Human Research Subjects

 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.

as adapted by the Alaska Native Science Commission from

the Kahnawake Schools Diabetes Prevention Project

Copyright 459302 (January 22, 1997)

(www.ksdpp.org/code.html)

 

INTRODUCTION

 

The [Name of Project] is a partnership of the people of the [Name of Community] and researchers of [Name of Research Organization]. In this document these groups are referred to as the Partners.

 

The community is represented by the [Name(s) of Community Organization and Community Researchers] and the researchers by the [Name(s) of Researchers].

 

The partners will work cooperatively and collaboratively in the design, implementation, analysis, interpretation, conclusion, reporting and publication of the experiences of the project. Each partner provides ideas and resources that come from the experience, knowledge and capability of all its members. Together, through respect for each other, consultation, and collaboration, they significantly strengthen the project and its outcomes. All partners of the project share an understanding that community based research is a powerful tool for learning about the community while contributing to the community in which it is being conducted.

 

Collaborative research acknowledges that there must be respect for the scientific and social integrity of the project. Each group has obligations towards the other partners.

 

PURPOSE OF THE CODE OF ETHICS:

 

The purpose of this code of ethics is to establish a set of principles and procedures to guide the partners to achieve the goals and objectives of the project. The code outlines the obligations of each of the partners through all of the phases of the project, from the design of the research through to the publication and communication of the experiences of the project.

 

POLICY STATEMENT

 

The sovereignty of the community to make decisions about research in the community is recognized and respected. The researchers should maximize the benefits to the community as a whole and to individual community volunteers. Research should empower the community to support community goals of health and wellness, to improve its conditions and to fulfill its traditional responsibility of caring for the generations to come.

 

PRINCIPLES:

 

1. The community must be involved as a full partner in all aspects of the research. Continuous consultation and collaboration should characterize the partnership. 
2. The strengths and culture of the community, including community researchers and staff as well as material resources, must be respected and utilized whenever possible. 
3. Written permission must be obtained from the partners before beginning the research projects. 
4. Permission from all individuals participating must be obtained prior to collecting personal information. 
5. The confidentiality of all individuals must be respected. If necessary, the community involved may choose to remain anonymous when reporting the results. 
6. All research results, analyses and interpretations must first be reviewed by the partners to ensure accuracy and avoid misunderstanding. 
7. All data collected belongs to the community and must be returned to the community. 
8. The partners must all be involved in making decisions about the publication and the distribution of all or parts of the research results. 
9. The community must agree to the release of information.

 

OBLIGATIONS OF THE PARTNERS OBLIGATIONS OF THE RESEARCHERS:

 

1. To do no harm to the community.
2.  To involve the community in active participation rather than passive acceptance. 
3. To ensure the design, implementation, analysis, interpretation, reporting, publication and distribution of the research are culturally relevant to the community and in agreement with the standards of competent research. 
4. To undertake research that will contribute something of value to the community in which the research is being conducted. To impart new skills to community members. 
5. To help to address any issues that are raised as a result of research. 
6. To provide expertise to scientifically answer questions that emerge from the community. 
7. To promote academic diffusion of knowledge through written publications and oral presentations. This includes the documentation of the undertaking of the project and of the results.
8.  To be guardians of the data until the end of the project and to return that data to the community at the end of the project. To be involved in any future analysis of the data after the data has been returned to the community.

 

OBLIGATIONS OF THE COMMUNITY RESEARCHERS:

 

Community researchers are regarded as the Project Staff and those Co-investigators who are employed within the community. In addition to the obligations listed for researchers, the community researcher is obligated:

 

1. To maintain a long-term relationship of trust in the dual role of caregiver, educator, and researcher: this will only be possible if the needs of the community are always considered as the first priority in any decision. 
2. To communicate with researchers during all phases of the research. 
3. To arrange for researchers to meet with the partner Committees and/or Board of Directors, and any other local organizations to implement and promote the project. 
4. To facilitate supervisory meetings of the Intervention and Evaluation teams. 
5. To participate in all phases of the project, review all research results, analyses and interpretations for accuracy and present information to the community.

 

OBLIGATIONS OF THE COMMUNITY PARTNER:

 

1. To represent the community through their respective organizations. 
2. To be updated by the Project Staff on a determined basis to support the development and offer analysis of the activities to ensure compatibility with the project goal and objectives. 
3. To meet with the Project Co-investigators to maintain awareness and to offer recommendations concerning the research aspect of the project. 
4. To communicate with representatives of other communities to share ideas and program development for benefit and involvement. 
5. To serve as the guardian of all evaluation data after the completion of the project. 
6. To receive all requests for the use of the data by other researchers after the completion of the project. 
7. To approve of or write a disagreement to the interpretation of the data analysis.

 

AUTHORSHIP GUIDELINES

INTRODUCTION

 

The purpose of the project is to investigate the research questions described in the protocol. Since this project is unique, the results will be of interest to many other communities. For this reason it is necessary to share the experience of the project with the largest audience who might benefit from it. Part of the research process includes the communication of research results to other people and organizations in similar areas of research.

 

AUDIENCE

 

Communications will be directed at four general audiences:

 

1. Health, Education and other officials 
2. Scientists and Researchers 
3. The Community Council or governing body 
4. The community, at large. 

 

Health, education and other officials are those people providing services or working on programming and planning. They will be interested in how the project was developed and implemented as well as the outcome of project efforts. Scientists and researchers will be interested in the methods used, the process of the program, the impacts measured, and the answers provided to the research questions. The community at large is everyone who participated in the project as well as those who are generally interested in the project goals.

 

PRINCIPLES

 

All aspects of the project can be considered as worthy of communication. All communication pertaining to the project will follow generally accepted ethical standards. The principles include:

 

1. Anonymity: Results to be presented in a grouped, not individual manner. 
2. Confidentiality: All personal information provided by individuals will be made anonymous whenever possible and remain confidential unless otherwise determined by the individuals. 
3. Priority of Communities Involved: The communities participating will be the first to review and receive results and the first invited to provide input and feedback on the results. 
4. Respect: Consideration for the communities and all participants must be observed in all communications. 

 

PROCESS

 

Results from research projects usually are presented in the following ways:

 

1. Articles in scientific journals, referred to as "a paper". 
2. Oral presentation of "a paper" at a scientific conference or meeting. 
3. Oral presentation to the community at large.
4.  Written document to the community at large. 
5. Teaching examples.

 

For scientific journals and oral presentations at scientific conferences and meetings there is a standard process involved. It is therefore possible to outline the steps from idea to final communication and outline the responsibilities for those involved with the authorship. However, these points should also apply to communications to the community. From here on the word communication will be used to describe both oral presentations and written papers.

 

It will be the responsibility of the project partners to ensure that the staff and investigators who have made significant contribution to the project can qualify for authorship. These are people who have worked directly on the project. However, being involved only in data collection or delivery of a program will not be sufficient for authorship.

