clinical professional nature, or (2) because a higher duty to church or ministry rules require a narrow exemption from this Code. Anyone claiming exemption to the Code has the burden of proving it, and the duty to draw that exemption as narrowly as possible, honoring all other Code requirements.

 

3-220 The Call of Christian Counseling to Gospel Fidelity

Pastors and pastoral counselors have a special call as intermediaries between Christian counseling and the church. They can challenge Christian counselors to hold faith to the Gospel and to apply counseling ministry to the mission and work of the church. They can mediate, explain, and refer parishioners to Christian counselors. They can also encourage involvement for those who need help, and communicate and explain the guidelines of the Code so that parishioners can better judge the value and safety of the Christian counseling work.

 

IV. STANDARDS & EXEMPTIONS FOR LAY HELPERS AND OTHER MINISTERS

 

ES4-100 Definitions and Roles of Lay Helpers and Non-ordained Ministers

Lay helpers or non-ordained ministers have a significant role in the counseling and care ministry of the church. They are not professional clinicians nor ordained ministers, but may work as salaried staff or as volunteers in designated helping roles. These helpers often function in one-to-one helping roles and are increasingly involved in developing and leading the many small support and recovery group ministries of the contemporary church.

 

ES4-200 Rules of Ethics Code Application and Exemption

 

4-210 General Rule of Ethical Code Application and Exemption

Lay helpers and non-ordained ministers shall honor the Code in it entirety, except for those code sections (1) not applicable due to their manifestly professional or pastoral nature, or (2) because a higher duty to church or ministry rules require a narrow exemption. Anyone claiming exemption to the Code has the burden of proving it, and the duty to draw that exemption as narrowly as possible, honoring all other Code requirements.

 

4-220 Lay Helping Under Supervision of the Church

Lay helpers minister only under the supervision of the church or a Christian counseling organization. Lay helpers seek out and secure supervision and spiritual-ethical covering by pastors and professional clinicians. Independent, unsupervised, and solo practice or ministry by lay and unlicensed helpers and non-ordained staff shall be avoided due to its excessive risk for legal, ethical, spiritual, interpersonal, and ecclesiastical trouble.

 

4-221 Lay Helpers Do Not Accept Fees or Communicate False Roles

Lay helpers shall not seek or accept fees or other remuneration for ministry. Lay helpers do not state or allow helpees to believe that they are professional or pastoral counselors. Some lay or non-ordained helpers may receive a salary as a church or ministry employee, income that should not be confused with fees for services.

 

4-222 Aiding and Abetting Unauthorized Practice.

Pastors and professional Christian counselors do not aid and abet the practice of unlicensed, untrained, unqualified, or unethical counseling or lay helping by anyone. In counseling situations requiring help clearly beyond the scope, training, experience, or license required of the helper, supervising pastors and clinicians will require and assist appropriate consultation and/or referral.

 

V. STANDARDS FOR RESOLVING ETHICAL-LEGAL CONFLICTS

 

ES5-100 Base Standards for Ethical Conflict Resolution

 

5-110 Base Rule for Resolving Ethical-Legal Conflicts

Christian counselors acknowledge the sometimes conflicting responsibilities to clients, to colleagues and employing organizations, to professional ethics, to the law, and to Christ. If a higher obligation to Christ or to the client's best interest suggests or requires action against legal, ethical, or organizational rules, we will act peaceably and humbly in its outworking, in a way that honors God and our role as Christian counselors.

 

5-111 First, Attempt to Harmonize Conflicting Interests

When caught between legal-ethical demands and the way of Christ or the best interests of the client, we will first attempt to harmonize biblical, clinical, legal, ethical, and client interests, if possible. We will secure proper consultation and take action that defines and offers a better and harmonious standard of professional conduct.

 

5-112 When Conflicts Cannot Be Harmonized

Christian counselors' fidelity to Christ sometimes calls us to respectfully decline adherence to non-Christian values and behavior. When such conflicts cannot be harmonized, some counselors will stand firm or act on Christian principle against the law of the state, the ethics of one's profession, or the rules of one's employing organization. Such action should be (1) defensible biblically and ethically, (2) according to the client's best interest, (3) done without self-seeking purposes, (4) done with sober consideration after consulting with informed colleagues and Christian counseling leaders, and (5) done with a willingness to pay any adverse consequences. Such action must never be done to hide wrongdoing or to justify an obscure or self-promoting position.

The AACC suggests that priority values in the resolution of these conflicts be (a) integrity to Christ and the revelation of Scripture, then (b) the client's best interests, then (c) fulfilling our legal, ethical, and organizational obligations in a way that is least harmful to Christ or our client's interest.

 

ES5-200 Resolving Conflicts with Employers and Colleagues

 

5-210 Ethical and Value Differences with Employers and Colleagues

If values and other differences with employers or colleagues become a source of conflict or influence client injustice, Christian counselors shall take appropriate action to resolve these problems in a way that honors Christ while also serving the client's best interest.

 

5-211 Christian Counselors Working in Public Agencies

Christian counselors working in public agencies will respect fair and circumspect rules against client evangelism or communicating Christian values without client consent. However, we may also challenge unjust prohibitions against the free expression of our beliefs, grounded in our biblical and constitutional right to religious freedom. These legitimate expressions of Christian beliefs include, but are not limited to: (1) serving Christian clients from a Christian value base; (2) sharing Christian values as a legitimate part of counselor self-disclosure; (3) responding to spiritual needs expressed by clients from a Christian frame of reference; and (4) displaying Christian symbols and literature in our office or place of work.

 

5-212 Conflict Resolution Process with Employers and Colleagues

Resolution of conflicts with employers or colleagues shall honor this process: (1) first attempt direct negotiations, (2) then mediation, and (3) then arbitration and/or binding arbitration. Litigation (4), when considered at all, shall be only as a last resort and only in cases of gross injustice where the offending party refuses or disdains all reasonable offers of non-litigated dispute resolution.

 

5-220 Law and Ethics Violations by Colleagues and Employers

Christian counselors with credible knowledge of legal or ethical violations by colleagues and employers shall take appropriate action to cure this problem, in the best interests of clients, and according to the requirements of applicable law-ethics. Curative action might include (1) confidential consultations (usually the first step), (2) direct communications with the violator, (3) report to one's own or the violator's supervisor, (4) assisting violated clients to take action, (5) report/complaint to the appropriate state agency or professional association, or (6) any other action appropriate to the matter.

 

ES5-300 Resolving Professional and Organizational Conflicts

 

5-310 The Higher Ethics of Jesus Christ

Christian counselors are bound to honor the ethics and rules of one's profession, church, or employing organization in every way possible. However, when these ethics and rules are in direct opposition to God, and if unable to harmonize the mandates of Scripture with these rules, we declare and support the right of Christian counselors to elect nonadherence to those ethics and rules that offend the way of Christ.

 

5-311 First, Act to Resolve Conflict with Church or Profession

Christian counselors always first seek peaceable and biblically-defensible resolution of disputes. After proper consultation with colleagues and Christian counseling leaders, we will define and advocate for a new ethical standard as an alternative to the offensive rule—one that honors Christ, protects the client's interest, and attempts fulfills the policy behind the ethical rule. 5-312 When Ethical Harmony Is Not Reached If ethical harmony is not possible, and after all attempts at resolution have been exhausted, Christian counselors may elect to violate the offending rule for the sake of Christ or the client. The violative action should be defensible biblically, logically, and clinically and, if possible, in accordance with the ethics intent. Counselors shall (1) define the rule that cannot be respected in the narrowest form possible, (2) declare to honor all other ethical mandates, (3) consult with other colleagues and soberly count the cost of such action and (4) be prepared to face any consequences for breach of ethics or rules.

 

ES5-400 Resolving Conflicts with the State and Its Laws

5-410 The Higher Law of Jesus Christ

Christian counselors are bound to honor the law in every way possible. However, when the law is in direct opposition to God, and if unable to harmonize the mandates of Scripture and the law, we declare and support the right of Christian counselors to elect nonadherence to those laws that offend the way of Christ.

 

5-411 First, Act to Resolve Legal Conflict

Christian counselors always seek first the peaceable and biblically-defensible resolution of disputes with the state and its laws. After proper consultation, including consulting with an attorney and with Christian counseling colleagues and leaders, we will attempt to define and advocate for a new and harmonious legal standard as an alternative to the law-offending rule at issue. This newly proposed standard will honor Christ, protects the client's best interest, and shows how the action of the new rule fulfills the intent or policy behind the law.

 

5-412 When Legal Harmony Is Not Reached

If harmony is not possible with the state and its laws, and after all attempts to resolve the issue have been exhausted, Christian counselor may elect action that violates the law for the sake of Christ or the client. The violative action should be defensible biblically, logically, clinically and, if possible, by the law's intent or policy.

Counselors shall (1) define the law that cannot be respected in the narrowest form possible, (2) declare to honor all other legal mandates, (3) consult with other colleagues, including lawyers, and soberly count the cost of such action, and (4) be prepared to face any consequences that may be imposed for violation of the law.

 

PROCEDURAL RULES

 

In order to fulfill its professional and ethical mission the AACC adopts these procedural rules for accurate assessment and the fair hearing and resolution of ethical complaints against its members. These rules purpose to (1) show society, the church, our related professions, and our multitude of clients and parishioners that the AACC has a serious commitment to live by and enforce these ethics, and (2) show our members that we are serious about protecting their ministries and reputations by honoring their right to justice and due process. In any action under these rules, the AACC shall consider this ethics code, its corporate bylaws, and the mandates of Scripture in the resolution of any problems in rule interpretation.

 

VI. AUTHORITY, JURISDICTION, AND OPERATION OF THE AACC LAW AND ETHICS COMMITTEE (LEC)

 

PR6-100 Mission, Authority, and Jurisdiction of LEC

 

6-110 LEC Mission

The mission of the AACC Law and Ethics Committee is to educate, encourage, and help maintain the highest levels of ethical conduct, practice excellence, and ministerial integrity among Christian counselors. This includes protecting clients and society-at-large from unethical conduct, educating and advocating this code to the AACC and the larger church and society, and to aid the AACC in its mission to bring unity and excellence to the Christian counseling field.

 

6-120 LEC Authority

LEC is authorized to formulate and promulgate ethical standards for Christian counseling that are to be honored by AACC members particularly, and the church and larger society more generally. LEC, or any committee it shall designate, shall investigate, hear, and act to justly resolve ethical complaints against AACC members. LEC shall also have authority to adopt rules and procedures, as needed, to govern the conduct of LEC and any person or matter within its jurisdiction. LEC shall also have authority to publish and publicly communicate its official actions, including disciplinary actions toward its members.

 

6-130 LEC Jurisdiction

LEC has personal jurisdiction with any member of the AACC. LEC also has subject matter jurisdiction regarding the ethical behavior and rules defined in this Code. LEC may, by the AACC's direction, address any issue or matter that affects the Association's integrity and ethical achievement of its mission.

 

6-200 General Orientation to Ethical Enforcement

 

6-210 Attitude and Action Toward Ethical Complaints

Neither LEC nor any member of the AACC shall refuse to hear nor uncritically accept a complaint against another member of the Association. Any LEC or Association member hearing a complaint individually shall take whatever action deemed appropriate to address and resolve the matter. When appropriate and feasible, this shall be done by direct consultation with violators or by working through local or regional collegial networks, taking care to honor the confidential and reputational rights of all those concerned in the matter.

 

6-211 Reporting Violations to LEC

If resolution attempts were unsuccessful by the member, or if the matter is more serious, or cannot be resolved by personal intervention, the member may direct the complainant to LEC.

 

6-220 Respecting Fundamental Rights of All Parties Involved

When LEC must act against an AACC member, it shall take care to maintain respect for the member's rights and reputation. The entire membership shall support LEC in this process, both to honor its ruling and to check and warn it when it might begin to stray from these values and purposes. Whenever possible, LEC shall balance and protect the multiple interests of client and community protection, Association integrity, and the legal and ethical rights and professional reputations of both complainants and complainees.

 

6-230 LEC Duties Toward the Complainant

Toward the complainant, LEC will honor his or her concerns, invite a full hearing of the complaint if needed, will seek to separate fact from rumor, and will take appropriate action to resolve the matter to the best of its ability to honor Christ and the complainant. 6-240 LEC Duties Toward the Complainee Toward the complainee, LEC will honor his or her right to be heard and defend against allegations, will protect the complainee's professional reputation and due process rights, will invite and give reasonable time to fairly respond to a complaint, and will narrow the issue(s) to that which is reasonably beyond dispute. LEC will always pursue the most just result, avoiding the extremes of minimized justice or excessive sanction.

 

PR6-300 Membership Response to LEC Action

 

6-310 Commitment to Cooperate with Ethics Process

AACC members assist the Association to honor and help enforce these ethical standards and rules. All members of the AACC shall cooperate fully and in a timely way with LEC and the entire ethics mission to assure the best achievement of our core commitment to excellence and unity in Christian counseling.

 

6-311 Failure to Cooperate with Ethics Process

Failure to cooperate with LEC or the ethics process in any manner shall not stop LEC from executing its duty. Failure to cooperate is itself a code violation and can result in ethical sanction.

 

VII. PROCEDURES FOR THE ADJUDICATION OF COMPLAINTS AGAINST AACC MEMBERS

 

PR7-100 General Rules of LEC Operation

 

7-110 Making and Amending Rules and Procedures

LEC may adopt and amend rules and procedures to govern the conduct of any matter within its jurisdiction. Any new or amended rule must be approved by a two-thirds vote of the Committee and also be ratified by a majority of the National Advisory Board. No new or amended rule shall adversely affect the rights of a member under investigation by LEC at the time of the rules adoption.

 

7-111 Choice of Procedures and Action

Except as otherwise denoted in these ethics and rules, LEC reserves the right to choose the appropriate procedures to resolve matters justly and efficiently, balancing the interests of the general public, affected clients, the AACC, and its members.

 

7-120 LEC Meetings and Officers

 

7-121 Frequency of Meeting and Quorum

LEC shall meet at regular intervals, as needed. Conference calls can substitute for face-to-face meetings. A quorum shall consist of the majority of LEC members and official actions may be authorized by LEC when its members respond in person, by phone, by fax, by letter, or any other agreed means of action.

 

7-122 Selection of Officers and Sub-committees

Officers and Sub-committees may be appointed by LEC and/or AACC executive leadership action to serve terms and engage issues as are agreed among LEC members and AACC executive leadership.

 

7-123 Duties of the Chairperson and the Vice-chair

The Chairperson of LEC is responsible for the executive leadership of the Committee. He or she shall direct, in person or through appropriate designees, the work and process of LEC in all its responsibilities to the AACC. The Vice-chair shall be empowered to perform all the duties of Chair when s/he is not able to perform them, and shall perform other duties as are assigned by the Chair.

 

7-124 Majority Rule

Unless otherwise directed by these rules (see section 7-110 above), all official actions of LEC shall be authorized by a majority vote of its members present, or by any other authorized means of voting (see 7-121).

 

7-130 Open vs. Confidential LEC Process

LEC meetings and activities shall be either open to the membership or closed and confidential, with access in closed meetings given only to those designated parties with an interest in the particular matter. Closed meetings shall be done in ethical adjudications where the privacy interests of members or others deserve confidential process. All other LEC meetings may be open to any interested member.

 

7-131 Access to Closed Meetings

LEC and the AACC reserve the right to invite AACC executives or other desired personnel, experts, or consultants into confidential meetings, as may be necessary or desired to assist the adjudicatory process.

 

7-132 Open vs. Confidential Records

Except to inform the membership of final official disposition of a formal case and to assist the information/disclosure needs of the Association and the parties to the matter, all information and records of ethical adjudication against a member shall held in confidence by LEC. This may be further accepted in cases where client-parishioner risk or risk to the public welfare is judged by LEC to be significant. All other proceedings and records of LEC action shall be open to the membership. PR7-200 Ethical Complaint Procedures

 

7-210 Reception of a Complaint.

Proceedings against a member are initiated by the reception of a formal complaint, in verbal and written form, by LEC. Complaints may be received from members or nonmembers of AACC.

 

7-211 LEC (Sua Sponte) Action.

LEC may initiate proceedings on its own when it has sufficient evidence to do so, or as a response against a member who files a frivolous complaint, or if the complainant has a primary intention to harm another member. 7-220 Procedure for Making a Complaint Members shall contact LEC or Association offices to present their complaint. The complaint should be outlined in writing, in no more than one page initially, and note both the alleged violation of AACC ethics or rules, and any direct and other evidence the complainant has to support it.

 

7-221 Unacceptable Complaints.

LEC will not initiate proceedings in situations of anonymous complaints, complaints against nonmembers, or in counter complaints. In the latter case, LEC may consider whether a counter complaint has cause to proceed further only after the initial complaint is fully resolved.

 

7-222 Multiple Complaints

When numerous complaints against a member are received simultaneously, LEC may elect to combine them into one action or deal with them separately. When consecutive complaints are heard, LEC may elect to consider the disposition of any previous case against the member in its resolution of a current complaint.

 

7-230 Warning Against Frivolous and Vindictive Complaints

AACC members shall not make frivolous reports, without substantiation, or that are primarily motivated by anger or vindictiveness, or with an intent to harm the alleged violator. The primary motivations in reporting ethical misconduct are to protect clients and parishioners, to maintain the honor of Christ and the church, the honor of our professions, and to assist the cure and restoration of violators to ethical and effective ministry, if possible.

 

PR7-300 Complaint Assessment and Initial Action by LEC

 

7-310 Inability to Take Further Action

Failure of any one of the following standards shall render LEC unable to take further action against an AACC member. If it is dismissed, LEC shall so rule, the complainant notified of LEC's decision, and the matter closed.

 

7-311 Lack of Jurisdiction

LEC shall first determine whether it has jurisdiction. Personal jurisdiction is met if the complaint is directed toward a member in good standing of the AACC. Subject matter jurisdiction is met when the alleged wrongdoing of a member, acting in a professional-ministerial capacity, intersects the standards of this code.

 

7-312 Insufficient Information to Act

Further LEC shall then determine whether it has sufficient information to take further action. There must be (a) a clear violation of the Association's ethics, policies, or procedural rules, and (b) the information supporting the violation must be of sufficient weight and quality that, in LEC's judgment, it cannot be dismissed.

 

7-313 Failure of Procedure or Time Limits

Finally, LEC shall determine that proper procedures and time limits have been honored in the complaint process, as defined by this code.

 

7-320 Cause for Further Action.

If, in LEC's judgment, the standard of section 7-310 and following are satisfied, then it shall rule that cause for further action exists. It shall then review and decide the steps necessary to seek the most just, restorative, and least costly resolution. It shall gather the most reputable evidence that applies to the matter at hand, rejecting evidence that is speculative, incredible, and unsupportable.

 

7-321 LEC May Seek Informal Resolution of the Matter.

LEC may empower the Chair or a committee to address the matter directly with the complainee to seek a just resolution. The intervener may then recommend to LEC whether or not to close the matter at this stage and the reasons for its recommendation, and LEC may elect whether or not to accept the recommendation of the committee or pursue further action.

 

7-330 Initial Notification to Complainee.

If informal resolution is not elected or does not work, the violations and evidence supporting it shall be simply and clearly outlined in a query letter signed by the Chair and Vice-chair of LEC. This letter and a copy of the applicable ethics and rules shall be delivered to the complainee by mail or in person by LEC.

 

7-331 Requests for Additional Information.

LEC may request additional information from the complainant, the complainee, or any appropriate source to assist resolution of the matter.

 

7-332 Time for and Response from Complainee—Complaint Stage.

Within 30 days of reception of the letter, the complainee may respond in writing to the allegations. The complainee must respond personally and not through a third-party. The LEC Chairman may waive or adjust the time requirement if good cause is shown.

 

7-340 Case Closure for Insufficient Evidence.

If it becomes clear that insufficient or competing evidence raises substantial doubt about the occurrence of ethical violation, then LEC will close the case. It this action is taken, LEC shall promptly notify both complainant and complainee of its decision and reasoning.

 

7-341 Reopening a Closed Case

A case closed for insufficient evidence may be reopened upon the receipt of new evidence significant enough (as defined by section 7-310 ff. above) to justify reopening the matter within a reasonable time from the reception of the original complaint.

 

7-342 Alternative/Supplementary Action May Be Recommended

LEC reserves the right, whether a case is closed or stays open, to recommend alternative or supplementary action—referral to any relevant professional association, denomination, state licensure board, administrative agency, or any other appropriate body to hear the complaint.

 

7-350 Case Resolution by Mutual Agreement.

LEC may pursue case closure through a pre-formal agreement with the complainee that is restorative and corrective. By discussion, prayer, reasoning together, and negotiation, LEC will seek to resolve the matter in a way that serves the best interests of both the AACC and its members.

 

7-351 Structure of Agreement

Such agreement will usually clarify misunderstandings, direct corrective action, establish a time-frame for renewal of ethical relations and proper trust, define a fair assessment of these objectives, or any combination of these things. This agreement shall be signed by the LEC Chair and the complainee and shall be disclosed to the complainant, the complainee, and anyone else agreed to by the signatories.

 

7-360 Cause for Formal Case Review

If the matter cannot be closed or resolved as defined above and in the judgment of LEC sufficient cause exists to pursue the matter further, LEC shall then decide that "cause for formal case review" exists, so shall rule, will notify the applicable parties, and then move prayerfully to the next level of adjudication.

 

PR7-400 Formal Case Review Procedures

 

7-410 Selection and Operation of Case Review Sub-committee

LEC shall form a three-person sub-committee (sub-com), chaired by the Chair or Vice-chair, to hear and resolve a formal ethics complaint. This sub-com shall be given sufficient authority and the necessary resources to resolve the matter, consistent with these ethics and rules, in a just and timely manner. Sub-com recommendations shall be forwarded to and accepted by LEC when 2 votes of the sub-com exist.

 

7-411 Presentation of a Charge Letter

The complainee shall receive a formal charge letter from LEC, detailing the alleged wrongdoing, the specific code sections implicated, and the supporting evidence. The letter shall instruct the complainee as to the manner and time for response to allegations. Any supporting materials that LEC will use to assist its review shall be copied and sent with the letter.

 

7-412 Time for and Response from Complainee—Review Stage

The complainee has 30 days from the letter date to respond to the allegations, either in person or in writing. The complainee must follow all charge letter instructions and rules. Any waiver of time and action requirements must be made, in person or in writing, within the 30-day time frame. Legal counsel or other help may be consulted and can attend the case hearing for consultation but cannot speak directly for his or her client at the hearing—this representation must be done directly by the complainee.

 

7-420 Documentation, Review of the Evidence, and Recommendations

Additional documentation may be sent to LEC by the complainee within the 30-day period. LEC will, within this 30-day period, forward any additional information it receives to the complainee. LEC will review the case and render a judgment no later than 120 days from the date of the charge letter. One of four recommendations will be made to LEC by the sub-com and the appropriate parties notified of this decision.

 

7-421 Recommendation to Dismiss Charges

If the sub-com finds (1) no evidence or very weak evidence of violation, or (2) has insufficient evidence to render an informed judgment, or (3) finds a slight violation that has been or is in process of being corrected, it shall recommend that LEC dismiss the charge(s).

