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Clinical Trials

There are currently no regulations governing the clinical trials of medical devices. The National Health Act, 2003 (Act No.61 of 2003) does however stipulate that ALL trials conducted on human participants must obtain ethical approval before commencing. It also stands to reason that research is therefore not allowed to be published without prior ethical approval.

In South Africa, most higher education and research institutions, and even some of the large service rendering health institutions have ethics committees, responsible for the ethical review of research protocols. Currently there are 34 registered research ethical committees in South Africa.

 

The National Health Act stipulates that the function of these Ethics Committees should be to:

 

  1. Review research proposals and protocols to ensure that research will be conducted in the spirit of endeavouring to promote health, and to prevent or cure disability and disease
  2. Ensure that humans involved in research are treated with dignity and that their well-being is not compromised, and that animals involved in research are treated compassionately;
  3. Ensure that informed consent is obtained in the case of human participants; and
  4.  Grant approval in instances where research proposals and protocols meet ethical standards.

Apart from approval from a recognized Research Ethics Committee (REC), applicants are also required to obtain approval from the Medicines Control Council (MCC). Although strictly speaking, the MCC was set up by the Minister of Health to oversee the regulation of medicines in South Africa, the MCC is also responsible for medical devices. As such, all clinical trials using medical devices on human participants must gain approval from the MCC (in practise, this is not happening - the MCC does not have the capacity to cope with medical devices). Once an applicant has MCC approval, the trial must be registered on the National Trials Registry with the National Health Research Ethics Council (process detailed below).

 

 

 

In order to maintain order and give direction on ethical issues relating to health, and develop guidelines for the conduct of research on human participants, the National Health Research Ethics Council (NHREC) was established as a statutory body in terms of the National Health Act (Act no 61 of 2003). The provisions of the said Act, allow the Minister of Health to appoint not more than 15 persons to be members of the NHREC who then observe and advise on international developments in health ethics issues through liaison with relevant international organisations. The NHREC will not replace existing ethics committees but will serve as a body to regulate matters of research ethics. All ethics committees approving health research in South Africa will be subjected to the registration/accreditation process and criteria determined by the NHREC. Continued education and regular auditing of ethics committees will be promoted by the NHREC to assist committees in attaining acceptable standards of operation.

For further help with taking your medical device through clinical trials, please contact us directly.