Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

45 CFR § 46.407

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45 CFR § 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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