Health Minister Manto Tshabalala-Msimang has requested an investigation by the research ethics council following concerns about the health of participants in microbicide clinical trials.
In a statement released on Tuesday, Tshabalala-Msimang said she had met with researchers following ”disturbing news” about preliminary results of a study conducted among 604 women in KwaZulu-Natal.
The purpose of the trials was to test the effectiveness of a vaginal microbicide — cellulose sulphate gel — in preventing the sexual transmission of HIV.
”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,” she said in a statement.
”Ethical practice of research has become a major concern in health research over the past few years, particularly regarding the vulnerability of research participants.”
Tshabalala-Msimang said she would request the investigation to establish whether the research followed the protocols approved by the Medicine Control Council and the ethics committees of the relevant research institutions.
She would want it to establish whether participants were given sufficient information to make informed decisions about their participation.
”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.”
Tshabalala-Msimang said her department had asked the independent data monitoring committee, which was overseeing the trials, to make available all information relating to its activities in South Africa.
”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.”
Recently, researchers halted two studies of an anti-Aids vaginal gel in Africa and India after early results suggested it might raise the risk of HIV infection instead of lowering it.
It was ”a disappointing and unexpected setback” to efforts to get a simple tool to protect women from the risk of Aids through sex, the United Nations World Health Organisation said last month.
It was reported that more than half of all new infections with the Aids virus in Africa involved women and girls.
Scientists and groups such as the Gates Foundation have long sought a method of protection women could use, even without their partners’ knowledge, as many men refuse to use condoms. — Sapa