In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter , each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51 , § 50.52 , or § 50.53 and the conditions of all other applicable sections of this subpart D.
21 CFR Part 50 · Protection of Human Subjects
§ 50.50 IRB duties
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FDA guidance that cites § 50.50
- Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry draft 24 Sept 2025
- Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs draft 26 Sept 2022
- FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Guidance for Industry 24 May 2021
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff 11 Jul 2019
- Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials 13 Mar 2019
- Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs 25 Sept 2017
Amendment history
Federal Register documents that created or amended this section.
- 45 FR 36390 30 May 1980