§97.407. Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
34 C.F.R. § 97.407
ED conducts or funds research that the IRB does not believe meets the requirements of § 97.404, § 97.405, or § 97.406 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 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; and
Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 97.408.
Notes, amendments, and revision history
Source
Source: 62 FR 63221, Nov. 26, 1997, unless otherwise noted.
Authority
Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b).
Source
Source: 56 FR 28012, 28021, June 18, 1991, unless otherwise noted.