Including Pregnant Women in Clinical Research: Practices and Decisions of IRBs

If you have ever reviewed a research study as a member or administrator of an IRB that included or involved pregnant research participants, you may be eligible for a new study on the enrollment of pregnant women in clinical research. As a practicing obstetrician-gynecologist, bioethicist, and the study principal investigator (PI), I hope you will consider participating in a 20 to 25 minute online survey on IRB views and experiences reviewing research involving pregnant women.

Why is this such a critical issue?
Diseases and medical treatments affecting pregnant women have been in the news lately, from concerns about Zika virus and associated birth defects to new warnings about a link between acetaminophen exposure during pregnancy and attention deficit hyperactivity disorder in children.

Did you know:

Yet the vast majority of drugs are never studied for use in pregnancy to determine drug effectiveness, to gather basic pharmacokinetic or pharmacodynamic data to inform proper dosing, or even to assess fetal safety. Due to dramatic changes in blood volume, metabolism, and other bodily functions during pregnancy, a dose of medication that would be appropriate outside of pregnancy may be ineffective in pregnancy. This becomes especially concerning when treating infectious diseases. More research is urgently needed to fill profound research gaps so that women and doctors have access to safe, effective, evidence-based interventions during pregnancy.

While there are many barriers to conducting research with pregnant women, much of the reluctance stems from a well-intentioned desire to avoid fetal harm. However, evidence suggests that even when clinical trial participation poses little to no fetal or maternal risk, pregnant women are often excluded from trial participation nonetheless. The reasons for this are unclear but may be partly related to confusing language in the federal regulations, which set criteria for research involving pregnant women in Subpart B of the U.S. Code of Federal Regulations (45 CFR 46.204).

Since IRB approval is key to conducting research that involves pregnant women, my team of investigators based at the University of North Carolina at Chapel Hill is seeking to understand how IRB members interpret and apply research regulations for minimal risk studies in pregnancy.  We are conducting a survey of IRB personnel funded by the National Institute of Allergy and Infectious Diseases and co-sponsored by PRIM&R. As the study PI, I am privileged to work with Dr. Anne Lyerly, Dr. Christine Grady, and Dr. Margaret Little – all experts in the field of bioethics who have worked tirelessly for many years to promote the ethically responsible inclusion of pregnant women in biomedical research.

We need your help to do this! We are seeking 100 administrators and 400 current or former IRB members to complete the survey. As a “thank you,” participants will be offered a $20 Amazon certificate after completion of the survey.

You can access the survey here or paste the following URL into your web browser:

If you have questions, or if you wish to participate in the study even after the available enrollment slots have been filled, please contact Many thanks to PRIM&R for helping to move the ball forward in this important work. And many thanks to all of you for sharing your perspectives with us as survey participants. Your voice will be critically important to inform guidance that will be meaningful for IRBs. Together, we can advance research that will improve the care of women during pregnancy.

Amina White, MD, MA, is a clinical associate professor in the Department of Obstetrics and Gynecology at the University of North Carolina at Chapel Hill. Dr. White is a board certified obstetrician-gynecologist and bioethicist who completed a fellowship at the Clinical Center Department of Bioethics at the National institutes of Health, where she first began to explore the ethics of including pregnant women in clinical trials. As faculty at the University of North Carolina at Chapel Hill, she provides patient care and conducts bioethics research.