Pregnant Women and Neonates

Pregnant women and neonates are a federally designated “protected population” with additional regulatory requirements and protections described in Subpart B of the Common Rule.

The UW supports the policy of providing pregnant women with the same opportunities as non-pregnant women to participate in research unless the individual meets exclusionary criteria or the study poses more than minimal risk to the fetus.

The reference materials below provide details for researcher and the IRB about meeting these additional requirements.

Reference Materials

SOP Pregnant Women
SOP Neonates
WORKSHEET Pregnant Women
WORKSHEET Neonates