§46.407. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
45 C.F.R. § 46.407
HHS will conduct or fund research that the IRB does not believe meets the requirements of § 46.404, § 46.405, or § 46.406 only if:
The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
The Secretary, 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, has determined either:
That the research in fact satisfies the conditions of § 46.404, § 46.405, or § 46.406, as applicable, or
The following—
The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
The research will be conducted in accordance with sound ethical principles;
Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 46.408.
Notes, amendments, and revision history
Source
Source: 48 FR 9818, Mar. 8, 1983, unless otherwise noted.
Authority
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).