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Whether children
HHS will conduct or fund research that the IRB does notthe requirements of §46.404, §46.405, or §46.406 only if:
(a) the IRB finds that thea reasonable opportunity to further the understanding, prevention, or alleviation of athe 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) thea reasonable opportunity to further the understanding, prevention, or alleviation of athe 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 ofor guardians, as set forth in §46.408.
§46.408 Requirements for permission by parents or guardians and for assent by children.
(a) In addition to theother applicable sections of this subpart, the IRB shall determine that adeq
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