HEALTH MINISTER'S PROPOSAL WOULD INCREASE BURDEN ON TRIAL SPONSORS

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Sponsors of clinical trials in South Africa should provide special medical insurance to compensate participants if they suffer adverse effects, according to South African Health Minister Manto Tshabalala-Msimang.

She also called for strengthened informed consent rules and other ethical protections for study participants and announced the establishment of a national clinical trial register to inform the Department of Health of ongoing trials and enable trial participants to get more information about the trials. Tshabalala-Msimang spoke at the opening of the scientific session of the Microbicides 2006 Conference in Cape Town.

Tshabalala-Msimang called for compensation and health insurance to protect trial participants who suffer from adverse effects. "The type of insurance that is available for research participants in developed countries should be extended to participants in developing countries. It is unethical that participants in one multi-country study should have unequal levels of protection," the health minister said.