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51. DHHS Regulations for the Protection of Human Research Subjects (45 CFR 46)

The Department of Health and Human Services was the first federal agency to codify regulations governing human research protection.

This part of the Code of Federal Regulations (45 CFR 46) describes the DHHS regulations for the protection of human subjects. The DHHS regulations require that research involving human participants

  • be subject to oversight by an IRB to ensure that the rights and welfare of research participants are protected, and
  • meets regulatory and institutional requirements.

Through its DHHS FWA, the University agrees to apply 45CFR46 Subparts A, B, C, and D to all human research conducted or otherwise supported by a federal department or agency, when University or affiliate investigators are engaged in the research.

Through its IRB Flexibility Policy, the University agrees to provide equivalent protections for human research that is not conducted or otherwise supported by a federal department or agency (see Institutional Authority... IRB policy for an overview of the Flexibility Policy. Information about equivalent protections can be found in the policies related to review types and processes, vulnerable populations, and parent permission and assent.

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