National Health Act, 2003 (Act No. 61 of 2003)Chapter 9 : National Health Research and Information72. National Health Research Ethics Council |
| (1) | A council to be known as the National Health Research Ethics Council is hereby established. |
| (2) | The Minister must— |
| (a) | after consultation with the National Health Council, appoint as members of the National Health Research Ethics Council not more than 15 persons nominated by interested parties at the invitation of the Minister by notice in the Gazette; and |
| (b) | publish the list of appointees in the Gazette. |
| (3) | A member of the National Health Research Ethics Council is appointed for three years but may be reappointed for one or more further terms. |
| (4) | A member of the National Health Research Ethics Council must vacate his or her office if he or she resigns or if requested by the Minister for good cause to resign. |
| (5) | If a member of the National Health Research Ethics Council vacates office or dies, the Minister may fill the vacancy by appointing a person in accordance with subsection (2) for the unexpired portion of the term of office of his or her predecessor. |
| (6) | The National Health Research Ethics Council must— |
| (a) | determine guidelines for the functioning of health research ethics committees; |
| (b) | register and audit health research ethics committees; |
| (c) | set norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials; |
| (d) | 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; |
| (e) | 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; |
| (f) | 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 |
| (g) | advise the national department and provincial departments on any ethical issues concerning research. |
| (7) | For the purposes of subsection (6)(c), "clinical trials" means a systematic study, involving human subjects that aims to answer specific questions about the safety or efficacy of or method of treatment. |