 

7-422 Recommendation to Educate and Repair

If the sub-com finds a more weighty violation, or a pattern of violation that is not too serious, and there is evidence of some correction, it may elect to recommend the complainee educate him or herself and repair the violation. Notification of such action will be communicated to the complainee and complainant only.

 

7-423 Recommendation to Reprimand and Suspend

If the sub-com finds a more serious violation, or a pattern of continuing violations with no repair started, but the likelihood of correction and restored practice is significant, it may recommend that LEC reprimand and suspend the member, with instructions for possible reinstatement. Such action, and the violations related to it, will be communicated to AACC members in official publications.

 

7-424 Recommendation to Terminate Membership

If the sub-com finds a very serious violation, or a pattern of continuing serious violations, especially after being challenged to change, and the likelihood of correction or value of it is slight (compared to the harm done), it may recommend to LEC that membership in the AACC be terminated. Such action, and the violations related to it, will be communicated to AACC members in official publications.

 

7-425 Agreed Resignation of Member

A member of the AACC may elect to resign his or her membership, or LEC may elect to offer such resignation to the member prior to termination of membership. Such action, and the violations related to it, will be communicated to AACC members in official publications.

 

7-430 Final Ruling of the Law and Ethics Committee

 

Recommendations for case disposition from the sub-com shall be heard and accepted by LEC. LEC rulings, tracking the recommendations of the sub-com, shall include sufficient information and instruction to satisfactorily achieve the stated objectives of the LEC ruling. Except in the case of termination of membership, all rulings by LEC at this stage shall be final, with no consequent appeal.

 

7-431 Limited Discretion to Modify Sub-committee Recommendations

LEC shall retain limited discretion to modify the recommendations of the sub-com if there is good reason to find that such change will yield a more just and restorative outcome. This discretion shall be used sparingly, and only in cases where there is a general consensus for such change among LEC members.

 

PR7-500 Formal Appeal Hearing Procedures

 

7-510 Complainee Election of Formal Appeal—Termination Cases

Only Appeal of rulings by LEC shall be allowed only in case of termination of AACC membership.

 

7-511 Time and Documentation

Both LEC and the complainee shall receive and argue from the same materials that formed the original judgment, plus any additional materials that are deemed necessary to support the appellate challenge. No hearing will take place within 30 days of the receipt of all relevant documents by both LEC and the complainee.

 

7-512 LEC Represented by the Chair or Vice-chair

LEC shall be represented by the Chair or Vice-chair of LEC (the other will sit on the appeals panel). They shall be responsible for arguing the case to the appeals panel to support the LEC ruling.

 

7-520 Standards and Conduct of the Formal Appeal Hearing

There shall one appeals hearing only, on a date and at a place that is most convenient for the appeals panel, whose ruling shall be final as to all matters concerning the case. The appeals panel will review the appeal and render a judgment no later than 30 days from the date of the appeals hearing.

 

7-521 The Appeals Panel

Appeals shall be heard by a five-person panel, consisting of the LEC Chair or Vice-chair (whoever is not representing LEC in the appeal) and at least two other LEC members (not those hearing the original action). Other panel members, if needed, shall be invited from the National Advisory Board.

 

7-522 The Appeals Standard—Unjust Result

The appellate panel must rule against the termination of membership if the complainee can show substantial evidence that (1) the sub-com panel or a member of it showed a clear intent to harm the complainee, or (2) that findings of fact or application of the ethics code were clearly erroneous, or (3) the application of termination was a clearly excessive and punitive sanction.

 

7-523 Representation by Self or with Legal Counsel

The complainee shall represent and speak for him or herself in all appellate actions, though they may choose to retain legal or other counsel who may help the complainee before and during the hearing.

 

7-524 Retention of Legal Counsel by the AACC

LEC may elect to retain legal counsel, or any other expert help it deems necessary.

 

7-530 Final Order of the Appeals Panel

The appeals panel shall rule, by at least 3 votes, either to uphold the prior LEC ruling or to reverse it. Upholding the rule will end the matter for the AACC. A reversal will lead to a dismissal of the prior ruling and an order for a new case review hearing with at least 2 new panel members on the sub-committee.

 

VIII. PROCEDURES FOLLOWING ACTION BY CHURCHES, COURTS, AND OTHER BODIES

 

PR8-100 LEC Authorized to Act Independently or With Others

 

8-110 Litigation, License Revocation, or Other Disciplinary Action Not a Bar to Action by LEC

LEC reserves the right to proceed with an ethics action even if the member is engaged in litigation, license revocation, or other disciplinary action for the same or similar issues.

 

8-111 LEC Election to Stay Process Pending Resolution

LEC reserves the right to suspend an ethics action until case disposition in another legal or disciplinary forum is completed. Any delay in action by LEC shall not waive jurisdiction and any time constraints shall be suspended until the action is begun or resumed.

 

8-112 Retention and Referral of Jurisdiction to Other Bodies

LEC reserves the right to refer a case to another recognized body for action, and to cooperate or work jointly with another tribunal. Any referral to another body shall not constitute waiver of jurisdiction by LEC, nor shall LEC be barred from acting on its own following referral.

 

PR8-200 Bases for and Procedure of a Show Cause Hearing

 

8-210 Five Bases for a Show Cause Hearing

An AACC member may be directed by LEC to show cause why official action by LEC should not be taken if the member is sanctioned for misbehavior substantially related to his or her professional or ministerial tasks, in the form of (1) conviction of a criminal offense, (2) a malpractice judgment, (3) a malpractice settlement of $25,000 or more, (4) a license revocation or suspension action, or (5) any church, denominational, or any other official organizational act of expulsion, suspension, or de-ordination.

 

8-220 Notice by LEC and Response of Member

Upon receipt from LEC of a show cause letter, the member will have 30 days from the letter date in which to respond. The member may show cause based on either the unjust result standard (see section 7-522 above), or the lack of due process in the other proceeding.

 

8-230 Review of Prior Action and Recommendation

The LEC Chair or Vice-chair will review the evidence and prior proceeding and determine whether just cause exists to challenge its rule. If so, a recommendation will be made to start a formal case review on the merits according to the procedures of this code. If cause is not shown, a recommendation of termination of membership will be made based of the finding of the prior proceeding. 8-231 Stipulated Resignations The AACC and the member may stipulate and agree on the resignation of the member. Whether termination or resignation, the result will be published in official AACC publications.

 

8-240 Final Order of the Law and Ethics Committee

Recommendations for case disposition shall be heard and accepted by LEC. LEC rulings, tracking these recommendations, shall include sufficient information and instruction to satisfactorily achieve the stated objectives of the LEC ruling. All rulings by LEC in a show cause hearing shall be final, with no consequent appeal.

 

FINAL ENCOURAGEMENT

 

May God be exalted, the Holy Spirit invited, and Jesus Christ be seen in all of our counseling and helping endeavors. If done, our clients and parishioners will be blessed and not harmed, their wounds will be healed, their sins forgiven, and they will be given hope for the future. If done, we will participate in a wonderful adventure—one that will likely never grow old or stale—and we will fulfill our call to excellence and ethical integrity in Christian counseling.

 

End of the 2004 Final Code

 PREAMBLE

 

Pharmacists are health professionals who assist individuals in making the best use of medications. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are established to guide pharmacists in relationships with patients, health professionals, and society.

 

I. A pharmacist respects the covenantal relationship between the patient and pharmacist.

 

Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust.

 

II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner.

 

A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.

 

III. A pharmacist respects the autonomy and dignity of each patient.

 

A pharmacist promotes the right of self-determination and recognizes individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable. In all cases, a pharmacist respects personal and cultural differences among patients.

 

IV. A pharmacist acts with honesty and integrity in professional relationships.

 

A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients.

 

V. A pharmacist maintains professional competence.

 

A pharmacist has a duty to maintain knowledge and abilities as new medications, devices, and technologies become available and as health information advances.

 

VI. A pharmacist respects the values and abilities of colleagues and other health professionals.

 

When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals or refers the patient. A pharmacist acknowledges that colleagues and other health professionals may differ in the beliefs and values they apply to the care of the patient.

 

VII. A pharmacist serves individual, community, and societal needs.

 

The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly.

 

VIII. A pharmacist seeks justice in the distribution of health resources.

 

When health resources are allocated, a pharmacist is fair and equitable, balancing the needs of patients and society.

 

* adopted by the membership of the American Pharmacists Association October 27, 1994.

SUMMARY of CHANGE

 

AR 70–25

Use of Volunteers as Subjects of Research

This change is published to correct a serious error that occurred during the final editing of the current revision. In attempting to respond to guidance from the Office of The Judge Advocate General that a subparagraph be moved from the text of the regulation to appendix F, the wrong sub-paragraph was moved.

 

Headquarters

Department of the Army

Washington, DC

25 January 1990

 

Research and Development

 

Use of Volunteers as Subjects of Research

 

*Army Regulation 70–25

Effective 24 February 1990

 

By Order of the Secretary of the Army:

CARL E. VUONO

General, United States Army Chief of S taff

 

Official:

Milton H. Hamilton

Administrative Assistant to the Secretary of the Army

 

 

 

History. This publication was last revised on 8 August 1988. Since that time, permanent Change 1 has been issued. As of 25 January 1990, that change remains in effect. This UPDATE printing incorporates that change into the text. This UPDATE printing publishes a Change 2. The portions being revised by this change are highlighted.

 

Summary. This revision implements Department of Defense (DOD) Directive (DODD) 3216.2. It reflects the present legal requirements pertaining to the use of humans as research subjects funded by research, development, test , and evaluation appropriations. This revision provides guidance for establishing human use committees (HUCs). Excluding limited situations, authority to approve research using human subjects can be delegated within the military chain of command.

 

Applicability. This regulation applies to research , development, test, and evaluation (RDTE) programs conducted by the Active Army. It does not apply to the Army National Guard (ARNG) or the U.S. Army Reserve (USAR) unless there is involvement of Active Army personnel.

 

Army management control process. This regulation is subject to the requirements of AR 11–2. It contains internal control provisions but does not contain checklists for conducting internal control reviews. A checklist will be published at a later date.

 

Supplementation. Supplementation of this regulation is prohibited unless prior approval is obtained from HQDA (DASG–RDZ), 5109 Leesburg Pike, Falls Church, VA 22041–3258.

 

Interim changes. Interim changes to this regulation are not official unless they are authenticated by the Administrative Assistant to the Secretary of the Army. Users will destroy interim changes on their expiration dates unless sooner superseded or rescinded.

 

Suggested Improvements. The proponent of this regulation is the Office of The Surgeon General. Users are invited to send comments and suggested improvements o n DA Form 2028 (Recommended Changes to Publications and Blank Forms) directly to Commander, U.S. Army Medical Research and Development Command , ATTN : SGRD–HR , Fort Detrick, Frederick, MD 21701–5012.

 

Distribution. Distribution of this publication is made in accordance with the requirements on DA Form 12–09–E, block number 3724, intended for command level D for Active Army and None for the ARNG and USAR.

 

Contents (Listed by paragraph and page number)

Chapter 1

Introduction, page 1

Purpose • 1–1, page 1

References • 1–2, page 1

Explanation of abbreviations and terms • 1–3, page 1

Limitations • 1–4, page 1

 

Chapter 2

Responsibilities, page 1

The Under Secretary of Defense for Aquisition (USD (A)) • 2–1, page 1

Assistant Secretary of Defense (Health Affairs) (ASD (HA)) • 2–2, page 1

Assistant Secretary of the Army (Research, Development, and Aquisition) (ASA (RDA)) • 2–3, page 1

The Deputy Chief of Staff for Personnel (DCSPER) • 2–4, page 1

The Surgeon General • 2–5, page 1

Commander, Soldier Support Center—National Capital Region (SSC–NCR) • 2–6, page 1

Major Army commanders • 2–7, page 2

Commanders of RDTE organizations • 2–8, page 2

Other responsibilities • 2–9, page 2

 

Chapter 3

Research, page 2

General guidance • 3–1, page 2

Procedural guidance • 3–2, page 3

 

Appendixes

A. References, page 8

B. Guidelines for Preparation of Research Protocol and/or Test Plan, page 9

C. Human Use Committees, page 10

D. Expedited Review Categories, page 11

E. Instructions for the Completion of the Volunteer Agreement Affidavit, page 11

F. Exemptions, page 12

G. Legal Implications, page 13

H. Volunteer Data Base, page 13

Glossary

 

*This regulation supersedes AR 70–25, 25 September 1989. AR 70–25

 

Chapter 1 Introduction

 

1–1. Purpose

This regulation—

a. Prescribes Army policy on the conduct and management of human subjects in testing, including—

(1) Command responsibilities.

(2) Review process requirements.

(3) Approval authorities.

(4) Reporting requirements.

 

b. Allows a decentralized approval option for those elements that have established review committees and an internal review process.

 

1–2. References

Required and related publications and prescribed and referenced forms are listed in appendix A.

 

1–3. Explanation of abbreviations and terms

Abbreviations and special terms used in this regulation are explained in the glossary.

 

1–4. Limitations

a. Nothing in this regulation is intended to supersede requirements for health hazard or other safety review required by Department of the Army(DA) regulations.

 

b. Nothing in this regulation limits the authority of a health care practitioner to provide emergency care under laws that apply in the jurisdiction in which care is provided.

 

c. Protocols for the use of drugs or Schedule I controlled substances for investigational purposes will be approved as per AR 40–7.

 

d. The guidance in this regulation pertains to the following, regardless of whether conducted by DA, a contractor, grantee, or other agency utilizing Army funds:

(1) Biomedical research and behavioral studies involving human subjects.

(2) RDTE involving new drugs, vaccines, biologicals, or investigational medical devices.

(3) Inclusion of human subjects, whether as the direct object of research or as the indirect object of research involving more than minimal risk in the development and testing of military weapon systems, vehicles, aircraft, and other materiel. The determination of whether a research protocol involves more than minimal risk will be made by review committees established in accordance with paragraph 3–2b of this regulation.

(4) Research involving deliberate exposure of human subjects to nuclear weapons effect, to chemical warfare agents, or to biological warfare agents.

(5) Activities funded by non-Army resources in which the human subjects are DA military or civilian personnel.

 

e. See appendix F for a listing of research exempt from the requirements of this regulation.

 

Chapter 2 Responsibilities

 

2–1. The Under Secretary of Defense for Aquisition (USD (A))

In accordance with DOD Directive 3216.2, the USD (A) or designee will be the approval authority for studies involving the actual exposure of human subjects to nuclear weapons effect, chemical warfare agents, or biological warfare agents.

 

2–2. Assistant Secretary of Defense (Health Affairs) (ASD (HA))

In accordance with DOD Directive 3216.2, the ASD (HA) serves as the DOD representative on matters relating to implementation of Food and Drug Administration (FDA) regulatory requirements.

 

2–3. Assistant Secretary of the Army (Research, Development, and Aquisition) (ASA (RDA))

The ASA (RDA) will manage all DA RDTE activities, including those in which human use is planned.

 

2–4. The Deputy Chief of Staff for Personnel (DCSPER)

The DCSPER will—

 

a. Supervise and review RDTE activities under the Army Personnel Performance and Training Program.

 

b. Within established areas of responsibility, monitor RDTE involving human subjects to ensure implementation of policies contained in this regulation.

 

c. Approve or disapprove those studies involving alcohol and drug abuse programs.

 

2–5. The Surgeon General

The Surgeon General (TSG) will—

 

a . Prepare policies and regulation so n research using human subjects.

 

b. Establish and maintain the Human Subjects Research Review Board(HSRRB), chaired by the Assistant Surgeon General for Research and Development.

 

c. Establish and maintain the Human Use Review and Regulatory Affairs Office (HURRAO) attached to the U.S. Army Medical Research and Development Command (USAMRDC) and reporting to the Assistant Surgeon General for Research and Development.

 

d. Approve or disapprove research proposals from major Army Commands (MACOMs) that do not have a HUC or an internal review process.

 

e. Provide an evaluation of protocols as described in paragraphs 2–1 and 2–4, above, and 2–6, below, to the following heads of offices or command:

(1) The USD (A).

(2) The DCSPER.

(3) Upon request, the Commander, SSC–NCR.

 

f. Be the approval authority for studies and research protocols involving human subjects using Schedule I controlled drug substances.

 

g. Be the approval authority for research involving minors, or other vulnerable categories of human subjects, when subjects are wards of a State or other agency, institution, or entity.

 

h. Be the approval authority for MACOM or agency requests to establish a HUC and a human use review process.

 

i. Manage the Army’s Health Hazard Assessment Program and assess health hazards of medical and nonmedical materiel.

 

j. Direct medical followup, when appropriate, on research subjects to ensure that any long-range problems are detected and treated.

 

k. Report on a frequent basis, findings associated with classified investigational drug and device studies to the USD (A), the ASD (HA), and the FDA.

 

l. Be the approval authority for all in-house and contract research(other than that noted in paras 2–1, 2–2, 2–4, and 2–6) involving human subjects for which the Army has been designated the executive agent. Except for those categories of research noted above for which TSG is specifically designated as the approval authority, the authority to approve such research may be delegated by TSG within the military chain of command to the lowest level operating a human-subjects review process approved pursuant to paragraph 3–2b.

 

2–6. Commander, Soldier Support Center—National Capital Region (SSC–NCR)

The Commander, SSC–NCR, will be the approval authority in accordance with AR 600–46 for attitude and opinion surveys or Army occupational surveys.

 

 12–7. Major Army commanders

These commanders will—

a. Monitor RDTE involving personnel within their command to ensure effective implementation of the policies and procedures contained in this regulation.

 

b. Provide assistance to volunteer recruiting teams.

 

c. Ensure that only individuals who freely volunteer to participate are enrolled in research protocols or studies.

 

2–8. Commanders of RDTE organizations

These commanders will—

 

a. Ensure the effective implementation of the policies and procedures contained in this regulation.

 

b. Use the established review process through TSG’s HSRRB for all protocols and test plans or establish a HUC and implement review process consistent with the policies and procedures contained in this regulation.

 

c. Ensure that research volunteers are adequately informed concerning the risks associated with their participation, and provide them with any newly acquired information that may affect their well-being when that information becomes available.

 

d. Comply with AR 40–10, AR 70–10, AR 385–16, AR 602–1, and AR 602–2 in planning and conducting development and/or operational testing.

 

2–9. Other responsibilities

 

a. Members of the HSRRB will—

(1) Evaluate methods by which DA involves human subjects in research.

(2) Recommend policy to TSG on the treatment of volunteers consistent with current moral, ethical, and legal standards. (See app G for legal implications.)

(3) Evaluate research protocols and test plans submitted to TSG for approval.

 

b. The Chief of the HURRAO will—

(1) Provide, for TSG, administrative support for the HSRRB.

(2) Conduct a compliance review of all protocols submitted to TSG for approval.

(3) Submit DA-sponsored Notices of Claimed Investigational Exemption for a New Drug (INDs) and Investigational Device Exemptions (IDEs) directly to the FDA.

(4) Submit DA-sponsored New Drug Applications (NDAs) directly to the FDA.

(5) Maintain DA record files for IND and NDA submissions to the FDA.

(6) Conduct post-marketing surveillance for NDAs sponsored by DA.

(7) Serve as the DA point of contact for policies and regulations on human use in RDTE programs.

(8) Advise and assist MACOMs and DA staff agencies that conduct research or sponsor research by contracts and grants that involve the use of human volunteers.

 

c. Investigators will—

(1) Prepare a protocol following the policies and procedures in this regulation.

(2) Prepare adequate records on—

(a) Receipt, storage, use, and disposition of all investigational drugs, devices, controlled drug substances, and ethyl alcohol.

(b) Case histories that record all observations and other data important to the study.

(c) Volunteer informed consent documents (see app E). The principal investigator will fill in the information in parts A and B of DA Form 5303–R and inform the subject of each entry on the form.

(3) Prepare progress reports, including annual reports, as determined by the approving authority and regulatory agencies.

(4) Promptly notify the approving authority, through the medical monitor, and the HUC of adverse effects caused by the research.

(5) Report serious and/or unexpected adverse experiences involving the use of an investigational device or drug to the sponsor and the FDA in accordance with AR 40–7.

(6) Ensure that the research has been approved by the proper review committee(s) before starting, changing, or extending the study.

(7) Ensure that all subjects, including those used as controls, or their representatives are fully informed of the nature of the research to include potential risks to the subject.

(8) Ensure that investigational drugs or devices are administered only to subject sunder their personal supervision, or that of a previously approved associate investigator.

(9) Ensure that a new principal investigator (PI) is appointed if the previously appointed PI cannot complete the research (for example, permanent change of station (PCS), retirement, etc.).

(10) Apprise the HUC of any investigator’s noncompliance with the research protocol.

(11) Seek HUC approval for other investigators to participate in the research.

(12) Ensure that research involving attitude or opinion surveys are approved in accordance with AR 600–46 (3–2c(5) below).

 

d. Volunteer recruiting teams.

Members will—

(1) Establish volunteer requirements prior to recruitment.

(2) Coordinate recruiting activities with unit commanders.

(3) Undertake recruiting in a moral, ethical, and legal manner.

 

e. Medical monitor. The medical monitor is responsible for serving as advocate for the medical safety of volunteers. The monitor will have responsibilities as determined by the approving official and the authority to suspend or terminate the effort consistent with the policies and procedures contained in this regulation.

 

Chapter 3 Research

3–1. General guidance

a. Only persons who are fully informed and volunteer in advance to take part may be used as subjects in research;except, when the measures used are intended to be beneficial to the subject, and informed consent is obtained in advance from a legal representative on the subject’s behalf.

 

b. Nothing in this regulation is intended to limit the authority of a health care practitioner to provide emergency medical care under applicable law of the jurisdiction in which care is provided.

 

c. Any human tissue or body fluid, obtained by autopsy, and used in research will be donated for such purpose. The donor will be the next of kin or legal representative of such person.Donation is made by written consent and relinquishes ownership and/or rights to the tissue or fluid. Consent to donate will not preclude payment for such donation. Organ donation intended for transplant will be accomplished in accordance with AR 40–3, chapter 18.

 

d. Any tissue or body fluid linked by identifiers to a particular person, obtained by surgical or diagnostic procedure and intended for use in research will be donated for such purpose.The donor will be the person from whom the tissue or fluid is removed or, in the event of death or legal disability of that person, the next of kin or legal representative of such person.Donation is made by written consent and relinquishes ownership and/or rights to the tissue or fluid. Consent to donate does not preclude payment for such donation.

 

e. The determination of level of risk in a research protocol will be made by a HUC established in accordance with this regulation. (See app G for a complete listing of legal implications.)

 

f. Moral, ethical, and legal concepts on the use of human subjects will be followed as outlined in this regulation. Voluntary consent of the human subject is essential. Military personnel are not subject to punishment under the Uniform Code of Military Justice for choosing not to take part as human subjects. Further, no administrative sanctions will be taken against military or civilian personnel for choosing not to participate as human subjects.

 

g. RDTE using human subjects is conducted in such a manner that risks to the subjects are minimized and reasonable in relation to anticipated benefits.

 

h. The proposed number of subjects is the minimum needed to ensure a statistically valid conclusion.

 

i. The research is conducted in such a manner as to avoid unnecessary physical and mental suffering. Preparations are made and adequate facilities provided to protect the subject and investigators against all foreseeable injuries, disabilities or death. Such research is not to be conducted if any reason exists to believe that death or injury will result.

