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. § 50.27

Documentation of informed consent

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(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.

(b) Except as provided in § 56.109(c), the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by § 50.25. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.

(2) A short form written consent document stating that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

[46 FR 8951, Jan. 27, 1981, as amended at 61 FR 57280, Nov. 5, 1996]
Notes of Decisions
Cited in 2 cases, 1995–1997 · leading case: Daum v. SpineCare Med. Grp., Inc., 97 Cal. Daily Op. Serv. 1262 (Cal. Ct. App. 1997).
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Daum v. SpineCare Med. Grp., Inc., 97 Cal. Daily Op. Serv. 1262 (Cal. Ct. App. 1997). · cites it 2× “( 21 C.F.R. § 50.27 (a) (1996).) Clearly, *1309 both California’s Protection of Human Subjects in Medical Experimentation Act and the federal regulations in 21 Code of Federal Regulations, part 50 were intended to prevent patients from becoming unwitting subjects in…”
Kus v. Sherman Hosp., 644 N.E.2d 1214 (Ill. App. Ct. 1995). “” ( 21 C.F.R. § 50.27 (a) (1993).) The IRB’s are also required to conduct "continuing review of research” on at least an annual basis, which includes the duty to review the informed consent process.”
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