C.F.R. » Title 45 » SUBCHAPTER A—GENERAL ADMINISTRATION › PART 46—PROTECTION OF HUMAN SUBJECTS › Subpart D—Additional Protections for Children Involved as Subjects in Research

45 C.F.R. § 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

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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:

(a) 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

(b) 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:

(1) That the research in fact satisfies the conditions of § 46.404, § 46.405, or § 46.406, as applicable, or

(2) The following:

(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) The research will be conducted in accordance with sound ethical principles;

(iii) 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 of Decisions
Cited in 1 case, 2001–2001 · leading case: Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001).
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Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001). · cites it 4× “45 C.F.R. section 46.407 therefore additionally provides: "Sec.”
— 45 C.F.R. § 46.407(b) — 1 case
Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001). “45 C.F.R. section 46.407 therefore additionally provides: "Sec.”
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