On August 27, 2013, the Food and Drug Administration (FDA) announced the availability of guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.” The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining whether the proposed research satisfies the criteria for approval contained in 21 C.F.R. § 56.111, which requires that risks to subjects are minimized and reasonable in relation to the anticipated benefit to such subjects.

The guidance, which primarily consists of a compilation of recommendations in previously issued FDA guidance documents, addresses the IRB’s role in reviewing (1) the qualifications of clinical investigators, (2) the adequacy of the research sites, and (3) the determination of whether an IND/IDE is required. The guidance does not operate to bind the FDA or the public.

The August 2013 publication finalizes the draft guidance dated November 2012 and replaces FDA guidance question 56 in the publication entitled, “Institutional Review Boards Frequently Asked Questions – Information Sheet – Guidance for Institutional Review Boards and Clinical Investigators.” The public may submit written or electronic comments on the guidance at any time.

The guidance is available here, and the FDA notice is available here.