21 C.F.R. § 50.25

Elements of informed consent

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(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

(2) A description of any reasonably foreseeable risks or discomforts to the subject.

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.

(3) Any additional costs to the subject that may result from participation in the research.

(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.

(6) The approximate number of subjects involved in the study.

(c) When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

(d) The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.

(e) Nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.

[46 FR 8951, Jan. 27, 1981, as amended at 76 FR 270, Jan. 4, 2011]

Notes of Decisions

Cited in 18 cases (2 in the last 5 years), 1984–2025 · leading case: Obermeier v. Nw. Mem'l Hosp., 2019 IL App (1st) 170553 (Ill. App. Ct. 2019).

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Obermeier v. Nw. Mem'l Hosp., 2019 IL App (1st) 170553 (Ill. App. Ct. 2019). “( 21 C.F.R. § 50.25 (a)(1) (1993).) While we agree that generally a hospital is not in the best position to inform a patient of risks, here it is clear that Sherman Hospital undertook the responsibility to inform the plaintiff of the experimental nature of his surgery.”

Daum v. SpineCare Med. Grp., Inc., 97 Cal. Daily Op. Serv. 1262 (Cal. Ct. App. 1997). · cites it 2× “( 21 C.F.R. § 50.25 (a)(1) (1996).) 9 They also require the subject to be given a copy of the written consent form.”

Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo. 1996). · cites it 2× “The elements of informed consent are laid out in the federal regulations, 21 C.F.R. § 50.25 , and incorporated by reference into the IDA requirements for intraocular lenses.”

Suthers v. Amgen, Inc., 372 F. Supp. 2d 416 (S.D.N.Y. 2005). · cites it 2× “One provision of the Common Rule, 21 C.F.R. § 50.25 (b)(2), anticipates that a study sponsor may seek the right to terminate a subject’s participation without his consent: When appropriate, one or more of the following elements of information shall also be provided to each…”

Estrada v. Jaques, 321 S.E.2d 240 (N.C. Ct. App. 1984). “8,942 , 8,944, and 8,951 (1981), as codified at 21 C.F.R. § 50.25 (a)(1) (1984). The Supreme Court of Montana has recognized an informed consent cause of action where plaintiff alleged that the *650 procedure was experimental and that the physician did not disclose this, even…”

Kus v. Sherman Hosp., 644 N.E.2d 1214 (Ill. App. Ct. 1995). · cites it 2× “) ( 21 C.F.R. § 50.25 (a)(1) (1993).) Part 50 also requires that informed consent be "documented by the use of a written consent form approved by the IRB and signed by the subject.”

Lenahan v. Univ. of Chicago, 808 N.E.2d 1078 (Ill. App. Ct. 2004). “at they each bear an independent institutional responsibility to obtain informed consent from all human subjects in the clinical trial, and that such informed consents must comply with applicable Pood and Drug Administration (FDA) and Department of Health and Human Services…”

Ctr. for Responsible Sci. v. Gottlieb, 346 F. Supp. 3d 29 (D.C. Cir. 2018). “It contends that participants should be warned that testing drugs on laboratory animals - which generally precedes clinical trials involving humans - can be a poor predictor of safety and efficacy in human subjects.”

Evraets v. Intermedics Intraocular, Inc., 94 Cal. Daily Op. Serv. 8164 (Cal. Ct. App. 1994). “) The elements of an informed consent are specified by regulation ( 21 C.F.R. § 50.25 (1994)), which is incorporated by reference into the IDE for intraocular devices.”

Covey v. Surgidev Corp., 815 F. Supp. 1089 (N.D. Ohio 1993). “21 C.F.R. § 50.25 . The plaintiff should also be informed that the procedure is, itself, a research study.”

Sita v. Long Island Jewish-Hillside Med. Ctr., 22 A.D.3d 743 (N.Y. App. Div. 2005). “Furthermore, because the injured plaintiff was not participating in a clinical investigation, FDA regulations did not require LIJ to obtain his informed consent or to disclose the regulatory status of the pedicle screw system (see 21 USC § 360j [g]; 21 CFR 50.25). Because as a…”

Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). “Informed Consent Process ( 21 C.F.R. § 50.25 (a)(2)). Plaintiff challenges the FDA-approved consent form and related communications as “materially misleading and deceptive.”

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