Informed Consent

The HHS regulations at 45 CFR 46 for the protection of human subjects in research require that investigators obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless:

  • The research is exempt under 45 CFR 46.101(b),
  • The Institutional Review Board (IRB) finds and documents that informed consent can be waived (45 CFR 46.116(c) or (d)), or
  • The IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.

When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117.

The Food and Drug Administration (FDA) regulations at 21 CFR 50 may also apply if the research involves a clinical investigation regulated by FDA for studies on drug(s), device(s) and/ or biologic(s). FDA does not allow consent form waiver with an exception of a limited class of research activities involving emergency medicine according to 21 CFR 50.24.

OHRP: General Informed Consent Requirements Video