Two points in the AAU report pertain to IRBs
Two points in the AAU report pertain to IRBs
Individual and institutional conflicts discussed
The Association of American Universities in Washington, DC, issued in October 2001 its report and recommendations on how institutions can deal with financial conflict of interest. Here are some of the key features of the Report on Individual and Institutional Financial Conflict of Interest:
1. Individual conflict of interest
• Conflicts of interest are considered across all academic fields, with analysis focusing only on financial conflicts of interest that involve faculty, research staff, and other officials.
• Institutions need robust campus management systems to identify potential conflicts and to determine how conflicts should be disclosed and managed.
• These should be handled on a case-by-case basis to determine whether a researcher’s financial interests are related to university research and constitute a conflict of interest.
Take special care with financial interests
• Special scrutiny should be paid to research involving human participants. In these cases, any related financial conflicts of interest among individual researchers and staff should not be allowed. When there are exceptions to this rule, there should be more stringent management measures, including disclosure to participants, to ensure research integrity and safety.
• Annually, researchers, faculty, staff, and administration should disclose all financial interests related to university research and provide updates when indicated.
• When research is submitted for publication, it should include a disclosure of financial interests related to the research, and it should be disclosed in oral presentations as well as to federal agencies.
• Campus IRBs have jurisdiction over determining whether and how financial interests should be disclosed to research participants. Both a conflict-of-interest committee and the IRB have important roles in examining conflicts of interest with regard to human subject research.
2. Institutional financial conflict of interest
• These conflicts of interest may involve university equity holdings or royalty arrangements and research programs; conflicts involving university officials who make decisions that have implications for the entire institution; and even cases in which a university official is a member of a board or corporation that is a major supplier of some goods or services to the university.
• Develop clear policies that are made public following a threefold approach: always disclose; manage the conflict in most cases; prohibit the activity when necessary to protect the public or community interest.
• Establish administrative policies and a review group on institutional conflict of interest that might consist of senior officers, faculty, and citizens, and have all potential conflicts disclosed to the review group.
• The review group will assess potential conflicts, weight risks and benefits, and take action regarding institutional conflicts, including the options of declining proposed research; reducing or modifying the financial stake involved; increasing segregation between the decision-making regarding the financial interests and research activities, and establishing a research monitoring process.
• Strictly scrutinize institutional conflicts when human participants are involved, including having the conflict review committee interact with the IRB.
• Scrutinize equity that is not liquid, looking for potential institutional conflicts.
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