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Institutional Review Board (IRB) Referrals of Pediatric Clinical Investigations to FDA Pursuant to 21 CFR 50.54

In accordance with the “Additional Safeguards for Children in Clinical Investigations” found at 21 CFR part 50, subpart D, an IRB may only approve the following research involving children: 

  • Research not involving greater than minimal risk (21 CFR 50.51)
  • Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (21 CFR 50.52)
  • Research involving no more than a minor increase over minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition (21 CFR 50.53)

If an IRB does not find the research involving children meets the requirements of 21 CFR 50.51, 50.52 or 50.53, the IRB may refer the research to FDA for review under 21 CFR 50.54. Such research may proceed only if the following criteria in 21 CFR 50.54 are satisfied:

  • The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

  • The FDA Commissioner, after consultation with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:

    • The research in fact satisfies 21 CFR 50.51, 50.52 or 50.53; or
    • The following three conditions are met:
      • The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
      • The research will be conducted in accordance with sound ethical principles; and
      • Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in 21 CFR 50.55.

     

The table below includes information from past IRB referrals to FDA pursuant to 21 CFR 50.54 that proceeded to a public meeting of the Pediatric Advisory Committee (PAC) and Pediatric Ethics Subcommittee (PES).

PAC/PES Meeting Date(s)

Protocol

Meeting Materials

May 18, 2017 (PAC/PES)A Double-Blind, Placebo-Controlled, Multicenter Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy (ESSENCE)

 

Dec 9, 2008 (PES)Children’s Oncology Group Protocol ASCT0631: A Phase III Randomized Trial of Granulocyte Colony Stimulating Factor (G–CSF) Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source in Matched Sibling Donor Transplantation
Nov 15, 2005 (PES)
Nov 16, 2005 (PAC)		Gonadotropin Releasing Hormone (GnRH) Agonist Test in Disorders of Puberty
June 28, 2005 (PES) 
June 29, 2005 (PAC)		Precursor Preference in Surfactant Synthesis of Human Preterm Infants
Sept 10, 2004 (PES) 
Sept 15, 2004 (PAC)		Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): A Functional Magnetic Resonance Study
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