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Code of Federal Regulations Title 21. Food and Drugs § 21.50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

Current as of January 02, 2025 | Updated by Findlaw Staff

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:

(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

(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:

(1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or

(2) That the following conditions are met:

(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;

(ii) The clinical investigation will be conducted in accordance with sound ethical principles;  and

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-50-54/

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