B04 - [IN-PERSON/RECORDED] “Do Not Take if You Are Pregnant”: Demystifying the Inclusion of Pregnant Participants in Research

This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

Due to hurdles throughout the clinical trial timeline, pregnant people are routinely excluded from participation. This has led to problematic knowledge gaps and making it hard to make evidence-informed decisions about medical care during pregnancy. Is it safe to continue taking anti-depressants? Is it okay to have surgery? Ethical oversight has been one such hurdle, with many sponsors and investigators finding it easier to exclude pregnant people than to navigate the intricacies of Subpart B IRB review. However, this exclusion represents an ethical dilemma that can addressed as an equitable inclusion matter. When IRBs consider the participation of pregnant people in this way, they have the opportunity to serve as levers for thoughtful inclusion.