On August 27, 2013, FDA issued a new guidance, “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed“. An IRB is an appropriately-constituted group that has been formally designated to review and monitor biomedical research involving human subjects. Following FDA’s regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. Accordingly, IRBs serve an important role in the protection of the rights and welfare of human research subjects.
The Guidance applies to drugs, biologics, and medical devices and was developed in consultation with the Department of Health and Human Services Office for Human Research Protections (“OHRP”), largely based on recommendations from previously-issued resources. FDA said that it issued the guidance to clarify the Institutional Review Board (“IRB’s”) responsibilities related to the selection of clinical investigators and research sites, because these items are normally considered a sponsor’s responsibility yet they have an impact on the rights and welfare of study subjects. The recommendations in the guidance apply to any IRB, whether serving as a local or centralized review process for multi-site studies. This guidance was developed as part of FDA’s and OHRP’s efforts to harmonize the agencies’ requirements and guidance for human subject protection.
While sponsors of clinical research select clinical investigators who are “qualified by training and experience as appropriate experts,” IRBs have a role in reviewing the investigators’ qualifications to conduct clinical research as proposed in a study protocol. Depending on the IRB’s relationship to the institution conducting the investigation and knowledge of the research, the IRB may already know that a proposed investigator is qualified to conduct the research or may need to dig deeper. In particular, for more high risk investigations, FDA and OHRP expects IRBs to apply a greater amount of scrutiny, especially if the study involves a sponsor-investigator, is outside the investigator’s expertise, or involves other characteristics that may increase risk to human subjects. For example, an IRB may observer, or have a third party observe, the consent process and the research.
An IRB is expected to check an investigator’s inspectional history, such as whether an investigator has been subject to an investigation, disqualified, or disbarred. In addition, IRBs are expected to consult other enforcement documents, such as Warning Letters. An IRB should check with the sponsor and clinical investigators whether an investigational drug/device exemption (“IND” or “IDE”) is required to conduct the proposed research and ask for the basis of this decision.
IRBs are also expected to assess the adequacy of the research site, including the research site’s staff, equipment, and availability of emergency care. For research sites that the IRB is unfamiliar with, the IRB may request that an investigator provide a description of the facility where the research will take place and its resources and staff.
Throughout the process, FDA is available to assist sponsors, investigators, and IRBs, including determining whether an IND or IDE would be required to conduct the proposed research. The goal of the process if for all parties to work together to protect the rights and welfare of study subjects.