Chapter 16 - Considerations for FDA Regulated Research

IRB Review of Studies Utilizing Drugs, Biologics and Devices

The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives. All such research studies must be conducted in accordance with FDA requirements for the protection of human subjects and IRBs, regardless of source of funding (21 CFR Parts 50 and 56).

When FDA regulated test articles are used in research conducted at the University of Pittsburgh and funded by another agency, more than one set of regulations may apply. For example, clinical trials involving FDA regulated test articles that are supported by the Department of Health and Human Services (DHHS) fall under the jurisdiction of both the FDA and the DHHS Office for Human Research Protections (OHRP). Such trials must comply with the FDA and the DHHS human participant regulations. Where regulations differ, the University of Pittsburgh IRB will apply the stricter regulation.

In addition to the other applicable requirements outlined in this document, for studies involving drugs, biologics or devices the IRB shall follow the procedures outlined below. As specified in Chapter 12, Meeting Materials, reviewers are provided with the sponsor protocol as well as other materials specific to the study, e.g. the investigator brochure and correspondence with the applicable regulatory agencies.