 

1. The Idea: All ideas for communications must be presented to the partners before writing begins.
2.  Preparing the Communication: The first author of an article (i.e. the person whose name appears first on the article) will assume the major responsibility for preparing the article. The first author will assume most of the writing responsibility. Other authors contributing to the communication will appear in descending order. This order will depend on the contribution made to the subject of the communication and the preparation and writing of the communication, including hunters and elders, in the body of the document and the author's section. 
3. Submitting a Communication: All authors on the paper must approve of the final version before the paper is submitted to the journal, conference, etc. Furthermore, final versions of all papers must be approved by the partners before submission. 
4. Peer Review: Communications may be reviewed by scientific and community people considered knowledgeable in the subject of the communication. This peer review process may result in suggested changes of the communication in order for publishing the article in the journal of interest. All the authors of the communication must approve any changes made in the review. This will be done by a letter to the editor signed by all the authors.                     

 

This next section deals with special communications.

5.  Abstracts: An abstract is a short summary of the content of a communication. When someone wants to present a paper at a conference, an abstract will be sent to the conference organizers. The abstract will then be used to decide if the communication will be accepted for presentation. In case of a late call for an abstract, the partners should be contacted as soon as possible. If there are no objections, the abstract should be sent immediately. The preparation of the communication will proceed following the steps outlined previously. 
5. Responsibility of Communication by the Partners: It is part of the shared responsibility of the partners to prepare communications for the community and the scientific community. Those who have more of an interest in them would appropriately prepare communications for the community: likewise for communication to the scientific communication. This should not limit the authors to one or the other.

 

EVALUATION GUIDELINES:

CODIFICATION, DATA ENTRY AND DATA CLEANING

 

1. The activities organized by the project should ensure that the data collection process is in accord with the host community values and norms, and competent scientific practice.
2.  Participation in the evaluation activities is voluntary for the people in both communities. The people who express the desire to withdraw will be able to do so at any time. 
3. All information or data collected on individuals will be kept strictly confidential. An identification number will be given and the names of participants will be removed. A file containing names and identification numbers will be kept for future follow-up. Only the Project Coordinator will have access to this file. 
4. For reasons of confidentiality, the person responsible for coding the collected information should not have access to the names of the participants. The names of the participants should be removed prior to data coding. 
5. The coordinator is responsible for the quality control of the data coding and entry.

 

PROCESS FOR APPLICATION TO RESEARCH IN CONJUNCTION WITH THE PROJECT:

 

The researcher and community need to meet for the purpose of discussion and approval of the research idea and the protocol involved. To meet this end, the following steps will be followed to make application:

 

• A letter is sent to one of the partners to request a meeting to discuss the research proposal. This letter is to include a summary description of the proposed research, a time frame for research, reporting, and the expected conclusion. 
• The recipient of the request is responsible to: distribute the material to the other partners within one working week of receipt of the letter, establish a meeting with the partners and the researcher, and send a copy of the Code of Research Ethics to the applicant to allow for preparation. 
• If there are no objections from any of the members of the partners to the research proposal, formal written consent is to be sent within thirty (30) days of the meeting. In the event of any objections, a second meeting with the proposed researcher is to be held within two working weeks for discussion on the objection. 
• The researcher must agree to comply with all aspects of the project Code of Research Ethics. The proposal will be rejected if the researcher refuses to comply with any aspect. 
• All partners will review and discuss the completed research document(s) before publication. This review is to take place thirty (30) days following receipt of the research document(s). 
• If there is any dissent, the dissenter is responsible to write and present a written response at this meeting. The dissent is to be included with the submission of the research document(s)

Background

 

The preparation of the ethics statement involved a unique partnership between the National Association for the Practice of Anthropology (NAPA) and the Southern California Applied Anthropology Network (SCAAN). Jean Gilbert, a SCAAN member and Chair of the NAPA Ethics Committee, worked with a local committee composed of several of her fellow SCAAN members (Claudia Fishman, Neil Tashima and Barbara Pillsbury) to create the first draft, which appeared in the December 1987 Anthropology Newsletter, pp 7-8. Membership comments were solicited at that time. The Guidelines were also sent to all of the local practitioner organizations (LPOs) for comment, and in addition were the topic of discussion in a regular SCAAN monthly meeting. The final version of the NAPA Ethical Guidelines for Practitioners was published in the November 1988 Anthropology Newsletter, pp 8-9. Gilbert thanked the membership of SCAAN and the following individuals who reviewed and commented on the draft: Fred Hess, Elvin Hatch, Barbara Frankel and Gene Anderson. The final version incorporated many of their comments.

 

NAPA Ethical Guidelines for Practitioners

 

These guidelines have been developed by the National Association for the Practice of Anthropology as a guide to the professional and ethical responsibilities that practicing anthropologists should uphold. A practicing anthropologist is a professionally trained anthropologist who is employed or retained to apply his or her specialized knowledge problem solving related to human welfare and human activities. The designation “practicing anthropologist” includes full-time practitioners who work for clients such as social service organizations, government agencies and business and industrial firms. This term also includes part-time practitioners, usually academically based anthropologists, who accept occasional assignments with such clients. The substantive work of practicing anthropologists may include applied research, program design and implementation, client advocacy and advisory roles and activities related to the communication of anthropological perspectives. These guidelines are provided with the recognition that practicing anthropologists are involved in many types of policy-related research, frequently affecting individuals and groups with diverse and sometimes conflicting interests. No code or set of guidelines can anticipate unique circumstances or direct practitioner actions in specific situations. The individual practitioner must be willing to make carefully considered ethical choices and be prepared to make clear the assumptions, facts and issues on which those choices are based. These guidelines therefore address general contexts, priorities and relationships which should be considered in ethical decision making in anthropological practice.

 

1. Our primary responsibility is to respect and consider the welfare and human rights of all categories of people affected by decisions, programs or research in which we take part. However, we recognize that many research and practice settings involve conflicts between benefits accruing to different parties affected by our research. It is our ethical responsibility, to the extent feasible, to bring to bear on decision making, our own or that of others, information concerning the actual or potential impacts of such activities on all whom they might affect. It is also our responsibility to assure, to the extent possible, that the views of groups so affected are made clear and given full and serious consideration by decision makers and planners, in order to preserve options and choices for affected groups.

 

2. To our resource persons or research subjects we owe full and timely disclosure of the objectives, methods and sponsorship of our activities. We should recognize the rights of resource persons, whether individuals or groups, to receive recognition for their contributions or to remain anonymous if they so desire or to decline participation altogether. These persons should be informed of our commitment to the principle of confidentiality throughout the design of research or other activities involving resource persons and should thoroughly investigate and understand all of the limitations on our claims of confidentiality and disclosure.

 

3. To our employers we owe competent, efficient, fully professional skills and techniques, timely performance of our work and communication of our findings and recommendations in understandable, non-jargonistic language.

 

As practicing anthropologists, we are frequently involved with employers or clients in legally contracted arrangements. It is our responsibility to carefully review contracts prior to signing and be willing to execute the terms and conditions stipulated in the contract once it has been signed.

