Sign in Join the beta My account Open Compliome

21 CFR Part 50 · Protection of Human Subjects

§ 50.20 General requirements for informed consent

Subpart B - Informed Consent of Human Subjects Official text on eCFR Amendment history

Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations 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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 50.20

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Bioresearch Monitoring).

  • Consent not obtained, exceptions do not apply 85
  • Circumstances of obtaining consent 34
  • Understandable language 28
  • Exculpatory language, waiving of rights 8

Warning letters citing § 50.20

15 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 50.20

and 16 more.

Amendment history

Federal Register documents that created or amended this section.