 

j. Volunteers are given adequate time to review and understand all information before agreeing to take part in a study.

 

k. Volunteers are authorized all necessary medical care for injury or disease that is a proximate result of their participation in research.

(1) Medical care for civilian employees who volunteer and who perform duty as a volunteer during their regularly scheduled tour of duty will be provided in accordance with AR 40–3.

(2) Medical care costs for all other categories of personnel, who under the provisions of AR 40–3 are routinely authorized care in a military MTF will be waived for the volunteer while in the hospital, if the volunteer would not normally enter the hospital for treatment but is requested to do so to facilitate the research. This also applies to a volunteer’s extension of time in a hospital for research when the volunteer is already in the hospital.

(3) Subsistence charges for all other categories of personnel, except for active duty and retired commissioned officers, may be waived in the circumstances noted in (2) above. The costs for subsistence charges for commissioned officers may be reimbursed to the officer by the research organization.

(4) Costs of medical insurance coverage or direct charges for medical care for volunteers participating in research performed by a contract or grant may be negotiated between the DA contracting officer and the contractor or grantee. (See app G.)

 

l . Information obtained during, or as a result of, an epidemiologic-assessment interview with a human immunodeficiency virus (HIV) serum positive member of the Armed Forces may not be used to support any adverse personnel action against the member. (See glossary for definition of the terms “epidemiologic-assessment interview,” “serum positive member of the Armed Forces,”and “adverse personnel action.”)

 

m. Research may be conducted outside the United States that involves non-U.S. citizens (for example, research on diseases of military interest, such as malaria, that are not endemic to the United States). However, in the conduct of such research, the laws, customs and practices of the country in which the research is conducted or those required by this regulation, whichever are more stringent, will take precedence. The research must meet the same standards of ethics and safety that apply to research conducted within the United States involving U.S. citizens, and will be conducted in accordance with applicable international agreements.

 

n. The use of prisoners of war and detainees as human research subjects is prohibited. o. Minors may be enrolled as human research subjects when the following conditions are met:

(1) The research is intended to benefit the subject, and any risk involved is justified by the expected benefit to the minor.

(2) The expected benefits are at least as favorable to the minor as those presented by available alternatives.

(3) A legally authorized representative has been fully informed and voluntarily consents, in advance, for the minor to participate in the research.

(4) The minor, if capable, has assented in writing.In determining whether the minor is capable of assenting, the HUC will consider the minor’s age, maturity, and psychological state. The HUC may waive assent for some or all minors involved in the study if it determines that the—

(a) Capability of some or all of the minors is so limited that they cannot be reasonably consulted, or

(b) Procedure involved in the research holds out a prospect for direct benefit that is important to the health or well-being of the minor, and is available only in the context of research.

 

p. The personnel responsible for the conduct of the research are the best qualified to recruit volunteers for a study and should be the primary recruiters whenever possible.

 

q. Only persons judged qualified by the appropriate approving official will conduct research involving human subjects.

 

r. A medical monitor is appointed by name if the HUC or approving official determines that the risk is more than minimal. A medical monitor may be appointed to minimal risk or less than minimal risk studies if so determined by the HUC or approving authority. The principal investigator may function as medical monitor only in situations where no other physician is reasonably available and approval for the principal investigator to function as medical monitor is granted by TSG. Requests for the principal investigator to function as the medical monitor will be sent to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012.

 

s. Safeguards or special conditions imposed on a protocol by a HUC may not be reduced or waived by the approving official upon approval of the protocol. The approving official may require additional safeguards, may disapprove the protocol, or may refer it to a higher review and approving authority.

 

t. User testing, as defined in AR 71–3, which involves the use of volunteers, is reviewed and approved by a HUC established in accordance with this regulation.

 

u. Research on medical devices is conducted in accordance with Part 812, Title 21, Code of Federal Regulations (21 CFR 812)

 

v. Emergency one-time use of an investigational drug or medical device is accomplished to the extent permitted under applicable law and in accordance with AR 40–7.

 

w. Public Affairs guidelines on the release of information are in AR 360–5.

 

3–2. Procedural guidance

a. Duties. MACOM commanders and organization heads conducting RDTE research involving human subjects will—

(1) Publish directives and regulations for—

(a) Protocol and/or test plan preparation (see app B).

(b) The use of volunteers as subjects of research conducted or sponsored by the organization.

(c) The procedures for reporting and responding to reports of improper use of volunteers as subjects of research conducted or sponsored by the organization.

(d) The procedures to assure that the organization can accomplish its “duty to warn” (see para 3–2h for a discussion of “duty to warn”).

(2) Forward one copy of published regulations and directives(see (1) above) to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012, within 60 days of publication.

(3) Establish a HUC, if appropriate (see bbelow).

(4) Establish a system that permits the identification of volunteers who have participated in research conducted or sponsored by that command or organization. Such a system will be established in accordance with AR 340–21. (App H describes data elements which could comprise such a system.)

 

b. Establishing a HUC. As noted in paragraph 2–8b, commanders or heads of RDTE organizations will either use TSG’s HSRRB or implement their own HUC.

(1) HUCs will be established for research conducted by DA in accordance with appendix C.

(2) Institutional review boards will be established by contractors or grantees in accordance with 45 CFR 46.

(3) RDTE organizations which establish an internal review process will forward the items listed below to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012.

(a) See a(2) above.

(b) A listing of the membership of the HUC and the curriculum vitae for each member.                    

(4) Newly established HUCs may not review research protocols until the items in (a) and (b) above are reviewed and approved by TSG.

 

c. Protocol and/or test plan review before submission to a HUC.

(1) A protocol or test plan will be prepared for all research requiring approval pursuant to this regulation. Certain studies may be exempt(see app F). The format in appendix B should be followed, but may be modified to meet local requirements. DA Pam 70–21 and DA Pam 71–3 provide guidance for preparation of test plans and equivalent documents. Protocols and test plans are exempt from management information requirements per AR 335–15, para 5–2b. An informed consent document will be prepared using DA Form 5303–R (Volunteer Agreement Affidavit), or functional equivalent, in accordance with appendix E (see d below). DA Form 5303–R will be reproduced locally on 8 1 ⁄2- by 11-inch paper. A copy for reproduction is located at the back of this regulation.

(2) If a study calls for the use of tissue or fluids obtained from a human, and is not an exempt study as defined by appendix F, paragraph e, then a protocol is prepared.The following must be considered in determining whether informed consent is required.

( a ) Fluid or tissue obtained at autopsy : informed consent is required.

(b) Fluid or tissue obtained at surgery or as the result of a diagnostic procedure and linked by identifiers directly or indirectly to a particular person intended for research: informed consent is required.

(c) Fluid or tissue obtained at surgery or as the result of a diagnostic procedure not intended for research and not linked by identifiers: no informed consent is required.

(d) Fluid or tissue obtained from a tissue or blood bank which is linked to a personal identifier and the research data is recorded in such a manner as to identify the donor: informed consent is required.

(e) Fluid or tissue obtained from a tissue or blood bank, which is linked to a personal identifier, but the research data is recorded in such a manner that the donor’s identity is unknown: no informed consent is required.

(f) Fluid or tissue obtained from a tissue or blood bank which is not linked to a personal identifier: no informed consent is required. Note. (The informed consent document used in these cases may be the DA Form 5303–R, an overprinted consent for surgery or autopsy, or other form approved by the HUC and the forms management office at the organization.)

(3) The protocol or test plan is submitted to a scientific review committee composed of individuals qualified by training and experience, and appointed by the commander of the unit to evaluate the validity of the protocol. The purpose of this peer review is to assure that the protocol design will yield scientifically useful data which meets the objective(s) of the study. The committee recommendations and actions taken by the investigator in response to the recommendations are submitted with the protocol to the HUC.

(4) When applicable, the protocol or test plan will be submitted to the radioisotope/radiation control committee, or equivalent, established in accordance with TB MED 525. The committee recommendations and actions taken by the investigator in response to those recommendations are submitted with the protocol to the HUC.

( 5 ) When applicable, the protocol will be submitted to the SSC–NCR for research which calls for the use of an attitude or opinion survey, as defined by AR 600–46 . If such studies are planned, the SSC–NCR must be contacted to determine whether the survey requires approval of that Center. This information should accompany the proposal when it is submitted for review.Surveys that cross command lines or are sent to other Services require approval. Inquiries should be directed to Commander, SSC–NCR, Attitude and Opinion Survey Division, ATTN: ATNC–MOA,200 Stovall Street, Alexandria, VA 22332–0 400 (AUTOVON221–9680).

 

d. Informed consent documentation. The subject’s agreement to participate in the study will be documented using DA Form 5303–R, or functional equivalent, in accordance with appendix E. If additional pages are required, plain bond paper will be used and each page will be initialed by the volunteer and the witness. This form is not appropriate for research performed by contract. The volunteer agreement will be written in language that is easily understood by the subject. In research conducted outside the United States involving non-U.S. citizens, a locally produced form in the subject’s native language may be used. An English translation of the form will be provided to the HUC.

 

e. Protocol and/or test plan review after submission to the local HUC.

(1) HUC actions.

(a) The HUC determines the level of risk associated with the protocol or test plan.

(b) The HUC may make the following recommendations to the approving authority: Approved, approved with modification, defer review to higher authority, disapproved, or exempt from further human use review.

(c) The HUC requires that the information given to subjects as a part of the informed consent is in accordance with the applicable portions of appendix E. The committee may require that information, in addition to that specifically mentioned in appendix E, be given to the subject when, in the HUC’s judgement, the information would meaningfully add to the protection of the rights and welfare of the subject.

(d) The HUC reviews research involving minors. The committee will determine if assent is required and establish the method documenting such assent. The committee may waive the requirement for assent provided the HUC finds and documents that the research could not practicably be carried out without the waiver (see para 3–1o(4)).

(e) The HUC reviews research involving wards of a State agency, and other vulnerable categories of human subjects. The HUC determines if the use of such a category of subjects is warranted.If, in the opinion of the committee, the use of this category of subjects is appropriate, then the protocol is forwarded through command channels to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012, for approval.

(f) The HUC conducts a continuing review of the research approved by the HUC at intervals appropriate to the level of risk, but at least annually. The format for the review (for example, progress report from the investigator) will be determined by the HUC.

(g) A HUC reviews research involving medical devices.If, in the opinion of the HUC, the device does not pose a significant risk to the research subject, the organization will not be required to submit an IDE to the FDA.

(h) Certain categories of research may be reviewed by the HUC using the expedited review procedures in gbelow.

(i) Exempt categories of research are discussed in appendix F.

(2) Approving official actions. Approving officials—

(a) Will accept or reject the recommendations of the HUC. Safeguards or special restrictions imposed on a protocol by a HUC may not be reduced or waived by approving officials upon approval of the protocol or test plan.

(b) May require additional safeguards, may disapprove the protocol or test plan, or may refer it to a higher review committee and approving authority.

(c) Appoint a medical monitor (see glossary) for all studies that are greater than minimal risk.

(d) Obtain a health hazard assessment prior to approving a research protocol or test plan involving human subjects in the operation of military materiel.

(e) Notify the investigator of their decision to approve or disapprove the research proposal, or of modifications required to secure approval.

(f) Ensure the continued evaluation of research programs by the program or project manager or equivalent official to assure that the policies and procedures established by this regulation are being followed.

(g) Will, when higher approval authority is required, forward two copies of the research protocol or test plan, informed consent documentation (DA Form 5303–R, or functional equivalent if applicable), all minutes of committees reviewing the protocol, and the commander’s recommendations through command channels to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Comm and, ATTN: SGRD–HR, Fort Detrick, Frederick, M D 21701–5012.

 

f. Actions taken by an organization without a local HUC.

(1) The investigator accomplishes the actions noted in c above.

(2) The commander or organizational head accomplishes the actions noted in e(2)(d) above, and forwards the protocol with his or her recommendations, through the military chain of command, to the next level of command having an approved HUC.

 

g. Expedited review procedures. These procedures are as follows:

(1) Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the categories listed at appendix D may be reviewed by the HUC through the expedited review procedure.

(2) The HUC may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Under an expedited review procedure, the HUC chairman or one or more HUC reviewers designated by the chairman may carry out the review. The reviewers may exercise all of the authorities of the HUC except that of disapproval. Research may be disapproved only after review according to the nonexpedited procedure in e above.

(3) Each HUC using an expedited review procedure adopts a method for keeping all members and the commander advised of approved proposals.

(4) The approving official may restrict, suspend, or end a HUC’s use of the expedited review procedure when necessary to protect the rights or welfare of subjects.

 

h. Duty to warn. Commanders have an obligation to ensure that research volunteers are adequately informed concerning the risks involved with their participation in research, and to provide them with any newly acquired information that may affect their wellbeing when that information becomes available.The duty to warn exists even after the individual volunteer has completed his or her participation in research. To accomplish this, the MACOM or agency conducting or sponsoring research must establish a system which will permit the identification of volunteers who have participated in research conducted or sponsored by that command or agency, and take actions to notify volunteers of newly acquired information. (See a above.)

 

i. Determining responsibility for review of protocols when more than one DOD or DA component is involved. The commander will determine primary responsibility based upon consideration of whether the subjects are inpatients or outpatients of a DOD medical treatment facility (MTF); whether the study is conducted in-house or by contract; or whether the prospective subjects are members of a DOD component.

(1) When the research, regardless of in-house or contract status, involves use of patients in a DOD MTF, the component to which t h e MTF belongs organizationally will have primary responsibility;except as provided in (3) below.

(2) For research not involving the use of inpatients at a DOD MTF, primary responsibility rests as follows:

(a) If the research is done on grant or contract, primary responsibility rests with the component providing funds.

(b) If research is conducted in-house, primary responsibility rests with the component to which the principal investigator is assigned.

(c) If research is not funded by a DOD or DA component and there is no DOD or DA principal investigator, primary responsibility rests with the component to which the prospective human subject is assigned.

(3) Studies funded by the Uniformed Services University of the Health Sciences (USUHS) or the Defense Nuclear Agency are reviewed and approved in accordance with policies established by the funding activity, and DODD 3216.2.

 

j. Records. Organizations or agencies conducting research involving volunteers will maintain records in accordance with AR25–400–2, which are pertinent to the research conducted.These records will include, at a minimum—

(1) Documentation of approval to conduct the study.

(2) A copy of the approved protocol or test plan.

(3) The volunteer’s signed informed consent (for example, DA Form 5303–R).

(4) A summary of the results of the research, to include any untoward reactions or occurrences. (See app H for a discussion of the composition of the Volunteer Data Base.)

 

k. Contractors or grantees. Contractors or grantees holding an approved Department of Health and Human Services(DHHS) Form HHS 596 (Protection of Human Subjects Assurance/Certification/ Declaration) are considered in compliance with this regulation. (See fig 3–1 for sample DHHS Form HHS 596.) In the absence of such an assurance, a special assurance will be negotiated by the contracting officer with the contractor or grantee. Organizations can verify that a contractor has a valid DHHS Form HHS 596 by contacting the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S.Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012. Even though a contractor has a review process which is consistent with Federal law (that is, 45 CFR 46), it is incumbent upon the approving official to administratively review the protocol to assure that it complies with the policies established in this regulation.

 

l. Technical reports and publications.

(1) Technical reports will be prepared in accordance with AR 70–31 and follow the format established in MIL–STD 847B or its revisions.

(2) Publications regarding the results of DA conducted research will be released by the approving official in accordance with the provisions of AR 360–5 and will contain the following statement: “The investigators have adhered to the policies for protection of human subjects as prescribed in AR 70–25.”

(3) Publications regarding the results of DA sponsored research conducted by contract or grant will note adherence with 45 CFR 46, as amended. m. Requests for exceptions to policy. Requests for exceptions to policy are submitted to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012. Requests will then be submitted to TSG’s HSRRB for evaluation and recommendation to TSG; and TSG’s recommendation to the ASD (HA) or USD(A), as appropriate. AR

 

Appendix A References

 

Section I Required Publications

 

AR 25–400–2

The Modern Army Recordkeeping System (MARKS). (Cited in paras 3–2j and C–6b.)

 

AR 40–3

Medical, Dental, and Veterinary Care. (Cited in para 3–1cand k.)

 

AR 40–7

Use of Investigational Drugs in Humans and the Use of Schedule I Controlled Drug Substances. (Cited in paras 1–4c,2–9c(5), and 3–1v.)

 

AR 40–10

Health Hazard Assessment Program in Support of the Materiel Acquisition Decision Process. (Cited in para 2–8d.)

 

AR 70–10

Test and Evaluation During Development and Acquisition of Materiel.(Cited in para 2-8d and the glossary.)

 

AR 70–31

Standards for Technical Reporting. (Cited in para 3-2l(1).)

 

AR 71–3

User Testing. (Cited in para 3-1t.)

 

AR 335–15

Management Information Control System. (Cited in para 3-2c(1).)

 

AR 340–21

The Army Privacy Program. (Cited in paras 3-2a(4) and H-1.)

 

AR 360–5

Army Public Affairs, Public Information (Cited in paras 3-1w and 3- 2l(2).)

 

AR 385–16

System Safety Engineering and Management.(Cited in para 2-8d.)

 

AR 600–46

Attitude and Opinion Survey Program. (Cited in paras 2-6, 2-9c(12), and 3-2c(5).)

 

AR 602–1

Human Factors Engineering Program. (Cited in para 2-8d.)

 

AR 602–2

Manpower and Personnel Integration (MANPRINT) in Materiel Acquisition Process. (Cited in para 2-8d.)

 

DA Pam 70–21

The Coordinated Test Program. (Cited in para 3-2c(1).)

 

DA Pam 71–3

Operational Testing and Evaluation Methodology and Procedures Guide.(Cited in para 3-2c(1).)

 

MIL–STD 847B

Format Requirements for Scientific and Technical Reports Prepared by or for the Department of Defense. (Cited in para 3-2l(1).) (This publication is available from the Naval Publications and Forms Center,5801 Tabor Avenue, Philadelphia, PA 19120-5099 using DD Form 1425(Specifications and Standards Requisition).)

 

TB MED 525

Occupational and Environmental Health Control of Hazards to Health from Ionizing Radiation Used by the Army Medical Department. (Cited in para 3-2c(4).)

 

Section II Related Publications

A related publication is merely a source of additional information. The user does not have to read it to understand this regulation.

 

AR 11–2

Internal Control Systems AR 40–38 Clinical Investigation Program

 

AR 40–66

Medical Record and Quality Assurance Administration

 

AR 70–14

Publication and Reprints of Articles in Professional Journals

 

AR 70–65

Management of Controlled Substances, Ethyl Alcohol, and Hazardous Biological Substances in Army Research, Development, Test, and Evaluation Facilities

 

AR 600–50

Standards of Conduct for Department of the Army Personnel

 

AR 611–3

Army Occupational Survey Program (AOSP)

 

DODD 3216.2

Protection of Human Subjects in DOD-Supported Research. (To obtain this publication, see MIL-STD 847B, sec I, above.)

 

DODD 6465.2

Organ Disposition After Autopsy. (To obtain this publication, see MIL-STD 847B sec I, above.)

 

FM 3–9/AFR 355–7

Military Chemistry and Chemical Compounds

 

DHHS Regulation, 45 CFR 46

Protection of Human Subjects. (This publication is available from Commander, USAMRDC, ATTN: SGRD-HR, Fort Detrick, Frederick, MD 21701-5012.)

 

FDA Regulation 21 CFR subchapters A, D, and H

Food and Drugs. (This publication is available for reference at the local installation staff judge advocate office.)

 

Memorandum of Understanding between the FDA and DOD

Investigational Use of Drugs by Department of Defense, May 21, 1987. (This publication is available from the Commander, USAMRDC, ATTN: SGRD-HR, Fort Detrick, Frederick, MD 21701-5012.)

 

10 USC 980

Limitation on the Use of Humans as Experimental Subjects.(This publication is available for reference at the local installation staff judge advocate office.)

 

10 USC 1102

Restriction on the Use of Information Obtained During Certain Epidemiologic-Assessment Interviews. (This publication is available for reference at the local installation staff judge advocate office.)

 

Unnumbered Publication

Convention on the Prohibition of the Development, Production, and Stockpile of Bacteriological (Biological) and Toxin Weapons and on their Destruction, Article I. (This article is printed as a part of the publication entitled “Arms Control and Disarmament Agreements: Text and Histories of Negotiations”, and is available from the U.S. Arms Control and Disarmament Agency, Washington, D.C. 20451.)

 

Section III Prescribed Forms

DA Form 5303–R

Volunteer Agreement Affidavit. (Prescribed in para 3-2c(1).)

 

Section IV Referenced Forms

 

DD Form 1425 Specifications and Standards Requisition

 

DHHS Form HHS 596

Protection of Human Subjects Assurance/Certification/ Declaration.(Only the contractor or grantee will obtain and use this form. This form after approval, however, is shown to the contracting officer as proof of the contractor’s or grantee’s compliance with this regulation. See para 3-2k, fig 3-1, and the glossary.)

 

Appendix B Guidelines for Preparation of Research Protocol and/or Test Plan

 

B–1. Project title

Enter complete project title. (If an amendment, the words “Amendment to. . . . . .” must precede the project title.)

 

B–2. Investigators

a. Principal investigator.

b. Associate investigators.

 

B–3. Location of study

List of facilities to be used.

 

B–4. Time required to complete

Give month and year of expected start and completion dates.

 

B–5. Introduction

a. Synopsis.

(1) One-page summary of proposed study similar to the abstract of a scientific paper.

(2) Major safety concerns for human subjects briefly highlighted.

 

b. Military relevancy. Explain briefly the medical importance and possible usefulness of the project.

 

c. Objectives. State briefly, but specifically, the objectives of the project. Include items below when applicable.

(1) Study design.

(2) Type of subject population observed. d. Status. State what has been accomplished or published in the proposed area of study. Describe the way in which the project will relate to, or differ from, that which has been accomplished.

 

e . Bibliography. List all references used in preparing the protocol.

 

B–6. Plan

 

Outline expected accomplishments in enough detail to show a clear course of action. Include technological validity of procedures and chronological steps to be taken. The plan should include, as a minimum, the information shown below on the study subjects.

 

a. Number of subjects. Give the total number of subjects expected to complete the study.

 

b. Age range.

 

c. Sex.

 

d. Inclusion criteria. Specific and detailed reasons for inclusion should be presented.

 

e. Diagnostic criteria for entry.

 

f. Evaluations before entry. Entries should include x ray, physical examinations, medical history, hematology, chemistry, and urinalysis as deemed appropriate.

 

g. Exclusion criteria. Include a complete list detailing the subjects, diseases, and medications that are excluded from the study.

 

h. Source of subjects. Describe briefly where the subjects will be obtained.

 

i. Subject identification. Describe the code system used.

 

j. Analysis of risks and benefits to subjects; risks to those conducting research.

 

k. Precautions to be taken to minimize or eliminate risks to subjects and those conducting the research.

 

l. Corrective action necessary.

 

m. Special medical care or equipment needed for subjects admitted to the project.

 

B–7. Evaluations made during and following the project

An evaluation may also be represented by using a project schematic. It is very important to identify in the protocol the person who will perform the evaluations below.

a. Specimens to be collected.

(1) Amount and schedule of collections.

(2) Evaluations to be made on specimens.

