医学研究中的伦理问题:对伦理委员会在研究协议中的意见进行定量分析。

Santiago Vasco-Morales, Gabriel Alejandro Vasco-Toapanta, Cristhian Santiago Vasco-Toapanta, Paola Toapanta-Pinta
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摘要

目的确定研究伦理委员会(REC)对研究中不遵守伦理原则的观察频率。研究方法我们检索了截至 2023 年 11 月 30 日发表的文章。数据库:PubMed、Scopus 和 Google Scholar。使用 R V.3.6.1 程序进行单比例荟萃分析。PROSPERO 注册表:CRD42021291893 结果:共查阅了 9 篇文献,包括横断面研究、回顾性队列研究和描述性研究。在所评估的方案中,100% 的方案未遵守公正的伦理原则。此外,9%(95% CI:7-12)的观察结果来自拉丁美洲,15%(95% CI:9-24)来自欧洲。在 26% (95% CI: 20-33) 的方案中观察到自主性,在实验研究中达到 17% (95% CI: 13-22)。在评估的方案中,受益性、缺乏依从性的比例从 41.17% 到 77.38%不等,每个方案的观察结果从 5.26% 到 27.11% 不等。讨论:研究结果凸显了地区和研究类型之间的差异,反映了文化、解释以及人力和机构资源方面的差异。区域执行委员会应确保全面、公平的评估,促进公平选择,尊重自主权,在最大限度地提高效益的同时,最大限度地降低参与者的风险。本研究对医学研究中的伦理实践进行了评估,强调了改善基本伦理原则遵守情况的关键领域。
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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. 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.
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