Institutional Review Board - Naming and Composition

Naming and Composition

Although "IRB" is a generic term used by the FDA and HHS, each institution that establishes an IRB may use whatever name it chooses. Regardless of the name chosen, the IRB is subject to the FDA's IRB regulations when studies of FDA-regulated products are reviewed and approved.

Originally, IRBs were committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems.

Today, some IRB reviews are conducted by for-profit organizations known as 'independent' or 'commercial' IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations. The composition of an IRB for the FDA's requirements is set in 21 CFR 56.107.

(a)1 The IRB must have at least five members.

(a)2 The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place.

(a)3 If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups. It is common for an IRB to include an advocate for prisoners when considering research that involves them.

(b)1 The IRB should include both men and women, as long as they aren't chosen specifically for their gender.

(b)2 The members of the IRB must not be all of the same profession.

(c) The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations.

(d) The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members."

(e) IRB members may not vote on their own projects.

(f) The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.

To vote on a proposal, more than half of the members of the board must be present and there must be a nonscientist present. Exceptions for expedited review are available, where only the chair of the committee or a designee reviews research, but these are relatively narrow.