This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46.
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 HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b) (2) the IRB finds and documents that informed consent can be waived ( 45 CFR 46.116(c) or (d)) or (3) 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. Regulations & Policy Archived Materials.Subpart C Certification Request to OHRP.Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations.Informed Consent Posting has sub items, about Informed Consent Posting.OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements.OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals.Decision Charts has sub items, about Decision Charts.Path to Revising the Common Rule (2011–2018).Preamble to the Revised Common Rule (2018 Requirements).Regulations has sub items, about Regulations.