Ethical standards and procedures for research with human beings
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
Other guidelines
Tool
WHO tool for benchmarking ethics oversight of health-related research involving human...
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...
Publications
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Ethical standards for research during public health emergencies: Distilling existing guidance to support...
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Standards and operational guidance for ethics review of health-related research with human participants
This document is intended to provide guidance to research ethics committees on which organizations rely to review and oversee the ethical aspects of research,...