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Title 45: Public Welfare
SUBTITLE A: DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A: GENERAL ADMINISTRATION
PART 46: PROTECTION OF HUMAN SUBJECTS
Subpart D: Additional Protections for Children Involved as Subjects in Research
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.
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.
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