[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: 45CFR46.204]



[Page 127-128]

 

                        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. 46.204  Research involving pregnant women or fetuses.



    Pregnant women or fetuses may be involved in research if all of the 

following conditions are met:

    (a) Where scientifically appropriate, preclinical studies, including 

studies on pregnant animals, and clinical studies, including studies on 

nonpregnant women, have been conducted and provide data for assessing 

potential risks to pregnant women and fetuses;

    (b) The risk to the fetus is caused solely by interventions or 

procedures that hold out the prospect of direct benefit for the woman or 

the fetus; or, if there is no such prospect of benefit, the risk to the 

fetus is not greater than minimal and the purpose of the research is the 

development of important biomedical knowledge which cannot be obtained 

by any other means;

    (c) Any risk is the least possible for achieving the objectives of 

the research;

    (d) If the research holds out the prospect of direct benefit to the 

pregnant woman, the prospect of a direct benefit both to the pregnant 

woman and the fetus, or no prospect of benefit for the woman nor the 

fetus when risk to the fetus is not greater than minimal and the purpose 

of the research is the development of important biomedical knowledge 

that cannot be obtained by any other means, her consent is obtained in 

accord with the informed consent provisions of subpart A of this part;

    (e) If the research holds out the prospect of direct benefit solely 

to the fetus then the consent of the pregnant woman and the father is 

obtained in accord with the informed consent provisions of subpart A of 

this part, except that the father's consent need not be obtained if he 

is unable to consent because of unavailability, incompetence, or 

temporary incapacity or the pregnancy resulted from rape or incest.

    (f) Each individual providing consent under paragraph (d) or (e) of 

this section is fully informed regarding the reasonably foreseeable 

impact of the research on the fetus or neonate;

    (g) For children as defined in Sec. 46.402(a) who are pregnant, 

assent and permission are obtained in accord with the provisions of 

subpart D of this part;



[[Page 128]]



    (h) No inducements, monetary or otherwise, will be offered to 

terminate a pregnancy;

    (i) Individuals engaged in the research will have no part in any 

decisions as to the timing, method, or procedures used to terminate a 

pregnancy; and

    (j) Individuals engaged in the research will have no part in 

determining the viability of a neonate.