Policies, Procedures, and IRB Records

Question 1

Per 45 CFR 46.103(b)(4) and 21 CFR 56.108(a), what must IRBs have written procedures for?

Answer 1

Procedures for initial/continuing review, assessing risk level, documenting consent, and reporting serious issues.

Question 2

Required by 45 CFR 46.115 and 21 CFR 56.115, what must IRBs keep comprehensive records of? (Name some. there are 6 listed in the answer, but if you mention a few, you’re good)

Answer 2

Protocols, consent forms, IRB minutes, membership rosters, SOPs, and communications.

Question 3

How long must IRB records be retained?

Answer 3

At least 3 years after completion of the research.