The FDA and the DHHS each have regulations governing the consent process with human subjects, and the general requirements of these agencies are the same. With few exceptions, “no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence” (45 CFR 46.116).
The following links provide access to the specific Federal regulations:
- The Common Rule at 45 CFR 46.116 describes the general requirements for informed consent.
- The Common Rule at 45 CFR 46.117 describes the documentation requirements for informed consent.
- FDA regulations at 21 CFR 50.20 describe the general requirements for informed consent.
- FDA regulations at 21 CFR 50.23 describe the exception from the general requirements.
- FDA regulations at 21 CFR 50.24 describe the exception from informed consent requirements for emergency research.
- FDA regulations at 21 CFR 50.25 describe the elements of informed consent.
- FDA regulations at 21 CFR 50.27 describe the documentation of informed consent.
Vulnerable subjects may have special informed-consent requirements. Additional regulatory information related to obtaining informed consent for vulnerable subjects can be found in Module 7.
The following links provide additional interpretive guidance from the FDA and DHHS including guidance on informed consent:
General guidance on many topics is available from the DHHS OHRP and the FDA at these links.