§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.
21 C.F.R. § 50.54
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
That the following conditions are met—
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;
The clinical investigation will be conducted in accordance with sound ethical principles; and
Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in § 50.55.
Notes, amendments, and revision history
Amendments
[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]
Source
Source: 66 FR 20598, Apr. 24, 2001, unless otherwise noted.
Authority
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.
Source
Source: 45 FR 36390, May 30, 1980, unless otherwise noted.
Amendments
[66 FR 20598, Apr. 24, 2001, as amended at 78 FR 12951, Feb. 26, 2013]