(3) Storage. State where and if special conditions are required.

(4) Labeling and disposition.

(5) Laboratories performing evaluations.

(6) Special precautions for subject and investigators.

 

b. Clinical assessments. Include how adverse effects are to be recorded.

 

c. Vital signs. When desired and frequency.

 

d. Follow up procedures .

 

e. Disposition of data. State location and duration of storage.

 

f. Methods used for data collection. State critical measurements used as end points to characterize safety, efficacy, or equivalency.

 

B–8. Departure from protocol for individual patients

a. When allowed. Use flexible but definite criteria.

 

b. Who will be notified. (For example, patient, HUC, approving official.)

 

B–9. Incidents

a. Definition of incidents.

 

b. Immediate reporting.

 

c. Routine reporting.

 

B–10. Modification of protocol

Describe the procedure to be followed if the protocol is to be modified, terminated, or extended.

 

B–11. Examples of all forms to be used in the protocol

 

B–12. Use of information and publications arising from the study

 

B–13. Special or unusual funding implications

 

B–14. Name and telephone number of the medical monitor, when applicable

 

B–15. Human use committee

Brief explanation of which HUC will provide initial, continued, and annual review.

 

B–16. Signature of appropriate approving official and date

 

B–17. Documentation

a. Completed DA Form 5303–R.

 

b. Institutional review of scientific and human use issues.

 

c. HUC review with commander’s approval.

 

d. Biographical sketch of principal and associate investigators.

 

Appendix C Human Use Committees

 

C–1. Membership

 

a. Membership will include only full-time Federally employed persons.

 

b. Each HUC will have at least five members. Members will have diverse backgrounds to ensure thorough review of research studies involving human volunteers as research subjects. Members should be sufficiently qualified through experience and expertise. The racial and cultural backgrounds of members and their sensitivity to such issues as community attitudes should ensure respect for their advice and counsel in safeguarding the rights and welfare of human subjects.

 

c. Besides having the professional competency to review research studies, the HUC will be able to determine if the proposed research is acceptable. Acceptability will be in terms of Army Medical Department (AMEDD) commitments and regulations, applicable law, and standards of conduct and practice. A HUC may review research periodically that involves vulnerable categories of human subjects (for example, those individuals with acute or severe physical or mental illness; or those who are economically or educationally disadvantaged). Therefore, it will include one or more persons concerned primarily with the welfare of these subjects.

 

d. Normally, no HUC may consist entirely of men or women, or members of one profession. However, the approving official may waive this requirement in those cases in which compliance is impractical.

 

e. Each HUC will include at least one member whose primary concerns are nonscientific; for example, lawyers, ethicists, and members of the clergy.Should a given proposal include more than minimal risk, a physician will be included as an ad hoc member of the committee.

 

f. Each HUC will include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution. This requirement may be met by appointing a member of an institution or organizational unit not subject to the immediate authority of the approving official.

 

g. Except to provide information requested by the HUC, no HUC member may take part in a review of any project in which the member serves as the principal investigator or associate investigator. h. A HUC may invite persons with special competence to assist in the review of complex issues that require expertise beyond that available on the HUC. These persons may not vote with the HUC.

 

i. The approving official may not be a member. The approving official may not approve research for which he or she is also a principal or associate investigator. A higher echelon of command must review and approve such research projects.

 

C–2. Functions and operations

Each HUC—

 

a. Will observe written procedures for the following:

(1) Conducting the initial and continuing review of the research.Included are reporting findings and actions to the investigator and the approving official.

(2) Determining those projects that must be—

(a) Reviewed more often than yearly.

(b) Verified from sources other than the investigators, that no material changes have occurred since the previous HUC review.

(3) Ensuring prompt reporting to the HUC of proposed changes in the research. Each HUC will ensure that changes in approved projects (during the period for which approval has already been given) are not initiated without HUC review except to eliminate immediate hazards to the subject.

(4) Ensuring prompt reporting to the HUC and approving official of unexpected problems involving risks to the subjects or others.

 

b. Will review proposed protocols at meetings attended by a majority of members except when an expedited review is used (see C–3 below). For the protocol to be approved, it will receive the approval of a majority of those members present.

 

c. Will report to the approving official any serious or continuing noncompliance with HUC requirements and determinations found by investigators.

 

d. Will conduct continuing review of research studies at intervals proper to the degree of risk, but not less than once per year.

 

e. Will have the authority to observe or have a third party observe the consent process and the investigation.

 

f. Will maintain a current list of HUC members. Members will be identified by name, earned degrees, representative capacity and, experience such as board certificates and licenses. The information will be complete enough to describe each member’s chief expected contributions to HUC reviews.Any employment or other relationship between members and the institution will be noted.

 

g. May recommend safeguards or special conditions to a protocol.If the HUC does so, the approving official may take the following action:

(1) Not reduce the safeguards or conditions if he or she approves the protocol.

(2) Require additional safeguards.

(3) Disapprove the protocol.

(4) Refer the protocol to a higher echelon approving authority and review committee.

 

C–3. Expedited review procedures

a. See appendix D for a list of categories of investigations that the HUC may review in an expedited review procedure.

 

b. See paragraph 3–2g for the expedited review procedure that the HUC will follow.

 

C–4. Criteria for HUC approval of activities/investigations requiring volunteers

a. In evaluating risks and benefits for research investigations, the HUC should consider only those that may result from the investigation.

 

b. To approve investigations covered by this regulation, the HUC will determine that all of the requirements below are met.

(1) Risks to subjects are minimized by using procedures that are—

(a) Consistent with sound investigation design and do not unnecessarily expose subjects to risk.

(b) Already being used on the subjects for diagnosis or treatment, when appropriate.

(2) Risks to subjects are reasonable in relation to anticipated benefits to subjects.

(3) In making an assessment for the selection of subjects, the HUC should take into account the— (a) Purpose of the investigation. (b) Setting in which the research investigation will be conducted.

(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.

(5) Informed consent will be properly documented.

(6) The plan makes adequate provision for monitoring the data collected to ensure the safety of subjects when appropriate.

(7) Adequate provisions exist to protect the privacy of subjects and to maintain the confidentiality of data when appropriate. c. Some or all of the subjects may be vulnerable to coercion or undue influence such as persons with acute or severe physical or mental illness, or those who are economically or educationally disadvantaged. If so, proper additional safeguards will be included in the study to protect the rights and welfare of these subjects.

 

C–5. Suspension or termination of approved research investigation

a. A HUC will have the authority to suspend or end an approved investigation that—

(1) Is not being conducted according to the HUC’s requirements.

( 2 ) Has been associated with unexpected serious harm to subjects.

 

b. Suspensions or terminations of research will include a statement of the reasons for the HUC’s action. They will be reported promptly to the principal investigator and approval official.

 

C–6. HUC records

a. A HUC will prepare and maintain adequate documents on HUC activities, including—

(1) Copies of all protocols reviewed, scientific evaluations that accompany the proposals, approved sample consent documents, progress reports submitted by investigators and reports of injuries and adverse reactions.

(2) Minutes of HUC meetings showing attendance; actions taken by the HUC; the vote on these actions, including the number of members voting for, against, and abstaining on a decision; the basis for requiring changes or disapproving the investigation; and a written summary of the discussion of controverted issues and their resolution.

(3) Records of continuing review activities.

( 4 ) Copies of all correspondence between the HUC and the investigators.

(5) A list of HUC members.

(6) Written procedures for the HUC.

(7) Statements of significant new findings.

 

b. The records required by this regulation will be retained permanently (see AR 25–400–2). Such records will be reasonably accessible for inspection and copying by authorized DA personnel and representatives of the FDA.

 

C–7. Conflict of interest

a. It is essential that the members of the HUC continue to be perceived and, in fact, are free from conflict of interest in their daily duties and especially in regards to the protocols they review.

 

b. The issue of conflict of interest has been addressed by public law, DOD directive, and Army regulation. The situations discussed below are merely examples of the types of activities and relationships which may result in conflict or the appearance of conflicts of interest. They are by no means the only ways that conflicts arise.

(1) The potential for personal or financial gain. A committee member who is deliberating a protocol which is to be performed by a contractor, in which the member or a member of his or her immediate family is a corporate officer, stockholder, consultant or employee, could be accused of conflict of interest if he or she voted on the protocol, regardless of his or her vote.

(2) The potential for personal reward. A committee member who is affiliated with a protocol in the capacity of principal, associate or co-investigator, could be accused of conflict of interest if he or she voted on the protocol, regardless of his or her vote.

(3) Command influence. The mission (for example, the purpose of the research) should not override or obscure its methods. It is imperative that the committee, through its members, continue to be recognized as a reasonable, deliberative body, whose bias is the safety and welfare of the research subject.It is incumbent upon each committee member to assure his or her concerns regarding the moral, ethical, and legal issues of each protocol are answered to his or her satisfaction before voting according to his or her conscience.

 

c. Commanders and organizational heads will establish a method to ensure that each committee member is familiar with the pertinent laws and regulatory guidance regarding conflict of interest.

 

C–8. Legal review

 

Prior to establishing a HUC, the commander or organizational head will obtain legal counsel from the staff judge advocate.

 

Appendix D Expedited Review Categories

D–1. Hair, nails, teeth

Collection of—

a. Hair and nail clippings in a nondisfiguring way.

 

b. Deciduous teeth.

 

c. Permanent teeth if patient care indicates a need for extraction.

 

D–2. Excreta and secretions

Collection of—

a. Excreta and external secretions including sweat and uncannulated saliva.

 

b. Placenta at delivery.

 

c. Amniotic fluid at the time of rupture of the membrane before or during labor.

 

D–3. Physical data

Recording of data from subjects who are 18 years of age or older, using noninvasive procedures routinely employed in clinical practice. This category—

a. Includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy.

 

b. Includes such procedures as—

(1) Weighing.

(2) Electrocardiography.

(3) Electroencephalography.

(4) Thermography. (5) Detection of naturally occurring radioactivity. (

6) Diagnostic echography.

(7) Electroretinography. c. Does not include exposure to electromagnetic radiation outside the visible range (for example, x rays or microwaves).

 

D–4. Blood

 

Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an 8-week period and no more often than two times per week.Subjects will be 18 years of age or older, in good health, and not pregnant.

 

D–5. Dental plaque and calculus

 

Collection of both supragingival and subgingival dental plaque and calculus.The procedure must not be more invasive than routine prophylactic scaling of the teeth. The process must be accomplished according to accepted prophylactic techniques.

 

D–6. Voice records

 

Voice recordings made for research purposes such as investigations of speech defects.

 

D–7. Exercise

 

Moderate exercise by healthy volunteers. D–8. Existing data Study of existing data, documents, records, or pathological or diagnostic specimens.

 

D–9. Behavior

 

Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subject’s behavior and research will not involve stress to subjects.

 

Appendix E Instructions for the Completion of the Volunteer Agreement Affidavit

 

E–1. Title and location

The title of the study and place where it is to be conducted.

 

E–2. Principal investigator

The name of the principal investigator conducting the study.

 

E–3. Description of the study

A statement that the study involves research. An explanation of the purpose of the study and the expected duration of the subject’s participation. A description of the procedures to be followed. An identification of any experimental procedures. A statement giving information about prior, similar, or related studies that provide the rationale for this study.

 

E–4. Risks

A description of any reasonably foreseeable risks or discomforts to the subject.

 

E–5. Benefits

A description of the benefits, if any, to the subject or to others that may reasonably be expected from the study. If there is no benefit to the subject, it should be so stated.

 

E–6. Alternative treatment

When applicable, a disclosure of proper alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

 

E–7. Confidentiality

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Also, in the case of an investigational drug or medical device protocol, a statement noting that the FDA may inspect the records. If the study is being performed by a contractor, a statement noting that representatives of the DOD may inspect the records.

 

E–8. Points of contact

An explanation of whom to contact for answers to pertinent questions about the study and the study subject’s rights, and whom to contact in the event of a study-related injury to the subject. This should include a name or office and the commercial and AUTOVON telephone numbers.

 

E–9. Subject’s rights

A statement that—

 

a. Participation is voluntary.

 

b. Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.

 

c. The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 

E–10. Compensation

For a study involving more than minimal risk, an explanation as to whether any compensation and medical treatment are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

 

E–11. Cautions

When appropriate, one or more of the elements of information below will also be given to each subject.

 

a. A statement that a certain treatment or procedure may involve risks to the subject (or to the embryo or fetus if the subject is or may become pregnant) that are currently unforeseeable. (Possible genetic effects to the offspring of males should be addressed when applicable.)

 

b. The anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.

 

c. Any additional costs to the subject that may result from participation in the study.

 

d. The consequences of a subject’s decision to withdraw from the study and procedures for the orderly end of the subject’s participation.

 

e. A statement that new findings developed during the course of the study which could affect the subject’s willingness to continue will be given to the subject.

 

f. The approximate number of subjects involved in the study.

 

g. The precautions to be observed by the subject before and after the study.

 

h. If photographs are to be taken, the degree to which actions will be taken to protect the identity of the subject.

 

i. A statement as to whether the results of the research will be made known to the subject.

 

E–12. Disposition of the informed consent

The principal investigator will retain the original signed informed consent.A copy will be provided to the volunteer. If the volunteer consents, the investigator will provide a copy of the signed DA Form 5303–R to the medical records custodian for inclusion in the volunteer’s medical treatment record(AR 40–66, para 6–2f.)

 

Appendix F Exemptions

F–1. Exempt activities

Activities in which human subjects are involved in one or more of the categories below are exempt from this regulation.

 

a. Routine epidemiological surveys that are of no more than minimal risk as set forth in the human protection regulations issued by the DHHS (45 CFR 46). (See the glossary for the definition of epidemiological survey.)

 

b. Research in educational settings which involves normal educational practices such as—

(1) Regular and special education strategies.

(2) The effectiveness of, or the comparison among, techniques of instruction, curricula, or classroom management methods.

 

c. Research that involves the use of educational tests when the data is recorded in such a way that subjects cannot be identified directly or indirectly.

 

d. Research that involves survey, interview procedures, or the observation of public behavior (including observation by participants) except where all the following exist:

(1) Responses or observations are recorded in such a way that subjects can be identified directly or indirectly.

(2) The subject’s responses or recorded observations, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability, or would damage the subject’s financial standing or employability.

(3) The research deals with sensitive aspects of the subject’s behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.

 

e. Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a way that subjects cannot be identified directly or indirectly.

 

f. Individual or group training of military personnel such as combat readiness, effectiveness, proficiency, or fitness exercise (for example, Army Training and Evaluation Program (ARTEP), Skill Qualification Test (SQT)). Evaluation of the training’s effect on the individual participants may or may not be exempt depending on how the evaluation is made (for example, drawing of blood is not exempt).

 

g. Job related tasks of military or civilian personnel who are qualified to test by duty assignments that call specifically for such qualifications.

 

h. Inclusion of human subjects as the indirect object of research involving minimal risk or less in the development and testing of military weapon systems, vehicles, aircraft, and other material are exempt from the requirement for obtaining informed consent from the participants. The determination of whether a proposal is minimal risk or less is made by a HUC established in accordance with paragraph 3–2b of this regulation.

 

i. Other research which is exempted by future changes to DHHS regulations, and which is consistent with this regulation and DOD Directive 3216.2.

 

F–2. Not used

 

Appendix G Legal Implications

 

G–1. Authority

The Secretary of the Army is authorized to conduct research and development programs including the procurement of services that are needed for these programs (10 USC 4503). The Secretary has the authority to “assign, detail and prescribe the duties”of the members of the Army and civilian personnel (10 USC 3013).

 

G–2. Military personnel and Department of the Army civilian employees

Compensation for the disability or death of a civilian employee resulting from personal injury or disease proximately caused by employment is payable under the Federal Employees Compensation Act (5 USC 8100 et seq.), regardless of whether employment was of a hazardous nature. The amount and type of disability compensation or other benefits payable by reason of the death or disability of a member of the Army resulting from injury or disease incident to service depends upon the individual status of each member, and is covered by various provisions of law. It may be stated generally that under present laws no additional rights against the government will result from the death or disability of military and civilian personnel participating in experiments by reason of the hazardous nature of the operations.

 

G–3. Private citizens

It is the policy of the United States to prohibit the acceptance of voluntary services (31 USC 1342). Individuals may, however, enter into an independent contractual relationship and participate for compensation as authorized by applicable directives (for example, volume 45 Decision of the Comptroller General, 1966, p. 649 (45 DCG 649)). Accordingly, any such service should be accompanied by a statement to the effect that the individual will not receive or become entitled to any compensation other than that stated in the contract for these services.

 

G–4. Use of appropriated funds for the purchase of insurance

Since the payment of insurance premiums on the life of an officer or employee of the United States is a form of compensation which is not currently authorized, payment of those premiums is prohibited.

 

G–5. Contractor’s employees

There appears to be no legal objection to the use of employees of contractors in research and development experiments. It is the responsibility of the contracting officer to determine whether the terms of the contract are sufficiently broad to permit the participation of these employees. Generally, benefits to which contract employees may become entitled by reason of death or disability resulting from their employment are payable under State Workmen’s Compensation law, except persons covered by the survivor’s insurance provisions of the Social Security Act (42 USC 402). Reimbursement of the employer for additional costs by reason of this liability for his or her employees will depend upon the terms of each contract. These employees are not disqualified from prosecuting claims against the government under the Federal Torts Claim Act (28 USC 2671 et seq.), if such a claim exists.

 

G–6. Irregular or fee-basis employees

Intermittent services of such employees are authorized. (Experts and consultants, 5 USC 3109(b) and Sec. 710 Defense Production Act of 1960 (64 Stat. 819, 50 USC App 2160); and for architects, engineers, and other technical and professional personnel on a fee-basis, 10 USC 4540.) Whether these employees can be detailed or assigned to the proposed experiments will depend upon the statutory authority for employment and the provisions of their employment agreement in each case. The Federal Employees Compensation Act, supra, in all probability applies with respect to these irregular and fee-basis employees for any injury or disease resulting from their employment, although a final determination in such cases will have to be made by the Federal agency responsible for deciding claims. Subject to such restrictions and limitations as may appear in the statutory authority under which he or she is employed, it would appear that the Government may legally bear the expense of premiums upon the life of an irregular or fee-basis employee whose rate of compensation is not fixed by law or regulations. In this regard, it may be advisable for the government to provide an additional allowance to the employee for financing such private insurance arrangements as he or she may wish to make rather than to undertake direct negotiations with insurance carriers for the desired coverage.

 

Appendix H Volunteer Data Base

 

H–1. General

The intent of the data base is twofold: first, to readily answer questions concerning an individual’s participation in research conducted or sponsored by the command; and second, to ensure that the command can exercise its “duty to warn.” The data base must contain items of personal information, for example, name, social security number (SSN), etc., which subjects it to the provisions of The Privacy Act of 1974. AR 340–21 addresses the requirements for establishing such a system of records. For assistance in developing the systems notice for publication in the Federal Register, contact Commander, U.S. Army Medical Research and Development Command , ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012, AUTOVON 343–2165.

 

H–2. Data elements

The elements listed below are representative of those items that could be found in such a data base. It is not meant to be all inclusive, and can be modified to meet individual command needs.

 

a. Records of the study. A copy of the—

(1) Approved test plan or protocol.

(2) Letter or other document approving the conduct of the test or protocol.

(3) Signed informed consent for each volunteer.

(4) Report generated by the results of the test or protocol.

 

b. Data elements—volunteer’s personal information.

(1) Name.

(2) Rank (if applicable).

(3) SSN.

(4) Sex.

(5) Date of birth.

(6) MOS or AOC (if applicable).

(7) Local address and telephone number.

(8) Permanent address and telephone number.

(9) Unit (if applicable).

 

c. Data elements—test plan or protocol information.

(1) Test or protocol title.

(2) Principal investigator’s name.

(3) Laboratory, unit, or facility conducting the test protocol.

(4) Location of the test.

(5) Test period.

(6) Challenge material data (if applicable).

(a) Name of the material used (both active and inert material).

(b) Manufacturer.

(c) Lot number.

(d) Expiration date.

(e) IND or IDE number.

(7) Date the volunteer completed or withdrew from the study.

(8) Reason for withdrawal (if applicable).

(9) Description of untoward reactions experienced by the volunteer (if none, so state).

 

H–3. Updating perishable data Selected items of personal information are perishable; for example, local address and telephone number. A method should be established, which is consistent with the potential for long-term risks of the test or protocol, to update this information. For example, the risks associated with testing a new parachute will be readily apparent; whereas the risks associated with the testing of new, obscurant smoke may not be known for some time to come.

 

Glossary

Section I Abbreviations

AIDS

Acquired immune deficiency syndrome

 

AMEDD

Army Medical Department

 

AOC

area of concentration

 

ARNG

Army National Guard

 

ARTEP

Army Training and Evaluation Program

 

ASA (RDA)

Assistant Secretary of the Army (Research, Development, and Acquisition)

 

ASD (HA)

Assistant Secretary of Defense (Health Affairs)

 

CFR

Code of Federal Regulations

 

DA

Department of the Army

 

DCSPER

Deputy Chief of Staff for Personnel

 

DHHS

Department of Health and Human Services

 

DOD

Department of Defense

 

DTF

dental treatment facility

 

FDA

Food and Drug Administration

 

HIV

human immunodeficiency virus

 

HSRRB

Human Subjects Research Review Board

 

HUC

human use committee

 

HURRAO

Human Use Review and Regulatory Affairs Office

 

IDE

Investigational Device Exemption

 

IND

Notice of Claimed Investigational Exemption for a New Drug

 

IRB

institutional review board

 

MACOM

major Army command

 

MOS

military occupation specialty

 

MTF

medical treatment facility

NDA

New Drug Application

 

OTSG

Office of the Surgeon General

 

PCS

permanent change of station

 

PI

principal investigator

 

RDTE

research, development, test, and evaluation

 

SI

skill identifier

 

SSC–NCR

Soldier Support Center—National Capital Region

 

SSN

social security number

 

SQT

skill qualification test

 

TSG

The Surgeon General

 

USAMRDC

U.S. Army Medical Research and Development Command

 

USAR

U.S. Army Reserve

 

USD (A)

Under Secretary of Defense for Acquisition

 

USUHS

Uniformed Services University of the Health Sciences

 

Section II Terms

 

Adverse personnel action

For the purposes of paragraph 3–1l, this term includes—

a. A court martial.

b. Non-judicial punishment.

c. Involuntary separation (other than for medical reasons).

d. Administrative or punitive reduction in grade.

e. Denial of promotion.

f. An unfavorable entry in a personnel record.

g. A bar to reenlistment.

h. Any other action considered by the DA to be an adverse personnel action.

 

Approving official

A military commander or civilian director of an organizational element of a DA component who has been delegated authority to approve the use of human subjects in research.

 

Assent

A child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

 

Associate investigator

A person who may be involved in the execution of research, but does not have overall primary responsibility. The FDA refers to such an individual as a subinvestigator.

 

Certificate of Assurance

See Protection of Human Subjects Assurance/ Certification/Declaration.

 

Chemical warfare agent (FM 3–9)

A chemical compound which, through its chemical properties, produces lethal or damaging effects on man. Excluded from consideration are riot control agents, anti-plant agents, and smoke and flame materials.

