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Responsible Research: A Systems Approach to Protecting Research Participants (2002)
Institute of Medicine (IOM)

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. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.

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Responsible Research: A Systems Approach to Protecting Research Participants

Box 6.6
Professional Societies’ Policies on Conflicts of Interest

One of the first attempts by professional organizations to address conflicts of interest in research was the 1990 report from the Association of American Medical Colleges (AAMC), in which conflicts of interest were defined as “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” (1990).

More recently, AAMC has offered detailed policy guidelines on individual financial conflicts of interest in research involving human participants (2001). AAMC declares that institutions should create and implement policies regarding financial conflicts of interest that should follow federal regulations and should contain a number of specific elements, including definitions; a description of the processes to report, assess, and manage conflicts of interest; the criteria for assessing conflicts; the sanctions for violations; and the processes for appeal.

The Association of American Universities (AAU) also released a report on conflicts of interest in 2001. That report, which addresses institutional as well as individual conflicts, classifies institutional conflicts into two categories: “potential conflicts involving university equity holdings or royalty arrangements and research programs; and potential conflicts involving university officials who make decisions with institution-wide implications, which can include department heads and leaders of laboratories” (2001, p.10). (AAMC released its Task Force on Financial Conflicts of Interest Report dealing with institutional conflicts of interest as this report went to press.) AAU emphasizes the need for effective policies to deal with conflicts of interest in research involving human participants and asserts that management of such conflicts is often more important than the conflicts themselves. AAU also offers a checklist of questions for institutional leaders regarding the management of individual conflicts of interest.

In 2000, the American Society of Gene Therapy (ASGT) adopted a policy on financial conflict of interest that states that “all investigators and team members directly responsible for patient selection, the informed consent process and/or clinical management in a trial must not have equity, stock options or comparable arrangements in companies sponsoring the trial. The ASGT requests its members to abstain from or to discontinue any arrangement that is not consonant with this policy” (ASGT, 2000).

The Association of Clinical Research Professionals’ Code of Ethics exhorts members to “avoid conflicts of interest in [their] own affairs and make full disclosure in advance of undertaking any matter that may be perceived as a conflict of interest” (ACRP, 2001).

Other professional societies also have policies on their members’ conflicts of interest and how to properly deal with them.

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