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The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the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 FDA said it issued the guidance to remind IRBs of their longstanding role in the review of the qualifications of the clinical investigator, the adequacy of the facility in which the research will take place and the determination of whether an 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 the FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This draft guidance document was developed as part of these efforts and in consultation with OHRP.