 

a. Chemical agents may be grouped according to use:

(1) Toxic chemical agents. Agents capable of producing incapacitation, serious injury, or death when used in field concentrations.

(2) Incapacitating agents. Agents that produce physiological or mental effects or both that may persist for hours or days after exposure, rendering individuals incapable of concerted efforts in the performance of their assigned duties. Complete recovery of incapacitating agent casualties is expected without medical treatment.

 

b . Nonchemical warfare agents may be grouped according to use as follows:

(1) Riot controlagents. Compounds widely used by governments for domestic law purposes, and which produce transient effects on man that disappear minutes after removal from exposure.

(2) Training agents and compounds.

(3) Screening and signaling smokes.

(4) Anti-plant agents.

 

c. It should be noted that the Convention on the Prohibition of the Development, Production, and Stockpile of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Article I, dated 26 March 1975, stipulates that— “Each State Party to this Convention undertakes never in any circumstance to develop, produce, stockpile, or otherwise acquire or retain:

(1) Microbial and other biological agents or toxins whatever their origin or method of production, of types or in quantities that have no justification for prophylactic, protective or other peaceful purposes;

(2) Weapons, equipment, or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.” Accordingly, chemical materials obtained from such sources or processes are considered biological, not chemical, weapons.

 

Clinical investigation

An organized inquiry into health problems for all conditions that are of concern in providing health care to beneficiaries of the military health care system, including active duty personnel, dependents, and retired personnel. T h e c l i n i c a l i n v e s t i g a t i o n p r o g r a m i s d e - scribed in AR 40–38.

 

Consent

See informed consent.

 

Development

Systematic use of scientific knowledge, directed toward—

 

a. Significant improvements in or creation of useful products to meet specific performance requirements.

 

b. Development of components for incorporation in end items to meet specific performance requirements.

 

c. Construction of hardware for test purposes to determine feasibility of technical approaches.

 

d . Formulation and refinement of techniques and procedures which improve Army capabilities in nonmateriel areas.

 

Epidemiologic-assessment interview

For the purpose of paragraph 3–1l, this term means questioning of a serum positive member of the Armed Forces for the purposes of medical treatment or counseling, or for epidemiologic or statistical purposes.

 

Epidemiological surveys

For the purpose of this regulation, the term means studies of the distribution and determinants of disease frequency in humans, involving no more that minimal risk in which research data is not linked to personal identifiers.Epidemiological surveys focus on “ills” of a population rather than on persons.

 

Evaluation

The subjective determination of the military value of a hardware item or system, real or conceptual, to the user. There are three types of evaluation:Developer, technical, and operational. See 70–10 for more detail.

 

Expedited review procedures

Those procedures used in research involving no more than minimal risk and those used for minor changes in approved investigations (see app D).These procedures minimize time required for review.

 

Experimental subject

See Human subject.

 

Health care personnel

Military personnel, civilian employees, or contract personnel (including military and civilian staff members, assigned to, employed by, or appointed to the USUHS) who provide patient care or patient care support services in military MTFs and dental treatment facilities (DTFs).

 

Health care delivery study

Application of scientific methods to the study of availability, organization, administration, and management of health services. The efficiency and effectiveness with which such services are delivered are included.

 

Health and Human Services Certificate of Assurance

See Protection of Human Subjects Assurance/ Certification/Declaration.

 

Human subject

a. A living individual about whom an investigator conducting research obtains data through interaction with the individual, including both physical procedures and manipulations of the subject or the subject’s environment.The term does not include military or civilian personnel who are qualified to test by assignment to duties that call specifically for qualifications such as test pilots or test engineers.

 

b. Minor (child). A person who has not attained the legal age for consent to treatments or procedures involved in research, under the applicable laws and jurisdiction in which the research will be conducted.

 

c. Human subjects may be thought of as direct objects when the research is to determine the effects of a new system on humans (for example. the effects of a weapon’s blast on hearing) as indirect objects when a test is conducted to determine how humans affect the ultimate performance of a system (doctrine concepts, training programs).

 

Human Subjects Research Review Board

The principal body of the Office of The Surgeon General (OTSG) for review of clinical investigation and research activities.

 

Human use committee

A body set up to provide initial and continuing review of research involving the use of human subjects. AHUC is fundamentally similar to an institutional review board (IRB) (45 CFR 46), but has somewhat different authority as compared to an IRB. Within DOD, authority to approve use of human subjects in research is vested in commanders. Commanders act on the recommendations of validly constituted HUCs. Outside DOD, IRBs tend to be vested with this authority. Appendix C describes the membership, functions, and operations of a HUC.

 

Informed consent

The legally effective agreement of the subject or subject’s legally authorized representative for the subject to participate in research covered by this regulation. Informed consent includes, when appropriate, those elements listed in appendix E of this regulation.

 

a. Permission. The agreement of parent(s) or guardian to the participation of their child or ward in research.

 

b. Guardian. An individual who is authorized under applicable State or local law to consent on behalf of a minor (child) to general medical care.

 

c. Assent. A minor’s (child’s) affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Institution Any public or private entity or agency (including Federal, State, or other agencies).

 

Investigational drug

A drug may be considered investigational when the composition is such that—

 

a. Its proposed use is not recognized for the use under the conditions prescribed; or its proposed use is not recommended or suggested in its approved labeling. Experts qualified by scientific training and experience evaluate the safety and effectiveness of drugs to make this determination.

 

b. Its use has become recognized as investigational, as a result of studies to determine its safety and effectiveness for use under such conditions.

 

Investigational medical device

a. A device that is not generally used in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans, and recognized as safe and effective.

 

b. Research is usually, but not necessarily, initiated to determine if the device is safe or effective.

 

Legally authorized representative

A person or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s taking a part in the procedures involved in the research.

 

Medical monitor

This person is a military or DA civilian physician qualified by the training and/or experience required to provide care to research subjects for conditions that may arise during the conduct of the research, and who monitors human subjects during the conduct of research. For the purpose of this regulation, the principal investigator may function as the medical monitor only in situations in which no other physician is available and approval for the principal investigator to function as medical monitor is granted by TSG. Requests for the principal investigator to function as the medical monitor will be sent to the Assistant Surgeon General for Research and Development, c/o Headquarters, U.S. Army Medical Research and Development Command, ATTN: SGRD–HR, Fort Detrick, Frederick, MD 21701–5012. In contractor performed research, a military or DA civilian physician may be the medical monitor; however, this is usually a contract o  provided resource.

 

Minimal risk

The proposed risks are not considered greater than these encountered in the subject’s daily life or during routine physical or psychological examinations.

 

Non-U.S. citizens Foreign nationals, excluding personnel on active duty.

 

Personal identifier

A method or system which links data to the individual from whom or about whom it pertains.

 

Principal investigator

A person, regardless of title, who is primarily responsible for the actual execution of the research.

 

Prisoner

Any person, (adult or minor) involuntarily confined or detained in a penal or correctional institution (for example, jail, workhouse, house of detention, prison, military stockade, or brig). The term is intended to encompass individuals detained pending arraignment, trial, or sentencing;and prisoners of war including detained personnel). The term does not include individuals voluntarily confined nor those persons subject to civil commitment procedures that are not alternatives to criminal prosecution.

 

Protection of Human Subjects Assurance/ Certification/Declaration A document issued by the Office for Protection from Research risk, DHHS, in which that office acknowledges that a research institution has established policies and procedures consistent with 45 CFR 46.

 

Protocol The written, detailed plan by which research is to be conducted. (See app B for an example of research protocol.) The plan contains, as a minimum—

a. The objectives of the project.

 

b. The information to be collected.

 

c. The means by which it will be collected and evaluated; an assessment of potential risk and benefits to subjects; safety measures, and other means to be used to reduce any risk to subjects.

 

Radioisotope/radiation control committee

A committee appointed by the commander to ensure that individual users of radioactive materiels within the medical facility and each radionuclide will be approved and controlled. The approval and control is in accordance with the requirements specified in the conditions of the Nuclear Regulatory Commission license and DA radioactive material authorization and appropriate Federal directives.

 

Research

A systematic investigation that is designed to develop or contribute to generalizable knowledge. The term does not include individual or group training of military personnel such as combat readiness, effectiveness, proficiency, or fitness exercises (DODD 3216.2)

 

Research, development, test, and evaluation

Includes those categories of research and development included in Program 6, Research and Development, and operational systems development contained in the Five-Year Defense Program.

 

Schedule I controlled drug substances

Any drug or substance by whatever official name, common or usual name, chemical name or brand name listed in 21 CFR 1308, for example, heroin.

 

Serum positive member of the Armed Forces

For the purposes of paragraph 3–1l, this term means a member of the Armed Forces who has been identified as having been exposed to a virus associated with the acquired immune deficiency syndrome (AIDS). Subinvestigator See associate investigator.

 

Test

A process by which data are accumulated to serve as a basis for assessing the degree to which an item or system meets, exceeds or fails to meet the technical or operational properties required. AR 70–10 has a more detailed discussion of the RDTE type test. There are no special terms. 

Preamble

 

The member States of the Council of Europe, the other States and the European Community, signatories hereto,

 

Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;

 

Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;

 

Bearing in mind the European Social Charter of 18 October 1961;

 

Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;

 

Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981;

 

Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;

 

Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;

 

Conscious of the accelerating developments in biology and medicine;

 

Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being;

 

Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;

 

Affirming that progress in biology and medicine should be used for the benefit of present and future generations;

 

Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;

 

Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;

 

Wishing to remind all members of society of their rights and responsibilities;

 

Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a convention on bioethics;

 

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine,

 

Have agreed as follows:

 

Chapter I – General provisions

 

Article 1 – Purpose and object

 

Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.

 

Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.

 

Article 2 – Primacy of the human being

 

The interests and welfare of the human being shall prevail over the sole interest of society or science.

 

Article 3 – Equitable access to health care

 

Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.

 

Article 4 – Professional standards

 

Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.

 

Chapter II – Consent

 

Article 5 – General rule

 

An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

 

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.

 

The person concerned may freely withdraw consent at any time.

 

Article 6 – Protection of persons not able to consent

 

Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.

 

Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

 

The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

 

Where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

 

The individual concerned shall as far as possible take part in the authorisation procedure.

 

The representative, the authority, the person or the body mentioned in paragraphs 2 and 3 above shall be given, under the same conditions, the information referred to in Article 5.

 

The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the person concerned.

 

Article 7 – Protection of persons who have a mental disorder

 

Subject to protective conditions prescribed by law, including supervisory, control and appeal procedures, a person who has a mental disorder of a serious nature may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health.

 

Article 8 – Emergency situation

 

When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned.

 

Article 9 – Previously expressed wishes

 

The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account. Chapter III – Private life and right to information

 

Article 10 – Private life and right to information

 

Everyone has the right to respect for private life in relation to information about his or her health.

 

Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.

 

In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.

 

Chapter IV – Human genome

 

Article 11 – Non-discrimination

 

Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited.

 

Article 12 – Predictive genetic tests

 

Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.

 

Article 13 – Interventions on the human genome

 

An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.

 

Article 14 – Non-selection of sex

 

The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided.

 

Chapter V – Scientific research

 

Article 15 – General rule

 

Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.

 

Article 16 – Protection of persons undergoing research

 

Research on a person may only be undertaken if all the following conditions are met:

 

i. there is no alternative of comparable effectiveness to research on humans; 
ii. the risks which may be incurred by that person are not disproportionate to the potential benefits of the research;

iii.the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability;

iv. the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection;

v. the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time.

 

Article 17 – Protection of persons not able to consent to research

 

Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met:

i. the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled;

ii. the results of the research have the potential to produce real and direct benefit to his or her health;

iii. research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

iv. the necessary authorisation provided for under Article 6 has been given specifically and in writing;

v. and the person concerned does not object.

 

Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, sub-paragraphs i, iii, iv and v above, and to the following additional conditions:

i. the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition;

ii. the research entails only minimal risk and minimal burden for the individual concerned.

 

Article 18 – Research on embryos in vitro

 

Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. The creation of human embryos for research purposes is prohibited.

 

Chapter VI – Organ and tissue removal from living donors for transplantation purposes

 

Article 19 – General rule

 

Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.

 

The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body.

 

Article 20 – Protection of persons not able to consent to organ removal

 

No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.

 

Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided the following conditions are met:

i. there is no compatible donor available who has the capacity to consent;

ii. the recipient is a brother or sister of the donor;

iii. the donation must have the potential to be life-saving for the recipient;

iv. the authorisation provided for under paragraphs 2 and 3 of Article 6 has been given specifically and in writing, in accordance with the law and with the approval of the competent body;

v. the potential donor concerned does not object.

 

Chapter VII – Prohibition of financial gain and disposal of a part of the human body

 

Article 21 – Prohibition of financial gain 

 

The human body and its parts shall not, as such, give rise to financial gain.

 

Article 22 – Disposal of a removed part of the human body

 

When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.

 

Chapter VIII – Infringements of the provisions of the Convention

 

Article 23 – Infringement of the rights or principles

 

The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice.

 

Article 24 – Compensation for undue damage

 

The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.

 

Article 25 – Sanctions

 

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention.

 

Chapter IX – Relation between this Convention and other provisions

 

Article 26 – Restrictions on the exercise of the rights

 

No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.

 

The restrictions contemplated in the preceding paragraph may not be placed on Articles 11, 13, 14, 16, 17, 19, 20 and 21.

 

Article 27 – Wider protection

 

None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.

 

Chapter X – Public debate

 

Article 28 – Public debate

 

Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation.

 

Chapter XI – Interpretation and follow-up of the Convention

 

Article 29 – Interpretation of the Convention

 

The European Court of Human Rights may give, without direct reference to any specific proceedings pending in a court, advisory opinions on legal questions concerning the interpretation of the present Convention at the request of: the Government of a Party, after having informed the other Parties; the Committee set up by Article 32, with membership restricted to the Representatives of the Parties to this Convention, by a decision adopted by a two-thirds majority of votes cast.

 

Article 30 – Reports on the application of the Convention

 

On receipt of a request from the Secretary General of the Council of Europe any Party shall furnish an explanation of the manner in which its internal law ensures the effective implementation of any of the provisions of the Convention.

 

Chapter XII – Protocols

 

Article 31 – Protocols

 

Protocols may be concluded in pursuance of Article 32, with a view to developing, in specific fields, the principles contained in this Convention. The Protocols shall be open for signature by Signatories of the Convention. They shall be subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve Protocols without previously or simultaneously ratifying accepting or approving the Convention.

 

Chapter XIII – Amendments to the Convention

 

Article 32 – Amendments to the Convention

 

The tasks assigned to "the Committee" in the present article and in Article 29 shall be carried out by the Steering Committee on Bioethics (CDBI), or by any other committee designated to do so by the Committee of Ministers.

 

Without prejudice to the specific provisions of Article 29, each member State of the Council of Europe, as well as each Party to the present Convention which is not a member of the Council of Europe, may be represented and have one vote in the Committee when the Committee carries out the tasks assigned to it by the present Convention.

 

Any State referred to in Article 33 or invited to accede to the Convention in accordance with the provisions of Article 34 which is not Party to this Convention may be represented on the Committee by an observer. If the European Community is not a Party it may be represented on the Committee by an observer.

 

In order to monitor scientific developments, the present Convention shall be examined within the Committee no later than five years from its entry into force and thereafter at such intervals as the Committee may determine.

 

Any proposal for an amendment to this Convention, and any proposal for a Protocol or for an amendment to a Protocol, presented by a Party, the Committee or the Committee of Ministers shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community, to any Signatory, to any Party, to any State invited to sign this Convention in accordance with the provisions of Article 33 and to any State invited to accede to it in accordance with the provisions of Article 34.

 

The Committee shall examine the proposal not earlier than two months after it has been forwarded by the Secretary General in accordance with paragraph 5. The Committee shall submit the text adopted by a two-thirds majority of the votes cast to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties for ratification, acceptance or approval.

 

Any amendment shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which five Parties, including at least four member States of the Council of Europe, have informed the Secretary General that they have accepted it.

 

In respect of any Party which subsequently accepts it, the amendment shall enter into force on the first day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance.

 

Chapter XIV – Final clauses

 

Article 33 – Signature, ratification and entry into force

 

This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and by the European Community.

 

This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

 

This Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Convention in accordance with the provisions of paragraph 2 of the present article. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of its instrument of ratification, acceptance or approval.

 

Article 34 – Non-member States

 

After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any non-member State of the Council of Europe to accede to this Convention by a decision taken by the majority provided for in Article 20, paragraph d, of the Statute of the Council of Europe, and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers.

 

In respect of any acceding State, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.

 

Article 35 – Territories

 

Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Any other State may formulate the same declaration when depositing its instrument of accession.

 

Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings. In respect of such territory the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary General.

 

Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. The withdrawal shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

 

Article 36 – Reservations

 

Any State and the European Community may, when signing this Convention or when depositing the instrument of ratification, acceptance, approval or accession, make a reservation in respect of any particular provision of the Convention to the extent that any law then in force in its territory is not in conformity with the provision. Reservations of a general character shall not be permitted under this article.

 

Any reservation made under this article shall contain a brief statement of the relevant law.

 

Any Party which extends the application of this Convention to a territory mentioned in the declaration referred to in Article 35, paragraph 2, may, in respect of the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs.

 

Any Party which has made the reservation mentioned in this article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of one month after the date of its receipt by the Secretary General.

 

Article 37 – Denunciation

 

Any Party may at any time denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe.

 

Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General.

 

Article 38 – Notifications

 

The Secretary General of the Council of Europe shall notify the member States of the Council, the European Community, any Signatory, any Party and any other State which has been invited to accede to this Convention of:

 

a. any signature;

b.  the deposit of any instrument of ratification, acceptance, approval or accession;

 

c. any date of entry into force of this Convention in accordance with Articles 33 or 34;

 

d. any amendment or Protocol adopted in accordance with Article 32, and the date on which such an amendment or Protocol enters into force;

 

e. any declaration made under the provisions of Article 35;

 

f. any reservation and withdrawal of reservation made in pursuance of the provisions of Article 36;

 

g. any other act, notification or communication relating to this Convention.

 

In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.

 

Done at Oviedo (Asturias), this 4th day of April 1997, in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaboration of this Convention, and to any State invited to accede to this Convention.

Preamble

 

The member States of the Council of Europe, the other States and the European Community, signatories to this Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (hereinafter referred to as “the Convention on Human Rights and Biomedicine”, ETS No. 164),

 

Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;

 

Considering that the aim of the Convention on Human Rights and Biomedicine, as defined in Article 1, is to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine;

 

Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (ETS No. 108) of 28 January 1981;

 

Bearing in mind the work carried out by other intergovernmental organisations, in particular the Universal Declaration on the Human Genome and Human Rights, endorsed by the General Assembly of the United Nations on 9 December 1998;

 

Recalling that the human genome is shared by all human beings, thereby forming a mutual bond between them while slight variations contribute to the individuality of each human being;

 

Stressing the particular bond that exists between members of the same family;

 

Considering that progress in medical science can contribute to saving lives and improving their quality;

 

Acknowledging the benefit of genetics, in particular genetic testing, in the field of health;

 

Considering that genetic services in the field of health form an integral part of the health services offered to the population and recalling the importance of taking appropriate measures, taking into account health needs and available resources, with a view to providing equitable access to genetic services of appropriate quality;

 

Aware also of the concerns that exist regarding possible improper use of genetic testing, in particular of the information generated thereby;

 

Reaffirming the fundamental principle of respect for human dignity and the prohibition of all forms of discrimination, in particular those based on genetic characteristics;

 

Taking into account national and international professional standards in the field of genetic services and the previous work of the Committee of Ministers and the Parliamentary Assembly of the Council of Europe in this field;

 

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to genetic testing for health purposes,

 

Have agreed as follows:

 

Chapter I – Object and scope

 

Article 1 – Object and purpose

 

Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the tests to which this Protocol applies in accordance with Article 2.

 

Article 2 – Scope

 

1 This Protocol applies to tests, which are carried out for health purposes, involving analysis of biological samples of human origin and aiming specifically to identify the genetic characteristics of a person which are inherited or acquired during early prenatal development (hereinafter referred to as “genetic tests”).

 

2 This Protocol does not apply:

a to genetic tests carried out on the human embryo or foetus;

b to genetic tests carried out for research purposes.

 

3 For the purposes of paragraph 1:

a “analysis” refers to:

i chromosomal analysis,

ii DNA or RNA analysis,

iii analysis of any other element enabling information to be obtained which is equivalent to that obtained with the methods referred to in sub-paragraphs a.i. and a.ii.;

 

b “biological samples” refers to:

i biological materials removed for the purpose of the test concerned,

ii biological materials previously removed for another purpose.

 

Chapter II – General provisions

 

Article 3 – Primacy of the human being

 

The interests and welfare of the human being concerned by genetic tests covered by this Protocol shall prevail over the sole interest of society or science.

 

Article 4 – Non-discrimination and non-stigmatisation

 

1 Any form of discrimination against a person, either as an individual or as a member of a group on grounds of his or her genetic heritage is prohibited.

 

2 Appropriate measures shall be taken in order to prevent stigmatisation of persons or groups in relation to genetic characteristics.

 

Chapter III – Genetic services

 

Article 5 – Quality of genetic services

 

Parties shall take the necessary measures to ensure that genetic services are of appropriate quality. In particular, they shall see to it that:

a genetic tests meet generally accepted criteria of scientific validity and clinical validity;

b a quality assurance programme is implemented in each laboratory and that laboratories are subject to regular monitoring;

c persons providing genetic services have appropriate qualifications to enable them to perform their role in accordance with professional obligations and standards.

 

Article 6 – Clinical utility

 

Clinical utility of a genetic test shall be an essential criterion for deciding to offer this test to a person or a group of persons.

 

Article 7 – Individualised supervision

 

1 A genetic test for health purposes may only be performed under individualised medical supervision.

 

2 Exceptions to the general rule referred to in paragraph 1 may be allowed by a Party, subject to appropriate measures being provided, taking into account the way the test will be carried out, to give effect to the other provisions of this Protocol.

 

However, such an exception may not be made with regard to genetic tests with important implications for the health of the persons concerned or members of their family or with important implications concerning procreation choices. Chapter IV – Information, genetic counselling and consent

 

Article 8 – Information and genetic counselling

 

1 When a genetic test is envisaged, the person concerned shall be provided with prior appropriate information in particular on the purpose and the nature of the test, as well as the implications of its results.

 

2 For predictive genetic tests as referred to in Article 12 of the Convention on Human Rights and Biomedicine, appropriate genetic counselling shall also be available for the person concerned.

 

The tests concerned are:

– tests predictive of a monogenic disease,

– tests serving to detect a genetic predisposition or genetic susceptibility to a disease,

– tests serving to identify the subject as a healthy carrier of a gene responsible for a disease.

 

The form and extent of this genetic counselling shall be defined according to the implications of the results of the test and their significance for the person or the members of his or her family, including possible implications concerning procreation choices.

 

Genetic counselling shall be given in a non-directive manner.

 

Article 9 – Consent

 

1 A genetic test may only be carried out after the person concerned has given free and informed consent to it. Consent to tests referred to in Article 8, paragraph 2, shall be documented.

 

2 The person concerned may freely withdraw consent at any time.

 

Chapter V – Persons not able to consent

 

Article 10 – Protection of persons not able to consent

 

Subject to Article 13 of this Protocol, a genetic test on a person who does not have the capacity to consent may only be carried out for his or her direct benefit.

