International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
Ethics and informed consent in clinical trial integrity: An international, multi-stakeholder consensus statement by Cairo Consensus Group.
СтатьяОбзорConsensus StatementНазвание и аннотация: Перевод пока не подготовлен
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Fawzy Mohamed, Khan Khalid Saeed, Chien Patrick, Bueno-Cavanillas Aurora, Martín-Díaz Manuel, Zamora Javier, Raviña Alberto Ruano, Pacey Allan, Zhang Jun Jim, Khalaf Yacoub, Serour Gamal, Aboulghar Mohamed, Sallam Hassan, Sánchez Vicente Martín, Morris R Katie, Odibo Anthony, Grandi Giovanni, Wattar Bassel, Ball Elizabeth, de Lecuona Itziar, Hooft Janneke van 't, Geary Michael, Andrews Jeffery, Wasim Tayyiba, Mahran Ali, Mignini Luciano, Bedaiwy Mohamed, Soliman Mohamed Yehia, El-Shalkany Amr, Jawaid Shaukat Ali, Joshi Miland, Scott James R, Irfan Khawaja Khadija, Elsuity Mohamad A
Аннотация
Recent studies have revealed issues with ethical practice and informed consent in randomized clinical trials (RCTs). We aimed to develop an international, multi-stakeholder consensus statement on human research ethics committee approval and informed participant consent for RCTs. The consensus process encompassed a systematic scoping review, modified two-round Delphi survey, and final consensus meeting of a multi-stakeholder 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-provided, 117 scoping review-generated) 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 = 11), journals' instructions and policies (n = 9), research institutions and funders' policies (n = 6), ethics committee regulations (n = 11), ethics committee evaluation and approval (n = 18), monitoring of informed consent procedures (n = 8), monitoring of trials for compliance (n = 3), post-publication concerns on ethics (n = 2), and recommendations for future research and development (n = 9). 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.