[Code of Federal Regulations]
[Title 45, Volume 1, Parts 1 to 199]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.208]

[Page 119-120]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
 Subpart B--Additional Protections Pertaining to Research, Development, 
 and Related Activities Involving Fetuses, Pregnant Women, and Human In 
                           Vitro Fertilization
 
Sec. 46.208  Activities directed toward fetuses in utero as subjects.

    (a) No fetus in utero may be involved as a subject in any activity 
covered by this subpart unless: (1) The purpose of the activity is to 
meet the health needs of the particular fetus and the fetus

[[Page 120]]

will be placed at risk only to the minimum extent necessary to meet such 
needs, or (2) the risk to the fetus imposed by the research is minimal 
and the purpose of the activity is the development of important 
biomedical knowledge which cannot be obtained by other means.
    (b) An activity permitted under paragraph (a) of this section may be 
conducted only if the mother and father are legally competent and have 
given their informed consent, except that the father's consent need not 
be secured if: (1) His identity or whereabouts cannot reasonably be 
ascertained, (2) he is not reasonably available, or (3) the pregnancy 
resulted from rape.