Monday, January 11, 2010

‘Microbicide gel trials did not cause HIV infection in Mazabuka women’

‘Microbicide gel trials did not cause HIV infection in Mazabuka women’
By Masuzyo Chakwe
Mon 11 Jan. 2010, 04:00 CAT

THE University of Zambia Biomedical Research Ethics Committee (UNZAREC) has said there is no cause to believe that the 46 women out of the 1,332 that were involved in the Mazabuka microbicide trials were infected as a result of their participation in the research.

UNZAREC acting chairperson Dr James Munthali said during a press briefing on Thursday that the involvement of UNZAREC with the Microbicides Development Programme (MDP) Trial 301 dated back to December 2004 when an application was made by the MDP to conduct a phase III randomised double blind placebo-controlled trial evaluating the safety and efficacy of the vaginal microbicide gel PRO 2000 for reducing the risk of vaginally acquired HIV infection in women.

He said Zambia would be part of a multicentre research also involving South Africa, Tanzania and Uganda.

Dr Munthali said the research proposal underwent rigorous review in accordance with the Standard Operating Procedures (SOPs) of UNZAREC to ensure that the dignity, rights, safety and well-being of the participants were safeguarded.

“Having met all the ethical requirements the researchers were then granted approval on 5th April 2005 to commence the research. The evolution of the study was followed through well documented procedures such as six monthly progress reports, annual renewals, adverse events reporting, protocol deviations reporting and reports from an independent Data and Safety Monitoring Board (DSMB) that was monitoring the safety and efficacy data coming in the other sites in South Africa, Tanzania and Uganda. The study was completed in August 2009 and UNZAREC was briefed about the findings on 10th December 2009 before the official dissemination,” he said.

He assured the people in Mazabuka and the nation that within their regulatory role there was no cause to believe that the 46 women out of the 1,332 were infected as a result of their participation in the research.

“This is in keeping with the results from the other sites in South Africa, Tanzania and Uganda. We will continue to ensure that the lives and health of Zambians participating in research are safeguarded through rigorous review and monitoring of any research to be conducted in the country,” said Dr Munthali.

He said UNZAREC was an independent ethics review committee of UNZA that safeguards the dignity, rights, safety and well-being of all human participants in research.

Dr Munthali said UNZAREC ensures that the cardinal ethics principles of respect for autonomy of the individual in their participation in research, beneficence benefit to the research participant, non-maleficence (absence of harm to the research participant) and justice in the distribution of burdens and benefits of research between communities are taken care of in the planning, conduct and reporting of the proposed research.

For this purpose, UNZAREC looks into the aspects of valid informed consent process, risk/benefit ratio, distribution of burdens and benefits.

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