India's premier medical research agency wakes up to the question of ethics
The Indian Council of Medical Research (ICMR) is preparing a new set of guidelines to deal with the "ethics and informed consent" in drug and genetic tests on people. The draft - Statement of principles on medical and genetic research on human subjects - prepared by a committee headed by justice M N Venkatachaliah, chairperson, National Human Rights Commission (NHRC), will soon be sent to 500 experts and the public for debate and comments, an ICMR spokesperson said. The guidelines gain importance in the context of new genetic research and international criticism about Indian drug trials on patients without informing them ( Down To Earth , Vol 5, No 22; April 15, 1995).
ICMR's research on cervical cancer conducted on over 1,000 women in Delhi without their written consent had come in for criticism from various medical bodies. Most of the women were illiterate, reports had pointed out.The Telegraph had reported in March 1997 that "62 (subjects) acquired low-grade cervical malignancies when doctors left them untreated to study the behaviour of pre-cancerous lesions". Soon after, there were angry responses in the British Medical Journal (April 12, 1997) about the irresponsible manner of the research. The aim of the 1980's research was to study the cancer-causing potential of lesions. International experts noted that advanced lesions lead to cancer if left untreated. ICMR also drew flak for testing a controversial contraceptive "Norplant" on illiterate women and leaving them without follow-up treatment ( Down To Earth , Vol 5, No 20; March 15, 1994).
The present 26-member ethical committee was constituted on September 10, 1996, as the council guidelines on the subject drawn up by the justice H R Khanna committee in the 1980's were considered inadequate in an age of DNA cloning, organ transplants and fertility tests. "I think that every medical institution should have its own ethical committee and they should meet regularly to review the guidelines," says Sameeran Nandi, senior physician at the Ganga Ram Hospital, New Delhi.
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