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Abstract：
BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil\'s national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project.
METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies.
RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs.
CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world\'s largest research ethics evaluation systems.
METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies.
RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs.
CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world\'s largest research ethics evaluation systems.
摘要：
背景：Q-CEP（巴西国家研究伦理委员会（Conep））是一个全国性的项目，由巴西国家研究伦理委员会（Conep）之间的合作产生，卫生部和医院MoinhosdeVento（HMV）。它的制定是为了巩固CEP/Conep系统所有成员对人类研究进行伦理审查的政策，巴西国家机构审查委员会制度。因此，这项研究的目的是报告Q-CEP项目的经验和结果。
方法：观察性，回顾性研究包括来自Q-CEP的数据，从访问该国所有机构研究伦理委员会(RECs)中获得。Q-CEP实施的行动是两步过程的一部分：（i）对每个REC进行培训访问；（ii）开发与研究道德评估有关的战略主题的远程学习模块。本文提供的数据涵盖第一步(培训访问)，由Q-CEP定义为项目的诊断阶段。对于像巴西这样一个社会和经济不平等的国家来说，这是一个特别重要的阶段；需要对现实的准确描述来为质量改进策略的规划提供信息。
结果：在2019-2021年，Q-CEP访问了832个REC，培训了11,197人。该样本涵盖了该国几乎所有活跃的REC；只有4个（0.5％）未进行评估。在评估的94个项目中，62%的人没有达到至少80%的目标，大约1/4(26%)的人低于50%的目标。该过程的诊断阶段揭示了REC在道德审查中的不足之处。对知情同意书的分析表明，只有131个REC（15.74％）符合。REC在其报告中对未决问题的描述符合19.33%(n=161)。超过一半的区域经济共同体也认为行政和业务方面不足。
结论：总体而言，巴西RECs在运营的几个方面表现出较差的合规性，在道德评估和其他过程中，这证明了额外的培训。Q-CEP项目是巴西卫生部推动的质量改进政策的一部分。在该项目的诊断步骤中获得的数据为世界上最大的研究伦理评估系统之一的资格和巩固做出了贡献。
方法：观察性，回顾性研究包括来自Q-CEP的数据，从访问该国所有机构研究伦理委员会(RECs)中获得。Q-CEP实施的行动是两步过程的一部分：（i）对每个REC进行培训访问；（ii）开发与研究道德评估有关的战略主题的远程学习模块。本文提供的数据涵盖第一步(培训访问)，由Q-CEP定义为项目的诊断阶段。对于像巴西这样一个社会和经济不平等的国家来说，这是一个特别重要的阶段；需要对现实的准确描述来为质量改进策略的规划提供信息。
结果：在2019-2021年，Q-CEP访问了832个REC，培训了11,197人。该样本涵盖了该国几乎所有活跃的REC；只有4个（0.5％）未进行评估。在评估的94个项目中，62%的人没有达到至少80%的目标，大约1/4(26%)的人低于50%的目标。该过程的诊断阶段揭示了REC在道德审查中的不足之处。对知情同意书的分析表明，只有131个REC（15.74％）符合。REC在其报告中对未决问题的描述符合19.33%(n=161)。超过一半的区域经济共同体也认为行政和业务方面不足。
结论：总体而言，巴西RECs在运营的几个方面表现出较差的合规性，在道德评估和其他过程中，这证明了额外的培训。Q-CEP项目是巴西卫生部推动的质量改进政策的一部分。在该项目的诊断步骤中获得的数据为世界上最大的研究伦理评估系统之一的资格和巩固做出了贡献。
