21 C.F.R. § 56.120

Lesser administrative actions

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(a) If apparent noncompliance with these regulations in the operation of an IRB is observed by an FDA investigator during an inspection, the inspector will present an oral or written summary of observations to an appropriate representative of the IRB. The Food and Drug Administration may subsequently send a letter describing the noncompliance to the IRB and to the parent institution. The agency will require that the IRB or the parent institution respond to this letter within a time period specified by FDA and describe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with these regulations.

(b) On the basis of the IRB's or the institution's response, FDA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, the Agency may require the IRB to:

(1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB;

(2) Direct that no new subjects be added to ongoing studies subject to this part; or

(3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects.

(c) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, FDA may notify relevant State and Federal regulatory agencies and other parties with a direct interest in the Agency's action of the deficiencies in the operation of the IRB.

(d) The parent institution is presumed to be responsible for the operation of an IRB, and the Food and Drug Administration will ordinarily direct any administrative action under this subpart against the institution. However, depending on the evidence of responsibility for deficiencies, determined during the investigation, the Food and Drug Administration may restrict its administrative actions to the IRB or to a component of the parent institution determined to be responsible for formal designation of the IRB.

[46 FR 8975, Jan. 27, 1981, as amended at 81 FR 19035, Apr. 4, 2016]

Notes of Decisions

Cited in 2 cases, 2017–2018 · leading case: Stega v. New York Downtown Hosp., 31 N.Y.3d 661 (NY 2018).

Sort: Relevance Newest Treatment

Stega v. New York Downtown Hosp., 31 N.Y.3d 661 (NY 2018). · cites it 2× “Nothing in the FDA regulations gives{**31 NY3d at 673} a third party, even one "with a direct interest" (21 CFR 56.120 [c]; 56.121 [c]) in the matter, the right to notice of an FDA report concerning IRB noncompliance ( see 21 CFR 56.”

Stega v. New York Downtown Hosp., 2017 NY Slip Op 139 (N.Y. App. Div. 2017). · cites it 2× “Under these regulations, the IRB and parent institution are informed of those observations, and a response describing the corrective actions to be taken is required ( see 21 CFR 56.120[a]). If it is determined that the IRB or the institution has failed to take adequate steps to…”

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.