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]
Notes of Decisions
Ctr. for Responsible Sci. v. Gottlieb, 311 F. Supp. 3d 5 (D.C. Cir. 2018).
“See 21 C.F.R. § 50.20 . Under current Agency regulations, informed-consent documents must contain eight elements, one of which describes "any reasonably foreseeable risks or discomforts to the subject.”
Daum v. SpineCare Med. Grp., Inc., 97 Cal. Daily Op. Serv. 1262 (Cal. Ct. App. 1997).
· cites it 2× “(c) & (e); 21 C.F.R. §50.20 (1996)). 10 Mr. Daum testified he was never informed before the day of surgery that the Wiltse II was an experimental or investigational device.”
Vodopest v. MacGregor, 913 P.2d 779 (Wash. 1996).
· cites it 2× “[3] See also 21 C.F.R. § 50.20 (1995) (prohibiting exculpatory agreements concerning negligence in clinical investigations regulated by the FDA).”
Hunsaker v. Surgidev Corp., 818 F. Supp. 744 (M.D. Penn. 1992).
· cites it 2× “Mitchell based its conclusion on a strained reading of 21 C.F.R. § 50.20 requiring informed consent and preventing a patient from waiving any legal rights.”
Southard v. Temple Univ. Hosp., 781 A.2d 101 (Pa. 2001).
“§ 360j(g)(3)(D); 21 C.F.R. § 50.20 et seq. Appellee was not a patient in one of these investigations.”
White v. Kennedy Krieger Inst., Inc., 110 A.3d 724 (Md. Ct. Spec. App. 2015).
“” Instructions 33A-33D are taken directly from 21 CFR §§ 50.20 , 50.23, 50.55, & 46.11 respectively, and pertain to the federal requirements for informed consent when an entity solicits the participation of children in a research study.”
Connelly v. Iolab Corp., 927 S.W.2d 848 (Mo. 1996).
“Moreover, 21 C.F.R. § 50.20 provides, “[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…”
Bourquin v. Melsungen, 670 A.2d 1322 (Conn. App. Ct. 1996).
“21 C.F.R. §§ 50.20 , 812.100 and 812.150 (a) (5) (1995).”
Hum v. Dericks, 162 F.R.D. 628 (D. Haw. 1995).
“and the detailed informed consent required by the FDA under 21 CFR 50.20 et seq. and any additional disclosure requirements under Hawai'i law; (9) Whether the Ligament was an adulterated, misbranded and/or unsafe medical device under federal and/or state law; (10) Whether the…”
Pomona Valley Hosp. Med. Ctr. v. Superior Court, 213 Cal. App. 4th 828 (Cal. Ct. App. 2013).
“2d 260 ] [“The statutes and federal regulations on which the Daums rely to establish the duty of disclosure clearly hold ‘the investigator’ ( 21 C.F.R. § 50.20 (1996)) or the ‘person who is primarily responsible for the conduct of a medical experiment’ (Health & Saf.”
Guckin v. Nagle, 259 F. Supp. 2d 406 (E.D. Pa. 2003).
“25 (g) and 21 C.F.R. § 50.20 . Curon also argues that because courts have allowed removal under 28 U.”
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