Comissão Nacional de Ética em Pesquisa (CONEP), SRTV 701, Via W 5 Norte, lote D - Edifício PO 700, Asa Norte, Brasília, 70719040, DF, Brazil.
Hospital Moinhos de Vento (HMV), R. Ramiro Barcelos, 910, Porto Alegre, 90035000, RS, Brazil.
BMC Med Ethics. 2024 Jun 10;25(1):68. doi: 10.1186/s12910-024-01065-5.
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.
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.
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.
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.
Q-CEP（Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep，组成 CEP/Conep 系统的伦理委员会资格认证）是一个全国性项目，由巴西国家伦理审查委员会（Conep）、卫生部和 Moinhos de Vento 医院（HMV）共同发起。该项目旨在巩固巴西全国机构审查委员会系统（CEP/Conep 系统）中所有成员对以人为对象的研究进行伦理审查的政策。因此，本研究旨在报告 Q-CEP 项目的经验和结果。
本研究为观察性、回顾性研究，数据来源于 Q-CEP，由全国所有机构研究伦理委员会（RECs）提供。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）开发关于研究伦理评估战略主题的远程学习模块。本文介绍的资料涵盖了第一步（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，这是一个特别重要的阶段；需要准确了解实际情况，以便为质量改进战略规划提供信息。
2019-2021 年，Q-CEP 共访问了 832 个 REC，并培训了 11197 人。该样本几乎涵盖了巴西所有活跃的 REC；只有 4 个（0.5%）未进行评估。在评估的 94 个项目中，62%未达到至少 80%的达标率，约四分之一（26%）的达标率低于 50%。该过程的诊断阶段揭示了 REC 在伦理审查方面的不足。对 REC 知情同意书的分析显示，只有 131 个 REC（15.74%）符合要求。REC 在报告中描述的待决问题符合规定的比例为 19.33%（n=161）。行政和运营方面也被超过一半的 REC 认为不达标。
总体而言，巴西 REC 在伦理评估和其他流程的运作方面都存在多个方面的合规性差，这证明需要进一步培训。Q-CEP 项目是巴西卫生部推动的质量改进政策的一部分。项目诊断阶段获得的数据有助于资格认证和巩固世界上最大的研究伦理评估系统之一。
