Center for the Study of Ethics in the Professions at IIT

Adopted by the Executive Council of the Association of American Medical Colleges February 22, 1990

Preface

As the revolution in biotechnology and other fields of science and medicine continues at an unprecedented pace, faculty at academic institutions are increasingly entering into collaborative arrangements with industry in fostering development of their research programs. Links with the industrial sector provide crucial research resources and channel scientific discoveries into the public domain. In addition, they stimulate innovation and creativity through transference of entrepreneurial spirit and enthusiasm.

However, the pursuit of these important opportunities must be carried out judiciously. Scientists have an overriding responsibility to maintain the highest standards of objectivity and freedom from bias. Incidents of scientists allowing personal or outside interests to cloud their professional judgment in conducting research are alarming and unacceptable. Such incidents are serious in and of themselves, but they are ever more troubling because, if true, such abuses of trust may pose risks to research subjects, institutional and individual reputations, the credibility of the scientific profession, and the well-being of society. In addition, they lead policy-makers to consider that academic institutions may be unable or unwilling to deal with situations in which personal interests may pose conflicts with professional duties.

The AAMC and its Ad Hoc Committee on Misconduct and Conflict of Interest in Research have addressed these issues, and find that the primary obligation for identifying and managing such conflicts lies with the research institutions themselves. In January 1989, the AAMC solicited policies from its membership to assess how medical schools and teaching hospitals were dealing with conflicts of interest and commitment in research. That solicitation and subsequent follow-up revealed that member institutions are attempting to deal with these issues effectively. The AAMC then extracted the fundamental elements from these policies, allowing the Ad Hoc Committee to develop this guidance document to further the efforts of our membership in these areas.

This document offers a conceptual framework; it defines institutional and individual responsibilities. In addition, it outlines a procedural approach that institutions may build upon and modify to fit their own unique circumstances. The document recognizes that the specifics of institutional policies and procedures are developed best by the institutions themselves. Each institution is best equipped to address its own needs in accordance with federal, state, and local requirements and with generally accepted academic values.

The AAMC and its Ad Hoc Committee continue to address this difficult problem. We appreciate any comment on this document and welcome suggestions for possible future action on the issue of conflict of interest.

Robert G. Petersdorf, M.D.
President
Association of American Medical Colleges



Introduction

The spectacular research accomplishments of the past four decades not only have expanded the frontiers of science but also have created significant opportunities for translating basic research findings into commercially viable products. Previously, drug company-sponsored clinical trials and contract research projects represented the principal venues for interaction between medical schools and industry. However, the recent revolutions in biotechnology and other fields, the dramatic expansion of opportunity for advances in therapy, and the desire of many researchers to join industry in creating products, methods of treatment, and other techniques have further engaged biomedical scientists in this exciting arena of activity. In addition, certain initiatives in federal policy aimed at bolstering the national economy and promoting international competitiveness, such as the Patent and Trademark Amendments Act (1980) and the Stevenson-Wydler Technology Innovation Act (1980), have enhanced the process by which universities and colleges may share in the fruits of the commercialization of discoveries made on campus. The sum of these developments has created an environment in which academic institutions and their faculty are developing and expanding collaborative arrangements with industry at an unprecedented rate. These collaborations are generally mutually beneficial, with industry drawing from the collective intellectual and creative talents of university faculty, and academia benefitting from additional sources of research and other funds as competition for federal dollars becomes increasingly keen.

As the interface between research and commercial activities expands, faculty in our democratic society are confronted with often-conflicting realities. On the one hand, the freedom to pursue one's own economic interests is guaranteed by our system of government and, indeed, is the driving force of our national economy. At the same time, the requirement for objectivity and commitment in biomedical and behavioral research dictates extreme care as scientists pursue research activities while also pursuing their own economic goals. Without institutional controls, this objectivity may be threatened, the line between academic and industrial obligations may blur, and the temptation to use institutional resources for unauthorized personal endeavors may grow.

The opportunity for investigators to receive financial or other personal rewards from their endeavors is not intrinsically unacceptable, as long as it does not adversely influence the objectivity, integrity, or professional commitment of an investigator. Hence, participation in a situation with opportunity for personal gain does not constitute an unacceptable situation of itself; it is the potential stimulus for unacceptable behavior that must be addressed. Accordingly, the objective of the document is to provide guidelines for institutional policies and procedures that minimize the risk of unacceptable behavior in potential conflict situations, while facilitating and encouraging the full professional and personal development of faculty investigators through their research.

