COI policy: Address potential conflicts
Policy should be threefold
By John Isidor, JD
CEO
Schulman Associates IRB
Cincinnati
Question: Should an IRB have a conflict of interest (COI) policy? If so, what should be in it?
Answer: Yes, an IRB should have a COI policy. The IRB should consider three potential sources of COI: member conflicts, institutional conflicts, and investigator conflicts.
• Member conflicts. An IRB must have a COI policy regarding its members. 21 CFR 56.107(e) and 45 CFR 46.107(e) state that:
— No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
— Accordingly, an IRB should develop a COI policy that covers a member’s financial, personal, and professional conflicts of interest.
— A financial COI might exist if the investigator has a financial interest in either the sponsor of the research or the test article. Financial interests also arise from owning stock in the sponsor’s company, having a consulting relationship with the sponsor, or being a spokesperson for the sponsor. The IRB should consider what level of financial interest would create a COI requiring the IRB member to be removed from IRB deliberations and voting.
— A personal COI arises when the IRB member is asked to review research being sponsored and/or conducted by a close friend or relative.
— A professional COI might exist when an IRB member is asked to review research being sponsored and/or conducted by a supervisor, such as a department chairperson.
— The COI policy should require the conflicted member to leave the room during deliberations and voting about the research in which the conflict exists.
• Institutional conflicts. Institutional conflicts of interest arise when institutions have equity interests, licensing agreements, or investments in the sponsor [HHS Draft Guidance on Financial Conflict of Interest in Clinical Trials, 68 Fed Reg 15,456 (March 31, 2003)].
The Institution should create a COI committee to deal with institutional conflicts of interest. The institutional COI committee should ensure that a mechanism is available to communicate institutional conflicts of interest to the IRB. Upon receipt of information regarding an institutional conflict, the IRB can decide on appropriate management of the conflict.
• Investigator conflicts. A conflict exists when an investigator has professional or financial interests that compromise or appear to compromise the investigator’s independent professional judgment in any aspect of the conduct of a clinical trial.
As with IRB member conflicts, investigator financial conflicts can arise from financial interests in the sponsor or test article. They also may arise from a compensation structure using milestone payments and/or incentives that reward investigators for rapid and/or high-volume enrollment of subjects. Professional conflicts could exist when an investigator attempts to recruit subjects from his or her own patients or employees.
As with institutional conflicts, the institution can establish a COI committee to review investigator conflicts and communicate those conflicts to the IRB. The COI committee and the IRB should jointly determine what types of COIs will be communicated to the IRB and how to manage them. For example, the COI committee might decide that certain conflicts, such as ownership of a small number of shares of stock in a publicly traded company, are so minor that they need not be reported to the IRB.
Institutional and investigator conflicts can be managed in a variety of ways. Effective ways of management include disclosure in the consent document, third-party monitoring of the consent process, additional monitoring of the research, use of a data safety monitoring board, divestiture of the financial interest that creates the conflict and preventing the conflicted institution or investigator from participating in the research.
Lastly, it is vitally important that institutions, investigators and IRB members educate themselves about COI. Available resources include professional association guidelines, the draft NIH guidance referenced above, the Internet, and conferences sponsored by groups such as PRIM’R/ ARENA.
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