[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.207]



[Page 129]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH 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.