Vol.21 No.6

Wednesday 14 January 2004    

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News
No legal protectionfor clinical trials

DONNY DITHATO
Staff Writer

1/14/2004 11:35:50 AM (GMT +2)

BOTSWANA has no legal provision to protect the rights of volunteers involved in clinical trials, an HIV/AIDS activist has said. The director of the Botswana Network on Ethics, Law and HIV/AIDS (BONELA) Christine Stegling told Mmegi in an interview that the lacuna in Botswana laws on clinical trials needs to be rectified.


She said there is need for a simple legal framework that will protect volunteers in the trials. "Respect of the rights, dignity and safety of trial participants lies at the very heart of any research activity," she said. She added that several members of the Community Advisory Board of Maiteko a Tshireletso "have commented on the research protocol and have raised crucial ethical issues that were taken up by researchers". In particular, the board advised on the informed consent process for the trial to ensure that participants truly understand what they are volunteering for.

Ministry of Health, which bears the ultimate liability for research related complications and adverse effects arising out of the trials.

Meanwhile legal academics and medical doctors contacted for comment by Mmegi have been unanimous that under Botswana laws there is nothing wrong in the recruitment of volunteers for the HIV vaccine trials in the country. Associate Professor in law at the University of Botswana John Kiggundu said the absence of laws to protect volunteers in clinical trials might be explained by the fact that such trials have never occurred in the country.

Professor Emmanuel Quansah shares the same sentiments as Kiggundu. He said it is often difficult to have laws in the absence of policy. A Gaborone medical doctor in Broadhurst speaking on a condition of anonymity also found nothing wrong with the vaccine trials as "all medicines have to be tested and such trials are a standard procedure worldwide". He said the issue of possible side effects is neither here nor there because even medicines that have been tested and passed still have side effects.

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