 

Where, according to law, a minor does not have the capacity to consent, a genetic test on this person shall be deferred until attainment of such capacity unless that delay would be detrimental to his or her health or well-being.

 

Article 11 – Information prior to authorisation, genetic counselling and support

 

1 When a genetic test is envisaged in respect of a person not able to consent, the person, authority or body whose authorisation is required shall be provided with prior appropriate information in particular with regard to the purpose and the nature of the test, as well as the implications of its results.

 

Appropriate prior information shall also be provided to the person not able to consent in respect of whom the test is envisaged, to the extent of his or her capacity to understand.

 

A qualified person shall be available to answer possible questions by the person, authority or body whose authorisation is required, and, if appropriate, the person in respect of whom the test is envisaged.

 

2 The provisions of Article 8, paragraph 2, shall apply in the case of persons not able to consent to the extent of their capacity to understand.

 

Where relevant, appropriate support shall be available for the person whose authorisation is required.

 

Article 12 – Authorisation

 

1 Where, according to law, a minor does not have the capacity to consent to a genetic test, that test may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

 

The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

 

2 Where, according to law, an adult does not have the capacity to consent to a genetic test because of a mental disability, a disease or for similar reasons, that test may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

 

Wishes relating to a genetic test expressed previously by an adult at a time where he or she had capacity to consent shall be taken into account.

 

The individual concerned shall, to the extent of his or her capacity to understand, take part in the authorisation procedure.

 

3 Authorisation to tests referred to in Article 8, paragraph 2, shall be documented.

 

4 The authorisation referred to in paragraphs 1 and 2 above may be withdrawn at any time in the best interests of the person concerned. Chapter VI – Tests for the benefit of family members

 

Article 13 – Tests on persons not able to consent

 

Exceptionally, and by derogation from the provisions of Article 6, paragraph 1, of the Convention on Human Rights and Biomedicine and of Article 10 of this Protocol, the law may allow a genetic test to be carried out, for the benefit of family members, on a person who does not have the capacity to consent, if the following conditions are met:

a the purpose of the test is to allow the family member(s) concerned to obtain a preventive, diagnostic or therapeutic benefit that has been independently evaluated as important for their health, or to allow them to make an informed choice with respect to procreation;

b the benefit envisaged cannot be obtained without carrying out this test;

c the risk and burden of the intervention are minimal for the person who is undergoing the test;

d the expected benefit has been independently evaluated as substantially outweighing the risk for private life that may arise from the collection, processing or communication of the results of the test;

e the authorisation of the representative of the person not able to consent, or an authority or a person or body provided for by law has been given;

f the person not able to consent shall, in proportion to his or her capacity to understand and degree of maturity, take part in the authorisation procedure. The test shall not be carried out if this person objects to it.

 

Article 14 – Tests on biological materials when it is not possible to contact the person concerned

 

When it is not possible, with reasonable efforts, to contact a person for a genetic test for the benefit of his or her family member(s) on his or her biological material previously removed for another purpose, the law may allow the test to be carried out in accordance with the principle of proportionality, where the expected benefit cannot be otherwise obtained and where the test cannot be deferred.

 

Provisions shall be made, in accordance with Article 22 of the Convention on Human Rights and Biomedicine, for the case where the person concerned has expressly opposed such test.

 

Article 15 – Tests on deceased persons

 

A genetic test for the benefit of other family members may be carried out on biological samples:

– removed from the body of a deceased person, or

– removed, when he or she was alive, from a person now deceased, only if the consent or authorisation required by law has been obtained.

 

Chapter VII – Private life and right to information

 

Article 16 – Respect for private life and right to information

 

1 Everyone has the right to respect for his or her private life, in particular to protection of his or her personal data derived from a genetic test.

 

2 Everyone undergoing a genetic test is entitled to know any information collected about his or her health derived from this test. The conclusions drawn from the test shall be accessible to the person concerned in a comprehensible form.

 

3 The wish of a person not to be informed shall be respected.

 

4 In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraphs 2 and 3 above in the interests of the person concerned.

 

Article 17 – Biological samples

 

Biological samples referred to in Article 2 shall only be used and stored in such conditions as to ensure their security and the confidentiality of the information which can be obtained therefrom.

 

Article 18 – Information relevant to family members

 

Where the results of a genetic test undertaken on a person can be relevant to the health of other family members, the person tested shall be informed. Chapter VIII – Genetic screening programmes for health purposes

 

Article 19 – Genetic screening programmes for health purposes

 

A health screening programme involving the use of genetic tests may only be implemented if it has been approved by the competent body. This approval may only be given after independent evaluation of its ethical acceptability and fulfilment of the following specific conditions:

a the programme is recognised for its health relevance for the whole population or section of population concerned;

b the scientific validity and effectiveness of the programme have been established;

c appropriate preventive or treatment measures in respect of the disease or disorder which is the subject of the screening, are available to the persons concerned;

d appropriate measures are provided to ensure equitable access to the programme;

e the programme provides measures to adequately inform the population or section of population concerned of the existence, purposes and means of accessing the screening programme as well as the voluntary nature of participation in it.

 

Chapter IX – Public information

 

Article 20 – Public information

 

Parties shall take appropriate measures to facilitate access for the public to objective general information on genetic tests, including their nature and the potential implications of their results.

 

Chapter X – Relation between this Protocol and other provisions and re-examination of the Protocol

 

Article 21 – Relation between this Protocol and the Convention

 

As between the Parties, the provisions of Articles 1 to 20 of this Protocol shall be regarded as additional articles to the Convention on Human Rights and Biomedicine, and all the provisions of the Convention shall apply accordingly.

 

Article 22 – Wider protection

 

None of the provisions of this Protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant persons concerned by genetic testing for health purposes a wider measure of protection than is stipulated in this Protocol.

 

Article 23 – Re-examination of the Protocol

 

In order to monitor scientific developments, the present Protocol shall be examined within the Committee referred to in Article 32 of the Convention on Human Rights and Biomedicine no later than five years from the entry into force of this Protocol and thereafter at such intervals as the Committee may determine.

 

Chapter XI – Final clauses

 

Article 24 – Signature and ratification

 

This Protocol shall be open for signature by Signatories to the Convention on Human Rights and Biomedicine. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol unless it has previously or simultaneously ratified, accepted or approved the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

 

Article 25 – Entry into force

 

1 This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 24.

 

2 In respect of any Signatory which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

 

Article 26 – Accession

 

1 After the entry into force of this Protocol, any State which has acceded to the Convention on Human Rights and Biomedicine may also accede to this Protocol.

 

2 Accession shall be effected by the deposit with the Secretary General of the Council of Europe of an instrument of accession which shall take effect on the first day of the month following the expiration of a period of three months after the date of its deposit.

 

Article 27 – Denunciation

 

1 Any Party may at any time denounce this Protocol by means of a notification addressed to the Secretary General of the Council of Europe.

 

2 Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

 

Article 28 – Notification The Secretary

 

General of the Council of Europe shall notify the member States of the Council of Europe, the European Community, any Signatory, any Party and any other State which has been invited to accede to the Convention on Human Rights and Biomedicine of:

a any signature;

b the deposit of any instrument of ratification, acceptance, approval or accession;

c any date of entry into force of this Protocol in accordance with Articles 25 and 26;

d any other act, notification or communication relating to this Protocol.

 

In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.

 

Done at Strasbourg, this 27th day of November 2008, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol, to any State invited to accede to the Convention on Human Rights and Biomedicine and to the European Community.

We—the members of the American Association for Public Opinion Research and its affiliated chapters—subscribe to the principles expressed in the following Code. Our goals are to support sound and ethical practice in the conduct of survey and public opinion research and in the use of such research for policy- and decision-making in the public and private sectors, as well as to improve public understanding of survey and public opinion research methods and the proper use of those research results.

 

We pledge ourselves to maintain high standards of scientific competence, integrity, and transparency in conducting, analyzing, and reporting our work; establishing and maintaining relations with survey respondents and our clients; and communicating with those who eventually use the research for decision-making purposes and the general public. We further pledge ourselves to reject all tasks or assignments that would require activities inconsistent with the principles of this Code.

 

The Code describes the obligations that we believe all research professionals have, regardless of their membership in this Association or any other, to uphold the credibility of survey and public opinion research.

 

It shall not be the purpose of this Code to pass judgment on the merits of specific research methods. From time to time, the AAPOR Executive Council may issue guidelines and recommendations on best practices with regard to the design, conduct, and reporting of surveys and other forms of public opinion research.

 

I. Principles of Professional Responsibility in Our Dealings with People

 

A. Respondents and Prospective Respondents

 

1.  We shall avoid practices or methods that may harm, endanger, humiliate, or seriously mislead survey respondents or prospective respondents.
2.  We shall respect respondents' desires, when expressed, not to answer specific survey questions or provide other information to the researcher. We shall be responsive to their questions about how their contact information was secured. 
3.  Participation in surveys and other forms of public opinion research is voluntary, except for the decennial census and a few other government surveys as specified by law. We shall provide all persons selected for inclusion with a description of the research study sufficient to permit them to make an informed and free decision about their participation. We shall make no false or misleading claims as to a study’s sponsorship or purpose, and we shall provide truthful answers to direct questions about the research. If disclosure could substantially bias responses or endanger interviewers, it is sufficient to indicate that some information cannot be revealed or will not be revealed until the study is concluded. 
4.  We shall not misrepresent our research or conduct other activities (such as sales, fundraising, or political campaigning) under the guise of conducting survey and public opinion research. 
5.  Unless the respondent explicitly waives confidentiality for specified uses, we shall hold as privileged and confidential all information that could be used, alone or in combination with other reasonably available information, to identify a respondent with his or her responses. We also shall not disclose or use the names of respondents or any other personally-identifying information for non-research purposes unless the respondents grant us permission to do so. 
6.  We understand that the use of our research results in a legal proceeding does not relieve us of our ethical obligation to keep confidential all respondent-identifying information (unless waived explicitly by the respondent) or lessen the importance of respondent confidentiality.

 

 B. Clients or Sponsors

 

1.  When undertaking work for a private client, we shall hold confidential all proprietary information obtained about the client and about the conduct and findings of the research undertaken for the client, except when the dissemination of the information is expressly authorized by the client, or when disclosure becomes necessary under the terms of Section I-C or III-E of this Code. In the latter case, disclosures shall be limited to information directly bearing on the conduct and findings of the research. 
2.  We shall be mindful of the limitations of our techniques and capabilities and shall accept only those research assignments that we can reasonably expect to accomplish within these limitations. 

 

C. The Public

 

1.  We shall inform those for whom we conduct publicly released research studies that AAPOR Standards for Disclosure require the release of certain essential information about how the research was conducted, and we shall make all reasonable efforts to encourage clients to subscribe to our standards for such disclosure in their releases. 
2.  We shall correct any errors in our own work that come to our attention which could influence interpretation of the results, disseminating such corrections to all original recipients of our content. 
3.  We shall attempt, as practicable, to correct factual misrepresentations or distortions of our data or analysis, including those made by our research partners, co-investigators, sponsors, or clients. We recognize that differences of opinion in analysis are not necessarily factual misrepresentations or distortions. We shall issue corrective statements to all parties who were presented with the factual misrepresentations or distortions, and if such factual misrepresentations or distortions were made publicly, we shall correct them in as commensurate a public forum as is practicably possible. 

 

D. The Profession

 

1.  We recognize our responsibility to the science of survey and public opinion research to disseminate as freely as practicable the ideas and findings that emerge from our research. 
2.  We can point with pride to our membership in the Association and our adherence to this Code as evidence of our commitment to high standards of ethics in our relations with respondents, our clients or sponsors, the public, and the profession. However, we shall not cite our membership in the Association nor adherence to this Code as evidence of professional competence, because the Association does not so certify any persons or organizations. 

 

 

II. Principles of Professional Practice in the Conduct of Our Work

 

A. We shall exercise due care in developing research designs and instruments, and in collecting, processing, and analyzing data, taking all reasonable steps to assure the reliability and validity of results.

 

1.  We shall recommend and employ only those tools and methods of analysis that, in our professional judgment, are well suited to the research problem at hand. 
2.  We shall not knowingly select research tools and methods of analysis that yield misleading conclusions. 
3.  We shall not knowingly make interpretations of research results that are inconsistent with the data available, nor shall we tacitly permit such interpretations. We shall ensure that any findings we report, either privately or for public release, are a balanced and accurate portrayal of research results. 
4.  We shall not knowingly imply that interpretations should be accorded greater confidence than the data actually warrant. When we use samples to make statements about populations, we shall only make claims of precision that are warranted by the sampling frames and methods employed. For example, the reporting of a margin of sampling error based on an opt-in or self-selected volunteer sample is misleading. 
5.  We shall not knowingly engage in fabrication or falsification. 6. We shall accurately describe survey and public opinion research from other sources that we cite in our work, in terms of its methodology, content, and comparability.

 

 B. We shall describe our methods and findings accurately and in appropriate detail in all research reports, adhering to the standards for disclosure specified in Section III.

 

 III. Standards for Disclosure

 

Good professional practice imposes the obligation upon all survey and public opinion researchers to disclose certain essential information about how the research was conducted. When conducting publicly released research studies, full and complete disclosure to the public is best made at the time results are released, although some information may not be immediately available. When undertaking work for a private client, the same essential information should be made available to the client when the client is provided with the results.

 

A. We shall include the following items in any report of research results or make them available immediately upon release of that report.

1.  Who sponsored the research study, who conducted it, and who funded it, including, to the extent known, all original funding sources. 
2.  The exact wording and presentation of questions and responses whose results are reported. 
3.  A definition of the population under study, its geographic location, and a description of the sampling frame used to identify this population. If the sampling frame was provided by a third party, the supplier shall be named. If no frame or list was utilized, this shall be indicated. 
4.  A description of the sample design, giving a clear indication of the method by which the respondents were selected (or self-selected) and recruited, along with any quotas or additional sample selection criteria applied within the survey instrument or post-fielding. The description of the sampling frame and sample design should include sufficient detail to determine whether the respondents were selected using probability or non-probability methods. 
5.  Sample sizes and a discussion of the precision of the findings, including estimates of sampling error for probability samples and a description of the variables used in any weighting or estimating procedures. The discussion of the precision of the findings should state whether or not the reported margins of sampling error or statistical analyses have been adjusted for the design effect due to clustering and weighting, if any. 
6.  Which results are based on parts of the sample, rather than on the total sample, and the size of such parts. 
7.  Method and dates of data collection. 

 

B. We shall make the following items available within 30 days of any request for such materials.

 

1.  Preceding interviewer or respondent instructions and any preceding questions or instructions that might reasonably be expected to influence responses to the reported results. 
2.  Any relevant stimuli, such as visual or sensory exhibits or show cards. 
3.  A description of the sampling frame’s coverage of the target population. 
4.  The methods used to recruit the panel, if the sample was drawn from a pre-recruited panel or pool of respondents. 
5.  Details about the sample design, including eligibility for participation, screening procedures, the nature of any oversamples, and compensation/incentives offered (if any). 
6.  Summaries of the disposition of study-specific sample records so that response rates for probability samples and participation rates for non-probability samples can be computed. 
7.  Sources of weighting parameters and method by which weights are applied. 
8.  Procedures undertaken to verify data. Where applicable, methods of interviewer training, supervision, and monitoring shall also be disclosed. 

 

C. If response rates are reported, response rates should be computed according to AAPOR Standard Definitions.

 

D. If the results reported are based on multiple samples or multiple modes, the preceding items shall be disclosed for each.

 

E. If any of our work becomes the subject of a formal investigation of an alleged violation of this Code, undertaken with the approval of the AAPOR Executive Council, we shall provide additional information on the research study in such detail that a fellow researcher would be able to conduct a professional evaluation of the study.

 INTRODUCTION

The first Code of Marketing and Social Research Practice was published by ESOMAR in 1948. This was followed by a number of codes produced by national bodies and by the International Chamber of Commerce (ICC). In 1976 ICC and ESOMAR agreed that it would be preferable to have a single international code instead of two differing ones and a joint ICC/ESOMAR Code was published the following year 1977. This was revised and updated in 1986 and 1994, making the current version the fourth edition of the ICC/ESOMAR Code, under a slightly altered title.

Effective communication between the providers and consumers of goods and services of all kinds is essential to any modern society. There are many methods of gathering information, and the channels available are multiplying with the development and use of internet-based technologies and other interactive media. One of the most important methods of gathering information is by using market research, which in this Code is taken to include social and opinion research. Market research depends for its success on public confidence – that it is carried out honestly, objectively and without unwelcome intrusion or disadvantage to its participants. The publishing of this Code is intended to foster public confidence and to demonstrate practitioners’ recognition of their ethical and professional responsibilities in carrying out market research.

The self-regulatory framework responsible for implementing this Code has been successfully in place for many years. The use of codes of this nature and their implementation have been referred to and accepted as best practice worldwide, as a recognized means of providing an additional layer of consumer protection.

 

PURPOSE OF THE CODE

 

 

This Code is designed primarily as a framework for self-regulation. With this in mind,

ICC/ESOMAR recommend the worldwide use of the Code, which intends to fulfill the following objectives:

• To set out the ethical rules which market researchers shall follow;

• To enhance the public’s confidence in market research by emphasizing the rights and safeguards to which they are entitled under this Code;

• To emphasize the need for a special responsibility when seeking the opinions of children and young people;

• To safeguard freedom for market researchers to seek, receive and impart information (as embodied in article 19 of the United Nations International Covenant of Civil and Political Rights);

• To minimize the need for governmental and/or inter-governmental legislation or regulation.

 

KEY FUNDAMENTALS OF THE CODE

The Code is based on these key fundamentals:

1. Market researchers shall conform to all relevant national and international laws.

2. Market researchers shall behave ethically and shall not do anything which might damage the reputation of market research.

3. Market researchers shall take special care when carrying out research among children and young people.

4. Respondents’ cooperation is voluntary and must be based on adequate, and not

misleading, information about the general purpose and nature of the project when their agreement to participate is being obtained and all such statements shall be honored.

5. The rights of respondents as private individuals shall be respected by market researchers and they shall not be harmed or adversely affected as the direct result of cooperating in a market research project.

6. Market researchers shall never allow personal data they collect in a market research project to be used for any purpose other than market research.

7. Market researchers shall ensure that projects and activities are designed, carried out, reported and documented accurately, transparently and objectively.

8. Market researchers shall conform to the accepted principles of fair competition.

 

SCOPE OF THE CODE

 

 

The Code applies to all market research. It should be read in conjunction with other ICC and ESOMAR codes and guidelines, principles and framework interpretations, available at www.iccwbo.org or www.esomar.org

The Code sets minimum standards of ethical conduct to be followed by all researchers and clients and is to be applied against the background of applicable law and of any stricter standards or rules that may be required in any specific market. Information about such requirements is available through ESOMAR.

 

INTERPRETATION

 

 

The Code is to be applied in the spirit as well as to the letter.

Acceptance of this International Code is a condition of membership of ESOMAR and of all other bodies that have officially adopted the Code1.

 

DEFINITIONS

 

 

(a) Market research, which includes social and opinion research, is the systematic gathering and interpretation of information about individuals or organizations using the statistical and analytical methods and techniques of the applied social sciences to gain insight or support decision making. The identity of respondents will not be revealed to the user of the information without explicit consent and no sales approach will be made to them as a direct result of their having provided information.

(b) Researcher is defined as any individual or organization carrying out, or acting as

a consultant on, a market research project, including those working in client organizations.

(c) Client is defined as any individual or organization that requests, commissions or subscribes to all or any part of a market research project.

(d) Respondent is defined as any individual or organization from which information is collected for the purposes of a market research project, whether they are aware of it or not, or is approached for interview.

(e) Interview is defined as any form of contact with a respondent in order to collect information for market research purposes.

 

ARTICLES

 

 

 Article 1 – Basic principles

(a) Market research shall be legal, honest, truthful and objective and be carried out in accordance with appropriate scientific principles.

(b) Researchers shall not act in any way that could bring discredit on the market research profession or lead to a loss of public confidence in it.

(c) Market research shall be conducted with professional responsibility and conform to the principles of fair competition, as generally accepted in business.

(d) Market research shall be clearly distinguished and separated from non-research activities including any commercial activity directed at individual respondents

(e.g. advertising, sales promotion, direct marketing, direct selling etc.).

Article 2 – Honesty

(a) Market research shall not abuse the trust of respondents or exploit their lack of experience or knowledge.

(b) Researchers shall not make false statements about their skills, experience or activities, or about those of their organization.

Article 3 – Professional responsibility

(a) Respondents' co-operation in a market research project is entirely voluntary at all stages. They shall not be misled when being asked for their co-operation.

(b) Researchers shall take all reasonable precautions to ensure that respondents are in no way harmed or adversely affected as a direct result of their participation in a market research project.

(c) Researchers shall not unjustifiably criticize other researchers.

 Article 4 – Transparency

(a) Researchers shall promptly identify themselves and unambiguously state the purpose of the research.

(b) Respondents shall be able to check the identity and bona fides of the researcher without difficulty.

(c) Researchers shall on request allow the client to arrange for checks on the quality of data collection and data preparation.

(d) Researchers shall provide their clients with appropriate technical details of any research project carried out for the clients.

(e) Researchers shall ensure that market research projects are designed, carried out, reported and documented accurately, transparently and objectively.

 Article 5 – Ownership

Market research proposals and cost quotations are the property of the organization or individual who developed them unless otherwise agreed.

 Article 6 – Recording and observation techniques

Respondents shall be informed before observation techniques or recording equipment are used for research purposes, except where these are openly used in a public place and no personal data are collected. If respondents so wish, the record or relevant section of it shall be destroyed or deleted. In the absence of explicit consent respondents' personal identity shall be protected.

Article 7 – Data protection and privacy

(a) Privacy policy

Researchers shall have a privacy policy which is readily accessible to respondents from whom they are collecting data.

(b) Collection of data

When collecting personal information from respondents researchers shall ensure

that:

- respondents are aware of the purpose of the collection; and

- respondents are aware of any quality control activity involving re-contact.

(c) Use of data

Personal information collected and held in accordance with this Code shall be:

- collected for specified research purposes and not used in any manner incompatible with these purposes;

- adequate, relevant and not excessive in relation to the purpose of the research for which they are collected and/or further processed; and

- preserved no longer than is required for the purpose for which the information was collected or further processed.

Researchers shall ensure that respondents’ personal identity is withheld from the client. The researcher may, communicate the respondent’s identifiable personal information to the client, unless national provisions require stricter regulations, under the following conditions:

i) the respondent has explicitly expressed this wish and/or

ii) the respondent has given their explicit consent and

iii) on the understanding that no commercial activity (as defined in Article 1d)

will be directed at them as a direct result of their having provided information.

(d) Security of processing

Researchers shall ensure that adequate security measures are employed in order to prevent unauthorized access, manipulation to or disclosure of the personal data.

If personal data are transferred to third parties, it shall be established that they employ at least an equivalent level of security measures.

(e) Rights of the respondent

Appropriate measures shall be taken to ensure that respondents understand and

can exercise their rights

- not to participate in a market research project;

- to withdraw from the market research interview at any time;

- to require that their personal data are not made available to others; and

- to delete or to rectify incorrect personal data which are held on them.