Institutions engaged in the conduct of biomedical research face a particularly difficult situation with respect to this issue. Publicly funded biomedical research is an enterprise in the public trust, which by its nature involves sensitive issues of human health and well-being. In addition, public awareness and scrutiny is more heavily focused on health- related research than other forms of research activities. Ruptures of public confidence that occur when biomedical researchers are involved in conflict situations, deliberate or otherwise, inflict long-term damage on societal trust and support.

Apart from considerations of public health and perception, it is a Public Health Service (PHS) requirement that grantee institutions have conflict of interest policies in place. The PHS Grants Policy Statement says,

Recipient organizations must establish safeguards to prevent employees, consultants, or members of
governing bodies from using their positions for purposes that are, or give the appearance of being motivated by a desire for private financial gain for themselves or others such as those with whom they have family business, or other ties. Therefore, each institution receiving financial support must have written policy guidelines on conflict of interest and the avoidance thereof. These guidelines should reflect State and local laws and must cover financial interest, gifts, gratuities and favors, nepotism, and other areas such as political participation and bribery.

The PHS statement adds that such policies must include provisions for implementation and sanctions for violations. Although the National Institutes of Health (NIH) and the Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) are in the process of developing additional requirements, PHS grantee institutions that now do not have conflict of interest policies in place are at risk of losing federal support for research.

Given the number of individual, institutional, and societal risks attendant to conflicts between personal and professional responsibilities in research, it is essential that institutions develop appropriate policies and procedures to deal with both the reality and appearance of such conflicts. As described in greater detail at the end of this document, other institutional policies will have relevance to conflict situations and must be carefully written to ensure that all facets of the issue are fully addressed. For example, if a situation involving a conflict calls into question the integrity of the investigator, the institutional policies and procedures on scientific misconduct may apply. The process of policy development should also be coordinated with affiliated institutions. For medical schools, this is important to avoid subjecting faculty with off-campus clinical appointments to contradicting standards of conduct.

The rest of this document outlines means to deal with the two principal, yet not entirely exclusive, forms of conflicting situations that may affect the performance of academic personnel: conflicts of commitment and conflicts of interest.


Conflicts of Commitment

The term "conflict of commitment" relates to an individual faculty member's distribution of effort between obligations to one's academic appointment (normally "full-time" in teaching, research, and/or patient care) and one's commitment to "outside" activities. These latter may include professionally-related and generally encouraged activities such as consulting, textbook authorship, involvement with professional societies, and participation on review panels. Such activities are usually expected of faculty members to promote professional development and to enrich their contributions to the institution, to their profession, and to the community. Consulting relationships, for example, may serve to create conduits for the exchange of information and technologies that enhance the university environment and permit faculty to test the soundness of their ideas.

A conflict of commitment arises when these or professionally removed activities (e.g., outside teaching or business) come to interfere with the paramount obligations to students, colleagues, and the primary missions of the academic institution by which one is appointed and salaried. Conflicts of commitment primarily involve questions of obligation and effort, but are often tied to financial inducements. Such conflicts do not generally pose strictly legal violations, but they may constitute abridgements or compromises of institutional policy or the responsibilities attendant to retention of academic appointment.

In 1965, the American Council on Education/Association of American University Professors concluded in their statement, On Preventing Conflicts of Interest in Government Sponsored Research, that "a system of precise time accounting is incompatible with the inherent character of the work of a faculty member since the various functions he performs are closely interrelated and do not conform to any meaningful division of a standard workweek." The AAMC agrees with this assessment and finds that there is no universally applicable standard or formula for determining appropriate levels of faculty effort. A 1989 review of relevant policies of the AAMC constituency revealed that permissible levels of outside activity vary, though most institutions afford their faculty one day per work week for scholarly pursuits that relate to and advance professional growth and public service.

It is important to recognize that the standards of behavior maintained by an investigator in permitted extramural activities may negatively influence the reputation of the faculty member or the institution. Accordingly, investigators should be advised to ensure that their extramural activities are subject to the same rigorous ethical standards that are applied to the performance of institutional responsibilities.

