IRB Practices in Promoting Inclusion of Pregnant People in Research

Stephanie Morain – Johns Hopkins Berman Institute of Bioethics; Sasha Kapur – Johns Hopkins University

Abstract: Pregnant individuals have historically been excluded from clinical research. This exclusion has resulted in a critical scientific evidence gap; it also represents a fundamental injustice, as it has denied pregnant individuals the potential direct benefits of research and has underrepresented their interests.

Over three decades ago, the Institute of Medicine recommended that pregnant individuals be presumed eligible to participate in clinical studies. Numerous additional reports and guidance documents have since affirmed the need to include pregnant people in research. These recommendations notwithstanding, exclusion of pregnant individuals remains common.

Facilitating appropriate inclusion of pregnant individuals in research requires altering entrenched cultural assumptions and corresponding norms. National and international experts have advised that institutional review boards (IRB), funders, and other stakeholders require justification when pregnant people are excluded from research. However, the extent to which institutions have adopted policies consistent with this recommendation remains unknown.

This presentation will discuss findings from a study of IRB policies and related guidance documents from the 50 US institutions receiving the highest amount of NIH funding (based on 2023 levels). These findings clarify the extent to which institutions adopt and disseminate guidance and policies that adhere to expert recommendations to promote inclusion of pregnant people in research. Finally, the presentation will highlight key areas of improvement and best practices for IRB and HRPP professionals.

Keywords: inclusion of pregnant people in research, IRB best practices