{"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":1788524202108,"version":"build-2803163510"},"reference-count":19,"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>Our study examines the perspectives of researchers and other research team members who conducted National Institutes of Health (NIH)\u2010funded studies about their use of a single institutional review board (sIRB) review and onboarding process. More than 84% (n = 639) of respondents agreed that NIH\u2010sponsored multisite clinical trials benefit from sIRB use. A higher proportion of super\u2010users (&gt;10 studies) of an sIRB than moderate users (1\u201010 studies) described the onboarding process positively (n = 119, 56% vs. n = 225, 42%, p = .01) and found sIRBs to be more cost\u2010effective than a site\u2010specific model (n = 113, 53.05% vs. n = 221, 41%, p &lt;.01). Timeline delays were experienced by over 90% (n = 680) of respondents and an increased administrative burden was reported by almost half (n = 353, 47%) of respondents. Respondents described increased administrative burden for sIRB approvals when an institution\u2010specific application was required (n = 299, 51% vs. n = 30, 29%, p &lt;.01). Most researchers judged sIRBs to be beneficial. However, delays in approval, increased administrative burden, and associated compulsory institution\u2010specific applications posed logistical challenges for researchers. Reform efforts must focus on aligning sIRB and local study site standards to optimize sIRB study review.<\/jats:p>","DOI":"10.1002\/eahr.70018","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:45:38Z","timestamp":1788522338000},"page":"26-36","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Perspectives of Researchers and Research Team Members Regarding Their Experience with sIRBs"],"prefix":"10.1002","volume":"48","author":[{"given":"Bhuchitra","family":"Singh","sequence":"first","affiliation":[{"name":"Director of clinical research in the Division of Reproductive Sciences &amp; Women's Health Research in the Department of Gynecology &amp; Obstetrics at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aileen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Medical student during this research in the Division of Reproductive Sciences &amp; Women's Health Research in the Department of Gynecology &amp; Obstetrics at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arun H.","family":"Patil","sequence":"additional","affiliation":[{"name":"Staff scientist at the Lieber Institute for Brain Development at Johns Hopkins University School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abigail","family":"Coco","sequence":"additional","affiliation":[{"name":"Medical student during this research in the Division of Reproductive Sciences &amp; Women's Health Research in the Department of Gynecology &amp; Obstetrics at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibelle","family":"Madera","sequence":"additional","affiliation":[{"name":"Undergraduate during this research in the Division of Reproductive Sciences &amp; Women's Health Research in the Department of Gynecology &amp; Obstetrics at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Olson","sequence":"additional","affiliation":[{"name":"Researcher in the Biostatistics, Epidemiology and Data Management Core at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Voegtline","sequence":"additional","affiliation":[{"name":"Associate in the Biostatistics, Epidemiology and Data Management Core at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Schisterman","sequence":"additional","affiliation":[{"name":"Perelman Professor in Biostatistics, Epidemiology and Informatics in the Department of Biostatistics, Epidemiology and Informatics at the University of Pennsylvania Perelman School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Segars","sequence":"additional","affiliation":[{"name":"Howard and Georgeanna Jones Professor in the Division of Reproductive Sciences &amp; Women's Health Research in the Department of Gynecology &amp; Obstetrics at Johns Hopkins School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,4]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.15-0706"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/08989620600588845"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-134-2-200101160-00016"},{"key":"e_1_2_5_5_1","unstructured":"Grants.nih.gov.NOT-OD-16-094: Final NIH policy on the use of a single institutional review board for multi-site research. June 21 2016. Accessed March 4 2023.https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-16-094.html"},{"key":"e_1_2_5_6_1","unstructured":"45 CFR 46.Protection of Human Subjects. Subpart A. As revised on January 19 2017 and amended on January 22 2018 and June 19 2018. Codified at 45 CFR 46 (2018)."},{"key":"e_1_2_5_7_1","unstructured":"SMARTIRB.The SMART IRB agreement. Accessed March 10 2023.https:\/\/smartirb.org\/agreement\/"},{"key":"e_1_2_5_8_1","unstructured":"HumanResearchProtectionProgram.University of Michigan. Single IRB-of-record (sIRB) process. Accessed March 5 2023.https:\/\/research-compliance.umich.edu\/human-subjects\/operations-manual-om\/single-irb-record-sirb-process"},{"key":"e_1_2_5_9_1","doi-asserted-by":"crossref","unstructured":"NicholsC KunkelLE BakerR et al. Use of single IRBs for multi-site studies: A case report and commentary from a National Drug Abuse Treatment Clinical Trials Network study.Contemp Clin Trials Commun.2019;14. doi:10.1016\/j.conctc.2019.100319","DOI":"10.1016\/j.conctc.2019.100319"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.23.2470"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/eahr.500149"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1556264619850440"},{"key":"e_1_2_5_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajogmf.2023.100861"},{"key":"e_1_2_5_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774519832911"},{"key":"e_1_2_5_15_1","doi-asserted-by":"crossref","unstructured":"JohnsonAR PautlerM BurrJS et al. Using single IRB consultations to meet the educational needs of investigative teams.Contemp Clin Trials Commun.2022;29. doi:10.1016\/j.conctc.2022.100971","DOI":"10.1016\/j.conctc.2022.100971"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/eahr.500016"},{"key":"e_1_2_5_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/cdn\/nzac063.014"},{"issue":"187","key":"e_1_2_5_18_1","article-title":"21 CFR Part 56. Institutional review boards; cooperative research","volume":"87","author":"US Food and Drug Administration","year":"2022","journal-title":"Fed Reg."},{"key":"e_1_2_5_19_1","unstructured":"US Food and Drug Administration.Institutional review boards: cooperative research (proposed rule) regulatory impact analysis. September 29 2022. 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