Whatever locally appropriate standards the institution chooses to adopt, both faculty and the academic institution have responsibilities to prevent and to correct situations in which expectations of commitment are not met. Failure by faculty to attend to university or teaching hospital obligations serves to undermine the academic mission and potential accomplishments of the institution. Therefore, as an integral part of professional duties, faculty members should:

Assure that research, teaching, and public service obligations to the academic institution are fully met,

Abide by restrictions on the type and amount of outside activity as determined by the academic institution, or by subsequent agreements between faculty and the university or hospital administration, and


Abide by commitments of effort as specified in contractual research agreements and grant applications.


Academic institutions, on the other hand, have a corresponding set of responsibilities. To encourage appropriate faculty behavior and to live up to institutional obligations, the university or teaching hospital should:


Develop policies that explicitly state acceptable levels of outside activity and define the types of activities and corresponding levels of remuneration that are acceptable,


Develop procedures to assure that proposals for research and outside activities are responsibly made and reasonably adhered to,


Comply with federal requirements for reporting unmet commitments to government-sponsored activities, and


Develop mechanisms whereby outside activities involving any potential conflicts of commitment are disclosed and evaluated on a regular basis, and resolved as necessary.


Policies and procedures that are related to conflict of commitment may be developed in parallel with conflict of interest policies as discussed below.



Conflicts of Interest

The term "conflict of interest" in science refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. The bias such conflicts may conceivably impart not only affects collection, analysis and interpretation of data, but also the hiring of staff, procurement of materials, sharing of results, choice of protocol, and the use of statistical methods. Conflicts of interest can affect other scholarly duties as well, but are particularly important to consider in biomedical and behavioral research because of the impact such conflicts can have on human health.

It is not possible to completely eradicate the potential for conflict of interest because there are certain rewards that are inherent in the structure of our research enterprise. Such rewards may be completely unrelated to relationships with industry or private sponsorship. For example, positive research results per se may contribute to opportunities for publication, promotion, tenure, grant renewals, and so forth. In addition, positive results are often more gratifying and lead to greater personal satisfaction than negative outcomes. In a sense, these influences can be as much a source of conflict in the search for truth as interests of a pecuniary nature. But kept in perspective, such incentives are not inherently bad and are indeed the motivating forces for diligent scientists. Such conflicts become detrimental when the potential rewards, financial or otherwise, cause deviation from absolute objectivity in the design, interpretation, and publication of research activities, or in other academic and professional decisions.

The mere appearance of a conflict may be just as serious and potentially damaging as an actual distortion of objectivity. Reports of conflicts based on appearances can undermine public trust in ways that may not be adequately restored even when mitigating facts of a situation are brought to light. Apparent conflicts, therefore, should be evaluated and managed with the same vigor as known conflicts.

Conflicts of interest also have the potential to bias other aspects of academic life, particularly when faculty are in a position to set university or hospital policies, manage contracts, select equipment and supplies, involve students in sponsored projects, or have other administrative roles in which objectivity and integrity are paramount. In addition to these "administrative" conflicts that occur at the faculty, or individual level, there are also conflicts that may occur at the institutional level. The university or hospital may enter into a contractual relationship or other affiliation with a company that presents a conflict with its academic mission, its non-profit status, the activities of its board members, its need to be objective in its dealings with faculty, or with its obligations to other organizations. Decisions regarding institutional conflicts of interest must be made by the governing board. Both administrative and institutional conflicts are important to manage and should be addressed in relevant policies, but will not be the primary focus of this document.

Individual conflicts of interest in research arise in large part because of the interplay between a faculty member's personal and financial interests and the opportunity to conduct externally-funded research. There is an inexhaustible matrix of situations in which faculty may find themselves, and it would be impossible for this document to provide a comprehensive list. Of the imaginable array of conflicting or potentially conflicting situations, it is up to the academic institution to decide which are acceptable in accordance with federal and state requirements and generally accepted academic values of honesty, objectivity, and integrity. This process is likely to be a difficult one and should involve joint participation of faculty and administration to avoid contention when cases arise.

