StacksVerified U.S. regulatory reference

45 CFR §46.207

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The Secretary will conduct or fund research that the IRB does not believe meets the requirements of § 46.204 or § 46.205 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 pregnant women, fetuses or neonates; and
  2. (b)The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either:
    1. (1)That the research in fact satisfies the conditions of § 46.204, 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 pregnant women, fetuses or neonates;
      2. (ii)The research will be conducted in accord with sound ethical principles; and
      3. (iii)Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.