FDA Issues Draft Guidance on IRB Responsibilities

FDA has issued the draft guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed."  The document is available on FDA's website: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM328855.pdf

FDA is issuing this guidance to remind institutional review boards (IRBs) of their longstanding role in the review of 1) the qualifications of the clinical investigator, 2) the adequacy of the facility in which the research will take place, and 3) the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) application is necessary for the proposed clinical investigation.

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 This draft guidance document was developed as a part of these efforts and in consultation with OHRP.

Comments are due by January 22, 2013.