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

Objective To determine the frequency of observations made by Research Ethics Committees (RECs) regarding non-compliance with ethical principles in research.

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

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%.

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. Competing Interest Statement The authors have declared no competing interest. Funding Statement This study did not receive any funding Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Email: gvasco{at}estud.usfq.edu.ec, Email: csvasco{at}estud.usfq.edu.ec, Email: ptoapanta{at}uce.edu.ec Data Availability All data produced in the present work are contained in the manuscript