StacksVerified U.S. regulatory reference

45 CFR §46.407

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
HHS will conduct or fund research that the IRB does not believe meets the requirements of § 46.404, § 46.405, or § 46.406 only if:
  1. (a)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
  2. (b)The Secretary, 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, has determined either:
    1. (1)That the research in fact satisfies the conditions of § 46.404, § 46.405, or § 46.406, as applicable, or
    2. (2)The following:
      1. (i)The research 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 research will be conducted in accordance with sound ethical principles;
      3. (iii)Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 46.408.