(a) Except as provided in §§ 56.104 and 56.105, any clinical investigation which must meet the requirements for prior submission (as required in parts 312, 812, and 813) to the Food and Drug Administration shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.
(b) Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part. The determination that a clinical investigation may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulations to submit the results of the investigation to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render inapplicable pertinent Federal, State, or local laws or regulations.
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]
Notes of Decisions
Cited in
6
cases, 1994–2007 · 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).
Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997).
· cites it 2× “21 C.F.R. §§ 56.103 (1997) (requiring IRB for clinical investigations under 21 C.”
P.J. v. Utah, 247 F.R.D. 664 (D. Utah 2007).
“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.F.R. § 56.103 (requiring IRBs to approve all clinical trials before initiation and…”
Cowan v. United States, 5 F. Supp. 2d 1235 (N.D. Okla. 1998).
“21 C.F.R. § 56.103 (emphasis added). The exemption from IRB application which Plaintiff references is § 56.”
Abney v. Amgen (6th Cir. 2006).
“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.F.R. § 56.103 (requiring institutional review boards to approve…”
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