Must investigators obtain IRB approval before involving human subjects in nonexempt research?
Yes. Investigators are responsible for obtaining IRB approval before beginning any nonexempt human subjects research (45 CFR 46.109(a) and (d)). Investigators are responsible for providing the IRB with sufficient information and related materials about the research (e.g., grant applications, research protocols, sample consent documents) so that the IRB can fulfill its regulatory obligations, including making the required determinations under 45 CFR 46.111 and, if applicable, subparts B, C and D. Investigators should follow institutional policies and procedures for IRB review that are required by HHS regulations at 45 CFR 46.
