The Secretary will conduct or fund research that the IRB does not believe meets the requirements of Sec. 46.204 or Sec. 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 the Federal Register, has determined either:
(1) That the research in fact satisfies the conditions of Sec. 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. Subpart C_Additional Protections Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
Source: 43 FR 53655, Nov. l6, 1978, unless otherwise noted.