Pregnant Women, Fetuses and Neonates: Regulations

IRB Member Fact Sheet--Version Date: Unknown

Summary
Federal regulations require that IRBs give special consideration to protecting the welfare of vulnerable subjects, such as prisoners. Title 45 CFR Part 46, Subpart B provides for “Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.”

IRB Member’s Role
When reviewing protocols that propose to enroll pregnant women, fetuses, or neonates, IRB members must pay particular attention to the additional regulatory requirements outlined in Subpart B. In order to approve the enrollment of pregnant women, fetuses, or neonates, each IRB member must assess the proposed project to determine whether it fits into one of the categories described below. Enrollment of pregnant women, fetuses, or neonates cannot be approved if the proposed project does not fit into one of the allowable categories.
46.204: Pregnant women or fetuses may be involved in research if all of the following conditions are met:

46.205:
ADDITIONAL UW-MADISON REQUIREMENTS
UW-Madison campus policy requires that any research conducted by UW-Madison faculty, staff or students, whether on or off the campus of the University of Wisconsin-Madison, utilizing human fetal tissue obtained from an abortion will comply with the requirements of Subpart B described above regardless of the source of funding.

UW-Madison campus policy also states that use of human fetal tissue obtained from an abortion in any research project which is carried out in whole or in part by UW-Madison faculty, staff or students, whether on or off the campus of the University of Wisconsin-Madison, requires an approved protocol which has been reviewed on at least an annual basis by a campus Institutional Review Board. The principal investigator on the protocol must maintain information on the use of such tissues, including the source of the tissue and the costs, if any, associated with the acquisition of the tissue.

DEFINITIONS
Dead fetus: A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Delivery: Complete separation of the fetus from the woman by expulsion or extraction or any other means.
Fetus: The product of conception from implantation until delivery.
Neonate: A newborn.
Nonviable neonate: A neonate after delivery that, although living, is not viable.
Pregnancy: 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.
Secretary: 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.
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.