This tool is intended to assist WHO Member States in evaluating their capacity to provide appropriate ethical oversight of health-related research with human subjects. It has been jointly developed by WHO’s Regulatory System Strengthening, Regulation and Safety Unit and the Health Ethics and Governance Unit and will help countries to identify strengths and limitations in their laws and in the organizational structures, policies, and practices of the bodies responsible for research ethics oversight. It is also intended to guide the development of recommendations to address the identified gaps and the assessment of countries’ progress in implementing those recommendations. In addition to assisting in capacity-building efforts, the tool is intended to promote policy convergence and best practices in research ethics oversight, to enhance public trust in health research, and to ensure that the rights and safety of humans involved in health-related research are adequately protected, both in ordinary times and during public health emergencies.