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2. Institutional Authority for Human Research Protection

Institutions engaged in human subject research supported or conducted by any federal department or agency must provide written assurance that it will comply with the requirements in the Code of Federal Regulations, under DHHS Protection of Human Subjects at 45 CFR 46.

The University provides this assurance through a DHHS FWA (FWA00002306).

As part of its FWA, for research conducted by University and affiliate researchers, the University agrees to

  • apply the Common Rule (i.e., 45 CFR 46 Subpart A) to human subject research conducted or otherwise supported by a federal department or agency (AKA: federally-funded research);
  • apply Subparts B, C, and D for research involving pregnant women, fetuses, neonates of uncertain viability, or nonviable neonates; prisoners; and children; respectively, to federally-funded research ; and
  • via the University IRB Flexibility Policy (IRB-Flex policy), provide equivalent protections for human subject research that is not conducted or otherwise supported by a federal department or agency.

The University's Research Integrity Office (RIO) and the IRB have the authority to ensure

  1. the rights and welfare of research participants are protected and
  2. human subject research meets regulatory and institutional requirements.

The federal regulations for the protection of human subjects exempt some research activities from the requirements for IRB review (§46.101(b)). The University has designated the RIO to review and authorize exempt research. For more information about exempt categories of research, see the exempt research policy sections.

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