(f) Transborder transactions

Particular care shall be taken to maintain the data protection rights of individuals when personal data are transferred from the country in which they are collected to another country.

When data processing is conducted in another country, all reasonable steps shall be taken to ensure that adequate security measures are observed and that the data protection principles of this Code are respected.

Article 8 – Children and young people

Researchers shall take special care when interviewing children and young people. The consent of the parent or responsible adult shall first be obtained before interviewing children.

Article 9 – Shared interviews

Researchers shall inform clients if the work to be carried out for them is to be combined or syndicated in the same project with work for other clients, without disclosing the identity of such clients without their permission.

Article 10 – Subcontracting

Researchers shall inform clients, prior to work commencing, when any part of the work for them is to be subcontracted outside the researchers’ own organization (including the use of any outside consultants). On request clients shall be told the identity of any such subcontractor.

Article 11 – Publishing findings

(a) When reporting on the results of a market research project, researchers shall make a clear distinction between the findings, the researchers’ interpretation of these findings, and any recommendations based on them.

(b) Where any of the findings of a research project are published by the client, the latter shall be asked to consult with the researcher as to the form and content of publication of the findings. Both the client and the researcher have a responsibility to ensure that published results are not misleading.

(c) Researchers shall always be prepared to make available the technical information necessary to assess the validity of any published findings.

(d) Researchers shall not allow their name to be associated with the dissemination of conclusions from a market research project unless they are adequately supported by the data.

Article 12 – Responsibility

Researchers have overall responsibility for ensuring that research is carried out in accordance with this Code, and for ensuring that clients and other parties to the research agree to comply with its requirements.

Article 13 – Effect of subsequent redress for contravention

Subsequent correction and/or appropriate redress for a contravention of the Code, by the party responsible, is desirable but does not excuse the contravention.

Article 14 – Implementation

(a) The Code and the principles enshrined in it, should be adopted and implemented, nationally and internationally, by the relevant local, national or regional selfregulatory bodies. The Code should also be applied, where appropriate, by all organizations, companies and individuals involved and at all stages in a market research project.

(b) Marketers, researchers and clients should be familiar with the Code and with other relevant local self-regulatory documents on market research, and should familiarize themselves with decisions taken by the appropriate self-regulatory body. Requests for interpretation of the principles contained in this Code may be submitted to the ICC Code Interpretation Panel or to the ESOMAR Professional Standards Committee.

 

1 A list of these is available at www.esomar.org

 

Last revised December 2007

This code is available in several defferent languages,  please click here to access.

Ethics for counselling and psychotherapy 

This statement, Ethics for Counselling and Psychotherapy, unifies and replaces all the earlier codes for counsellors, trainers and supervisors. It is intended to guide the practice of counselling and psychotherapy by all members of the British Association for Counselling and Psychotherapy (BACP) and inform the practice of closely related roles that are delivered in association with counselling and psychotherapy or as part of the infrastructure to deliver these services. Being ethically mindful and willing to be accountable for the ethical basis of practice are essential requirements of membership of this Association.

 

In this statement the term ‘practitioner’ is used generically to refer to anyone with responsibility for the provision of counselling or psychotherapy-related services. ‘Practitioner’ includes anyone undertaking the role(s) of counsellor, psychotherapist, trainers and educators for these roles, providers of coaching and mentoring in association with counselling and psychotherapy, supervisors, and practitioner researchers. Members of this Association who are providers of services using counselling skills, embedded counsellors, managers and researchers of therapeutic services, are required to be accountable in accordance with the Ethical Framework in ways appropriate to their role and to communicate appropriately the basis of their ethical accountability and expectations. The term ‘client’ is used as a generic term to refer to the recipient of any of these services. The client may be an individual, couple, family, group, organisation or other specifiable social unit. Alternative names may be substituted for ‘practitioner’ and ‘client’ in the practice setting, according to custom and context. 

 

This statement marks an important development in approach to ethics within the Association. One of the characteristics of contemporary society is the coexistence of different approaches to ethics. This statement reflects this ethical diversity and supports practitioners being responsive to differences in client abilities, needs and culture and taking account of variations between settings and service specialisations by considering:

 

• Values
• Principles
• Personal moral qualities

This selection of ways of expressing ethical commitments does not seek to invalidate other approaches. The presentation of different ways of approaching ethics alongside each other in this statement is intended to draw attention to the limitations of relying too heavily on any single ethical approach. Ethical principles are well suited to examining the justification for particular decisions and actions. However, reliance on principles alone may detract from the importance of the practitioner’s personal qualities and their ethical significance in the counselling or therapeutic relationship. The provision of contextually sensitive and appropriate services is also a fundamental ethical concern. Variations in client needs and cultural diversity differences are often more easily understood and responded to in terms of values. Therefore, professional values are becoming an increasingly significant way of expressing ethical commitment.

 

Values of counselling and psychotherapy  

The fundamental values of counselling and psychotherapy include a commitment to:

• Respecting human rights and dignity
• Protecting the safety of clients
• Ensuring the integrity of practitioner-client relationships
• Enhancing the quality of professional knowledge and its application
• Alleviating personal distress and suffering
• Fostering a sense of self that is meaningful to the person(s) concerned
• Increasing personal effectiveness
• Enhancing the quality of relationships between people
• Appreciating the variety of human experience and culture
• Striving for the fair and adequate provision of counselling and psychotherapy services

Values inform principles. They represent an important way of expressing a general ethical commitment that becomes more precisely defined and action-orientated when expressed as a principle.

 

Ethical principles of counselling and psychotherapy  

Principles direct attention to important ethical responsibilities. Each principle is described below and is followed by examples of good practice that have been developed in response to that principle.

Ethical decisions that are strongly supported by one or more of these principles without any contradiction from others may be regarded as reasonably well founded. However, practitioners will encounter circumstances in which it is impossible to reconcile all the applicable principles and choosing between principles may be required. A decision or course of action does not necessarily become unethical merely because it is contentious or other practitioners would have reached different conclusions in similar circumstances. A practitioner’s obligation is to consider all the relevant circumstances with as much care as is reasonably possible and to be appropriately accountable for decisions made.

 

Being trustworthy: honouring the trust placed in the practitioner (also referred to as fidelity)
Being trustworthy is regarded as fundamental to understanding and resolving ethical issues. Practitioners who adopt this principle: act in accordance with the trust placed in them; strive to ensure that clients’ expectations are ones that have reasonable prospects of being met; honour their agreements and promises; regard confidentiality as an obligation arising from the client’s trust; restrict any disclosure of confidential information about clients to furthering the purposes for which it was originally disclosed.

 

Autonomy: respect for the client’s right to be self-governing
This principle emphasises the importance of developing a client’s ability to be self-directing within therapy and all aspects of life. Practitioners who respect their clients’ autonomy: ensure accuracy in any advertising or information given in advance of services offered; seek freely given and adequately informed consent; emphasise the value of voluntary participation in the services being offered; engage in explicit contracting in advance of any commitment by the client; protect privacy; protect confidentiality; normally make any disclosures of confidential information conditional on the consent of the person concerned; and inform the client in advance of foreseeable conflicts of interest or as soon as possible after such conflicts become apparent. The principle of autonomy opposes the manipulation of clients against their will, even for beneficial social ends.

 

Beneficence: a commitment to promoting the client’s well-being
The principle of beneficence means acting in the best interests of the client based on professional assessment. It directs attention to working strictly within one’s limits of competence and providing services on the basis of adequate training or experience. Ensuring that the client’s best interests are achieved requires systematic monitoring of practice and outcomes by the best available means. It is considered important that research and systematic reflection inform practice. There is an obligation to use regular and on-going supervision to enhance the quality of the services provided and to commit to updating practice by continuing professional development. An obligation to act in the best interests of a client may become paramount when working with clients whose capacity for autonomy is diminished because of immaturity, lack of understanding, extreme distress, serious disturbance or other significant personal constraints.

 

Non-maleficence: a commitment to avoiding harm to the client

Non-maleficence involves: avoiding sexual, financial, emotional or any other form of client exploitation; avoiding incompetence or malpractice; not providing services when unfit to do so due to illness, personal circumstances or intoxication. The practitioner has an ethical responsibility to strive to mitigate any harm caused to a client even when the harm is unavoidable or unintended. Holding appropriate insurance may assist in restitution. Practitioners have personal and professional responsibility to challenge, where appropriate, the incompetence or malpractice of others; and to contribute to any investigation and/or adjudication concerning professional practice which falls below that of a reasonably competent practitioner and/or risks bringing discredit upon the profession. 

 

Justice: the fair and impartial treatment of all clients and the provision of adequate services
The principle of justice requires being just and fair to all clients and respecting their human rights and dignity. It directs attention to considering conscientiously any legal requirements and obligations, and remaining alert to potential conflicts between legal and ethical obligations. Justice in the distribution of services requires the ability to determine impartially the provision of services for clients and the allocation of services between clients. A commitment to fairness requires the ability to appreciate differences between people and to be committed to equality of opportunity, and avoiding discrimination against people or groups contrary to their legitimate personal or social characteristics. Practitioners have a duty to strive to ensure a fair provision of counselling and psychotherapy services, accessible and appropriate to the needs of potential clients. 

Personal moral qualities  
 

Conclusion 

The challenge of working ethically means that practitioners will inevitably encounter situations where there are competing obligations. In such situations it is tempting to retreat from all ethical analysis in order to escape a sense of what may appear to be unresolvable ethical tension. These ethics are intended to be of assistance in such circumstances by directing attention to the variety of ethical factors that may need to be taken into consideration and to alternative ways of approaching ethics that may prove more useful. No statement of ethics can totally alleviate the difficulty of making professional judgements in circumstances that may be constantly changing and full of uncertainties. By accepting this statement of ethics, members of the British Association for Counselling and Psychotherapy are committing themselves to engaging with the challenge of striving to be ethical, even when doing so involves making difficult decisions or acting courageously.

 

Guidance on good practice in counseling and psychotherapy  

The British Association for Counselling and Psychotherapy is committed to sustaining and advancing good practice. This guidance on the essential elements of good practice has been written to take into account the changing circumstances in which counselling and psychotherapy are now being delivered, in particular:

• changes in the range of issues and levels of need presented by clients
• the growth in levels of expertise available from practitioners with the expansion in the availability of training and consultative support/supervision
• the accumulated experience of this Association from its founding in 1977 after many years as a Standing Conference.

Variations in client needs and the diversity of settings within which counselling and psychotherapy services are delivered have also been carefully considered. Clients vary in their requirements in order to communicate effectively and to gain access to services. Ethically aware services strive to meet these needs and to avoid excluding someone from receiving a service or lowering the quality of that service solely on the grounds of a client’s learning difficulty or physical disability. Services may be provided by the independent practitioner working alone, one or more practitioners working to provide a service within an agency or large organisation, specialists working in multidisciplinary teams, and by specialist teams of counsellors and psychotherapists. Most work is undertaken face to face but there are also a growing number of telephone and online services. Some practitioners are moving between these different settings and modes of delivery during the course of their work and are therefore required to consider what constitutes good practice in different settings. All practitioners encounter the challenge of responding to the diversity of their clients and finding ways of working effectively with them. This statement therefore responds to the complexity of delivering counselling and psychotherapy services in contemporary society by directing attention to significant issues that practitioners ought to consider and resolve in the specific circumstances of their work.

The terms ‘practitioner’ and ‘client’ are used in the same way as defined in Ethics for counselling and psychotherapy (see page 2). Practitioners’ behaviour may vary from these guidelines provided the variation is ethically justifiable; the client is supportive of the variation; it is demonstrably to the benefit of the client; and that practitioners are willing to be appropriately accountable to people affected, and this Association for their practice and the reputation of therapy in general.

 

Providing a good standard of practice and care 

All clients are entitled to good standards of practice and care from their practitioners in counselling and psychotherapy. Good standards of practice and care require professional competence; good relationships with clients and colleagues; and commitment to being ethically mindful through observance of professional ethics.

    

Good quality of care

1. Good quality of care requires competently delivered services that meet the client’s needs by practitioners who are appropriately supported and accountable.
2. Practitioners should give careful consideration to the limitations of their training and experience and work within these limits, taking advantage of available professional support. If work with clients requires the provision of additional services operating in parallel with counselling or psychotherapy, the availability of such services ought to be taken into account, as their absence may constitute a significant limitation.
3. Good practice involves clarifying and agreeing the rights and responsibilities of both the practitioner and client at appropriate points in their working relationship.
4. Dual relationships arise when the practitioner has two or more kinds of relationship concurrently with a client, for example client and trainee, acquaintance and client, colleague and supervisee. The existence of a dual relationship with a client is seldom neutral and can have a powerful beneficial or detrimental impact that may not always be easily foreseeable. For these reasons practitioners are required to consider the implications of entering into dual relationships with clients, to avoid entering into relationships that are likely to be detrimental to clients, and to be readily accountable to clients and colleagues for any dual relationships that occur.
5. Practitioners are advised to keep appropriate records of their work with clients unless there are good and sufficient reasons for not keeping any records. All records should be accurate, respectful of clients and colleagues and protected from unauthorised disclosure. Any records should be kept securely and adequately protected from unauthorised intrusion or disclosure. Practitioners should take into account their responsibilities and their clients’ rights under data protection legislation and any other legal requirements.
6. Clients are entitled to competently delivered services that are periodically reviewed by the practitioner. These reviews may be conducted, when appropriate, in consultation with clients, supervisors, managers or other practitioners with relevant expertise.

   Maintaining competent practice 

7. All counsellors, psychotherapists, trainers and supervisors are required to have regular and on-going formal supervision/consultative support for their work in accordance with professional requirements. Managers, researchers and providers of counselling skills are strongly encouraged to review their need for professional and personal support and to obtain appropriate services for themselves.
8. Regularly monitoring and reviewing one’s work is essential to maintaining good practice. It is important to be open to, and conscientious in considering, feedback from colleagues, appraisals and assessments. Responding constructively to feedback helps to advance practice.
9. A commitment to good practice requires practitioners to keep up to date with the latest knowledge and respond to changing circumstances. They should consider carefully their own need for continuing professional development and engage in appropriate educational activities.
10. Practitioners should be aware of and understand any legal requirements concerning their work, consider these conscientiously and be legally and professionally accountable for their practice. 

    Keeping trust 

11. The practice of counselling and psychotherapy depends on gaining and honouring the trust of clients. Keeping trust requires:
    1. attentiveness to the quality of listening and respect offered to clients
    2. culturally appropriate ways of communicating that are courteous and clear
    3. respect for privacy and dignity
    4. careful attention to client consent and confidentiality
12. Clients should be adequately informed about the nature of the services being offered. Practitioners should obtain adequately informed consent from their clients and respect a client’s right to choose whether to continue or withdraw.
13. Practitioners should ensure that services are normally delivered on the basis of the client’s explicit consent. Reliance on implicit consent is more vulnerable to misunderstandings and is best avoided unless there are sound reasons for doing so. Overriding a client’s known wishes or consent is a serious matter that requires adequate and reasoned justification. Practitioners should be prepared to be readily accountable to clients, colleagues and this Association if they override a client’s known wishes.
14. Situations in which clients pose a risk of causing serious harm to themselves or others are particularly challenging for the practitioner. These are situations in which the practitioner should be alert to the possibility of conflicting responsibilities between those concerning their client, other people who may be significantly affected, and society generally. Resolving conflicting responsibilities may require due consideration of the context in which the service is being provided. Consultation with a supervisor or experienced practitioner is strongly recommended, whenever this would not cause undue delay. In all cases, the aim should be to ensure for the client a good quality of care that is as respectful of the client’s capacity for self-determination and their trust as circumstances permit.
15. Working with young people requires specific ethical awareness and competence. The practitioner is required to consider and assess the balance between young people’s dependence on adults and carers and their progressive development towards acting independently. Working with children and young people requires careful consideration of issues concerning their capacity to give consent to receiving any service independently of someone with parental responsibilities and the management of confidences disclosed by clients.
16. Practitioners should normally be willing to respond to their client’s requests for information about the way that they are working and any assessment that they may have made. This professional requirement may not apply if it is considered that imparting this information would be detrimental to the client or inconsistent with the counselling or psychotherapeutic approach previously agreed with the client. Clients may have legal rights to this information and these need to be taken into account.
17. Practitioners must not abuse their client’s trust in order to gain sexual, emotional, financial or any other kind of personal advantage. Sexual relations with clients are prohibited. ‘Sexual relations’ include intercourse, any other type of sexual activity or sexualised behaviour. Practitioners should think carefully about, and exercise considerable caution before, entering into personal or business relationships with former clients and should expect to be professionally accountable if the relationship becomes detrimental to the client or the standing of the profession.
18. Practitioners should not allow their professional relationships with clients to be prejudiced by any personal views they may hold about lifestyle, gender, age, disability, race, sexual orientation, beliefs or culture.
19. Practitioners should be clear about any commitment to be available to clients and colleagues and honour these commitments.

    Respecting privacy and confidentiality 

20. Respecting clients’ privacy and confidentiality are fundamental requirements for keeping trust and respecting client autonomy. The professional management of confidentiality concerns the protection of personally identifiable and sensitive information from unauthorised disclosure. Disclosure may be authorised by client consent or the law. Any disclosures of client confidences should be undertaken in ways that best protect the client’s trust and respect client autonomy.
21. Communications made on the basis of client consent do not constitute a breach of confidentiality. Client consent is the ethically preferred way of resolving any dilemmas over confidentiality.
22. Exceptional circumstances may prevent the practitioner from seeking client consent to a breach of confidence due to the urgency and seriousness of the situation, for example, preventing the client causing serious harm to self or others. In such circumstances the practitioner has an ethical responsibility to act in ways which balance the client’s right to confidentiality against the need to communicate with others. Practitioners should expect to be ethically accountable for any breach of confidentiality.

    Teaching and training 

23. Confidential information about clients may be shared within teams where the client has consented or knowingly accepted a service on this basis; the information can be adequately protected from unauthorised further disclosures; and the disclosure enhances the quality of service available to clients or improves service delivery.
24. Practitioners should be willing to be accountable to their clients and to their profession for their management of confidentiality in general and particularly for any disclosures made without their client’s consent. Good records of existing policy and practice and of situations where the practitioner has breached confidentiality without client consent, greatly assist ethical accountability. In some situations the law forbids the practitioner informing the client that confidential information has been passed to the authorities, nonetheless the practitioner remains ethically accountable to colleagues and the profession.
25. All practitioners are encouraged to share their professional knowledge and practice for the benefit of their clients and to promote awareness of counselling and psychotherapy in the public through providing information and education. 
26. Practitioners who provide formal education and training should acquire the skills, attitudes and knowledge required to be competent teachers and facilitators of learning in their subject. 
27. Practitioners are required to be fair, accurate and honest in their assessments of their students.
28. Prior consent is required from clients if they are to be observed, recorded or if their personally identifiable disclosures are to be used for training purposes.
29. All training in counselling and psychotherapy should model standards and practice consistent with those expected of practitioners in the role for which the training is being provided. 
30. All trainers and educators in counselling and psychotherapy have a responsibility to protect the standards of the profession. Trainers are responsible for taking reasonable steps to prevent clients being exposed to risk or harm by trainees.
31. Where information is held by more than one person involved in the assessment of a trainee, it should normally be shared to produce the fairest possible evaluation of the person concerned. Any confidentiality agreements between trainers and trainees ought to be established in ways that permit the appropriate sharing of information for assessment and the protection of clients.

    Supervising and managing 

32. Practitioners are responsible for clarifying who holds responsibility for the work with the client.
33. There is a general obligation for all counsellors, psychotherapists, supervisors and trainers to receive supervision/consultative support independently of any managerial relationships.
34. Supervisors and managers have a responsibility to maintain and enhance good practice by practitioners, to protect clients from poor practice and to acquire the attitudes, skills and knowledge required by their role.
35. Supervisors and managers may form a triangular relationship with a counsellor or psychotherapist, particularly where services are being provided within an agency. All parties to this relationship have a responsibility to clarify their expectations of each other and, in particular, the steps that ought to be taken to address any concerns over client safety. The role of an independent supervisor is widely considered to be desirable in promoting good practice but, to be most effective, requires clarity in how such a role relates to line management and the division of tasks and responsibilities between a supervisor and any line manager.

    Researching 

36. The Association is committed to fostering research that will inform and develop practice. All practitioners are encouraged to support research undertaken on behalf of the profession and to participate actively in research work. 
37. All research should be undertaken with rigorous attentiveness to the quality and integrity both of the research itself and of the dissemination of the results of the research.
38. The rights of all research participants should be carefully considered and protected. The minimum rights include the right to freely given and informed consent, and the right to withdraw at any point. A client’s entitlement to receiving a service should not be affected by their willingness or refusal to participate in research.
39. The research methods used should comply with the standards of good practice in counselling and psychotherapy and must not adversely affect clients.

    Fitness to practise

40. Practitioners have a responsibility to monitor and maintain their fitness to practise at a level that enables them to provide an effective service. If their effectiveness becomes impaired for any reason, including health or personal circumstances, they should seek the advice of their supervisor, experienced colleagues or line manager and, if necessary, withdraw from practice until their fitness to practise returns. Suitable arrangements should be made for clients who are adversely affected. 

    If things go wrong with own clients 

41. Practitioners should respond promptly and appropriately to any complaint received from their clients. An appropriate response in agency-based services would take account of any agency policy and procedures.
42. Practitioners should endeavour to remedy any harm they may have caused to their clients and to prevent any further harm. An apology may be the appropriate response.
43. Practitioners should discuss, with their supervisor, manager or other experienced practitioner(s), the circumstances in which they may have harmed a client in order to ensure that the appropriate steps have been taken to mitigate any harm and to prevent any repetition.
44. Practitioners are strongly encouraged to ensure that their work is adequately covered by insurance for professional indemnity and liability.
45. If practitioners consider that they have acted in accordance with good practice but their client is not satisfied that this is the case, they may wish to use independent dispute resolution, for example: seeking a second professional opinion, mediation, or conciliation where this is both appropriate and practical.
46. Clients should be informed about the existence of the Professional Conduct Procedure of this Association and any other applicable complaints or disciplinary procedures. If requested to do so, practitioners should inform their clients about how they may obtain further information concerning these procedures.

    Responsibilities to all clients 

47. Practitioners have a responsibility to protect clients when they have good reason for believing that other practitioners are placing them at risk of harm.
48. They should raise their concerns with the practitioner concerned in the first instance, unless it is inappropriate to do so. If the matter cannot be resolved, they should review the grounds for their concern and the evidence available to them and, when appropriate, raise their concerns with the practitioner’s manager, agency or professional body.
49. If they are uncertain what to do, their concerns should be discussed with an experienced colleague, a supervisor or raised with this Association.
50. All members of this Association share a responsibility to take part in its professional conduct procedures whether as the person complained against or as the provider of relevant information. 

    Working with colleagues 
    The increasing availability of counselling and psychotherapy means that most practitioners have other practitioners working in their locality, or may be working closely with colleagues within specialised or multidisciplinary teams. The quality of the interactions between practitioners can enhance or undermine the claim that counselling and psychotherapy enable clients to increase their insight and expertise in personal relationships. This is particularly true for practitioners who work in agencies or teams.

