Question:
Can our hospital’s Institutional Review Board (“IRB”) be structured like and function as a medical staff committee?
Answer:
No. The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.” The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46). Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.
This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration. It is becoming commonplace for the auditing agency to take issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document. The auditors pointed generally to the language cited above, that it is an institutional responsibility to maintain an appropriate IRB not a medical staff responsibility. As a practical matter, the concern is that (however unlikely), if the IRB procedures need to be revised because of a regulatory change, the medical staff may refuse to do so as is contemplated by the amendment process to these rules. By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action. Again, while the likelihood of a Medical Executive Committee or a Medical Staff as a whole acting in such an obstructionist manner is very slim, it is a valid concern.
Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board. For this reason, a medical staff committee should not act as the IRB. There may be substantial overlap of the IRB membership with those of a medical staff committee. However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.