Title 45: Public Welfare
PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
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§ 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
The Secretary will conduct or fund research that the IRB does not believe meets the requirements of §§46.204 or 46.205 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 pregnant women, fetuses or neonates; and
(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in theFederal Register,has determined either:
(1) That the research in fact satisfies the conditions of §46.204, 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 pregnant women, fetuses or neonates;
(ii) The research will be conducted in accord with sound ethical principles; and
(iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
