Melody Lin, deputy director of National Institutes of Health - Office for Human Research Protection, US, said that training research teams on basic ethical practices in research followed globally within the country will increase the world’s interest in India as a venue for clinical trials

India has become one of the key players in international biomedical research, with its IT capabilities, willingness of the government to start reforms and trained technicians, Melody Lin, deputy director, National Institutes of Health - Office for Human Research Protection, U.S., said.

Training research teams on basic ethical practices in research followed globally within the country will increase the world’s interest in India as a venue for clinical trials, she said. Dr. Lin was speaking at the inauguration of Indo-US CITI workshop on ‘Promoting Research Ethics Education in India’ organised at Sri Ramachandra University (SRU), here, on Tuesday.

Talking about the varsity’s partnership with University of Miami, U.S., its Pro-Chancellor (research) S.P. Thyagarajan said it was significant that these two institutions had come together to launch the ‘Collaborative Institutional Training Initiative (CITI)’ Research Ethics programme in the country. It will fulfil a great need, even as India emerges as a hot destination for clinical research involving human subjects and patients.

He added that clinical trials in India were growing at an annual aggregated growth ratio of 60 per cent. In 2004, the budget for clinical trials in India had crossed USD 100 million and it is being predicted that by 2010, the industry will spend USD 300 million or more. At present there are over 150 research organisations that are co-ordinating and conducting clinical trials on behalf of and in association with multinationals.

The reasons why India’s popularity in the circuit included a comparative cost advantage, the availability of a huge pool of trained manpower, a large population base with a diverse disease spectrum, he added. “While it is definitely an opportunity for India, we should be extremely careful to ensure that we do no harm,” Prof. Thyagarajan explained. It was in this context that an orientation on the ethics governing bio medical research would be timely.

SRU also hopes to emerge as a CITI centre of excellence, taking the training to other medical and research institutions. Paul Braunschweiger, director, Office of Research Education, University of Miami, said most funding for scientific research is being supported by public funding by the government. Therefore, without public trust, there will be no research on public health and consequently, no prosperity. Stressing on didactic training on ethics for the entire research team, he said that the CITI programme’s online modules would provide high quality of research ethics education.

V.Kumaraswami, director, Tuberculosis Research Centre and National Institute of Epidemiology, Indian Council for Medical Research (ICMR) institutions, said the ICMR has tried to address the issues relating to medical research as early as in the 1980’s. A more formal guide was published in 2000 and it was followed up by a revised set of guidelines in 2006. These guidelines govern social sciences research, stem cell research and animal research.

The ICMR was also interested in capacity building at all levels for medical research in partnership with the NIH. There was also a partnership with the Indira Gandhi National Open University for distance learning modules for ethics, he added.

V.K.Subburaj, Principal Secretary, Health, said the State government and its research institutions would be keen on participating in such training programmes for medical research ethics. S.Thanikachalam, chairman and director, Cardiac Care Centre, SRU, released the ethics education material on the occasion.

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