§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.
45 C.F.R. § 46.207
The Secretary will conduct or fund research that the IRB does not believe meets the requirements of § 46.204 or § 46.205 only if:
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
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 the Federal Register, has determined either:
That the research in fact satisfies the conditions of § 46.204, as applicable; or
The following—
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;
The research will be conducted in accord with sound ethical principles; and
Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.
Notes, amendments, and revision history
Source
Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted.
Authority
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).