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 Khadija, Elsuity Mohamad A
IbnSina (Sohag), Banon (Assiut), Amshaj (Sohag), and Qena (Qena) IVF Centres, Sohag, Egypt.
University of Granada, Granada, Spain.
Int J Gynaecol Obstet. 2025 Aug 13. doi: 10.1002/ijgo.70374.
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.
近期研究揭示了随机临床试验（RCT）在伦理实践和知情同意方面存在的问题。我们旨在就RCT的人类研究伦理委员会批准和参与者知情同意制定一份国际多利益相关方共识声明。共识达成过程包括系统的范围审查、两轮修改后的德尔菲调查，以及一个多利益相关方小组的最终共识会议，该小组包括试验者、伦理委员会成员、方法学家、患者代表、期刊编辑以及其他RCT专家。德尔菲共识采用多数意见平均百分比（APMO）阈值。来自五大洲12个国家的36名利益相关方参与其中。第一轮和第二轮德尔菲调查的回复率分别为67%（24/36名利益相关方）和69%（25/36名利益相关方）。初始长列表中有135条声明（18条由利益相关方提供，117条由范围审查生成）。在德尔菲轮次中又提供了3条声明。第一轮和第二轮德尔菲调查的APMO阈值分别为81.33%和75.05%。通过共识，最终集合在以下领域整合了77条声明：一般方面（n = 11）、期刊的说明和政策（n = 9）、研究机构和资助者的政策（n = 6）、伦理委员会规定（n = 11）、伦理委员会评估与批准（n = 18）、知情同意程序监测（n = 8）、试验合规性监测（n = 3）、发表后伦理问题（n = 2）以及未来研发建议（n = 9）。总之，这份国际共识声明提供了一个全面的诚信框架，以应对RCT伦理和知情同意方面的独特挑战。它强调了强有力的伦理委员会评估、利益相关方培训、患者参与以及试验监测程序的重要性。