The following examples of possible conflicts of interest are provided to alert institutions to situations that may be of concern. This list is suggestive and should be supplemented by each institution. The institution should consider not only situations that are unacceptable, but should also consider the "gray" areas that might involve the "appearance" of a conflict or in which monitoring or certain modifications of the situation might make it acceptable. A considerable degree of "brainstorming" should go into developing this list as for every situation contemplated, there will be some variant which adds a new set of considerations. Some possibly problematic situations include:

Situations That May Impart Bias in Research


Undertaking basic or clinical research when the investigator or the investigator's immediate family has a financial, managerial, or ownership interest in the sponsoring company or in the company producing the drug/device under evaluation


Accepting gratuities or special favors from research sponsors


Entering into a consultantship arrangement with an organization or individual having an economic interest in related research


Situations That May Involve Inappropriate Use of Institutional Assets and Resources
in Research


Using students or employees of the institution to perform services for a company in which a faculty member has an ownership interest or from which he/she receives any type of remuneration


Unreimbursed or unauthorized use of institutional resources, such as equipment, supplies, and facilities, for personal purposes or to support the activities of an independent entity in which an investigator holds a financial or other interest


Associating one's name or one's work with the institution in such a way as to profit monetarily by trading on the reputation or good-will of the university or hospital, rather than on one's professional competence


Situations That May Involve Inappropriate Use of Information


Unauthorized use of privileged information acquired in connection with one's professional responsibilities


Accepting support for basic or clinical research under terms and conditions that results be held confidential, unpublished, or significantly delayed in publication


Providing privileged access to information, developed with university resources or supported by independent sponsors, to an entity in which the faculty member has a financial interest


Situations That May Involve Self-Dealing


Purchasing equipment, instruments, or supplies for research or teaching from a firm in which the faculty member has a financial or other interest


Influencing the negotiation of contracts between the academic institution and outside organizations with which a faculty member has a financial interest or other relationship


Requiring or recommending one's own textbook or other teaching aids


Special Considerations in Consulting to Federal Agencies


Consulting to a federal agency when one is also conducting federally-sponsored research (the federal conflict of interest statutes 18 U.S.C. 202-209 should be consulted)


As with conflicts of commitment, the institution and faculty must work together to see that conflicts of interest are either avoided or properly managed when they arise. Faculty play a particularly pivotal role in identifying and managing potential conflict situations because it is ultimately up to the faculty to recognize potential problems and report them to appropriate institutional officials. Faculty can enhance their ability to avoid conflicts of interest if, in addition to abiding by proper deportment regarding conflict of commitment, they:


Uphold as a primary responsibility the academic institution's scholarly mission of research, teaching, and public service,


Read and adhere to institutional policies for review of all research proposals,


Abide by institutional conflict of interest policies and standards,


Conduct research and report results in an objective manner unbiased insofar as possible by the prospect of personal gain or recognition,


Disclose fully those professional and relevant personal activities when required by the institution, or when there is potential for conflict of interest, and


Remain cognizant of the potential for conflicts and take initiative to manage, disclose, or resolve conflicting situations as appropriate.


To assist faculty in reporting and dealing with conflicts, institutions should have appropriate mechanisms in place to enhance faculty awareness and to make effective use of disclosed information. Therefore institutions should:


Develop and disseminate policies that clearly articulate the institution's position on 1) sponsored research, 2) acceptable types and levels of outside financial and professional interests, 3) the need to recognize and deal openly with real or apparent conflicts, and 4) the relationship of faculty and staff to outside institutions and third parties,


Develop procedures for full disclosure to the institution, and to the interested public, of financial and professional interests that may influence, or may be perceived to influence, research activity or other scholarly responsibilities,


Implement enforcement procedures, including appropriate sanctions and notification of university and other officials as required, when apparent violations of institutional rules or federal, state, or local laws occur,


Develop procedures to assure that all research proposals are responsibly prepared and appropriately reviewed in accordance with institutional requirements,


Implement accounting procedures which assure that research funds are expended for the purposes for which they have been provided and that all expected services have been performed,


Assure appropriate and effective management and/or resolution of conflicts of interest through the institutional administrative officers and review committees,


Respond expeditiously and with clarity to questions raised concerning potential conflict situations, and


Serve as a model for faculty behavior and preclude inadvertently exposing faculty to conflicts and concomitant liabilities by avoiding conflicts at an institutional level.


