Policy & Guidance Refresher
Pregnant women, fetuses, and neonates are a vulnerable population and, as such, require additional protections when they are research subjects. It is recognized, however, that pregnant women, fetuses, and neonates should not be denied the benefits of participating in research. Distinction must be made between studies for which the reproductive status of the pregnant woman or the unique characteristics of fetuses and neonates are criteria for inclusion in the research, and studies for which the pregnancy status of the woman is incidental.
During their review of research that involves pregnant women, the Columbia IRBs consider the requirements of the DHHS and FDA regulations for the protection of vulnerable human subjects and must make specific determinations related to risk, benefit, and informed consent
Awareness by researchers of the regulations and affiliated required determinations will facilitate inclusion, in the submission to the IRB, of the information that must be considered before these determinations can be made.