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 46.  Although the University of Pittsburgh has chosen to "uncheck" the box on its FederalWide Assurance, all regulatory requirements are applied across studies with minor exceptions as outlined in other sections of this document.  Where this occurs, equivalent protections are included.
  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. Where applicable, other federal, state and local regulations regarding research involving human subjects.
  4. The provisions of the Federal Wide Assurance Agreements (FWA) for the University of Pittsburgh (FWA #00006790), UPMC (FWA #00006735), UPMC Cancer Centers (FWA #00003338), UPMC Children’s Hospital of Pittsburgh (FWA #00000600), 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’s website, the FDA's Information Sheets for IRBs and Clinical Investigators; and to other interpretative directives, information documents and guidance materials disseminated by OHRP, DHHS, the National Institutes of Health (NIH) the FDA and other federal agencies (e.g., Office of Civil Rights).

version 12.9.2015