Source: https://www.law.cornell.edu/cfr/text/21/50.54
Timestamp: 2016-05-29 06:09:40
Document Index: 472418448

Matched Legal Cases: ['art 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50', '§ 50']

21 CFR 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. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 50 › Subpart D › Section 50.54 21 CFR 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.
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:
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
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:
That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or
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;
Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in § 50.55.
(1) That the clinical investigation in fact satisfies the conditions of § 50.51, § 50.52, or § 50.53, as applicable, or
(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.