 

At the outset of a relationship or contract with an employer or client, we have an obligation to determine whether or not the work we are requested to perform is consistent with our commitment to deal fairly with the rights and welfare of persons affected by our work, recognizing that different constituencies may be affected in different ways. At this time, we should also discuss with our employer or client the intended use of the data or materials to be generated by our work and clarify the extent to which information developed during our activities can be made available to the public. Issues surrounding the protection of subject confidentiality and disclosure of information or findings should be thoroughly reviewed with the potential employer or client. We will not undertake activities which compromise our ethical responsibilities.

 

We will carry out our work in such a manner that the employer fully understands our ethical priorities, commitments and responsibilities. When, at any time during the course of work performance, the demands of the employer require or appear to require us to violate the ethical standards of our profession, we have the responsibility to clarify the nature of the conflict between the request and our standards and to propose alternatives that are consistent with our standards. If such a conflict cannot be resolved, we should terminate the relationship.

 

4. In our relations with students and trainees, we will be candid, fair, nonexploitative, nondiscriminatory and committed to the student’s or trainee’s welfare. We recognize that such mentoring does involve an exchange in which practitioners share their knowledge and experience in return for the significant effort and contribution of the students/trainees. We should be honest and thorough in our presentation of material and should strive to improve our teaching and training techniques and our methods of evaluating the effectiveness of our instruction.

 

As practicing anthropologists we are frequently called upon to instruct, train or teach individuals, anthropologists and others in nonacademic settings (workshop participants, in-service trainees, continuation or certification program trainees and research teams). To such persons, we owe training that is informed, timely and relevant to their needs.

 

Our instruction should inform both students and trainees of the ethical responsibilities involved in the collection and use of data. To our students and trainees we owe respect for and openness to nonanthropological methods and perspectives. Student and trainee contributions to our work, including publications, should be accurately and completely attributed.

 

5. To our colleagues, anthropologists and others, we have a responsibility to conduct our work in a manner that facilitates their activities or that does not unjustly compromise their ability to carry out professional work.

 

The cross-disciplinary nature of the work of practicing anthropologists requires us to be informed and respectful of the disciplinary and professional perspectives, methodologies and ethical requirements of nonanthropological colleagues with whom we work.

 

We will accurately report the contribution of our colleagues to our research, practice-related activities and publications.

6. To the discipline of anthropology we have a responsibility to act in a manner that presents the discipline to the public and to other professional colleagues in a favorable light. We will point out the value of anthropological contributions to the understanding of human problems and humankind. Where appropriate in the context of our work, we will encourage the use of anthropological approaches and recommend the participation of other anthropologists.

 

We will contribute to the growth of our discipline through communicating and publishing scientific and practical information about the work in which we are engaged, including, as appropriate, theory, processes, outcomes and professional techniques and methods.

 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

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.

Effective July 1, 2001

 

Preamble

 

The Board of Directors of the American Association for Marriage and Family Therapy (AAMFT) hereby promulgates, pursuant to Article 2, Section 2.013 of the Association's Bylaws, the Revised AAMFT Code of Ethics, effective July 1, 2001.

 

The AAMFT strives to honor the public trust in marriage and family therapists by setting standards for ethical practice as described in this Code. The ethical standards define professional expectations and are enforced by the AAMFT Ethics Committee. The absence of an explicit reference to a specific behavior or situation in the Code does not mean that the behavior is ethical or unethical. The standards are not exhaustive. Marriage and family therapists who are uncertain about the ethics of a particular course of action are encouraged to seek counsel from consultants, attorneys, supervisors, colleagues, or other appropriate authorities.

 

Both law and ethics govern the practice of marriage and family therapy. When making decisions regarding professional behavior, marriage and family therapists must consider the AAMFT Code of Ethics and applicable laws and regulations. If the AAMFT Code of Ethics prescribes a standard higher than that required by law, marriage and family therapists must meet the higher standard of the AAMFT Code of Ethics. Marriage and family therapists comply with the mandates of law, but make known their commitment to the AAMFT Code of Ethics and take steps to resolve the conflict in a responsible manner. The AAMFT supports legal mandates for reporting of alleged unethical conduct.

 

The AAMFT Code of Ethics is binding on Members of AAMFT in all membership categories, AAMFT-Approved Supervisors, and applicants for membership and the Approved Supervisor designation (hereafter, AAMFT Member). AAMFT members have an obligation to be familiar with the AAMFT Code of Ethics and its application to their professional services. Lack of awareness or misunderstanding of an ethical standard is not a defense to a charge of unethical conduct.

 

The process for filing, investigating, and resolving complaints of unethical conduct is described in the current Procedures for Handling Ethical Matters of the AAMFT Ethics Committee. Persons accused are considered innocent by the Ethics Committee until proven guilty, except as otherwise provided, and are entitled to due process. If an AAMFT Member resigns in anticipation of, or during the course of, an ethics investigation, the Ethics Committee will complete its investigation. Any publication of action taken by the Association will include the fact that the Member attempted to resign during the investigation.

 

Principle I

Responsibility to Clients

 

Marriage and family therapists advance the welfare of families and individuals. They respect the rights of those persons seeking their assistance, and make reasonable efforts to ensure that their services are used appropriately.

 

1.1. Marriage and family therapists provide professional assistance to persons without discrimination on the basis of race, age, ethnicity, socioeconomic status, disability, gender, health status, religion, national origin, or sexual orientation.

 

1.2 Marriage and family therapists obtain appropriate informed consent to therapy or related procedures as early as feasible in the therapeutic relationship, and use language that is reasonably understandable to clients. The content of informed consent may vary depending upon the client and treatment plan; however, informed consent generally necessitates that the client: (a) has the capacity to consent; (b) has been adequately informed of significant information concerning treatment processes and procedures; (c) has been adequately informed of potential risks and benefits of treatments for which generally recognized standards do not yet exist; (d) has freely and without undue influence expressed consent; and (e) has provided consent that is appropriately documented. When persons, due to age or mental status, are legally incapable of giving informed consent, marriage and family therapists obtain informed permission from a legally authorized person, if such substitute consent is legally permissible.

 

1.3 Marriage and family therapists are aware of their influential positions with respect to clients, and they avoid exploiting the trust and dependency of such persons. Therapists, therefore, make every effort to avoid conditions and multiple relationships with clients that could impair professional judgment or increase the risk of exploitation. Such relationships include, but are not limited to, business or close personal relationships with a client or the client’s immediate family. When the risk of impairment or exploitation exists due to conditions or multiple roles, therapists take appropriate precautions.

 

1.4 Sexual intimacy with clients is prohibited.

 

1.5 Sexual intimacy with former clients is likely to be harmful and is therefore prohibited for two years following the termination of therapy or last professional contact. In an effort to avoid exploiting the trust and dependency of clients, marriage and family therapists should not engage in sexual intimacy with former clients after the two years following termination or last professional contact. Should therapists engage in sexual intimacy with former clients following two years after termination or last professional contact, the burden shifts to the therapist to demonstrate that there has been no exploitation or injury to the former client or to the client’s immediate family.

 

1.6 Marriage and family therapists comply with applicable laws regarding the reporting of alleged unethical conduct.

 

1.7 Marriage and family therapists do not use their professional relationships with clients to further their own interests.

