52 - Overdue: Delayed Revision of Institutional Review Board Policies Characterizing Pregnant Women After the Revised Common Rule

Background: Pregnant persons have historically been excluded from clinical research. To facilitate improved inclusion of pregnant persons in research, the Common Rule was revised in 2018 to no longer describe pregnant persons as subjects who, like children or individuals with impaired decision-making capacity, are “vulnerable to coercion or undue influence.” However, the extent to which institutional IRBs have revised policies to reflect this change remains unknown.

Methods: NIH funding was used as a proxy for clinical research intensity. The 50 institutions receiving the highest amount of funding from the NIH in 2023 (the most recent year for which data were available) were identified and ranked using the RePORTER tool. Institutions that did not conduct clinical trials with human subjects were excluded.

IRB policies and related guidance regarding inclusion and/or exclusion of pregnant persons were identified using internet searches and reviews of institutional websites. When guidance was not publicly available, institutional representatives were contacted. Document dates were recorded to capture whether policies had been updated since the implementation of the 2018 revisions to the Common Rule.

Two authors independently reviewed each document to identify whether pregnant persons are described as “vulnerable.” Any disagreements between reviewers were resolved through discussion.

Results: Materials for 44 institutions were publicly available, and materials for 4 additional institutions were provided via email. The remaining 2 institutions
policies were not accessible.

In the final sample (n=48), 72.9% of institutions (35 of 48) described pregnant persons as vulnerable at least once within their institutional policies, even though 93.8% of institutions (45 of 48) had updated their policies since the 2018 revisions of the Common Rule went into effect. Of those institutions, 12 specifically referenced pregnant women as a population that is vulnerable to coercion or undue influence.

Limitations: This study focused on academic institutions; therefore, the results do not reflect policies from other contexts, including contract research organizations. This study may also not capture the influence of independent IRBs, which are likely increasingly influential, particularly following the move to single IRBs. NIH funding may be an imperfect proxy for research output given that it does not directly reflect clinical research funding. Institutions may have had policies not identified by the study team. There may be other constraints on including pregnant women in research, such as an interest in shielding against pregnancy-related litigation.

Discussion: Despite calls to move from a posture of presumed exclusion to one that affirms the need for inclusion of research with pregnant persons, nearly three quarters of top institutions continue to describe pregnant women as “vulnerable” in IRB guidance. While research during pregnancy presents complex considerations related to risk for physical harms for both pregnant women and their offspring, IRB policy language referring to pregnant women as “vulnerable” often references coercion or undue influence, inappropriately suggesting that pregnant women may be less capable of making their own decisions about research participation. These findings suggest a considerable gap between scholarship on the importance of promoting ethical inclusion of pregnant women and on-the-ground IRB policies. Our findings notwithstanding, examples from within our sample offer potential models for improving institutional policies related to pregnant research participants.