SRMC - Press Release - 24th November 2009

ETHICS EDUCATION IN MEDICAL RESEARCH:SRI RAMACHANDRA TIE-UP WITH MIAMI UNIVERSITY

The University of Miami, USA is setting up a nodal centre at Sri Ramachandra University for a “Collaborative Institutional Training Initiative (CITI) Research Ethics Educational Programme of US in India”. A memorandum of understanding for this was signed here today by Dr.Paul Braunschweiger Director, Office of Research, Miami University and Dr.S.P.Thyagarajan, Pro Chancellor (Research), SRU. To mark this occasion an Indo-US CITI workshop on “Promoting Research Ethics Education in India” was organized in which representatives from the United States, Nepal, Bangladesh and Srilanka besides representatives from all over India participated.

Speaking on the occasion, Dr.Braunschweiger said that clinical research worldwide has to be conducted to the highest ethical standards so that we do not lose the public trust. Therefore formal training is necessary for all those involved in medical research. CITI he said has networked over 1300 institutions worldwide and expressed the hope that the nodal centre at SRU will help in educating researchers in the south asian region.

Mr.V.R.Venkataachalam, Chancellor, Sri Ramachandra University honoured the distinguished guests.

In his inaugural address Prof.Kumaraswamy, Director, Tuberculosis Research Centre and National Institute of Epidemiology speaking on behalf of Dr.V.M.Katoch, secretary to Government of India, Department of Health Research and Director General, Indian Council of Medical Research said while clinical research being outsourced to countries like India are on the increase there are growing concerns whether we can stand up to the highest standards of ethics in clinical research. The ICMR guidelines document is very comprehensive and in line with international standards. But we need to have a massive capacity building education among all those involved in clinical research, he added.

In his presidential address, Mr.V.K.Subburaj, Principal Secretary, Health and Family Welfare, Tamilnadu Government said that there is a huge disease burden in India and there is an urgent need for quick research to find suitable treatment protocols. Pointing out that there is conflict between ethics and commercial clinical research he said in the United States over a hundred drugs have been withdrawn and some of them had been cleared through fast track approval system. Some of these banned drugs are in use in India in different combinations. Therefore it is high time that ethical codes are strictly followed, he said.

Explaining the research scenario Dr. S. P.Thyagarajan, Pro Chancellor (Research), SRU said India today is becoming a hot destination for clinical research involving human subjects and patients. Clinical trials are growing 60 percent every year and by 2010 the industry will spend $300 million on clinical trials in India. At present there are more than 150 clinical research organizations that are coordinating and conducting clinical trials in association with multi national companies. In order to have the ethics culture among our medical fraternity, universities in general and medical universities in particular should inculcate ethics education in medical practice for UGs and PGs and researches; develop, operate and review policies on clinical research and clinical trials consistent with international standards and best practices and establish university and faculty based research ethics committees to permit and monitor clinical research and clinical trials. SRU he said has 261 research projects of which 31 are clinical trials funded by multinational pharmaceutical companies.

Dr.Melody Lin, Deputy Director, National Institute of Health and Office of Human Research Protection, USA, said India is a key player in multinational clinical research and therefore the CITI programme in India set up at SRU will help in educating all researchers in ethical practices.

Dr.S.Thanikachalam, Chairman and Director, Cardiac Care Centre, SRU released the ethics educational material for the workshop and said “DO NO HARM’ to animals or human beings should be the guiding spirit in doing clinical research.

Dr.S.Adikrishnan and Dr.Murugan of the Department of Dermatology of SRU which organized the event also participated.

Dr.K.V.Somasundaram, Dean of Faculties, SRU offered the vote of thanks.

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For more information please contact Dr. S. P. Thyagarajan, Pro Chancellor - Research, SRU, 9840046575, 23860186.