§ 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.

218 words·~1 min read·/us/cfr/t21/s§ 50.54·

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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. [66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]

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§ 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.

Fed. Reg.×38

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