On August 27, 2013, FDA issued final guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed." All of the parties who conduct or have oversight responsibilities for biomedical research—sponsors, clinical investigators, and institutional review boards (IRBs)—have responsibility for ensuring that the research complies with applicable laws and regulations and that risks to subjects are minimized. Although selection of clinical investigators and research sites, and determining if an investigational new drug application (IND) or investigational device exemption (IDE) is required are viewed primarily as sponsor responsibilities, FDA is issuing this guidance to clarify IRBs' responsibilities related to these activities and to encourage all parties to work together in order to protect the rights and welfare of study subjects.
Many of the recommendations in this guidance have appeared in other FDA guidance documents. FDA has compiled the recommendations from these various sources into this guidance to ensure that all IRBs have access to it. In addition, FDA provides guidance on how IRBs may efficiently fulfill these important responsibilities.
To enhance protection of human subjects 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 and is now available on FDA’s website:
