C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 50—PROTECTION OF HUMAN SUBJECTS › Subpart B—Informed Consent of Human Subjects

21 C.F.R. § 50.22

Exception from informed consent requirements for minimal risk clinical investigations

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The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or may waive the requirement to obtain informed consent, provided the IRB finds and documents the following:

(a) The clinical investigation involves no more than minimal risk to the subjects;

(b) The clinical investigation could not practicably be carried out without the requested waiver or alteration;

(c) If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;

(d) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

(e) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

[88 FR 88248, Dec. 21, 2023]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2025–2025 · leading case: Ward v. Dep't of Health & Human Servs. (N.D. Fla. 2025).
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Ward v. Dep't of Health & Human Servs. (N.D. Fla. 2025). · cites it 2× “In his complaint, Plaintiff seeks to invalidate 21 C.F.R. § 50.22 , which he claims authorizes the government to conduct secret “biomedical experimental studies” on unsuspecting Americans.”
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