Process of Disclosure and Review

One of the keys to preventing and resolving conflicting situations is full disclosure followed by aggressive monitoring and conflict management. Full disclosure of relevant information is in the best interest of both the institution and the faculty member. It demonstrates good faith on the part of the investigator and protects his or her reputation and that of the university or hospital. Disclosure will not necessarily restrict or preclude an investigator's activities. In fact, activities that might be veiled in a cloud of suspicion and doubt may be found acceptable and permissible when all facts regarding
the activity are brought to light a priori. The disclosure process probably will be carried out differently at each institution, and this is appropriate given the unique organizational and legal issues they face. However, a few guiding procedural principles are suggested.

First, all privately and federally sponsored research agreements in which a faculty member anticipates taking part should receive prior review and approval through appropriate institutional channels. Such approval should require the signatures of all relevant officials to document that appropriate review took place. In addition, such signatures impart accountability upon the reviewers and help assure that these officials are aware of the nature and terms of the agreement. Academic institutions should also require disclosure of the investigator's relevant personal interests, including those of the immediate family. These may include, but are not limited to, equity interests, outside professional positions, outside professional salary, gifts, honoraria, and loans. Such disclosure should accompany contractual research agreements and grant applications as they receive institutional review. Additional disclosure should be established on a regular basis by the institution based on local requirements and any relevant changes in faculty status. At a minimum such disclosure should occur annually.

Initially, reporting mechanisms for disclosure should flow to chairpersons of departments, or equivalent supervisors, though simultaneous reporting could occur to the sponsored projects office. For some large departments, the chairperson may wish to develop a mechanism in which initial input is coordinated and evaluated at the level of section chiefs. Thus, the responsibility for initial collection and review of disclosure information rests with a supervisor closely familiar with the area or discipline that disclosure covers. This supervisory individual should advise the dean (or next level of review) of those cases which require further examination. The supervisor may also serve as an advisor to faculty uncertain regarding the appropriateness of a given activity or how to handle a given disclosure issue. It is, therefore, incumbent upon the supervisor to be familiar with institutional policy and federal, state, and local requirements so as to understand fully the implications of the situation in question. The supervisor may need to consult or engage the institutional offices of legal counsel, business, research administration, government relations, and technology-transfer, as appropriate. In addition, when presented with a questionable situation, the supervisor should reflect on issues raised by the "review questions" that follow this section, to evaluate the nature and acceptability of the situation. Such an evaluation should be supplemented with personal knowledge of institutional policy, local law, and federal requirements.

After appropriate evaluation, the supervisor may find that a proposed or ongoing research agreement and the faculty member's personal interests show no conflict or apparent conflict and are acceptable without further review. Conversely, the supervisor may determine that a given situation raises some questions of propriety and requires a higher level of review. The next level of review should be pursued whenever there is any doubt.

Subsequent review should occur at the level of the dean, chief executive officer, or other designated senior institutional official. The senior official should evaluate the situation in much the same way as the supervisor, employing key review questions and consultation. After appropriate consideration, the senior official may conclude that there is no conflict and should report such findings back to the departmental level. If the senior official determines that there is any reasonable question of conflict or legitimacy regarding the situation, then all relevant information should be passed on to a designated institutional committee responsible for review of possible conflicts of interest.

The institutional committee for review of possible conflicts of interest should be, preferably, a standing committee. It should consist of institutional officials who represent or have access to the expertise of the university or hospital legal counsel, research administration, government relations, technology-transfer, and other pertinent offices. The committee's role should be tripartite.

The first role is evaluative. The committee should review all relevant information and make the final determination whether a conflict situation exists. Naturally, the review process should be designed to protect confidential information to the degree permitted by law. As part of its evaluation, the committee should make use of the review questions in the following section.

The second role of the committee is both adjudicative and arbitrative. The committee is ultimately responsible for determining how any conflicts might be managed or resolved. This begins with the committee reporting its findings to the administrative officials who have reviewed the case, the faculty member and, where appropriate per federal requirements, the funding agency. After appropriate evaluation, most situations will be found to be


Unacceptable and thus prohibited, or


Permitted with the implementation of one or more committee recommendations to preclude unreasonable levels of bias or inappropriate activities, or


Permitted as is because the disclosed personal information does not represent a possible source of unreasonable bias or an inappropriate activity.


