(a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
Notes of Decisions
Cited in
7
cases (
1 in the last 5 years), 1994–2026 · leading case:
Edward Abney, Barbara Allen, James Day, Robert Green, Delbert Jackson, James Pugh, Roger L. Thacker, & Daniel Hunter Webster v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006).
Stega v. New York Downtown Hosp., 31 N.Y.3d 661 (NY 2018).
“The FDA is the government agency with authority to regulate IRBs ( see 21 CFR 56.101 [a]), just as the NASD "is the primary regulator of the broker-dealer industry" ( Rosenberg , 8 NY3d at 366 ).”
Halikas v. Univ. of Minnesota, 856 F. Supp. 1331 (D. Minnesota 1994).
· cites it 3× “Halikas also asks the Court to order the University to indemnify him for his attorneys’ fees and costs. Dr. Halikas seeks redress, pursuant to 42 U.”
P.J. v. Utah, 247 F.R.D. 664 (D. Utah 2007).
“”); 21 C.F.R. § 56.101 (requiring a university conducting clinical trials to establish IRBs for the purpose of “protecting] the rights and welfare of human subjects involved in” clinical trials); see also 21 C.”
Cowan v. United States, 5 F. Supp. 2d 1235 (N.D. Okla. 1998).
· cites it 2× “Davis has effectively established an IRB which will review Dr.”
Graw (E.D. Mo. 2026).
“”) (citing 21 C.F.R. § 56.101 ); Zeman v. Williams, No.”
Abney v. Amgen (6th Cir. 2006).
“21 C.F.R. § 56.101 (requiring university conducting clinical trials to establish institutional review boards for the purpose of “protect[ing] the rights and welfare of human subjects involved in” clinical trials); see also 21 C.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.