What is informed consent and when, why, and how must it be obtained?
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. When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117. [Food and Drug Administration (FDA) regulations at 21 CFR part 50 may also apply if the research involves a clinical investigation regulated by FDA.] The requirement to obtain the legally effective informed c
Related Questions
- Our laboratorys test requisition form includes a place for physician certification that informed consent was obtained. Can the laboratory continue to use this form after the new law goes into effect?
- May informed consent be obtained by telephone from a legally authorized representative?
- What is informed consent and when, why, and how must it be obtained?
