Regulatory Mandates

The IRB and the research community adhere to the following regulations and policies for human subject research activities:

1. The Federal Policy regulations for the protection of human research subjects (45 CFR Part 46; Subpart A also known as the “Common Rule”), as well as all additional subparts outlined in 45 CFR Part 46. Equivalent protections will be applied all research reviewed under the jurisdiction of the IRB.
2. When research involves articles subject to regulation by the FDA, the FDA regulations for the protection of human subjects (21 CFR Parts 50) and Institutional Review Boards (21 CFR Parts 56).
3. When research is supported by other federal agencies, applicable regulatory requirements will be followed (see Chapter 26 “Additional Requirements for Research Supported by Other Federal Agencies).”
4. Where applicable, other state and local laws and regulations regarding research involving human subjects.
5. The provisions of the Federal Wide Assurance Agreements (FWA) for the University of Pittsburgh (FWA #00006790), UPMC (FWA #00006735), UPMC Cancer Centers (FWA #00003338), and Magee Women’s Research Institute (FWA #00003567).
   
   When making determinations concerning the rights and welfare of human subjects participating in research studies, the IRB will also refer to current guidance available on OHRP and FDA websites; and to other interpretative directives, information, documents and guidance materials related to human subjects research.

When making determinations concerning the rights and welfare of human subjects participating in research studies, the IRB will also refer to current guidance available on OHRP and FDA websites; and to other interpretative directives, information, documents and guidance materials related to human subjects research.

revised 12.9.2015, 11.2.2018, 11.6.2023