21 CFR 50.20: General requirements for informed consent
Requires investigators to obtain legally effective informed consent before enrolling subjects in research, using understandable language, allowing time to decide, minimizing coercion, and prohibiting exculpatory language waiving legal rights or liability, except for emergency and exception provision
Part 50, Protection of Human Subjects · Subpart B, Informed Consent of Human Subjects
How FDA words it
The opening lines investigators use most when they cite 50.20, from the 483s we hold.
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.Most used
Recent 483s citing 50.20
- Cliantha Research Limited · Ahmedabad, Gujarat, IndiaLegally effective informed consent was not obtained from a subject or the subject’s… Apr 17, 2026
- Hennepin County Medical Center, Dept Of Emergency Medicine · Minneapolis, MinnesotaLegally effective informed consent was not obtained from a subject or the subject's… Apr 26, 2019
- Lauren R. Klein, MD, MS, Sponsor-Investigator · Minneapolis, MinnesotaLegally effective informed consent was not obtained from a subject or the subject's… Apr 23, 2019
- Lotus Labs Private Limited | 141/2, John Nagar, Koramangala II] Block · Bangalore, IndiaA. You performed study-specific screening procedures without obtaining prior… Aug 22, 2017
- Stanislaw R Burzynski, M.D · Houston, MarylandLegally effective informed consent was not obtained from a subject or the subject's… Mar 15, 2013
The regulation text
§ 50.20 General requirements for informed consent.
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.
[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999; 88 FR 88248, Dec. 21, 2023]
Questions
What does 21 CFR 50.20 require?
Requires investigators to obtain legally effective informed consent before enrolling subjects in research, using understandable language, allowing time to decide, minimizing coercion, and prohibiting exculpatory language waiving legal rights or liability, except for emergency and exception provision
How do FDA investigators word a 50.20 observation?
The most common opening is: “Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.”
Which sections are cited alongside 50.20?
In the same 483s, investigators most often also cite 312.60 (General responsibilities of investigators), 312.62 (Investigator recordkeeping and record retention), 312.66 (Assurance of IRB review), 50.23 (Exception from general requirements).