{"data":{"id":"us/45-cfr-46.407","jurisdiction":"us","citation":"45 CFR 46.407","heading":"Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.","body":"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:\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 children; and\n(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:\n(1) That the research in fact satisfies the conditions of § 46.404, § 46.405, or § 46.406, 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 children;\n(ii) The research will be conducted in accordance with sound ethical principles;\n(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.","path":["Title 45—Public Welfare","SUBTITLE A—Department of Health and Human Services","SUBCHAPTER A—GENERAL ADMINISTRATION","PART 46—PROTECTION OF HUMAN SUBJECTS","Subpart D—Additional Protections for Children Involved as Subjects 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":"6d05c3a8d651b4d84f67c9e3dd3d3f77e1252acaa3da230b48c0d113f9f72545","source_id":"us-cfr","stale":true,"prev":"us/45-cfr-46.406","next":"us/45-cfr-46.408"},"notice":"GroundRules: Original legal text. Not legal advice."}