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Manto to look at microbicides
By KERRYN VAN DER WESTHUYZEN
JOHANNESBURG – Health Minister Manto Tshabalala-Msimang announced yesterday that her department would launch an investigation into microbicide clinical trials.
This follows a report in which a US organisation, Conrad, had to terminate its study of potential vaginal microbicide cellulose sulphate last week, after learning that the preliminary results indicated the compound could lead to an increased risk of HIV infection in women.
Julian Jacobs of the South African Medical Research Council said the findings were unexpected, as 11 earlier safety and contraceptive trials of cellulose sulphate involving more than 500 participants in Africa, India and the USA had identified no safety concerns.
Yesterday the Health Minister convened a meeting with the researchers involved in five microbicide clinical trials now taking place in KwaZulu-Natal (KZN)
The purpose, according to the department, was to establish the details with regard to the interim results of the study, and gain further insight into other microbicide trials under way in the country.
Tshabalala-Msimang explained that her department had been making efforts to ensure that research was conducted in an ethical manner.
“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,” she
said.
With reference to the study in KZN, the Minister has called upon the National Health Research Ethics Council to conduct a thorough investigation.
Msimang said the investigation should establish:
* Whether the study followed all the protocols approved by the Medicines Control Council (MCC) and the ethics committees of the relevant research institutions;
* Whether the participants were given sufficient information to make informed decisions about their participation; and
* Any other issue that might shed light on the preliminary results, and the implications for the participants.
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