{"data":{"id":"us/45-cfr-46.207","jurisdiction":"us","citation":"45 CFR 46.207","heading":"Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.","body":"The Secretary will conduct or fund research that the IRB does not believe meets the requirements of § 46.204 or § 46.205 only if:\n(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\n(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:\n(1) That the research in fact satisfies the conditions of § 46.204, as applicable; or\n(2) The following:\n(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;\n(ii) The research will be conducted in accord with sound ethical principles; and\n(iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.","path":["Title 45—Public Welfare","SUBTITLE A—Department of Health and Human Services","SUBCHAPTER A—GENERAL ADMINISTRATION","PART 46—PROTECTION OF HUMAN SUBJECTS","Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-45.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:21Z","sha256":"3f0e36467e12a2c325d663da0ad0dd5be0baadf0a8e695b5dcd5d8d838506fae","source_id":"us-cfr","stale":true,"prev":"us/45-cfr-46.206","next":"us/45-cfr-46.301"},"notice":"GroundRules: Original legal text. Not legal advice."}