AAMC issues its guidelines concerning financial COI
Here’s a brief look at recommendations
The Task Force on Financial Conflicts of Interest in Clinical Research for the Association of American Medical Colleges (AAMC) of Washington, DC, has issued new guidelines. Called "Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research," the October 2002 recommendations contain the following points:
• Assessing institutional conflicts of interest in human subjects research: A conflict of interest may exist when the financial interests of an institution or its official might affect institutional processes involving human subjects research. Therefore, institutions should ensure that all functions and administrative responsibilities related to human subjects research are separate from those related to investment management and technology licensing.
• Identifying individual financial gain that conflicts with research: Individuals who hold dual roles (i.e., a dean of research who is the head of a laboratory where research is conducted) are in a position to make decisions that affect human subjects research. Such a person might also hold a significant financial interest in the investigational product or the research sponsor. AAMC recommends such individuals disclose all relevant circumstances to a superior, and all conflicts of interest should be eliminated or managed effectively. If this cannot be done, then the institution should not conduct the research.
• Scrutinizing ipso facto conflicts of interest: Since some financial relationships between institutions and commercial sponsors of research may appear to present a conflict of interest, there should be the highest degree of scrutiny in every instance, even when the institution has separated its research and investment functions. AAMC recommends that when such a circumstance occurs, the institution should conduct a specific, fact-driven inquiry into whether the financial relationship may affect or appear to affect human subjects research conducted at the institution.
Some examples of this type of potential conflict are as follows:
— royalties that an institution might receive from the sale of an investigational product being researched;
— equity interest by institution in a nonpublicly traded sponsor of research at the institution;
— ownership interest of more than $100,000 in value in a publicly traded sponsor of research at the institution;
— institutional researchers and research officials who have an equity interest in a nonpublicly traded sponsor of research conducted at the university;
— institutional researchers and research officials holding equity interest in excess of a minimum amount, excepting mutual funds, in a publicly traded sponsor of research conducted at the institution;
— individuals receiving consulting fees, gifts, and other compensation from a sponsor of human subjects research conducted at the institution;
— individuals receiving an appointment to serve as an officer, director, or board member of a commercial sponsor of human subjects research;
— individuals appointed to serve on the scientific advisory board of a commercial sponsor of research conducted at the institution.
• Monitor other financial relationships: Institutions should determine nature of such relationships and decide how closely to scrutinize these in assessing potential conflict of interest:
— Investigator, research administrator, or institutional official with research oversight authority participate in a procurement of supplies from a commercial entity that sponsors human subjects research at the institution.
— An institution receives substantial gifts from a potential commercial sponsor of human subjects research.
• Creating institutional conflict of interest committee (ICOI): AAMC recommends that an ICOI committee be formed to review potential conflicts of interest involving human subjects research. The committee should consist of people with seniority and expertise, and they should be independent of the direct line of authority for human subject research oversight within the institution.
• Considering other circumstances: Institutions holding ipso facto financial interests that will not be eliminated should not conduct related human subjects research except as the nonprimary site in a multicenter trial.
Also, the ICOI committee should approve special circumstances such as where the conflict may exist and the research is both early stage and the researchers’ expertise is essential to the research.
ICOI committees may consider contracting with an outside IRB to provide a second level of review and oversight when the circumstances dictate this course. AAMC recommends that institutions consider other special circumstances, as well.
• IRB members and conflicts of interest: Institutions should require IRB members to report annually any personal and significant financial conflicts of interest in sponsors of human subjects research when the sponsor is or might be involved with research at the institution. The ICOI committee should review the IRB members’ reports.
Also, IRB members, by federal regulation, must recuse themselves from voting or participating in deliberation involving protocols in which they have conflicting interests.
The Task Force on Financial Conflicts of Interest in Clinical Research for the Association of American Medical Colleges (AAMC) of Washington, DC, has issued new guidelines. Called Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institutions Financial Interests in Human Subjects Research, the October 2002 recommendations contain the following points.
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