StacksVerified U.S. regulatory reference

21 CFR §50.54

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
If an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of § 50.51, § 50.52, or § 50.53, the clinical investigation may proceed only if:
  1. (a)The IRB finds that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
  2. (b)The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:
    1. (1)That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or
    2. (2)That the following conditions are met:
      1. (i)The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
      2. (ii)The clinical investigation will be conducted in accordance with sound ethical principles; and
      3. (iii)Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in § 50.55.