In a case where current faculty activity is permitted but requires implementation of certain recommendations, options for resolution and a mechanism for reporting back to the committee should be developed. The possible options are as numerous as the types of situations the committee may review. However, as the committee gains experience in the review of these cases, the appropriate action may become more obvious over time. Possible options include, but are not limited to:


Public disclosure of all relevant information,


Reformulation of the research workplan,


Close monitoring of the research project,


Divestiture of relevant personal interests,


Termination or reduction of involvement in the relevant research project,


Termination of inappropriate student involvement in projects, and


Severance of outside relationships that pose conflicts.


The final role of the committee should relate to policy development. By virtue of the experience it will accumulate in handling this issue, the committee will be the most appropriate body for advising the dean, hospital CEO, and other administrative officials on policy issues. New policies or changes to existing policy should be formulated, or at least reviewed, by this committee.

Violations of institutional policies regarding the acceptance of honoraria, gifts, salary and so forth, must be handled expeditiously and conclusively through institutional mechanisms for dealing with inappropriate faculty behavior. Such mechanisms are often described in the faculty handbook under the rubric "standards of conduct." Violations that appear to have resulted in a misrepresentation of research results or other unprofessional conduct should be handled according to the institution's policies for dealing with allegations of misconduct in research. Violations of federal or state statutes
and guidelines must be handled according to federal and state laws and requirements. All decisions must be documented. The nature and handling of such documents should be discussed by the committee or appropriate institutional officials.



Review Questions

Individuals at all levels of review of disclosure information and research proposals need a framework for evaluating whether a situation presented before them is acceptable, and for assessing the degree to which it poses risk to the faculty member, the institution, and other entities that may be affected by the research in question. Presented below are sample review questions that should be utilized by anybody evaluating a potential case of conflict of interest. The list is not inclusive and other questions appropriate for special circumstances should be added.

When presented with the facts of a given situation, the reviewer must first determine if there is legitimate cause for concern over inappropriate behavior or the injection of undue bias into the professional activities of the faculty member. Therefore, initially one should ask, among other possible questions,


Has all relevant information concerning the faculty member's activities been acquired (i.e., has there been full disclosure)?


Do the faculty member's relevant financial interests exceed predetermined thresholds of acceptability, where specified?


Do the faculty member's reported external commitments exceed permissible levels?


Is there any indication that research results have not been faithfully and accurately reported?


Is there any indication that the faculty member in his or her professional role has improperly favored any outside entity or appears to have incentive to do so?


Has the faculty member inappropriately represented the institution to outside entities?


Does the faculty member appear to be subject to incentives that might lead to inappropriate bias?


Is there any indication that obligations to the university are not being met?


Is the faculty member involved in a situation similar to any of those described earlier in the document that might raise questions of bias, self-dealing, inappropriate use of university assets, poor data management, or impropriety?


Could the faculty member's circumstances represent any possible violation of federal, state, or local laws and requirements?


Could the current engagements of the faculty member present any conflicts between _outside_ interests (e.g., working on projects simultaneously for competing business entities)?


If it appears that there is genuine cause for concern, the reviewer must ascertain whether appropriate controls are in placeto deal with possible conflicts. The reviewer should ask, as relevant,


Will the negotiation of relevant research affiliations or other contracts be handled by truly disinterested representatives of the institution?


Will the research workplan receive independent peer review prior to its initiation?


Are there mechanisms in place to prevent the introduction of bias into research projects (i.e., Is the protocol double-blinded? Are research subjects randomly selected?)?


Will the project be supervised by someone with authority and no conflicting interests?


Are there means to verify research results (e.g., independent corroboration in another lab, FDA review)?


Will data and materials be shared openly with independent researchers? If not, who determines accessibility to such resources?


Will the product of the collaborative effort with an outside party be published in the peer-reviewed scientific literature?


Will the sponsorship and relevant interests receive acknowledgment in public presentations of the research results?


The goal in applying these questions should be to determine the correct mode of dealing with any real or apparent conflicts as discussed earlier.



Other Relevant Policies

The issues of conflict of commitment and conflict of interest have far-reaching implications for a large number of institutional activities; it may not be possible to address fully all the important issues in a single policy. Instead, institutions may need to develop a matrix of policies, each with their special focus, that to some degree support the principal framework for avoiding conflicts. These may include, but are not limited to:


Patent and licensing policies


Publication policies


Policies addressing student participation in research


Policies concerning administrative conflicts of interest (procurement, board of trustees, etc.)


