{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T12:16:42Z","timestamp":1788524202034,"version":"build-2803163510"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T00:00:00Z","timestamp":1788480000000},"content-version":"vor","delay-in-days":3,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ethics &amp; Human Research"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>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\u2010the\u2010ground IRB policies.<\/jats:p>","DOI":"10.1002\/eahr.70020","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:45:38Z","timestamp":1788522338000},"page":"6-13","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["IRB Policies on the Inclusion of Pregnant Women in Research"],"prefix":"10.1002","volume":"48","author":[{"given":"Stephanie R.","family":"Morain","sequence":"first","affiliation":[{"name":"Dracopoulos Rising Professor at the Berman Institute of Bioethics and in the Department of Health Policy &amp; Management at the Johns Hopkins Bloomberg School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caleigh","family":"Propes","sequence":"additional","affiliation":[{"name":"Doctoral candidate at the Berman Institute of Bioethics and the Department of Health Policy &amp; Management at the Johns Hopkins Bloomberg School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth R.","family":"Faden","sequence":"additional","affiliation":[{"name":"Philip Franklin Wagley Professor of Biomedical Ethics at the Berman Institute of Bioethics and in the Department of Health Policy &amp; Management at the Johns Hopkins Bloomberg School of Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,4]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"Enrolling Pregnant Women: Issues in Clinical Research","author":"Office of Research on Women's Health","year":"2010"},{"key":"e_1_2_6_3_1","volume-title":"Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies","author":"Institute of Medicine","year":"1994"},{"key":"e_1_2_6_4_1","unstructured":"Task Force on Research Specific to Pregnant and Lactating Women.Report to Secretary Health and Human Services Congress. September2018.https:\/\/www.nichd.nih.gov\/sites\/default\/files\/2018-09\/PRGLAC_Report.pdf"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25846"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.07.037"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2019.01.011"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.07.009"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e3182a9ca67"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12978-017-0430-2"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2023.10.057"},{"key":"e_1_2_6_12_1","unstructured":"US Department of Health and Human Services.Protection of Human Subjects. 45 CFR 46. Subpart B (2017)."},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2017-104446"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.whi.2012.10.003"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/eahr.500100"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-26512-4_6"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/eahr.500036"},{"issue":"1","key":"e_1_2_6_18_1","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1002\/eahr.70000","article-title":"Policies for the inclusion of pregnant women in research: results from an international and a US study","volume":"48","author":"Lyerly AD","year":"2026","journal-title":"Ethics Hum Res."},{"key":"e_1_2_6_19_1","volume-title":"Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness","author":"US Government Accountability Office","year":"2023"},{"key":"e_1_2_6_20_1","unstructured":"NIH Reporter.https:\/\/reporter.nih.gov\/"},{"key":"e_1_2_6_21_1","doi-asserted-by":"crossref","unstructured":"PropesC MorainSR. Overdue: delayed revision of institutional review board policies characterizing pregnant women after the revised Common Rule.Ann Intern Med. Published online November 4 2025. doi:10.7326\/ANNALS-25-02499","DOI":"10.7326\/ANNALS-25-02499"},{"key":"e_1_2_6_22_1","unstructured":"US Food and Drug Administration.Policy for the protection of human subjects. 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