A World Health Organization tool for assessing research ethics oversight systems.

Abstract

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.