FDA WARNING_LETTER - Coast Institutional Review Board - July 18, 2007

The FDA issued a Warning Letter to Coast Institutional Review Board (IRB) following a July 10-18, 2007 inspection, which found violations of regulations governing IRBs and human subject protection (21 CFR Parts 56 and 50). The violations were identified through review of written procedures and a specific study ([redacted] Protocol [redacted]).

Key violations include: 1. **Failure to follow expedited review procedures (21 CFR 56.110(b))**: An inexperienced member conducted an expedited review, and the reviewed research (an advertisement) did not qualify for expedited review, having been previously considered and disapproved by the full IRB. The CEO lacked authority to designate reviewers. 2. **Failure to follow written procedures for review and reporting (21 CFR 56.108(a)(1) and 56.110(c))**: IRB members were not informed of research approved via expedited review, contrary to Coast IRB's SOP. 3. **Failure to maintain detailed meeting minutes (21 CFR 56.115(a)(2))**: Minutes for a March 1, 2007 meeting did not document the IRB's approval with changes for the advertisement.

As a result, the FDA has suspended Coast IRB's use of expedited review procedures until further notice. Coast IRB must respond within fifteen working days,