Abstract
Objective: To determine the frequency with which Research Ethics Committees (RECs) identify breaches of ethical principles in research protocols. Theoretical Framework: Ethical principles in human research are established in the Nuremberg Code (informed consent and the common good), the Declaration of Helsinki (protection of vulnerable groups), and the Belmont Report (autonomy, beneficence, and justice). These principles are monitored by RECs to protect participants and ensure fairness in resource use. Informed consent ensures autonomy and the integrity of the research. Method: Searches were conducted in PubMed, Scopus, and Google Scholar up to November 30, 2023. A meta-analysis of single proportions was performed. PROSPERO Registration: CRD42021291893 Results and Discussion: Nine publications were reviewed, revealing violations of the principle of justice in up to 100% of protocols. In Latin America, violations were observed in 9% (95% CI: 7-12) of protocols, while in Europe, the rate was 15% (95% CI: 9-24). Autonomy was observed in 26% (95% CI: 20-33) of protocols, with 17% (95% CI: 13-22) in experimental studies. Observations on beneficence varied between 41.17% and 77.38%. Protocol-specific observations ranged between 5.26% and 27.11%, showing regional disparities among study types. RECs must ensure thorough evaluations to uphold autonomy and maximize benefits for participants. Research Implications: Provide a foundation for future investigations on the work of RECs, the implementation of ethical principles, and equity in research. Originality/Value: The publication of observations on ethical principles made by the Research Ethics Committees is essential for drafting new research protocols.
Published Version
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