{"data":{"id":"us/21-cfr-50.54","jurisdiction":"us","citation":"21 CFR 50.54","heading":"Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.","body":"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:\n(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\n(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:\n(1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or\n(2) That the following conditions are met:\n(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;\n(ii) The clinical investigation will be conducted in accordance with sound ethical principles; and\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 50—PROTECTION OF HUMAN SUBJECTS","Subpart D—Additional Safeguards for Children in Clinical Investigations"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"16e20dbd93b55bb4cc200706ee229e41b11087a0e0225cb251b822dad8211769","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-50.53","next":"us/21-cfr-50.55"},"notice":"GroundRules: Original legal text. Not legal advice."}