Weber Florencia, Pscheidl Tamara, Sydenham Emma, Meybohm Patrick, Weibel Stephanie
Intensive Care, Emergency and Pain Medicine, Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany.
Cochrane Central Editorial Service, Cochrane, London, UK.
BMJ Open. 2025 Mar 24;15(3):e092244. doi: 10.1136/bmjopen-2024-092244.
Ethical compliance of randomised controlled trials (RCTs) documented as ethics committee (EC) approval is vital for participant protection but is often overlooked by evidence synthesis producers despite regulatory mandates. We aimed to systematically assess reporting of ethics approval and informed consent (IC) in RCTs included in evidence syntheses and examined its potential impact on the study pool as part of a research integrity assessment (RIA).
Meta-epidemiological study.
Assessment of ethics approval; domain 3 of the RIA tool developed for evidence syntheses.
PARTICIPANTS/SUBJECTS: COVID-19 RCTs included in evidence syntheses.
We extracted ethical items from study reports, that is, ethics approval statements, EC details, ethics approval numbers (ENs), IC and verified national recognition of ECs. RCTs were assessed regarding ethics approval and categorised as 'no concern', 'awaiting classification' or 'exclude' from the study pool. We also examined the impact of study settings on ethics approval reporting and discussed assessment reliability.
We included 188 RCTs. 93% of primary study reports contained an ethics statement, 70% provided EC details, 44% reported EN and 91% mentioned IC. Trial registration records identified the EC in 8 RCTs and EN in 25 RCTs. Overall, 41% of RCTs reported all ethical items. Authors of 95 RCTs were contacted for missing information, yielding 22 satisfactory responses. Of the 151 RCTs with identified ECs, 88% were nationally recognised. Overall, 53% of RCTs were classified as 'no concern', 47% as 'awaiting classification' and none were excluded. Most were 'awaiting classification' due to reporting-related reasons. No significant differences in ethics approval reporting were observed across study settings, countries, or sample sizes.
Reporting of ethical items in RCTs remains inadequate. Including ethics approval details in reporting guidelines such as Consolidated Standards of Reporting Trials could improve this. Current under-reporting issues limit the reliability of the RIA tool's ethics approval assessment.
The protocol is available on OSF (https://osf.io/3bzeg).
以伦理委员会（EC）批准为记录的随机对照试验（RCT）的伦理合规性对于保护参与者至关重要，但尽管有监管要求，证据综合分析的生产者却常常忽视这一点。我们旨在系统评估证据综合分析中纳入的RCT的伦理批准和知情同意（IC）报告情况，并作为研究诚信评估（RIA）的一部分，考察其对研究库的潜在影响。
元流行病学研究。
伦理批准评估；为证据综合分析开发的RIA工具的第3领域。
参与者/受试者：证据综合分析中纳入的COVID-19随机对照试验。
我们从研究报告中提取伦理项目，即伦理批准声明、伦理委员会详情、伦理批准编号（ENs）、知情同意，并核实伦理委员会的国家认可情况。对随机对照试验的伦理批准情况进行评估，并分类为“无问题”、“等待分类”或从研究库中“排除”。我们还考察了研究设置对伦理批准报告的影响，并讨论了评估的可靠性。
我们纳入了188项随机对照试验。93%的主要研究报告包含伦理声明，70%提供了伦理委员会详情，44 %报告了伦理批准编号，91%提到了知情同意。试验注册记录在8项随机对照试验中识别出伦理委员会，在25项随机对照试验中识别出伦理批准编号。总体而言，41%的随机对照试验报告了所有伦理项目。我们就缺失信息联系了95项随机对照试验的作者，得到了22份满意的回复。在151项已识别出伦理委员会的随机对照试验中，88%得到了国家认可。总体而言，53%的随机对照试验被分类为“无问题”，47%为“等待分类”，没有被排除的。大多数因报告相关原因而“等待分类”。在研究设置、国家或样本量方面，未观察到伦理批准报告的显著差异。
随机对照试验中伦理项目的报告仍然不足。在诸如《试验报告统一标准》等报告指南中纳入伦理批准细节可能会改善这种情况。当前报告不足的问题限制了RIA工具伦理批准评估的可靠性。
该方案可在OSF上获取（https://osf.io/3bzeg）。
