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21CFR50.54

§ 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.

Regulation Text

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 .

Authority

21 U.S.C. 321,343,346,346a,348,350a,350b,352,353,355,360,360c-360f,360h-360j,371,379e,381;42 U.S.C. 216,241,262.

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Related Guidelines (10)

21CFR50.54 — § 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. | CFR Explorer | BioRegHub