Health Ethics & Governance
We provide a focal point for the examination of ethical issues raised by activities throughout the Organization and foster discussion and debate on diverse topics in global health ethics.
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Ethical standards and procedures for research with human beings
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- Ethical standards and procedures for research with human beings
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Background
Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants.
As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.
The WHO Manual (Section XV.2) defines research with human subjects as 'any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings:
- are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment; or
- become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records.
WHO guidelines

28 May 2020
Guidance for research ethics committees for rapid review of research during public...Conducting research on new medications or vaccines during a pandemic is essential, and research ethics committees need to be prepared to rapidly review...
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Other guidelines
Tool

25 September 2023
WHO tool for benchmarking ethics oversight of health-related research involving human...This tool is intended to assist countries in evaluating their capacity to provide appropriate ethical oversight of health-related research.
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25 September 2023
WHO tool for benchmarking ethics oversight of health-related research involving human participants: user...Jointly developed by WHO’s Regulatory System Strengthening, Regulation and Safety Unit and the Health Ethics & Governance Unit, it is intended...
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Publications

3 May 2020
Key criteria for the ethical acceptability of COVID-19 human challenge studiesThe widespread use of safe and efficacious vaccines for COVID-19 could save many lives, prevent disease, and permit the safe relaxation of other public...
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29 March 2020
Ethical standards for research during public health emergencies: Distilling existing guidance to support...There is an ethical imperative to conduct research during public health emergencies, as some research questions can be adequately investigated only in...
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29 September 2011
Standards and operational guidance for ethics review of health-related research with human participantsThis document is intended to provide guidance to research ethics committees on which organizations rely to review and oversee the ethical aspects of research,...
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