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5 December 2013 11:26 am ,
Vol. 342 ,
An animal rights group known as the Nonhuman Rights Project filed lawsuits in three New York courts this week in an...
Researchers have been hot on the trail of the elusive Denisovans, a type of ancient human known only by their DNA and...
Thousands of scientists in the Russian Academy of Sciences (RAS) are about to lose their jobs as a result of the...
Dyslexia, a learning disability that hinders reading, hasn't been associated with deficits in vision, hearing, or...
Exotic, elusive, and dangerous, snakes have fascinated humankind for millennia. They can be hard to find, yet their...
Researchers have sequenced and analyzed the first two snake genomes, which represent two evolutionary extremes. The...
Snake venoms are remarkably complex mixtures that can stun or kill prey within minutes. But more and more researchers...
At age 30, Dutch biologist Freek Vonk has built up a respectable career as a snake scientist. But in his home country,...
- 5 December 2013 11:26 am , Vol. 342 , #6163
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India's Supreme Court Mandates Videotaped Consent in Clinical Trials
22 October 2013 2:15 pm
The Indian Supreme Court yesterday ordered the central government to issue regulations mandating videotaped informed consent of all participants in any clinical trial conducted on Indian soil, as well as additional cost-benefit analyses of potential drugs before trials can proceed.
The precedent-setting directive comes as the two-judge panel continues to hear arguments on a petition filed in January 2012 alleging that multinational drug companies and Indian collaborators are using underprivileged Indians as guinea pigs in clinical trials. In July, the court ordered a temporary halt to 162 clinical trials then under way in India. Yesterday, it permitted five trials to resume and referred the other 157 to a new government advisory committee for more detailed scrutiny. The court asked the committee to compare the likely benefits of the trial drugs to treatments already on the Indian market while keeping in mind the nation’s medical needs, according to a report in The Times of India.
Observers say the court’s directives will impose a heavy burden on clinical researchers. “The intent is correct, but the path chosen by the court is tough,” says Maharaj Kishan Bhan, a vaccine researcher and former secretary of the Department of Biotechnology. While videotaping informed consent would provide additional accountability, Bhan says, “the right balance has to be struck between how much more additional burden needs to be loaded on researchers vis-à-vis requirements of ensuring better patient safety.”