Daniel Ribeiro Paes de Castro, Camilo Hernan Manchola Castillo, João Paulo Dias Ferreira, João Paulo Alves Oliveira, Tassila Fernandes Kirsten, Paulo Henrique Condeixa de França, Lisiane Silveira Zavalhia, Regina Kuhmmer Notti, Renata Kochhann, Sérgio Luís Amantéa
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The aim of this study was therefore to report on the experience and results of the Q-CEP project.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
项目背景Q-CEP(Qualificação dos Comités de Ética em Pesquisa que compõem o Sistema CEP/Conep)是巴西国家研究伦理委员会(Conep)、卫生部和Moinhos de Vento医院(HMV)合作开展的一个全国性项目。该项目旨在整合 CEP/Conep 系统(巴西全国机构审查委员会系统)所有成员的人类研究伦理审查政策。因此,本研究旨在报告 Q-CEP 项目的经验和成果:观察性、回顾性研究包括 Q-CEP 的数据,这些数据来自对全国所有机构研究伦理委员会 (REC) 的访问。由 Q-CEP 实施的行动分为两个步骤:(i) 对每个 REC 进行培训访问;(ii) 开发与研究伦理评估相关的战略主题远程学习模块。本文提供的数据涵盖了第一步(培训访问),Q-CEP 将其定义为项目的诊断阶段。对于巴西这样一个存在社会和经济不平等的国家来说,这是一个尤为重要的阶段;需要对现实情况有一个准确的了解,以便为质量改进战略的规划提供依据:2019-2021 年,Q-CEP 共访问了 832 个区域医疗中心,培训了 11,197 人。该样本几乎涵盖了全国所有活跃的区域医疗中心;只有 4 个(0.5%)未接受评估。在 94 个评估项目中,62% 没有达到至少 80% 的达标率目标,约 1/4 (26%)的达标率低于 50%。该过程的诊断阶段显示,区域经济委员会在伦理审查方面存在不足。对知情同意书的分析表明,只有 131 个区域执行委员会(15.74%)符合要求。区域执行委员会在报告中对未决问题的描述符合要求的占 19.33%(n = 161)。半数以上的区域协调中心还认为行政和运作方面存在不足:总体而言,巴西的区域经济委员会在道德评估和其他流程的多个运作方面表现不佳,因此有必要开展更多培训。Q-CEP 项目是巴西卫生部推行的质量改进政策的一部分。在项目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认证和巩固做出了贡献。
Ethical regulation of biomedical research in Brazil: a quality improvement initiative.
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.
期刊介绍:
BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.