AAMC issues recommendations on institutional conflicts of interest

AAMC issues recommendations on institutional conflicts of interest

Research institutions should segregate human subjects research administration from technology licensing and investment management to avoid institutional conflict of interest (ICOI), according to the second report from a special task force of the Association of American Medical Colleges.

The first report of the Task Force on Financial Conflicts of Interest in Clinical Research, released in December 2001, focused on conflicts of interest for individual researchers. This second effort, "Protecting Subjects, Preserving Trust, Promoting Progress II," offers "principles and recommendations for oversight of an institution's financial interests in human subjects research." It was released September 23.

Individual responsibility for human subjects research should not overlap or coincide with responsibility for institutional financial interests that could be directly affected by research outcome, because institutional officers might affect (or appear to affect) the process of research review, conduct or oversight.

The report goes so far as to recommend that, "under some circumstances, human subjects research not be conducted at a conflicted institution, unless compelling circumstances warrant."

The 28-member task force, chaired by William Danforth, chancellor emeritus of Washington University, includes representatives of the public and patient groups, lawyers, ethicists, media, industry, research and academia.

The report contains guidelines for establishing an Institutional Conflict of Interest Committee. Possible triggers for ICOI Committee investigation include an institution that has obtained an equity interest or entitlement to equity of any value in a non-publicly traded sponsor of human subjects research at the institution, an institution that has obtained an ownership interest or entitlement to equity of greater than $100,000 in value in a publicly-traded sponsor of human subjects research at the institution, or an institution where officials hold a "significant financial interest" in the commercial research sponsor or the investigational product.

Another list of considerations for establishing institutional policy includes circumstances involving gifts and contracts. A gift that, even when held in the general endowment for the benefit of the entire institution, stands out because of its magnitude, or an institutional officer who was in a position to solicit such a gift, might trigger an ICOI inquiry.

The task force points out it is not trying to keep institutions from "accepting the philanthropy" of corporate research sponsors, but that such gifts should be disclosed and the conflict or appearance of conflict managed through "clear policies."

IRB members, like other institutional officials, should disclose any potential conflicts of interest regarding human subjects research, the task force writes. Following the individual guidelines from their first report, IRB members should observe the Public Health Service threshold of 5% or $10,000 in equity interest. Institutional policies should reiterate federal regulations stating disclosure and recusal are required on a protocol-by-protocol basis for all IRB members, says the task force.

Finally, the task force recommends that disclosure of institutional financial interests should be made to the IRB of record, to research subjects and in all publications.

Source: Washington Fax, September 24, 2002