The Food and Drug Administration (FDA or the Agency) has been working with the Department of Health and Human Services, Office for Human Research Protections, to harmonize the agencies’ regulatory requirements and guidance regarding human subject research. As part of this ongoing initiative, FDA finalized recently two guidance documents related to the responsibilities of institutional review boards (IRBs) and requirements for investigational new drug applications (INDs). The purpose of both guidances is to clarify existing regulatory requirements by consolidating former policies and guidance on the same topics and providing answers to frequently asked questions from academia and industry.

Responsibilities of IRBs

At the end of August, FDA announced the availability of final guidance clarifying the responsibilities of IRBs to ensure appropriate protection of the rights and welfare of human subjects involved in biomedical research.1 In particular, the guidance addresses the IRB’s role in reviewing the qualifications of clinical investigators, evaluating the adequacy of research sites, and determining whether an IND or investigational device exemption (IDE) is necessary. Many of the recommendations are not new, having appeared in various other FDA policies and guidance documents; however, the final guidance, summarized below, consolidates these principles and confirms the role and responsibilities of IRBs.

Clinical investigators — Although FDA regulations make sponsors responsible for the selection of clinical investigators who conduct FDA-regulated research, the final guidance reconfirms the IRB’s responsibility, already established by regulation, to review the investigators’ qualifications. Such review may be straightforward or involved, depending upon the proposed research and relationship of the IRB to the investigator. FDA recommends that IRBs pay special attention to an investigator’s qualifications where the study involves a sponsor investigator, a study that is outside of the investigator’s area of expertise, and/or any study design features that may significantly increase risks to subjects.