Ethics in medical research: A quantitative analysis of the observations of Ethics Committees in research protocols.

Abstract

Objective: To determine the frequency of observations made by Research Ethics Committees (RECs) regarding non-compliance with ethical principles in research. Methods: We searched for articles published up to November 30, 2023. In the databases: PubMed, Scopus and Google Scholar. Single-proportion meta-analyses were performed with the R V.3.6.1 program. PROSPERO Registry: CRD42021291893 Results: 9 publications were reviewed, including cross-sectional, retrospective cohort, and descriptive studies. Lack of adherence to the ethical principle of justice was detected in up to 100% of the protocols evaluated. In addition, 9% (95% CI: 7-12) of observations in Latin America and 15% (95% CI: 9-24) in Europe. Autonomy was observed in 26% (95% CI: 20-33) of the protocols, reaching 17% (95% CI: 13-22) in experimental studies. Beneficence, lack of adherence in the protocols evaluated from 41.17% to 77.38%, observations per protocol ranged from 5.26% to 27.11%. Discussion: The findings highlighted disparities between regions and types of studies, reflecting cultural, interpretive, and human and institutional resource differences. RECs should ensure thorough and equitable assessments, promote fair selection, respect autonomy, and maximize benefits while minimizing risks to participants. This study provides an assessment of ethical practices in medical research, highlighting key areas for improving compliance with fundamental ethical principles.