Coleman Carl H, Khadem Alireza, Reeder John C, Sillo Hiiti B, Gaspar Rogerio, Reis Andreas
Seton Hall Law School, 1109 Raymond Blvd, Newark, New Jersey, 07102, United States of America.
Access to Medicines and Health Products, World Health Organization, Geneva, Switzerland.
Bull World Health Organ. 2025 Jun 1;103(6):403-409. doi: 10.2471/BLT.24.292219. Epub 2025 May 3.
Although most countries have ethical oversight systems for health-related research involving human participants, mechanisms for assessing the quality of those systems are not regularly used, particularly in low-resource settings. To address this gap, the Regulatory System Strengthening, Regulation and Safety unit and Health Ethics and Governance unit of the World Health Organization (WHO) recently released a tool for benchmarking ethics oversight of health-related research involving human participants. The tool provides a simple, easy-to-measure set of indicators for assessing the quality of research ethics oversight systems without the need to invest a great deal of resources. The tool comprises 48 indicators divided across three areas: (i) the national context; (ii) research ethics committees; and (iii) institutions that conduct health-related research involving humans, such as academic medical centres. Indicators related to the national context are intended to be evaluated in a single assessment applicable to the country as a whole, whereas indicators related to research ethics committees and research institutions are evaluated on an entity-by-entity basis. Some countries may choose to assess a representative sample of research ethics committees and institutions; alternatively, national authorities might ask research ethics committees and institutions to undertake self-assessments and report the results. Research ethics committees or institutions could also use WHO's tool on their own as part of a process of quality improvement. WHO is working with global partners to disseminate the tool and support global implementation. Widespread use of the tool is expected to enhance policy coherence in ethics oversight and facilitate multinational research.
尽管大多数国家都有针对涉及人类受试者的健康相关研究的伦理审查系统，但评估这些系统质量的机制并未得到定期使用，尤其是在资源匮乏的环境中。为了填补这一空白，世界卫生组织（WHO）的监管系统强化、监管与安全部门以及健康伦理与治理部门最近发布了一种工具，用于对涉及人类受试者的健康相关研究的伦理审查进行基准评估。该工具提供了一套简单、易于衡量的指标，用于评估研究伦理审查系统的质量，而无需投入大量资源。该工具包括48项指标，分为三个领域：（i）国家背景；（ii）研究伦理委员会；以及（iii）开展涉及人类的健康相关研究的机构，如学术医疗中心。与国家背景相关的指标旨在通过适用于整个国家的单一评估进行评估，而与研究伦理委员会和研究机构相关的指标则逐个实体进行评估。一些国家可能选择评估研究伦理委员会和机构的代表性样本；或者，国家当局可能要求研究伦理委员会和机构进行自我评估并报告结果。研究伦理委员会或机构也可以自行使用WHO的工具，作为质量改进过程的一部分。WHO正在与全球合作伙伴合作，传播该工具并支持其在全球的实施。预计该工具的广泛使用将提高伦理审查方面的政策一致性，并促进跨国研究。
