The National Health Researh 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. 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:
- Determine guidelines for the functioning of health research ethics committees;
- Register and audit health research ethics committees;
- Set norms and standards for conducting research on humans and animals including norms and standards for conducting clinical trials;
- Adjudicate complaints about the functioning of health research ethics committees and hear any complaint by a researcher who believes that he or she has been discriminated against by a health research ethics committee
- Refer to the relevant statutory health professional council matters involving the violation or potential violation of an ethical or professional rule by a health care provider;
- Institute such disciplinary action as may be prescribed against any person found to be in violation of any norms and standards, or guidelines, set for the conducting of research in terms of this Act; and
- Advise the national department and provincial departments on any ethical issues concerning research.
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.