ArticleBMJ open2025
Investigation of ethics approval as part of a research integrity assessment of randomised controlled trials in COVID-19 evidence syntheses: a meta-epidemiological study.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Adherence to ethics reporting standards in locally accredited medical journals: a case study from a developing country.The Libyan journal of medicine · 2026Article
- Reporting of ethical aspects in validation studies conducted in Peru.BMC medical ethics · 2026Article
- A literature review and reflection on clinical trials: current challenges, future directions, and potential strategies to overcome practical barriers.AME clinical trials review · 2026Article
- Impact of a Research Integrity Assessment (RIA) of Randomized Controlled Trials Included in Interventional COVID-19 Systematic Reviews: A Meta-Epidemiological Study.Cochrane evidence synthesis and methods · 2026Article
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesEthical 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).
designMeta-epidemiological study.
settingAssessment of ethics approval; domain 3 of the RIA tool developed for evidence syntheses. PARTICIPANTS/SUBJECTS: COVID-19 RCTs included in evidence syntheses. PRIMARY OUTCOMES: 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.
resultsWe 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.
conclusionsReporting 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. PROTOCOL REGISTRATION: The protocol is available on OSF (https://osf.io/3bzeg).
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