Pregnant women and their fetuses are considered special classes of vulnerable subjects and there are additional protections and requirements for their participation in research. These protections are provided in 45 CFR 46 Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research.
CHOP's FWA requires that the IRB apply the Subpart B protections for all research involving pregnant women and the fetus. IRB SOP 502: Research Involving Pregnant Women, the Fetus and Neonates details the CHOP IRB's policies regarding research covered by Subpart B.
In addition, girls who become pregnant are no longer considered children in the State of Pennsylvania since they may consent for their own treatment.