[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: 45CFR46.202]



[Page 126-127]

 

                        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. 46.202  Definitions.



    The definitions in Sec. 46.102 shall be applicable to this subpart 

as well. In addition, as used in this subpart:



[[Page 127]]



    (a) Dead fetus means a fetus that exhibits neither heartbeat, 

spontaneous respiratory activity, spontaneous movement of voluntary 

muscles, nor pulsation of the umbilical cord.

    (b) Delivery means complete separation of the fetus from the woman 

by expulsion or extraction or any other means.

    (c) Fetus means the product of conception from implantation until 

delivery.

    (d) Neonate means a newborn.

    (e) Nonviable neonate means a neonate after delivery that, although 

living, is not viable.

    (f) Pregnancy encompasses the period of time from implantation until 

delivery. A woman shall be assumed to be pregnant if she exhibits any of 

the pertinent presumptive signs of pregnancy, such as missed menses, 

until the results of a pregnancy test are negative or until delivery.

    (g) Secretary means the Secretary of Health and Human Services and 

any other officer or employee of the Department of Health and Human 

Services to whom authority has been delegated.

    (h) Viable, as it pertains to the neonate, means being able, after 

delivery, to survive (given the benefit of available medical therapy) to 

the point of independently maintaining heartbeat and respiration. The 

Secretary may from time to time, taking into account medical advances, 

publish in the Federal Register guidelines to assist in determining 

whether a neonate is viable for purposes of this subpart. If a neonate 

is viable then it may be included in research only to the extent 

permitted and in accordance with the requirements of subparts A and D of 

this part.