    Working in teams  

51. Professional relationships should be conducted in a spirit of mutual respect. Practitioners should endeavour to attain good working relationships and systems of communication that enhance services to clients at all times.
52. Practitioners should treat all colleagues fairly and foster equality opportunity.
53. They should not allow their professional relationships with colleagues to be prejudiced by their own personal views about a colleague’s lifestyle, gender, age, disability, race, sexual orientation, beliefs or culture. It is unacceptable and unethical to discriminate against colleagues on any of these grounds.
54. Practitioners must not undermine a colleague’s relationships with clients by making unjustified or unsustainable comments.
55. All communications between colleagues about clients should be on a professional basis and thus purposeful, respectful and consistent with the management of confidences as declared to clients.

    Awareness of Context 

56. The practitioner is responsible for learning about and taking account of the different protocols, conventions and customs that can pertain to different working contexts and cultures.
57. All routine referrals to colleagues and other services should be discussed with the client in advance and the client’s consent obtained both to making the referral and also to disclosing information to accompany the referral. Reasonable care should be taken to ensure that:
58. the recipient of the referral is able to provide the required service;
1. any confidential information disclosed during the referral process will be adequately protected;
2. the referral will be likely to benefit the client.
59. Prior to accepting a referral the practitioner should give careful consideration to:
    1. the appropriateness of the referral;
    2. the likelihood that the referral will be beneficial to the client;
    3.  the adequacy of the client’s consent for the referral.
60. If the referrer is professionally required to retain overall responsibility for the work with the client, it is considered to be professionally appropriate to provide the referrer with brief progress reports. Such reports should be made in consultation with clients and not normally against their explicit wishes. 

    Probity in professional ethics 
    Ensuring the probity of practice is important both to those who are directly affected but also to the standing of the profession as a whole.

    Providing clients with adequate information

61. Practitioners are responsible for clarifying the terms on which their services are being offered in advance of the client incurring any financial obligation or other reasonably foreseeable costs or liabilities.
62. All information about services should be honest, accurate, avoid unjustifiable claims, and be consistent with maintaining the good standing of the profession.
63. Particular care should be taken over the integrity of presenting qualifications, accreditation and professional standing.

    Financial arrangements 

64. Practitioners are required to be honest, straightforward and accountable in all financial matters
    concerning their clients and other professional relationships.
    Conflicts of interest
     
    Conflicts of interest  
65. Conflicts of interest are best avoided, provided they can be reasonably foreseen in the first instance
    and prevented from arising. In deciding how to respond to conflicts of interest, the protection of the
    client’s interests and maintaining trust in the practitioner should be paramount.
    Care of self as a practitioner
    Attending to the practitioner’s well-being is essential to sustaining good practice. 
66. Practitioners have a responsibility to themselves to ensure that their work does not become
    detrimental to their health or well-being by ensuring that the way that they undertake their work
    is as safe as possible and that they seek appropriate professional support and services as the
    need arises. 
67. Practitioners are entitled to be treated with proper consideration and respect that is consistent with
    this Guidance.

Professional Conduct Procedure 

It is the responsibility of all Members and Complainants to ensure that they fully understand the Professional Conduct Procedure and the associated protocols. This procedure forms an essential part of BACP’s commitment to the protection of the public. Members are required to inform any client who indicates that they have a complaint or grievance about the existence of this procedure and any other applicable complaints or disciplinary procedures. If requested to do so, practitioners should inform their clients about how they may obtain further information concerning these procedures. Further information may be obtained by contacting the Professional Conduct Department at BACP directly; alternatively, all documentation is available on the BACP website at www.bacp.co.uk.

 

1 Introduction  

1.1 Aim
The aim of the Professional Conduct Procedure is to provide complainants with an open and transparent route of remedy where complaints are made against members of this Association. In processing such complaints, the Association aims to protect members of the public, the name and reputation of BACP and the professions referred to within the Ethical Framework.

 

1.2 Bringing a complaint
A complaint can be brought by either:

a) a member of the public who has sought or received a service provided by a member of the Association; or

b) a current member of the Association who may bring complaints for services sought or received directly from another member; or who has witnessed poor practice delivered by another member; or on behalf of another where their written permission has been obtained and where that person is unable to bring the complaint on their own behalf (explanation is required in writing as to the nature of the inability); or

c) a legal guardian or other appropriately authorised adult on behalf of a minor and/or an adult lacking legal capacity for services sought or received; or

d) a third party who can demonstrate sufficient interest and who has been directly affected by the actions of the practitioner, subject to the protocol on third party complaints.

 

1.3 Complaints against non-members

The Association cannot deal with complaints against individuals or organisations that were not members of the Association at the time of the alleged misconduct and/or are not current members of the Association.

 

1.4 Complaints against members

A complaint made against a member and brought within the timescale detailed below, may cover the entirety of the professional relationship in so far as the member concerned was a member of the Association at the time of the alleged professional misconduct.

 

1.5 Timescale
A complaint must be submitted either:

a) within three years of the ending of the professional relationship; or

b) within three years of the date when the Complainant reasonably became aware of the alleged professional misconduct. The Complainant must provide a written explanation as to when/how they became aware and this will be considered by the Pre-Hearing Assessment Panel which will decide if the explanation given is good and/or sufficient; or

c) within a reasonable time of the alleged professional misconduct.

The Association will not consider any complaints where the substantive matters have previously been considered by the Association under these procedures, unless there is overwhelming and compelling new evidence which suggests that the case should be reconsidered.

 

1.6 Records
All records will be kept for a period of seven years. The Association reserves the right to reconsider complaints previously submitted when similar/other complaints subsequently arise that give good reason to suggest that the practitioner’s continuing membership should be considered under Article 4.6 of the Memorandum & Articles of Association. 

Where the outcome of a complaint has resulted in withdrawal of membership of the Association, all records will be kept unless and/or until such time as the person concerned has successfully re-applied for membership of the Association. Such records will be considered in any re-application for membership of the Association.

 

1.7 Administration
The administration of the Professional Conduct Procedure will follow the protocols laid down and as amended from time to time by the Association. These will be administered by the Head of Professional Conduct.

There is benefit in furthering the charitable aims of the Association by carrying out audits and/or research into complaints. The data from complaints will be processed for the purposes of research and statistical analysis. Where this work is carried out, either by BACP or a third party, under strict protocols of confidentiality, the confidentiality of the parties concerned will be respected and any published research and/or analysis will not contain any personally identifiable information.

 

1.8 Expenses
The Association is not responsible for travel or any other expenses incurred either by the Complainant or the Member Complained Against or any support person/representative in connection with any stage of the complaint. The Association cannot order one party in a complaint to pay another party’s costs.

However, where a witness is called by the Chair of the Panel, BACP will reimburse reasonable travel expenses upon the production of valid receipts and completion of an expense claim form. 

 

1.9 Dual accountability
The Association may decide to hear a complaint against a member when another organisation is involved in a similar process arising out of the same substantive matters. Where information is received for consideration under the Professional Conduct Procedure and where it is known that the member concerned is also a member of another professional body, the Association reserves the right to formally notify any other organisation of the issues being considered.

 

1.10 Resolution
Before submitting a complaint to BACP, the Complainant is expected to attempt to resolve the issue with the individual or organisational Member Complained Against and details of any attempt at resolution should be included with the complaint. If local resolution is not possible/feasible or is considered inappropriate in the particular circumstances of the case, the Complainant will be required to provide a written explanation as to why this is the case.

 

1.11 Complaints and findings
The Association reserves the right to notify other professional bodies and/or agencies about complaints and to distribute any findings upheld against a member, where it considers it right and just to do so in all circumstances.

 

2 Making A Complaint

2.1 The complaint
The complaint must satisfy the following conditions:

a) The Complainant must provide a detailed account of the practice giving rise to the complaint, together with details of dates when the event(s) occurred. Reference may be made to the standards of practice outlined in the Ethical Framework for Good Practice in Counselling and Psychotherapy and/or the relevant Codes of Ethics and Practice in force at the time, together with all supporting evidence as appropriate. Reference may also be made to the Ethical guidelines for researching counselling and psychotherapy, as appropriate.

b) The individual or organisational Member Complained Against is named and is a current member of the Association and was a member of the Association at the time the alleged breach occurred.

c) It is in writing, dated, signed and received by the Head of Professional Conduct.

A complaint not satisfying the above conditions will not be accepted or processed under these procedures.

 

2.2 Notification 

The Member Complained Against will be notified that a complaint has been received, given a copy of that complaint and details of the procedure to be followed. The Member Complained Against is not required to respond at this stage, but will be given an opportunity at a later stage if the complaint is accepted under the formal Professional Conduct Procedure (as set out in section 3).

 

2.3 Receipt of a complaint
The complaint will be submitted to a Pre-Hearing Assessment Panel, whereupon the Panel will decide:

a) whether to accept the complaint to be dealt with at a Professional Conduct Hearing, refer it back for further information/clarification or reject it. The Panel has discretion to interview the Complainant and/or Member Complained Against if deemed appropriate;

b) if further information/clarification is requested, upon receipt of same, the complaint will be re-submitted to the Pre-Hearing Assessment Panel which will decide whether to accept it or reject it;

c) once the complaint is accepted, the Complainant and Member Complained Against will be formally notified of this decision in writing. The Head of Professional Conduct will then start the formal Professional Conduct Procedure (as set out in section 3);

d) if the complaint is not accepted by the Pre-Hearing Assessment Panel, the Complainant and Member Complained Against will be formally notified of this decision in writing.

 

2.4 Appeal following decision of the Pre-Hearing Assessment Panel
The Complainant may appeal against the decision of the Pre-Hearing Assessment Panel. An appeal must be received by the Head of Professional Conduct within 14 days of notification of the Panel’s decision. The Complainant can appeal on the following grounds:

a) the decision was made against the weight of evidence;

b) there is new evidence that was not available at the time of the Pre-Hearing Assessment Panel (subject to the conditions laid down in the relevant protocol).

The intention to appeal must be accompanied by the evidence to support the submission.

The ground(s) of appeal, together with the original submissions and any new evidence considered by the Pre-Hearing Assessment Panel, will be considered by an independent Appeal Assessor. The Appeal Assessor’s decision will be final.

 

3 The Formal Professional Conduct Procedure

3.1 Acceptance of complaint
The Complainant and Member Complained Against will be notified in writing that the complaint will proceed to a Professional Conduct Hearing.

 

3.2 Responding to a formal complaint
The Member Complained Against will be notified of the acceptance of the complaint and will have 28 days to respond to it, having previously been supplied with a copy of the complaint. The Member Complained Against will also be furnished with any further information submitted by the Complainant and considered by the Pre-Hearing Assessment Panel. Any response to the complaint must be forwarded to the Head of Professional Conduct.

 

3.3 Evidence
All evidence submitted for the purpose of the Professional Conduct Hearing, by either the Complainant or the Member Complained Against, shall be available to the parties involved in the complaint. The Head of Professional Conduct will distribute to the parties copies of all submissions made.

 

3.4 Conduct
It is the duty of the parties taking part in the Professional Conduct Procedure to comply with the implementation of the Professional Conduct Procedure. Such persons shall comply with the relevant protocols as laid down by the Association. Any failure to comply may result in the termination of the Professional Conduct Procedure or withdrawal of membership under Article 4.6 of the Memorandum and Articles of Association. 

 

3.5 Lapsed membership
Failure to renew membership by a Member Complained Against during the course of a complaint will not normally terminate the Professional Conduct Procedure. 

A member’s resignation from membership of the Association will not normally terminate nor invalidate the processing and/or hearing of a complaint by the Association.

 

4 The Professional Conduct Hearing

4.1 Venue
Professional Conduct Hearings will be held at a neutral venue within the vicinity of the Association’s headquarters, other than in exceptional circumstances.

 

4.2 Professional Conduct Panel
The Head of Professional Conduct will appoint an independently constituted panel of not less than three persons, including lay representation, to hear the complaint.

 

4.3 Declaration of interest
Members of the Professional Conduct Panel have a duty to declare any interest which may be considered by the Head of Professional Conduct to affect their impartiality, or likely to be thought so to do.

 

4.4 Purpose
The purpose of the Professional Conduct Hearing is for the Professional Conduct Panel to examine all the written and oral evidence presented by both parties and decide whether the complaint is proved or not. If proved, the Panel will decide whether or not any sanction should be imposed.

 

4.5 Presence of a representative/support person
When appearing at the Professional Conduct Hearing, the Complainant and Member Complained Against may each be accompanied by a representative who may support and/or speak on behalf of the party concerned. Such details of a representative/support person must be received by the Head of Professional Conduct not less than 28 days prior to the date fixed for the Professional Conduct Hearing.

 

4.6 Additional evidence 
Written evidence and/or submissions and witness statements must be submitted in advance by the Complainant and the Member Complained Against. Such papers must be received by the Head of Professional Conduct not less than 28 days prior to the date fixed for the Professional Conduct Hearing. Such papers will be circulated to the Professional Conduct Panel, the Complainant and the Member Complained Against, within a reasonable period prior to the Hearing. The Chair of the Professional Conduct Panel may take advice on these papers and/or procedural matters from the Head of Professional Conduct or such relevant person as may be deemed appropriate.

 

4.7 New evidence
The Chair of the Professional Conduct Panel will determine whether or not new evidence will be accepted on the day of the Hearing. The decision will be based on the conditions laid down in the relevant protocol. The Chair of the Professional Conduct Panel may take advice on such matters from the Head of Professional Conduct.

 

4.8 Attendance by witnesses
A witness can only be called if the witness has supplied a written statement contained within the parties’ submissions to BACP. Parties wishing to call witnesses must notify the Head of Professional Conduct of the names and details of such witnesses not less than 28 days prior to the date fixed for the Hearing. The Chair of the Panel will only permit the attendance of a witness if the Panel considers their written statement requires further clarification. The Professional Conduct Panel, Complainant and Member Complained Against may call witnesses to attend the Hearing. The Chair of the Panel has discretion to refuse attendance by a witness if it is reasonably believed that such attendance is not relevant and/or will not add any weight to the issue(s) being considered. Witnesses may be questioned by the Panel and by either party connected with the case. 

 

4.9 Failure to attend the Professional Conduct Hearing
Where a Complainant or Member Complained Against fails or refuses to attend a Professional Conduct Hearing, the Head of Professional Conduct has the power to decide to either:

4.10 Notification of findings
The decision of the Professional Conduct Panel will be notified in writing to the parties within 28 days of the Professional Conduct Hearing.

The entirety of the decision of the Professional Conduct Panel, together with the details of any sanction, will be published on the Association’s website and in its journal.

 

5 Sanction

5.1 The Professional Conduct Panel, having regard to the findings, may impose one or more of the sanctions detailed in the relevant protocol.

The Head of Professional Conduct will appoint an independently constituted Sanction Panel which will consist of not less than three people, usually two members of the Association and one lay member, to consider any evidence of compliance.

 

5.2 Lifting of sanction
The Sanction Panel will decide if the requirements of the sanction have been fulfilled and thus, whether the sanction should be lifted.

The Member Complained Against will be notified in writing of any decision made. Where a sanction has been successfully complied with and, thus, lifted, a Sanction Compliance Notice will be published on the Association’s website and in its journal.

 

5.3 Failure or refusal to comply with sanction

Failure or refusal to comply with a sanction may result in membership of the Association being withdrawn immediately. The Chair of the Association will notify the Member Complained Against of any such decision in writing. In such circumstances, a Withdrawal of Membership Notice will be published on the Association’s website and in its journal.

 

6 Formal Appeal Procedure

6.1 The Member Complained Against may appeal on the ground(s) detailed in paragraph 6.5. An appeal against the decision of the Professional Conduct Panel must be submitted in writing by the deadline given (see paragraph 6.6), be accompanied by any supporting documentation and submitted to the Head of Professional Conduct.

6.2 The ground(s) for appeal will be considered by an independent Appeal Assessor who will decide whether the appeal should be accepted to go forward to an Appeal Hearing or not.

6.3 If leave to appeal is accepted under paragraph 6.2, a notice to that effect shall be given to the Head of Professional Conduct and the case will proceed to an Appeal Hearing, where the appeal will be considered by an independent Appeal Panel, as set out in Section 7. The Appellant  and the Complainant will be notified of this decision and given details of the procedure to be followed.

6.4 If there is insufficient evidence to satisfy any of the ground(s) for appeal, the leave to appeal will be rejected. The Appellant and the Complainant will be notified in writing of this decision which will be final.

6.5 An appeal will be considered on any of the following ground(s):

a) the facts were found against the weight of evidence;

b) the sanction is disproportionate to the findings and decision of the Professional Conduct Panel and is unjust in all the circumstances; 

c) there is evidence to suggest that a procedural impropriety may have had a material affect on the findings and decision of the Professional Conduct Panel;

d) there is new evidence which was not available at the time of the Professional Conduct Hearing, subject to the conditions laid down in the relevant protocol.

 

6.6 Timescale for appeal
An appeal must be in writing, and must specify which ground(s) it is submitted under and be accompanied by any supporting documentation and served upon the Head of Professional Conduct within 28 days of notification of the findings and decision and/or sanction of the Professional Conduct Panel.

 

7 Appeal Hearing

7.1 Venue
Appeal hearings will be held at a neutral venue within the vicinity of the Association’s headquarters, other than in exceptional circumstances.

 

7.2 Appeal Panel
The Head of Professional Conduct will appoint an independently constituted panel of not less than three persons, including lay representation, to decide the appeal.

 

7.3 Declaration of interest
Members of an appeal panel have a duty to declare any interest which may be considered by the Head of Professional Conduct to affect their impartiality, or likely to be thought so to do.

 

7.4 Purpose
The purpose of an appeal hearing is for an appeal panel to examine all the written and oral evidence presented by both parties to decide whether the appeal is upheld or not.

 

7.5 Format of the Appeal Hearing
The Appeal Hearing will be by way of a review of the Professional Conduct Panel’s decision in light of the evidence put before it. The Appeal Panel will then consider the appeal documentation in its entirety, together with any verbal submissions and mitigating factors before reaching its decision.

 

7.6 Presence of a representative/support person
When appearing at the Appeal Hearing, both parties may be accompanied by a representative who may support and/or speak on behalf of the party concerned. Such details of a representative/support person must be received by the Head of Professional Conduct not less than 28 days prior to the date fixed for the Appeal Hearing.

 

7.7 Additional evidence
Written evidence and/or submissions and witness statements must be submitted in advance by the Appellant and the Complainant. Such papers must be received by the Head of Professional Conduct not less than 28 days prior to the date fixed for the Appeal Hearing. Such papers will be circulated to the Appeal Panel, the Appellant and the Complainant, within a reasonable period prior to the Hearing. The Chair of the Appeal Panel may take advice on these papers and/or procedural matters from the Head of Professional Conduct, or such relevant person as may be deemed appropriate.

 

7.8 New evidence
The Chair of the Appeal Panel will determine whether or not new evidence will be accepted on the day of the Appeal Hearing. The decision will be based on the conditions laid down in the relevant protocol. The Chair of the Appeal Panel may take advice on such matters from the Head of Professional Conduct. 

 

7.9 Attendance by witnesses
A witness can only be called if the witness has supplied a written statement contained within the parties’ submissions to BACP. Parties wishing to call witnesses must notify the Head of Professional Conduct of the names and details of such witnesses not less than 28 days prior to the date fixed for the Hearing. The Chair of the Appeal Panel will only permit the attendance of a witness if the Panel considers that their written statement requires further clarification. The Appeal Panel, Appellant and Complainant may call witnesses to attend the Hearing. The Chair of the Appeal Panel has discretion to refuse attendance by a witness if it is reasonably believed that such attendance is not relevant and/or will not add any weight to the issue(s) being considered. Witnesses may be questioned by the Panel and by either party connected with the case.

 

7.10 Failure to attend the Appeal Hearing
Where an Appellant fails or refuses to attend an Appeal Hearing, the Head of Professional Conduct has the power to decide to either:

7.11 Notification of decision
The decision of the Appeal Panel will be notified to the parties in writing within 28 days of the Appeal Hearing.

Where an Appeal has not been successful, in whole or in part, the decision of the Appeal Panel, including details of any sanction, incorporating any amendment(s) made by the Appeal Panel, will be published on the Association’s website and in its journal.

If the decision is that the Appellant’s membership of the Association should be withdrawn, the Head of Professional Conduct will communicate this decision to the Chair of the Association  who, in turn, will formally notify the Appellant in writing and implement the Panel’s decision. This decision will be final.

 

8 Publication

8.1 Where a complaint is upheld in whole or in part, the decision of the Professional Conduct and/or Appeal Panel, together with details of any sanction, will be published on the Association’s website and in its journal in such detail as deemed appropriate to the findings.

8.2 The withdrawal of membership under the Professional Conduct Procedure will be published on the Association’s website, in its journal and elsewhere as it considers appropriate and just to do so, and in the interests of public protection.

8.3 Under these procedures, any notification that the Association is entitled to publish on its website and in its journal may be published elsewhere by the Association at its discretion and in the interests of public protection.

 

9 Effective Date

This Professional Conduct Procedure 2010 will apply to all complaints received by the Association from 1 February 2010. 

 

Heads of Complaint  

The Professional Conduct Panel is responsible for determining whether the ground(s) of the complaint are upheld or not, according to the standards of civil law. If upheld, the Panel has to consider its decision and make a finding under one or more of the following heads of complaint. The decision about the head must ultimately rest upon consideration of all the circumstances in the case. The information that follows is intended to inform the choice between the three heads of complaint available to the Panel. These are:

1. Professional Misconduct
2. Professional Malpractice
3. Bringing the Profession into Disrepute

Professional Misconduct
A finding of professional misconduct signifies that the practitioner has contravened the ethical and behavioural standards that should reasonably be expected of a member of this profession. Misconduct is defined as acting in contravention of the written and unwritten guidance of the profession.

A finding of serious professional misconduct is appropriate if the misconduct is of sufficient seriousness to merit a period of suspension of rights of membership and/or the withdrawal of membership of the Association.

 

Professional Malpractice
A finding of professional malpractice signifies that the service(s) for which the practitioner is responsible have fallen below the standards that would reasonably be expected of a practitioner exercising reasonable care and skill. Examples of malpractice include, but are not restricted to:

1. Incompetence
2. Negligence
3. Recklessness
4. The provision of inadequate professional services

A finding of serious professional malpractice is appropriate if the malpractice is of sufficient seriousness to merit a period of suspension of rights of membership and/or the withdrawal of membership of the Association.

 

Bringing the Profession into Disrepute
A finding of bringing the profession into disrepute signifies that the practitioner has acted in such an infamous or disgraceful way that the public’s trust in the profession might reasonably be undermined, or might reasonably be undermined if they were accurately informed about all the circumstances of the case.

A finding under this head must amount to ‘disgraceful conduct in a professional respect’. This involves consideration of three elements:

Conduct that is regarded as ‘disgraceful’ need not amount to moral turpitude or be restricted to acts of serious immorality.

The conduct must have had some connection with a professional role in order to be considered as falling ‘in a professional respect’. It ought not to be concerned with matters that can reasonably be viewed as solely personal and private.

Conduct ‘in a professional respect’ is not confined to the pursuit of the profession in question.

What is not considered to be disgraceful to an ordinary person may be considered to be disgraceful to a professional person.

A finding of bringing the profession into disrepute will result in withdrawal of membership.