Caleigh Propes1 and Stephanie Morain2
1Johns Hopkins University Berman Institute of Bioethics, 1809 Ashland Ave, Baltimore, Maryland 21205-1505, USA
2Johns Hopkins University Berman Institute of Bioethics, 1809 Ashland Ave Baltimore, Baltimore, Maryland 21205-2103, USA
Corresponding Author: Caleigh Propes, Johns Hopkins University Berman Institute of Bioethics, 1809 Ashland Ave, Baltimore, Maryland 21205-1505, USA.
Email: cpropes1@jh.edu
Background: Pregnant persons have historically been excluded from clinical research. To facilitate improved inclusion of pregnant persons in research, the Common Rule (the federal policy governing research with human subjects in the United States) was revised in 2018 to no longer describe pregnant persons as “vulnerable.” This change brought U.S. federal policy in closer alignment with international ethics guidance from the Council for International Organizations of Medical Sciences (CIOMS), which advises that pregnant women “must not be considered vulnerable simply because they are pregnant,” while nevertheless recognizing the potential need for special protections (such as those outlined in subpart B of the Common Rule). 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 U.S. 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 participants 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 were described as “vulnerable.” Any disagreements between reviewers were resolved through discussion. Statistical analyses were completed using STATA software to determine the proportion of institutions describing pregnant persons as vulnerable. Two-sample t-tests were used to determine whether level of institutional funding was associated with describing pregnant persons as vulnerable.
Results: Materials for 43 institutions were publicly available, and materials for 3 additional institutions were provided via email. The remaining 4 institutions were not included due to inability to access documents. In the final sample (n=46), 73.9% of institutions (34/46) described pregnant persons as vulnerable at least once within their institutional policies, even though 93.5% of institutions (43/46) had updated their policies since the 2018 revisions of the Common Rule went into effect. Two-sample t-test to determine the association between institutional funding and describing pregnant persons as vulnerable was not statistically significant (p = 0.6597).
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.
Discussion: These findings collectively suggest gaps in translation between scholarship on the importance of research with pregnant persons and on-the-ground IRB policy and practice even in the most highly funded institutions. Despite calls to move from a posture of presumed exclusion to one that affirms the need for inclusion of research with pregnant persons, the exclusionary posture persists in institutional policies. Moving forward, institutions should modify their policies where appropriate to avoid outdatedly describing pregnant research participants as “vulnerable.” Our findings notwithstanding, examples from within our sample offer potential models for improving institutional policies related to pregnant research participants.
Keywords: IRB performance/Quality/Assessment/Evaluation, research ethics, women, federal policies/Guidelines/Office of human research protections, FDA, regulatory requirements, clinical trials
Full text reference:
Propes, C., & Morain, S. R. (2025). Overdue: Delayed revision of institutional review board policies characterizing pregnant women after the revised common rule. Annals of Internal Medicine, 178(12), 1798–1800. [Epub 4 November 2025]. https://doi.org/10.7326/ANNALS-25-02499
Author Biographies
Stephanie Morain, PhD, MPH, is the Dracopoulos Rising Professor at the Berman Institute of Bioethics and Associate Professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. She conducts both empirical and normative research into issues at the intersection of clinical research, public health, and health policy. Dr. Morain's work focuses on two key areas: ethical and practical challenges presented by the integration of research and care, such as occurs in pragmatic clinical trials and comparative effectiveness, and issues related to women's reproductive health.
Caleigh Propes is a doctoral student in Bioethics and Health Policy in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. Her primary research interests include the ethics of medical product development and regulation and clinical research ethics, with a special interest in ethical considerations related to pragmatic clinical trials.
