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.

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