IRB Membership and Authority

Question 1

What’s the minimum composition of an IRB?

Answer 1

At least 5 members, including 1 scientist, 1 nonscientist, and 1 unaffiliated member.

Question 2

What is required for IRB quorum?

Answer 2

A majority of members, including at least one nonscientific member.

Note: A Quorum essentially means a viable panel.

Question 3

True or False: Members with a conflict of interest must recuse themselves from discussion, but can vote and count towards quorum.

Answer 3

False: Must recuse, can’t vote, and don’t count towards quorum.

Question 4

Can consultants vote?

Answer 4

No

Question 5

What is the IRB authorized to do under 45 CFR 46.109?

Answer 5

Approve, disapprove, or require modifications to research; conduct continuing review; and observe consent or research processes.

Question 6

Alternate members must:

Answer 6

have comparable qualifications to the member they are acting as an alternate for.