2. Institutional Authority for Human Research Protection

Updated July 26, 2021

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

The University provides this assurance through a DHHS Federalwide Assurance (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 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 research that is not conducted or otherwise supported by a federal department or agency.

The University's Research Integrity office and the IRB have the authority to:

  1. Ensure the rights and welfare of research participants are protected;
  2. Ensure human research meets regulatory and institutional requirements;
  3. Approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the University;
  4. Suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants;
  5. Observe, or have a third party observe, the consent process;
  6. Observe, or have a third party observe, the conduct of the research.

The federal regulations for the protection of human participants exempt some research activities from the requirements for IRB review (§46.104). The University has designated Research Integrity and the IRB to review and authorize exempt research. For more information about exempt categories of research, see the exempt research policy sections.

The University complies with the research standards in the International Conference on Harmonization - Good Clinical Practice E6 only so far as these reflect the regulatory requirements of DHHS, FDA, and other federal agencies as applicable.