A new FDA guidance was announced today in the Federal Register (emphasis added):
FDA is announcing the availability of a draft guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research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.” This guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining that the proposed research satisfies the criteria for approval contained in 21 CFR 56.111, that “* * * the risks to subjects are minimized * * * and reasonable in relation to anticipated benefits, if any, to subjects * * *.” In particular, the guidance addresses the IRB’s role in reviewing: (1) The qualifications of investigators, (2) the adequacy of the research site, and (3) the determination of whether an IND/IDE is needed. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance entitled “Institutional Review Boards Frequently Asked Questions—Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.”
FDA is issuing this as a draft guidance. Although many of these recommendations have appeared in other FDA guidance documents, FDA has compiled the information here in order to assure that all IRBs are aware of and have access to it. The guidance also explains how IRBs may efficiently fulfill these important responsibilities.
To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts and in consultation with OHRP. In addition, FDA acknowledges HHS’s publication of the advanced notice of proposed rulemaking (ANPRM), “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” in the Federal Register of July 26, 2011 (76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal human subject protection regulations should be modified in a number of ways. In finalizing this draft guidance, “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed,” FDA intends to consider relevant public comments submitted in response to both the draft guidance and the ANPRM.
The draft guidance will be posted on FDA’s website. Comments should be submitted by January 22, 2013.
