Ethical standards and procedures for research with human beings
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.
Standards and operational guidance for ethics review of health-related research with human participants
International ethical guidelines for health-related research involving humans
- World Medical Association: Declaration of Helsinki
- European Group on Ethics
Directive 2001/20/ec of the European Parliament and of the Council
- Council of Europe (Oviedo Convention - Protocol on biomedical research)
Nuffield Council: The ethics of research related to healthcare in developing countries
WHO Research Ethics Review Committee (ERC)
The ERC ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects, involving human participants supported either financially or technically by WHO.