Institutional affiliation policies


Policies addressing the use of institutional assets


Faculty standards of conduct




Conclusion

There is no simple approach to dealing with conflicts of interest among faculty. The strategies for managing conflicts are just as numerous as the types of conflicts that may occur. Therefore, this document can strive only to provide a useful level of guidance in assisting institutions in developing their own policies and procedures to fit their unique situations and local requirements.

It is important to be cognizant, however, that conflicts in research indeed will arise at some point in time. They are a natural product of the intersection of the vast matrix of faculty personal responsibilities and needs with the network of professional affiliations and activities that must be maintained. Conflicts are not necessarily unacceptable and many can be managed provided adequate mechanisms are in place for disclosure and oversight.

To be effective in dealing with conflicts of interests and commitment in research, academic institutions must have 1) standards of conduct that delineate the boundaries of conflict of interest and commitment, 2) requirements for timely disclosures of relevant information, 3) adequate review of disclosed information and potential conflicts of interest, 4) procedures for enforcing standards and providing sanctions for violations, and 5) policies and procedures consistent with governmental policies and rules. General awareness (institutional and public) of an investigator's relevant funding sources, financial interests, and professional roles, serve to direct appropriate scrutiny at elements of research commitment, design, and reporting of data that might be biased or undermined by these factors. The investigator's cognizance of that scrutiny further encourages vigilance to avoid any biases or diversions that inadvertently may be introduced. Naturally, for this system to work, the disclosure process must assure that information regarding possible conflicts reaches all individuals with an appropriate interest in evaluating the research in question.

The AAMC continues to work on various aspects of this issue and invites commentary on this document and other facets of the issue in which the Association may play an effective role.



References

1.Conflict of Interest Statutes 18 U.S.C. 202-209 as amended

2.American Council on Education and the Association of American University Professors, On Preventing Conflicts of Interest in Government-Sponsored Research at Universities, Washington, D.C. 1965

3.Association of American Universities, University Policies on Conflict of Interest and Delay of Publication, Report of the Clearinghouse on University-Industry Relations, Washington, D.C. 1985

4.American Council on Education, Higher Education and Research Entrepreneurship: Conflicts Among Interest, Washington D.C. 1986

5.U.S. Public Health Service, PHS Grants Policy Statement, DHHS Publication No. 82-50,000 (Rev.), January 1, 1987

6."Request for Comment on Proposed Guidelines for Policies on Conflict of Interest," National Institutes of Health and the Alcohol, Drug Abuse and Mental Health Administration, NIH Guide for Grants and Contracts, September 15, 1989



Acknowledgements

The AAMC wishes to thank the following members of the AAMC Ad Hoc Committee on Misconduct and Conflict of Interest in Research for their valuable advice and assistance in developing this document.

Ad Hoc Committee Members

Michael J. Jackson, Ph.D., Chairman, Dean for Research, George Washington University School of
Medicine and Health Sciences

David A. Blake, Ph.D., Associate Dean for Administration and Planning, Johns Hopkins University School of Medicine

William T. Butler, M.D., President, Baylor College of Medicine

Rita Charon, M.D., Assistant Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons

David H. Cohen, Ph.D., Vice President for Research and Dean of the Graduate School, Northwestern University

Joe Dan Coulter, Ph.D., Chair, Department of Anatomy, University of Iowa College of Medicine

Spencer Foreman, M.D., President, Montefiore Medical Center

Ernst R. Jaffe, M.D., Senior Associate Dean, Albert Einstein College of Medicine

Ralph W. Muller, President, University of Chicago Hospitals

Max Poll, President and CEO, Barnes Hospital

Robert E. Tranquada, M.D., Dean, University of Southern California School of Medicine

Staff

Thomas E. Malone, Ph.D., Vice President for Biomedical Research, Association of American Medical Colleges

Douglas E. Kelly, Ph.D., Associate Vice President for Biomedical Research, Association of American Medical Colleges

Allan C. Shipp, M.H.A, Staff Associate, Association of American Medical Colleges


Revised: 29 January 1998