The National Health Research Ethics Council (NHREC) is a statutory body established under the National Health Act No 61 of 2003. The Act mandates the Minister of Health to establish the Council and it sets out NHREC’s functions, which in short involves giving direction on ethical issues relating to health and to develop guidelines for the conduct of research involving humans and animals. The Council observes and advises on international developments in health ethics issues through liaison with relevant international organisations.
The following are the functions of the NHREC:
Research involving human participants is based on a moral commitment to advancing human welfare, knowledge and understanding, and to exploring cultural dynamics. This has become prominent especially where large-scale trials conducted in developing countries are concerned.
Of fundamental importance is the duty to conduct scientifically sound research while acting in the participant’s best interests and respecting and protecting the participant’s autonomy. Some guiding principles of ethics are respect for: human dignity, autonomy, informed consent, vulnerable persons, confidentiality, the lack of harm, maximum benefit, and justice. Issues of informed consent are of particular importance, as specified in the Constitution of the Republic of South Africa.