Skip to main content Skip to navigation
Washington State University

HRPP policies & procedures manual

500: Pregnant women, fetuses and neonates

1. Purpose

The policy describes the requirements concerning review of research that involves pregnant women, human fetuses, and neonates.  This group could be potentially vulnerable to coercion in regard to autonomy, and present conditions that may affect risk/benefit determinations or bearing unequal burden in research.

2. Policy

Research involving women who are pregnant should receive special attention from the IRB because of women’s additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus. Special attention is justified because of the involvement of the fetus that may be affected but cannot give consent.

3. Definitions

Dead fetus: a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord

Fetus: the product of conception from implantation until delivery

Neonate: newborn (birth to four (4) weeks)

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 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.

Viable, as it pertains to a neonate: being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration

3.1 Pregnant women and fetuses

Pregnant women or fetuses prior to delivery may be involved in research. The IRB  members will confirm that all the conditions and determinations are met.

3.2 Neonates

Neonates may be involved in research. The IRB members will confirm that all the conditions and determinations are met.

3.4 Research sponsored by the Environmental Protection Agency

  • For research conducted or supported by the EPA
    • Research involving intentional exposure of pregnant women or children to any substance is prohibited and not approved by the IRB.
  • For research intended for submission to the EPA
    • Research involving intentional exposure of pregnant women or children to any substance is prohibited and not approved by the IRB.
  • The EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as subjects in observational research, i.e., research that does not involve intentional exposure to any substance.
  • The IRB will review observational research involving pregnant women and fetuses using 40 CFR 26 and 45 CFR 46 Subpart B.
  • EPA policy requires submission of IRB determinations and approval to the EPA Human Subjects Research Review official for final review and approval before the research can begin.
  • For research not conducted or supported by any federal agency that has regulations for protecting human research subjects and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research subjects apply, including:
    • EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.
    • EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.

4. Applicable regulations and guidelines

The Belmont Report

45 CFR 46 Subpart B

45 CFR 46.305, 45 CFR 46.122

21 CFR 56.111

Office for Human Research Protections IRB Guidebook

5. Forms

None

6. Procedures employed to implement this policy & assignment of responsibility

WhoTask
IRB coordinatorSelect appropriate reviewers and obtain expert consultant, if appropriate.