{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T05:52:43Z","timestamp":1791179563651,"version":"4.1.0"},"reference-count":129,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T00:00:00Z","timestamp":1755043200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl J Gynecology &amp; Obste"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Recent studies have revealed issues with ethical practice and informed consent in randomized clinical trials (RCTs). We aimed to develop an international, multi\u2010stakeholder consensus statement on human research ethics committee approval and informed participant consent for RCTs. The consensus process encompassed a systematic scoping review, modified two\u2010round Delphi survey, and final consensus meeting of a multi\u2010stakeholder group, including trialists, ethics committee members, methodologists, patient representatives, journal editors, and other experts on RCTs. Delphi consensus deployed the Average Percentage of Majority Opinions (APMO) threshold. There were 36 stakeholders from 12 countries in five continents. Delphi survey response rates were 67% (24\/36 stakeholders) and 69% (25\/36 stakeholders) in the first and second rounds, respectively. There were 135 statements (18 stakeholder\u2010provided, 117 scoping review\u2010generated) in the initial long list. Three additional statements were provided during the Delphi rounds. APMO threshold was 81.33% and 75.05% for the first and second Delphi rounds, respectively. Through consensus, the final set consolidated 77 statements in the following domains: general aspects (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200911), journals' instructions and policies (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20099), research institutions and funders' policies (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20096), ethics committee regulations (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200911), ethics committee evaluation and approval (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200918), monitoring of informed consent procedures (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20098), monitoring of trials for compliance (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093), post\u2010publication concerns on ethics (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092), and recommendations for future research and development (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20099). In conclusion, this international consensus statement provides a comprehensive integrity framework to address the unique challenges in RCT ethics and informed consent. It highlights the importance of robust ethics committee assessments, stakeholder training, patient engagement, and trial monitoring procedures.\n                  <\/jats:p>","DOI":"10.1002\/ijgo.70374","type":"journal-article","created":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T13:41:32Z","timestamp":1755092492000},"page":"828-844","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Ethics and informed consent in clinical trial integrity: An\u00a0international, multi\u2010stakeholder consensus statement by Cairo Consensus Group"],"prefix":"10.1002","volume":"172","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8756-3612","authenticated-orcid":false,"given":"Mohamed","family":"Fawzy","sequence":"first","affiliation":[{"name":"IbnSina (Sohag), Banon (Assiut), Amshaj (Sohag), and Qena (Qena) IVF Centres  Sohag Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5084-7312","authenticated-orcid":false,"given":"Khalid Saeed","family":"Khan","sequence":"additional","affiliation":[{"name":"University of Granada  Granada Spain"},{"name":"Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP)  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5998-9592","authenticated-orcid":false,"given":"Patrick","family":"Chien","sequence":"additional","affiliation":[{"name":"RCSI &amp; UCD Malaysia  Penang Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurora","family":"Bueno\u2010Cavanillas","sequence":"additional","affiliation":[{"name":"University of Granada  Granada Spain"},{"name":"Epidemiology and Public Health Networking Biomedical Research Centre (CIBERESP)  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Mart\u00edn\u2010D\u00edaz","sequence":"additional","affiliation":[{"name":"General Surgery Department Hospital Santa Ana  Motril, Granada Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Zamora","sequence":"additional","affiliation":[{"name":"University of Granada  Granada Spain"},{"name":"Hospital Ram\u00f3n y Cajal  Madrid Spain"},{"name":"Ramon y Cajal Institute for Biohealth Research (IRYCIS)  Madrid Spain"},{"name":"University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto Ruano","family":"Ravi\u00f1a","sequence":"additional","affiliation":[{"name":"Department of Preventive Medicine and Public Health University of Santiago de Compostela  Santiago Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan","family":"Pacey","sequence":"additional","affiliation":[{"name":"Faculty of Biology, Medicine, and Health University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Jim","family":"Zhang","sequence":"additional","affiliation":[{"name":"Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yacoub","family":"Khalaf","sequence":"additional","affiliation":[{"name":"Guy\u2019s &amp; St Thomas\u2019 Hospital Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gamal","family":"Serour","sequence":"additional","affiliation":[{"name":"Egyptian IVF Centre  Cairo Egypt"},{"name":"Al\u2010Azhar University  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Aboulghar","sequence":"additional","affiliation":[{"name":"Egyptian IVF Centre  Cairo Egypt"},{"name":"Cairo University  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassan","family":"Sallam","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Alexandria University  Alexandria Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicente Mart\u00edn","family":"S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences University of Le\u00f3n  Le\u00f3n Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. 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