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."
Were protocols followed?
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 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."
Dealing in myths?
According to the Treatment Action Campaign (TAC) ,misconceptions about microbicide trials abound. “The myth is that participants in microbicide trials (as well as vaccine trials and the recently conducted circumcision trials) are encouraged to have unprotected sex or, in the myth's most extreme version, are exposed to HIV by researchers,” the TAC said in their newsletter.
“On the contrary,” the TAC said, “participants in these trials must be counselled about safer sex. If a trial is conducted properly, participants are arguably at less risk of contracting HIV than the general population, because they have all been through a standardised comprehensive counselling session, approved by a regulatory ethics committee.”
The TAC also spoke out against what they called the “sensationalising” of the story in the media. Regarding a story that appeared in City Press on Sunday, the TAC said, “it referred to the fully informed and consenting trial participants as guinea pigs, and reported unsubstantiated serious allegations against the trial researchers without verifying whether these allegations were true. This unfairly undermines public confidence in science as well as the future of essential clinical trials that will likely save many lives.”
A disappointing setback
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)
The gels that may stop HIV
HIV gel studies halted