 

1.8 Marriage and family therapists respect the rights of clients to make decisions and help them to understand the consequences of these decisions. Therapists clearly advise the clients that they have the responsibility to make decisions regarding relationships such as cohabitation, marriage, divorce, separation, reconciliation, custody, and visitation.

 

1.9 Marriage and family therapists continue therapeutic relationships only so long as it is reasonably clear that clients are benefiting from the relationship.

 

1.10 Marriage and family therapists assist persons in obtaining other therapeutic services if the therapist is unable or unwilling, for appropriate reasons, to provide professional help.

 

1.11 Marriage and family therapists do not abandon or neglect clients in treatment without making reasonable arrangements for the continuation of such treatment.

 

1.12 Marriage and family therapists obtain written informed consent from clients before videotaping, audio recording, or permitting third-party observation.

 

1.13 Marriage and family therapists, upon agreeing to provide services to a person or entity at the request of a third party, clarify, to the extent feasible and at the outset of the service, the nature of the relationship with each party and the limits of confidentiality.

 

Principle II

Confidentiality

 

Marriage and family therapists have unique confidentiality concerns because the client in a therapeutic relationship may be more than one person. Therapists respect and guard the confidences of each individual client.

 

2.1 Marriage and family therapists disclose to clients and other interested parties, as early as feasible in their professional contacts, the nature of confidentiality and possible limitations of the clients’ right to confidentiality. Therapists review with clients the circumstances where confidential information may be requested and where disclosure of confidential information may be legally required. Circumstances may necessitate repeated disclosures.

 

2.2 Marriage and family therapists do not disclose client confidences except by written authorization or waiver, or where mandated or permitted by law. Verbal authorization will not be sufficient except in emergency situations, unless prohibited by law. When providing couple, family or group treatment, the therapist does not disclose information outside the treatment context without a written authorization from each individual competent to execute a waiver. In the context of couple, family or group treatment, the therapist may not reveal any individual’s confidences to others in the client unit without the prior written permission of that individual.

 

2.3 Marriage and family therapists use client and/or clinical materials in teaching, writing, consulting, research, and public presentations only if a written waiver has been obtained in accordance with Subprinciple 2.2, or when appropriate steps have been taken to protect client identity and confidentiality. 2.4 Marriage and family therapists store, safeguard, and dispose of client records in ways that maintain confidentiality and in accord with applicable laws and professional standards.

 

2.5 Subsequent to the therapist moving from the area, closing the practice, or upon the death of the therapist, a marriage and family therapist arranges for the storage, transfer, or disposal of client records in ways that maintain confidentiality and safeguard the welfare of clients.

 

2.6 Marriage and family therapists, when consulting with colleagues or referral sources, do not share confidential information that could reasonably lead to the identification of a client, research participant, supervisee, or other person with whom they have a confidential relationship unless they have obtained the prior written consent of the client, research participant, supervisee, or other person with whom they have a confidential relationship. Information may be shared only to the extent necessary to achieve the purposes of the consultation.

 

Principle III

Professional Competence and Integrity

 

Marriage and family therapists maintain high standards of professional competence and integrity.

 

3.1 Marriage and family therapists pursue knowledge of new developments and maintain competence in marriage and family therapy through education, training, or supervised experience.

 

3.2 Marriage and family therapists maintain adequate knowledge of and adhere to applicable laws, ethics, and professional standards.

 

3.3 Marriage and family therapists seek appropriate professional assistance for their personal problems or conflicts that may impair work performance or clinical judgment.

 

3.4 Marriage and family therapists do not provide services that create a conflict of interest that may impair work performance or clinical judgment.

 

3.5 Marriage and family therapists, as presenters, teachers, supervisors, consultants and researchers, are dedicated to high standards of scholarship, present accurate information, and disclose potential conflicts of interest.

 

3.6 Marriage and family therapists maintain accurate and adequate clinical and financial records.

 

3.7 While developing new skills in specialty areas, marriage and family therapists take steps to ensure the competence of their work and to protect clients from possible harm. Marriage and family therapists practice in specialty areas new to them only after appropriate education, training, or supervised experience.

 

3.8 Marriage and family therapists do not engage in sexual or other forms of harassment of clients, students, trainees, supervisees, employees, colleagues, or research subjects.

 

3.9 Marriage and family therapists do not engage in the exploitation of clients, students, trainees, supervisees, employees, colleagues, or research subjects.

 

3.10 Marriage and family therapists do not give to or receive from clients (a) gifts of substantial value or (b) gifts that impair the integrity or efficacy of the therapeutic relationship.

 

3.11 Marriage and family therapists do not diagnose, treat, or advise on problems outside the recognized boundaries of their competencies.

 

3.12 Marriage and family therapists make efforts to prevent the distortion or misuse of their clinical and research findings.

 

3.13 Marriage and family therapists, because of their ability to influence and alter the lives of others, exercise special care when making public their professional recommendations and opinions through testimony or other public statements.

 

3.14 To avoid a conflict of interests, marriage and family therapists who treat minors or adults involved in custody or visitation actions may not also perform forensic evaluations for custody, residence, or visitation of the minor. The marriage and family therapist who treats the minor may provide the court or mental health professional performing the evaluation with information about the minor from the marriage and family therapist’s perspective as a treating marriage and family therapist, so long as the marriage and family therapist does not violate confidentiality.

 

3.15 Marriage and family therapists are in violation of this Code and subject to termination of membership or other appropriate action if they: (a) are convicted of any felony; (b) are convicted of a misdemeanor related to their qualifications or functions; (c) engage in conduct which could lead to conviction of a felony, or a misdemeanor related to their qualifications or functions; (d) are expelled from or disciplined by other professional organizations; (e) have their licenses or certificates suspended or revoked or are otherwise disciplined by regulatory bodies; (f) continue to practice marriage and family therapy while no longer competent to do so because they are impaired by physical or mental causes or the abuse of alcohol or other substances; or (g) fail to cooperate with the Association at any point from the inception of an ethical complaint through the completion of all proceedings regarding that complaint.

 

Principle IV

Responsibility to Students and Supervisees

 

Marriage and family therapists do not exploit the trust and dependency of students and supervisees.

 

4.1 Marriage and family therapists are aware of their influential positions with respect to students and supervisees, and they avoid exploiting the trust and dependency of such persons. Therapists, therefore, make every effort to avoid conditions and multiple relationships that could impair professional objectivity or increase the risk of exploitation. When the risk of impairment or exploitation exists due to conditions or multiple roles, therapists take appropriate precautions.

 

4.2 Marriage and family therapists do not provide therapy to current students or supervisees.

 

4.3 Marriage and family therapists do not engage in sexual intimacy with students or supervisees during the evaluative or training relationship between the therapist and student or supervisee. Should a supervisor engage in sexual activity with a former supervisee, the burden of proof shifts to the supervisor to demonstrate that there has been no exploitation or injury to the supervisee.

 

4.4 Marriage and family therapists do not permit students or supervisees to perform or to hold themselves out as competent to perform professional services beyond their training, level of experience, and competence.

 

4.5 Marriage and family therapists take reasonable measures to ensure that services provided by supervisees are professional.

