Friday, June 10, 2011

Doing what is right when the result of research is death

There is something intrinsically sacrificial about participating in biomedical research. Research exposes participants to some risks and often offer little no individual benefits. In some rare and extreme cases, research participants make the ultimate sacrifice: they die as a result of the intervention being tested. When this happens, there is a strong intuition that the participant's family should receive compensation for their loss. The intuition is also embedded in influential ethics guidance that researchers and their funders are supposed to adhere to: those conducting clinical trials are required to have insurance to cover such eventualities.

A column in the Times of India suggests a serious gap between regulations and reality. The records of the Drug Controller General of India (DCGI) indicate that 25 people died in clinical trials as direct result of study participation, but only the five families received any compensation. Of the minority who received compensation, the financial compensation for research-related death was quite low: between 3400 and 6700 US Dollars. The DCGI is apparently ready to take the major pharmaceutical companies on, having organized a meeting on June 6 to discuss lack of adherence to regulations. It will be interesting to see who wins this clash between for-profit and regulatory powers in India, where rapidly increasing numbers of clinical trials are taking place.

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