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Who needs to be at an IRB meeting?

Who, exactly, needs to be in attendance for us to be able to actually hold an IRB meeting?

The regulation describing IRB membership, 45 CFR 46.107, is arguably somewhat non-specific. It requires an IRB to have at least 5 members. We have substantially more than 5 members on each committee roster, which is appropriate for a board that reviews as many studies as we do. As far as who must be at the meeting, the regulation requires only that a majority of the IRB members, including a non-scientist, be present. We interpret “a majority” to mean one more than half the members listed on the roster. So, yes, you are reading that correctly — as long as we have one more than half of the listed membership, and a non-scientist, in the room, we good to go. Not even the chair has to be present, according to the regulation, but we are dead in the water without our nonscientist.

Real life, however, gets a tad more demanding. The chair, or an alternate chair, attends each of our meetings, because, after all, the buck needs to stop on somebody’s desk, right? Also, we try to ensure that we have an appropriate degree of expertise present in the room as needed for a particular agenda. Clinical trials involving treatment ideally should have someone with a medical background looking at them, and mental health studies benefit from a psychologist’s or psychiatrist’s review. Our accrediting agency, AAHRPP, has noticed (and not in a good way) situations where we were reviewing a pediatric study without a pediatric representative in the room, or a study involving pregnant women/fetuses with no one with obstetrics expertise participating. So we take care to ensure that pediatrics and/or OB and/or other specialists are available as needed. The regs also specifically require a prisoner representative to participate in reviews of studies involving prisoners. Note that children, pregnant women and fetuses, and prisoners are three vulnerable populations specifically mentioned in regulations at 45 CFR 46, which underscores the need to have specialists in those areas present.

So when you get calls from us asking us to attend to a meeting that’s not your usual one, that’s why. We’re either short on the number of members, and/or we need certain expertise represented, and/or our usual nonscientist(s) can’t make it, and we need someone to fill in. We also may call in members when we know someone on the committee has a conflict of interest and therefore can’t participate in a review, and losing that person would cause us to lose quorum and/or our nonscientist.