 

4.6 Marriage and family therapists avoid accepting as supervisees or students those individuals with whom a prior or existing relationship could compromise the therapist’s objectivity. When such situations cannot be avoided, therapists take appropriate precautions to maintain objectivity. Examples of such relationships include, but are not limited to, those individuals with whom the therapist has a current or prior sexual, close personal, immediate familial, or therapeutic relationship.

 

4.7 Marriage and family therapists do not disclose supervisee confidences except by written authorization or waiver, or when mandated or permitted by law. In educational or training settings where there are multiple supervisors, disclosures are permitted only to other professional colleagues, administrators, or employers who share responsibility for training of the supervisee. Verbal authorization will not be sufficient except in emergency situations, unless prohibited by law.

 

Principle V

Responsibility to Research Participants

 

Investigators respect the dignity and protect the welfare of research participants, and are aware of applicable laws and regulations and professional standards governing the conduct of research.

 

5. 1 Investigators are responsible for making careful examinations of ethical acceptability in planning studies. To the extent that services to research participants may be compromised by participation in research, investigators seek the ethical advice of qualified professionals not directly involved in the investigation and observe safeguards to protect the rights of research participants.

 

5. 2 Investigators requesting participant involvement in research inform participants of the aspects of the research that might reasonably be expected to influence willingness to participate. Investigators are especially sensitive to the possibility of diminished consent when participants are also receiving clinical services, or have impairments which limit understanding and/or communication, or when participants are children.

 

5.3 Investigators respect each participant’s freedom to decline participation in or to withdraw from a research study at any time. This obligation requires special thought and consideration when investigators or other members of the research team are in positions of authority or influence over participants. Marriage and family therapists, therefore, make every effort to avoid multiple relationships with research participants that could impair professional judgment or increase the risk of exploitation.

 

5.4 Information obtained about a research participant during the course of an investigation is confidential unless there is a waiver previously obtained in writing. When the possibility exists that others, including family members, may obtain access to such information, this possibility, together with the plan for protecting confidentiality, is explained as part of the procedure for obtaining informed consent.

 

Principle VI

Responsibility to the Profession

 

Marriage and family therapists respect the rights and responsibilities of professional colleagues and participate in activities that advance the goals of the profession.

 

6.1 Marriage and family therapists remain accountable to the standards of the profession when acting as members or employees of organizations. If the mandates of an organization with which a marriage and family therapist is affiliated, through employment, contract or otherwise, conflict with the AAMFT Code of Ethics, marriage and family therapists make known to the organization their commitment to the AAMFT Code of Ethics and attempt to resolve the conflict in a way that allows the fullest adherence to the Code of Ethics.

 

6.2 Marriage and family therapists assign publication credit to those who have contributed to a publication in proportion to their contributions and in accordance with customary professional publication practices.

 

6.3 Marriage and family therapists do not accept or require authorship credit for a publication based on research from a student’s program, unless the therapist made a substantial contribution beyond being a faculty advisor or research committee member. Coauthorship on a student thesis, dissertation, or project should be determined in accordance with principles of fairness and justice.

 

6.4 Marriage and family therapists who are the authors of books or other materials that are published or distributed do not plagiarize or fail to cite persons to whom credit for original ideas or work is due.

 

6.5 Marriage and family therapists who are the authors of books or other materials published or distributed by an organization take reasonable precautions to ensure that the organization promotes and advertises the materials accurately and factually.

 

6.6 Marriage and family therapists participate in activities that contribute to a better community and society, including devoting a portion of their professional activity to services for which there is little or no financial return.

 

6.7 Marriage and family therapists are concerned with developing laws and regulations pertaining to marriage and family therapy that serve the public interest, and with altering such laws and regulations that are not in the public interest. 6.8 Marriage and family therapists encourage public participation in the design and delivery of professional services and in the regulation of practitioners.

 

Principle VII

Financial Arrangements

 

Marriage and family therapists make financial arrangements with clients, third-party payors, and supervisees that are reasonably understandable and conform to accepted professional practices.

 

7.1 Marriage and family therapists do not offer or accept kickbacks, rebates, bonuses, or other remuneration for referrals; fee-for-service arrangements are not prohibited.

 

7.2 Prior to entering into the therapeutic or supervisory relationship, marriage and family therapists clearly disclose and explain to clients and supervisees: (a) all financial arrangements and fees related to professional services, including charges for canceled or missed appointments; (b) the use of collection agencies or legal measures for nonpayment; and (c) the procedure for obtaining payment from the client, to the extent allowed by law, if payment is denied by the third-party payor. Once services have begun, therapists provide reasonable notice of any changes in fees or other charges.

 

7.3 Marriage and family therapists give reasonable notice to clients with unpaid balances of their intent to seek collection by agency or legal recourse. When such action is taken, therapists will not disclose clinical information.

 

7.4 Marriage and family therapists represent facts truthfully to clients, third-party payors, and supervisees regarding services rendered.

 

7.5 Marriage and family therapists ordinarily refrain from accepting goods and services from clients in return for services rendered. Bartering for professional services may be conducted only if: (a) the supervisee or client requests it, (b) the relationship is not exploitative, (c) the professional relationship is not distorted, and (d) a clear written contract is established.

 

7.6 Marriage and family therapists may not withhold records under their immediate control that are requested and needed for a client’s treatment solely because payment has not been received for past services, except as otherwise provided by law.

 

Principle VIII

Advertising

 

Marriage and family therapists engage in appropriate informational activities, including those that enable the public, referral sources, or others to choose professional services on an informed basis.

 

8.1 Marriage and family therapists accurately represent their competencies, education, training, and experience relevant to their practice of marriage and family therapy.

 

8.2 Marriage and family therapists ensure that advertisements and publications in any media (such as directories, announcements, business cards, newspapers, radio, television, Internet, and facsimiles) convey information that is necessary for the public to make an appropriate selection of professional services. Information could include: (a) office information, such as name, address, telephone number, credit card acceptability, fees, languages spoken, and office hours; (b) qualifying clinical degree (see subprinciple 8.5); (c) other earned degrees (see subprinciple 8.5) and state or provincial licensures and/or certifications; (d) AAMFT clinical member status; and (e) description of practice.

 

8.3 Marriage and family therapists do not use names that could mislead the public concerning the identity, responsibility, source, and status of those practicing under that name, and do not hold themselves out as being partners or associates of a firm if they are not.

 

8.4 Marriage and family therapists do not use any professional identification (such as a business card, office sign, letterhead, Internet, or telephone or association directory listing) if it includes a statement or claim that is false, fraudulent, misleading, or deceptive.

 

8.5 In representing their educational qualifications, marriage and family therapists list and claim as evidence only those earned degrees: (a) from institutions accredited by regional accreditation sources recognized by the United States Department of Education, (b) from institutions recognized by states or provinces that license or certify marriage and family therapists, or (c) from equivalent foreign institutions.

 

8.6 Marriage and family therapists correct, wherever possible, false, misleading, or inaccurate information and representations made by others concerning the therapist's qualifications, services, or products.

