Section 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 childrenIf 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