August 27, 2013—The US Food and Drug Administration has issued guidance for institutional review boards (IRBs), clinical investigators, and sponsors. The document, which is available on the FDA website, addresses IRBs' responsibilities for reviewing the qualifications of investigators, the adequacy of research sites, and the determination of whether an investigational new drug application (IND) or investigational device exemption (IDE) is needed.

The document details the FDA's position that an IRB must review the qualifications of clinical investigators who conduct FDA-regulated research; that IRBs can use publicly available information from the FDA to learn about a clinical investigator's inspectional history; and that an IRB is responsible for reviewing the adequacy of a research site. Also, the FDA outlines an IRB's responsibilities with respect to verifying the determination of whether an IND or IDE is required for an FDA-regulated investigation.

This guidance was prepared by the FDA's Office of Good Clinical Practice in the Office of the Commissioner with input from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs.

As stated in the document, this guidance represents the FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations. Alternative approaches can be discussed with the FDA staff who are responsible for implementing this guidance. Contact information for various departments is provided in the document.

According to the FDA's guidance, all of the parties who conduct or have oversight responsibilities for biomedical research—sponsors, clinical investigators, and 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 IND or 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.

This guidance, like other FDA guidance documents, does not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required.

The FDA notes that many of the recommendations in this guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly about these issues. The FDA has also provided instructions to its field investigators on the types of records that should be reviewed during an IRB inspection to determine whether the IRB performed an evaluation of an investigator's qualifications, assessed the adequacy of a site, and questioned whether an IND or IDE is necessary. The FDA has compiled the recommendations from these various sources into this guidance to ensure that all IRBs have access to it. In addition, the FDA provides guidance on how IRBs may efficiently fulfill these important responsibilities.

The recommendations in this guidance are applicable to any IRB, independent or affiliated with an institution, whether serving as a local IRB or as the central IRB for other IRBs or institutions participating in a centralized review process for multisite studies. The recommendations are general in order to provide IRBs with necessary flexibility in developing agreements for cooperative research as described in 21 CFR 56.114.

As discussed in Guidance for Industry—Using a Centralized IRB Review Process in Multicenter Clinical Trials, which is available on the agency's website, the FDA recommends that IRBs and institutions participating in a centralized review process agree on how to divide and carry out these responsibilities, and that such agreements be in writing to help ensure that the rights and welfare of study subjects are protected.