INDIA: New Guidelines Promise Stronger Bioethics

  Pallava Bagla

Science, Nov. 3, 2000

 URL: http://www.sciencemag.org/cgi/content/full/290/5493/919

 NEW DELHI--The Indian government has issued new guidelines for conducting medical research on humans that would raise standards and tighten oversight at most institutions. The voluntary guidelines, released on 18 October, are also expected to bolster international collaborations by putting Indian practices on a par with standards in the West.

 Although the guidelines will mean more paperwork for an already clogged bureaucracy, most scientists say that they are an important step toward ensuring ethical research. "It is expected that all institutions that carry out any form of biomedical research involving human beings should follow these guidelines," says Nirmal Kumar Ganguly, director-general of the Indian Council of Medical Research (ICMR) in New Delhi. 

 Four years in the making, the new guidelines would create a network of institutional review boards. That in itself would be a major change: An ICMR survey last year of 30 leading research institutions found that most had no ethical committees overseeing experiments involving humans. The few committees that did exist were generally moribund, meeting rarely and having little influence on major research decisions.

  The new guidelines, titled "Ethical Guidelines for Biomedical Research on Human Subjects," stipulate that each research proposal that involves human testing will be vetted by an institutional ethics committee. Its five to seven members must include a legal expert, a social scientist, a philosopher, and a community representative in addition to researchers. All committee decisions will be made at a "formal meeting" and not "through the circulation of a proposal." Once cleared, the protocols would receive no further ethical review.

  In addition to enshrining the principles of informed consent and confidentiality, the guidelines specify the nonexploitation of vulnerable groups such as the poor and mentally challenged people. It also says that anyone in a trial who has an adverse reaction should receive the "best possible nationally available care."

  The guidelines were unveiled at a meeting here of the Indo-U.S. Biomedical Research Policy Forum, which seeks to resolve obstacles to collaborative biomedical research between the two countries. Gerald Keusch, director of the Fogarty International Center of the U.S. National Institutes of Health, who attended the meeting, called the guidelines "comprehensive." He said they "have the same philosophic context" as those that federally funded researchers and their U.S. institutions must follow.

  Absent binding legislation and additional resources, the success of the voluntary guidelines will depend on the response of the scientific community. "There is no way the ICMR can be the policing agency," says Vasantha Muthuswamy, chief of basic biomedical research at ICMR and secretary of the Central Ethics Committee on Human Research, which formulated the guidelines. And that puts the burden on those who fund the research, as well as those who carry it out. "Now that a strong ethical framework has been put in place, it is up to the grant-giving agencies to ensure that funding is not given in instances where ethical violations are noticed," says Prakash Narain Tandon, a neurosurgeon and professor emeritus at the All Indian Institute of Medical Sciences in New Delhi.