Ethics of Clinical Research in South Africa


Clinical research is conducted in South Africa within the framework of the Regulatory Authority (Medicines Control Council) and the Health Research Ethics Committees. There are approximately 33 private and academic Health Research Ethics Committees in South Africa. All health research conducted in South Africa must be reviewed and approved by an accredited research ethics committee.


The National Research Ethics Council (NHREC) was established in terms of the National Health Act, 2003 (Act No. 61 of 2003). The NHREC serves as a body to regulate matters of research ethics in South Africa. Ethics Committees in South Africa are subject to an accreditation process as determined by the NHREC. Auditing of research ethics committees and continued education is also promoted by the NHREC. The guidance document: Ethics in Health Research: Principles, Structures and Processes gives guidance to the composition and procedures required of South Africa Research Ethics Committees.