“Indian Guinea Pigs for Sale: Outsourcing Clinical Trials”

“”The quality of voluntary informed consent obtained in clinical trials is very poor,” says Dr Joshi. “If they were informed that they were in a trial, 90% would not participate. For non-affording patients the doctor is God. They will sign on the dotted line. They will assume the drug is for their benefit, that it is not experimental. It takes time to inform patients properly.” The ICMR guidelines represent an enormous improvement on previous available ethical guidelines for research in India, since they implicitly recognize that the investigator-subject relationship can be unequal and therefore potentially coercive. The category of ‘vulnerable groups’ includes the economically or socially disadvantaged who should not be used to benefit the better-off. However, while such inequalities – and the potential for their exploitation- are recognized, the language of the guidelines is open-ended. It is up to ethics committee members to note that, for example, patients of public hospitals are an especially vulnerable population in giving their consent. EC members must also carefully scrutinize patient information sheets and informed consent forms in English and the other languages to be used, to ensure that they are truthful, complete and comprehensible. Finally, in the absence of independent monitoring, it is not possible to say whether the process of getting informed consent is done ethically.”
Source-India Resource Center

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