About the Author
Proxima CRO Team
Stephanie Mull
Sr. Director of Clinical Operations
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.

No. Although 21 CFR 56.108(c) does not specifically require the presence of a member not otherwise affiliated with the institution to constitute a quorum, FDA considers the presence of such members an important element of the IRB's diversity. Therefore, frequent absence of all non-affiliated members is not acceptable to FDA. Acknowledging their important role, many IRBs have appointed more than one member who is not otherwise affiliated with the institution. FDA encourages IRBs to appoint members in accordance with 21 CFR 56.107(a) who will be able to participate fully in the IRB process.

Related FAQs:
More Questions? We're here to help!