 

8.7 Marriage and family therapists make certain that the qualifications of their employees or supervisees are represented in a manner that is not false, misleading, or deceptive.

 

8.8 Marriage and family therapists do not represent themselves as providing specialized services unless they have the appropriate education, training, or supervised experience.

 

This Code is published by:

American Association for Marriage and Family Therapy

112 South Alfred Street, Alexandria, VA 22314

Phone: (703) 838-9808 - Fax: (703) 838-9805

 

www.aamft.org

 

© Copyright 2001 by the AAMFT. All rights reserved. Printed in the United States of America. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

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.

Code of Ethics

* JIBS Code of ethics for authors 
* JIBS Code of ethics for editors 
* JIBS Code of ethics for reviewers 

The Journal of International Business Studies (JIBS) aspires to select and publish, through peer review, the highest quality research in international business. In order to achieve this goal, the entire peer review and publication process should be thorough, objective and fair. Journal reputation depends heavily on the trust by all stakeholders in the fairness of the peer review and publication process. A formal code of ethics, outlining guidelines for good behavior and proposing solutions to ethical dilemmas facing Authors, Editors and Reviewers, can build stakeholder trust and improve journal reputation. With this goal in mind, the JIBS Code of Ethics is designed to be a comprehensive policy for peer review and publication ethics in the Journal of International Business Studies. The Code describes JIBS's policies for ensuring the ethical treatment of all participants in the peer review and publication process. JIBS Authors, Editors and Reviewers are encouraged to study these guidelines and address any questions or concerns to the JIBS Editor-in-Chief, Lorraine Eden, at editor-in-chief@jibs.net. These guidelines will apply to manuscripts submitted to JIBS starting July 1, 2007, and may be revised at any time by the Editor-in-Chief.

 

JIBS CODE OF ETHICS FOR AUTHORS
 

Accuracy:

Authors have the ultimate responsibility for all materials included in a manuscript submitted to JIBS. Authors are obligated to present an accurate account of the research performed as well as an objective discussion of the significance of the research. Authors should report their findings fully and should not omit data that are relevant within the context of the research question(s). Results should be reported whether they support or contradict expected outcomes. Authors should take particular care to present relevant qualifications to their research or to the findings and interpretations of them. Underlying assumptions, theories, methods, measures and research designs relevant to the findings and interpretations of their work should be disclosed. The manuscript should contain sufficient detail and references to permit peers with access to the same dataset to repeat the work. If an Author discovers a significant error or inaccuracy in his/her own work, it is the Author's obligation to promptly notify the Journal Editor and cooperate with the Editor to retract or correct the paper. If the Editor or the publisher learns from a third party that a published work contains a significant error, it is the obligation of the Author to promptly retract or correct the manuscript or provide evidence to the Editor of the correctness of the original paper.
 

Originality:
 

When an Author submits a manuscript to JIBS:

• The manuscript must be an original work. Authors must not submit the same work to two places of publication at the same time, or at any time while the manuscript is under review at JIBS. It is also improper for an Author to submit a manuscript describing essentially the same research to more than one place of publication, unless it is a resubmission of a manuscript rejected for or withdrawn from publication.
• The manuscript must not have been previously published or accepted for publication elsewhere, either in whole (including book chapters) or in part (including paragraphs of text or exhibits), whether in English or another language. The only exception is a conference proceedings paper, where the paper is work in progress toward the manuscript submitted to JIBS. The Author must inform the JIBS Office of the conference proceedings paper and, if requested by the JIBS Office, send it to the JIBS Editor handling the manuscript. JIBS holds the copyright to all published articles.
• If the manuscript contains materials that overlap with work that is previously published, that is in press, or that is under consideration for publication elsewhere, the Author must cite this work in the manuscript. The Author must also inform the JIBS Office of the related work and, if requested, send the manuscript to the Editor. Authors should explicitly cite their own earlier work and ideas, even when the work or ideas are not quoted verbatim or paraphrased in the manuscript. If exact sentences or paragraphs that appear in another work by the Author are included in the manuscript, the material should be put in quotation marks and appropriately cited.
• The manuscript should identify the origin, and originality, of any proprietary, non-standard datasets used in the paper. If the dataset has been used elsewhere by this or another Author the manuscript should cite these other works, whether published or not.
• While self-citation is encouraged, Authors should avoid excessively citing their earlier works in order to inflate their citation count. Authors should also avoid self-citation that might violate the double-blind review process. In such cases, the Author should include the information in the manuscript's Acknowledgements (which are not forwarded to the Reviewers) and also inform the JIBS Editor handling the manuscript.
• Authors should not submit a manuscript to JIBS that was previously submitted to and rejected by a JIBS Editor. If an earlier version was previously rejected by JIBS, and the Author wishes to submit a revised version for review, this fact and the justification for resubmission should be clearly communicated by the Author to the JIBS Managing Editor at the time of submission. Only under rare circumstances will a second submission be permissible.
   

Co-Authorship:

All Co-Authors of papers should have made significant contributions to the work and share accountability for the results. Authorship and credit should be shared in proportion to the various parties' contributions. Authors should take responsibility and credit, including authorship credit, only for work they have actually performed or to which they have contributed. Other contributions should be cited in the manuscript's Acknowledgements or an endnote. Authors should normally list a student as the principal Co-Author on multiple-authored publications that substantially derive from the student's dissertation or thesis. Authors who analyze data from others should explicitly acknowledge the contribution of the initial researchers. The Corresponding Author who submits a manuscript to JIBS should have sent all living Co-Authors a draft and obtained their assent to submission and publication.
 

Conflicts of Interest:

A conflict of interest is some fact known to a participant in the publication process that if revealed later, would make a reasonable reader feel misled or deceived (or an Author, Reviewer, or Editor feel defensive). Conflicts of interest may influence the judgment of Authors, Reviewers, and Editors. Possible conflicts often are not immediately apparent to others. They may be personal, commercial, political, academic, or financial. Financial interests may include employment, research funding (received or pending), stock or share ownership, patents, payment for lectures or travel, consultancies, non-financial support, or any fiduciary interest in the company. The perception of a conflict of interest is nearly as important as an actual conflict, since both erode trust. Authors should avoid conflicts of interest or the appearance of conflicts of interest throughout the research process.

• All such interests (or their absence) should be declared in writing by Authors upon submission of the manuscript. If any are declared, they should be published with the article. If there is doubt about whether a circumstance represents a conflict, it should be disclosed, so that Editors may assess its significance. Any queries about possible conflicts of interest should be addressed to the JIBS Office or Editor-in-Chief.
• Authors should disclose in the manuscript's Acknowledgements any financial or other substantive conflict of interest that might be construed to influence the results or interpretation of their manuscript. All sources of financial support for the project should be disclosed. Authors may withhold the names of specific sponsors if they provide an adequate and full description of the sponsor's nature and interest.
• When submitting a manuscript to JIBS, the Corresponding Author should recommend an Editor and up to four possible Reviewers for the manuscript. Authors should avoid any possible conflict of interest, or appearance of conflict of interest, in these selections. Such conflicts of interest apply not only to the Corresponding Author but to any Co-Authors on the manuscript. Examples of possible conflicts of interest include: (1) the Author is at the same institution as the Editor or Reviewer; (2) the Author was a member of the Editor or Reviewer's dissertation committee, or vice versa; or (3) the Author and Editor or Reviewer are currently Co-Authors on another manuscript or have been Co-Authors on a manuscript within the past two years. Authors should not nominate individuals whom they know have already read the manuscript or a previous version of the manuscript since such knowledge would automatically violate the double-blind review process.
   

