§ 50.51 Clinical investigations not involving greater than minimal risk

Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:

(a) No greater than minimal risk to children is presented; and

(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in § 50.55 .

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What FDA inspectors cite under § 50.51

Form FDA 483 observations citing this section, fiscal years 2013–2017 (Bioresearch Monitoring).

• Provisions for soliciting assent and permission 2

FDA guidance that cites § 50.51

• Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry draft 24 Sept 2025
• Considerations for Including Tissue Biopsies in Clinical Trials draft 7 Jan 2025
• Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors 15 Aug 2023
• Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations draft 17 May 2023
• Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors draft 30 Mar 2023
• Human Gene Therapy for Neurodegenerative Diseases: Guidance for Industry 21 Oct 2022
• Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs draft 26 Sept 2022
• General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products draft 7 Sept 2022
• Human Gene Therapy for Hemophilia: Guidance for Industry 28 Jan 2020
• Human Gene Therapy for Rare Diseases: Guidance for Industry 28 Jan 2020
• Human Gene Therapy for Retinal Disorders: Guidance for Industry 28 Jan 2020
• 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
• Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs 25 Sept 2017
• Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry 27 Jun 2015
• Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff 24 Mar 2014

and 3 more.

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 12951 26 Feb 2013