IRB Policies on the Inclusion of Pregnant Women in Research.

Pregnant women have historically been excluded from clinical research, denying pregnant women the benefits of the societal investment in biomedical research and potential direct benefits from research participation. National and international guidance documents have called upon institutional review boards (IRBs) to institute policies to establish the expectation for inclusion of pregnant women in clinical research and require justification when pregnant women are excluded. However, only limited evidence exists regarding the extent to which IRBs have adopted policies consistent with these recommendations. We reviewed IRB policies and related guidance documents from the top 50 research institutions in the United States and the two largest independent IRBs. Four academic and one independent IRB included language that reinforced the view that pregnant women should not be included in research. Conversely, eight academic institutions included language that expressly fostered a culture of inclusion, and five academic institutions included language describing a requirement to justify decisions to exclude pregnant women. Neither independent IRB required justification for exclusion. While some institutions have implemented changes to advance the goal of ethical inclusion, considerable gaps remain between widely endorsed recommendations that IRBs contribute to facilitating appropriate inclusion of pregnant women in research and on-the-ground IRB policies.