[Code of Federal Regulations] [Title 45, Volume 1] [Revised as of October 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 45CFR46.207] [Page 118] TITLE 45--PUBLIC WELFARE AND HUMAN SERVICES PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents Subpart B--Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Sec. 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 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.