Human Subjects:

Authors have a responsibility to preserve and protect the privacy, dignity, well-being and freedom of human subjects and research participants. Informed consent should be sought from all human subjects, and if confidentiality or anonymity is requested it should be honored. Manuscripts involving human subjects (surveys, simulations, interviews) should comply with the relevant Human Subject Protocol requirements at the Author's university.
 

Double-Blind Review:

JIBS follows a double-blind review process, whereby Authors do not know Reviewers and vice versa. Authors should respect the confidentiality of the review process and should not reveal themselves to Reviewers, and vice versa. For example, the manuscript should not include any self-revealing information that would identify the Author to a Reviewer. Authors should not post their submitted manuscript (including working papers and prior drafts) on websites where it could be easily discovered by potential Reviewers.
 

Plagiarism:

All work in the manuscript should be free of any plagiarism, falsification, fabrications, or omission of significant material. Plagiarism takes many forms, from "passing off" another's paper as the Author's own paper, to copying or paraphrasing substantial parts of another's paper without attribution, to claiming results from research conducted by others. Authors are expected to explicitly cite others' work and ideas, even if the work or ideas are not quoted verbatim or paraphrased. This standard applies whether the previous work is published, unpublished, or electronically available. Plagiarism in all its forms constitutes unethical publishing behavior and is unacceptable.

Self-plagiarism is also unacceptable publishing behavior. Self-plagiarism can occur in at least two ways: (1) Authors recycle portions of their previous writings by using identical or nearly identical sentences or paragraphs from earlier writings in subsequent research papers, without quotation or acknowledgement; or (2) Authors create multiple papers that are slight variations on each other, which are submitted for publication in different journals but without acknowledgement of the other papers. Authors can and often do develop different aspects of an argument in more than one manuscript. However, manuscripts that differ primarily in appearance, but are presented as separate and distinct research without acknowledging other related work, constitute attempts (whether unintentional or deliberate) to deceive reviewers and readers by overinflating the intellectual contribution of the manuscript. Authors should minimize their recycling of previous writings. If recycling is unavoidable, the Author should inform the Editor at the time of submission and reference the previous writings in the manuscript. Such self-referencing should be worded carefully so as to avoid compromising the double-blind review process.
 

Copyright Law:

Authors should check their manuscripts for possible breaches of copyright law (e.g., where permissions are needed for quotations, artwork or tables taken from other publications) and secure the necessary permissions before submission. Authors should avoid anything in the text of the manuscript that might be actionable, such as defamation. Authors should avoid using sexist and biased language that could be interpreted as denigrating to ethnic or other groups; for example, plural rather than single pronouns ("they" rather than "he") are recommended.

Timeliness:

Authors should be prompt with their manuscript revisions. If an Author cannot meet the deadline given, the Author should contact the JIBS Managing Editor as soon as possible to determine whether a longer time period or withdrawal from the review process should be chosen.
 

JIBS CODE OF ETHICS FOR EDITORS
 

Independence:

JIBS Editors must maintain their editorial independence and work to ensure that Authors have editorial freedom. Responsibility for acceptance or rejection of manuscripts rests with the Editors. Doing so normally entails advice from Reviewers; however, manuscripts that Editors deem clearly inappropriate may be rejected without such review.
 

Unbiased:

Editors should exercise their position of privilege in a confidential, unbiased, prompt, constructive and sensitive manner. Editors have the duty to judge manuscripts only on their scholarly merits. Editors should operate without personal or ideological favoritism or malice.
 

Decision Quality:

Editors have a responsibility to provide the Author with an explanation of the editorial decision on a manuscript. Editors should write high-quality editorial letters that integrate reviewer comments and offer additional suggestions to the Author. Editors should not send a decision letter, without explanation, attached to a set of reviewer comments.
 

Conflict of Interest:

Editors should avoid any practice that gives rise to a conflict of interest or the reasonable appearance of one. For example:

• To avoid any appearance of a potential conflict of interest, the Editor-in-Chief should not publish in the Journal except for materials that are clearly identifiable or identified as non-refereed or single-blind refereed. Editorial responsibility and authority for any manuscript authored by a JIBS Editor and submitted to JIBS should be delegated by the JIBS Editor-in-Chief to another qualified person, such as a past Editor of the Journal or a member of the JIBS Consulting Editors Board. Editorial consideration of the manuscript in any way or form by the Author-Editor is never acceptable.
• Editors should excuse themselves from considering a manuscript in which they have conflicts of interest resulting from competitive, collaborative, financial or other relationships or connections with any of the Authors, companies or institutions connected to the manuscript. Examples of connections that represent possible Editor-Author conflicts of interest include: (1) the Editor and Author are both employed by the same institution; (2) the Editor was a member of the Author's dissertation committee, or vice versa; or (3) the Author and Editor are currently Co-Authors on another manuscript or have been Co-Authors on a manuscript within the past two years.
   

Double-Blind Review:

JIBS follows a double-blind review process, whereby Authors do not know Reviewers and vice versa. Where articles appear in the Journal that were not double-blind reviewed, the standard of review should be clearly stated in the printed Acknowledgements accompanying the article. For example, an introductory article written by Guest Editors for a Special Issue would normally be single-blind reviewed, and should be so identified when published. The level of review for an invited work published in the Journal (for example, a Commentary written by the Author(s) who received the JIBS Decade Award) should be stated in the Acknowledgements.
 

Confidentiality:

Editors and their editorial staff including student workers shall not disclose information about a manuscript to anyone other than Reviewers and Authors. Office procedures should be in place to maintain confidentiality of the review process. JIBS Editors are expected to ensure the confidentiality of the double-blind review process and not divulge any information that might identify Authors to Reviewers or vice versa. The anonymity of Reviewers can only be lifted if Editors receive permission from Reviewers to reveal their identities. Editors should ensure that their staff members conform to this practice. Unpublished materials disclosed in a submitted manuscript should not be used in an Editor's own research without the express written consent of the Author. Privileged information or ideas obtained through peer review should be kept confidential and not used for personal advantage.
 

Review Quality:

Normally, three Reviewers should be invited to comment on a manuscript, but a minimum of two Reviewers is acceptable. Authors may request that certain Reviewers not be used, but this decision should be left to Editor's discretion. The Editor should routinely assess all reviews for quality. In rare circumstances, an Editor may edit a review before sending it to an Author (for example, to remove a phrase that would identify the Reviewer) or not send the review to the Author if it is not constructive or appropriate. Ratings of review quality and other performance characteristics should be periodically assessed by the JIBS Editor-in-Chief to assure optimal journal performance. These ratings should also contribute to decisions on reappointment to the JIBS Editorial Review Board and to ongoing review requests. Individual performance data on Reviewers should be available to the Editors but otherwise kept confidential.
 

