Question Regarding Research Pharmacist and COI as IRB Member
(08/28/2008)

Question 1:

A research pharmacist currently serves as an IRB member. She has now been delegated to be the research pharmacist on all of the investigational drug studies run at one of our sites (and reviewed by the IRB on which she sits), and is now listed on the Delegation Of Authority Form submitted to the Sponsor.

The research pharmacist recuses herself from voting and discussion for the applicable drug studies, as the IRB notes the potential COI.

My question is for a note of clarification: Does the nature of the pharmacist's role on the study affect the potential COI? Meaning, if the pharmacist is merely dispensing inv drug tablets and has no responsibility for preparing the test article or evaluating or reporting data relative to the study activities, does this affect her role as a voting member of the IRB? This was posed by the IRB.

Answer 1:

As you know, the "primary purpose" of IRB review is "...to assure the protection of the rights and welfare of the human subjects..." (See 21 CFR 56.102(g).) In order to protect study subjects, IRB members need to be able to exercise independent judgment as they vote to approve or disapprove research. If a member feels compelled to vote in a certain way--because of direct or indirect conflict of interest--then the IRB will not be fulfilling its primary purpose. For an IRB to review studies under such circumstances would not be ethical, and would not be in the best interests of the study subjects. The IRB and the institution served by the IRB therefore need to give careful consideration as to how the IRB conducts its business.

Under FDA's IRB regulations, 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. (See 21 CFR 56.107(e)) In comment 60, in the preamble to the 1981 IRB regulations, the agency clarified that "FDA believes that the IRB or the institution should determine what constitutes a conflicting interest." (46 FR 8958 at 8966, January 27, 1981). Therefore it is up to your IRB to decide what constitutes a conflicting interest by a pharmacist. The existence of a conflict of interest would depend in part on the nature of the transferred responsibilities described in the Delegation of Authority Form.

That being said, there are some individuals who, as part of an investigative team make a direct and significant contribution to the research data and may be generally seen as having a conflict. Hospital staff, including nurses, residents, or fellows and office staff who provide ancillary or intermittent care but who do not make a direct and significant contribution to the data are simply doing their job and would not be seen as conflicted. Similarly, if a pharmacist is only dispensing tablets and has no responsibility for preparing the test article(s) or evaluating or reporting data relative to the study activities, then the pharmacist can serve on the IRB without conflict and need not abstain from voting on that protocol. In fact, the regulations support the pharmacist's involvement in the IRB's membership through its requirement that the IRB possess the professional competence necessary to review the specific research activities (See 21 CFR 56.107). On the other hand, if the pharmacist will be compounding, labeling, monitoring, and reporting test article compliance data, it would be appropriate to limit the pharmacist's involvement to providing information requested by the IRB and document that the pharmacist did not vote on the study in which there was a conflict (See 21 CFR 56.107(e)).


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