6 February 2007
Today, I convened a meeting with the researchers involved in at least 5 microbicides clinical trials that are taking place in South Africa.
The meeting follows the disturbing news about the preliminary results of the study conducted amongst a group of 604 women in KwaZulu-Natal, to test the effectiveness of a vaginal microbicide - cellulose sulphate gel - in preventing the sexual transmission of HIV.
The purpose of the meeting was to establish the details with regard to the interim results of the cellulose sulphate study and gain further insights into the other microbicide trials that are underway in the country.
Health research which includes the conduct of clinical trials as one method of research is a critical component of advancement of health sciences. In addition, it contributes to improved management of various health conditions. However, ethical practice of research has become a major concern in health research over the past few years, particularly regarding the vulnerability of research participants.
South Africa provides a unique environment for research. The former advantaged areas of our country have good infrastructure, skilled researchers and well-equipped research institutions comparable to many developed countries. The rest of our population is affected by the burden of diseases common to many poor, developing countries particularly in sub-Saharan Africa.
Increasing research activity, competition and attractive research environment may sometimes have undesired outcomes.
That is why the Department of Health has been making efforts to ensure that research is conducted in an ethical manner. Over the past years, the Department has put in place several mechanisms to ensure good research management.
We have produced Good Clinical Practice Guidelines as well as Ethics Guidelines which spell out the responsibility of researchers, research sponsors and other authorities to research participants. These guidelines are enforceable in terms of the National Health Act of 2006.
With regard to this particular study in KwaZulu-Natal, I have asked the National Health Research Ethics Council to conduct a thorough investigation into this matter. The Ethics Council which has been established in terms of the National Health Act, commenced its functions last month.
This investigation should establish:
We have also requested the Ethics Council to look into the other microbicide trials that are registered in the country and satisfy itself that these trials are being conducted in terms of the required protocols.
We have asked the Independent Data Monitoring Committee that was overseeing the trial to make available as soon as possible all the information relating to the South African arm of the trial.
While we support innovation through health research, the government of South Africa is determined to ensure that the health of our people is not compromised in the process.
Dr Manto Tshabalala-Msimang
Minister of Health
Contact: Sibani Mngadi @ 0827720161