Accuracy:

An Editor presented with convincing evidence by a Reviewer that the substance or conclusion of an unpublished manuscript is erroneous should promptly inform the Author. If similar evidence is presented for a published manuscript, the Editor should ensure prompt publication of a correction, retraction, expression of concern, or other note, as appropriate.
 

Timeliness:

Editors should take steps to ensure the timely review of all manuscripts and respond promptly to inquiries from Authors about the status of a review.
 

Authority:

The JIBS Editor-in-Chief is selected by, reports directly to and serves at the pleasure of the Academy of International Business (AIB) Executive Board. The Editor-in-Chief must have ultimate authority and responsibility for the Journal. The Editor-in-Chief should respect the Journal's constituents (readers, Authors, Reviewers, Editors, editorial staff and publisher), and work to ensure the honesty and integrity of the Journal's contents and continuous improvement in journal quality. The Editor-in-Chief should select the members of the editorial team, including an Editorial Review Board; outline the rights and responsibilities of these individuals; and regularly assess their performance. The Editor-in-Chief should develop a strategy plan for the future of the Journal, including facilitating transition to the next editorial team.
 

Performance:

The Editor-in-Chief should develop performance metrics for the Journal. These metrics should be presented to the AIB Executive Board on a regular basis. The Journal should publish annual audits of acceptance rates, publication intervals, percentage of submissions sent out for external peer review, and other performance data. Performance measures should be used to assess changes in peer review and publication processes that might improve Journal performance.
 

JIBS CODE OF ETHICS FOR REVIEWERS
 

Reciprocity:

Reviewing for journals is a professional activity that provides value for the profession as a whole, and should be encouraged. Scholars who submit manuscripts to JIBS are normally expected to reciprocate by accepting an invitation to review for the Journal.
 

Right of Refusal:

Refusals to review a manuscript are from time to time necessary. For example, a Reviewer who feels inadequately qualified to judge the research reported in a manuscript should refuse to review the manuscript. Reviewers should refuse to review a manuscript if there is a potential conflict of interest. If asked to review a manuscript they have previously reviewed, Reviewers should make that prior review known to the JIBS Editor, unless it is clear that they are being asked to provide a reappraisal.
 

Double-Blind Review:

JIBS has a double-blind review process. Reviewers should refuse to review manuscripts where they have provided written comments on the manuscript or an earlier version to the Author. If a Reviewer knows the identity of an Author or Co-Author, this would normally be grounds for refusal to review. Reviewers also have a responsibility to avoid writing, doing or saying anything that could identify them to an Author.
 

Conflict of Interest:

Normally, Reviewers should refuse to review manuscripts in which they have any conflicts of interest resulting from collaborative, financial, institutional, personal, or other relationships or connections with any of the companies, institutions, or people connected to the papers. Reviewers who might have a conflict of interest on a particular manuscript should reveal that conflict to the Editor, who will then determine their appropriate level of involvement. An example occurs when the Reviewer has a similar manuscript under review in the same or another journal or a similar research project nearing completion. Note that under the double-blind review process, since Reviewers do not know Authors, Reviewers are unlikely to be aware of and are therefore not bound by conflicts of interest involving Authors. If Reviewers do become aware of such conflicts, they should inform the Editor.
 

Unbiased:

Reviewers should evaluate manuscripts objectively, fairly and professionally. Reviewers should avoid personal biases in their comments and judgments.
 

Confidentiality:

Reviewers should respect the confidentiality of the review process. It is important to recognize that the manuscript is confidential. Reviewers should not discuss the manuscript with anyone other than the JIBS Editor, nor should they discuss any information from the manuscript without permission. If Reviewers suspect misconduct, they should notify the Editor in confidence, and should not share their concerns with other parties unless officially notified by the Journal that they may do so.
 

Accuracy:

In evaluating the manuscript and crafting comments to the Author(s), Reviewers should always keep in mind that their review captures their scholarly judgment about the manuscript. Reviewers should be honest with the Author in terms of their concerns about the manuscript. Reviewers should explain and support their scholarly judgments adequately; that is, they should provide sufficient detail to the Author to justify their recommendation to the Editor. Reviews should not be "two-faced", providing overly friendly reviews to the Author but very negative reviews in private to the Editor.
 

Timeliness: 
Reviewers should be prompt with their reviews. If a Reviewer cannot meet the deadline given, the Reviewer should contact the JIBS Managing Editor as soon as possible to determine whether a longer time period or a new Reviewer should be chosen.
 

NOTES

The JIBS Code of Ethics was developed with the research assistance of Dean Matula. Helpful comments were received from Paul Beamish, Michael Hitt, Anne Hoekman, Bruce Kogut, Lee Radebaugh, Anne Tsui, Rosalie Tung and Alain Verbeke. The Code draws heavily from the following on-line sources, which are recommended reading on ethical guidelines for journals:

* Academy of Management. 2005. Academy of Management Code of Ethics. Accessed June 16, 2007.http://www.aomonline.org/governanceandethics/aomrevisedcodeofethics.pdf
* American Chemical Society. 2006. Ethical Guidelines to the Publication of Chemical Research. Accessed June 16, 2007. http://pubs.acs.org/ethics/ethics.pdf?sessid=1658
* American Institute of Chemical Engineers. Ethical Guidelines for AIChE Publications. Accessed June 16, 2007. http://www.aiche.org/Publications/Resources/Ethics.aspx
* Council of Science Editors (CSE). CSE's White Paper on Promoting Integrity in Scientific Journal Publications. Accessed June 16, 2007. http://www.councilscienceeditors.org/editorial_policies/whitepaper/entire_whitepaper.pdf
* Elsevier. Ethical Guidelines for Journal Publication. Accessed June 16, 2007. http://www.elsevier.com/wps/find/intro.cws_home/ethical_guidelines
* Green, Lelia. 2005. Reviewing the Scourge of Self-Plagiarism. M/C Journal, 8(5). Accessed September 10, 2007. http://journal.media-culture.org.au/0510/07-green.php
* Journal of Wildlife Diseases. Ethical Guidelines to Publication in the Journal of Wildlife Diseases. Accessed June 16, 2007. http://www.wildlifedisease.org/Documents/JWD/WDA_Ethics.pdf
* Rockwell, Sara. Ethics of Peer Review: A Guide for Manuscript Reviewers. Accessed June 16, 2007. http://radonc.yale.edu/pdf/Ethical_Issues_in_Peer_Review.pdf
* Taylor & Francis. 2006. Ethical Guidelines to Publication of Scientific Research. February. Accessed June 16, 2007. http://www.tandf.co.uk/journals/pdf/announcements/tmph_guidelines06.pdf
* World Association of Medical Editors (WAME). WAME Publication Ethics Policies for Medical Journals. Accessed June 16, 2007. http://www.wame.org/resources/publication-ethics-policies-for-medical-journals

Prepared by Lorraine Eden, JIBS Editor-in-Chief Elect
Last revision: September 10th, 2007

Developed by the Journal of International Business Studies, 2007