Wednesday, 2 March 2016

IMA to set up an independent ethics committee to evaluate and grant proposals for clinical research by medical practitioners

IMA to set up an independent ethics committee to evaluate and grant proposals for clinical research by medical practitioners New Delhi, March 01, 2016: The last ten years have seen a steep rise in the number of clinical research studies in India. The biopharmaceutical majors world over are turning toward India, given its rich technical resource pool, ease of patient recruitment, and sheer diversity inherent in our country's genetic texture. However, the migration of international clinical trial projects to India have brought concerns about the quality of clinical research, sighting timelines for regulatory approval, deficiencies found in the functioning of the ethics committees, and an unethical approach to the recruitment of trial subjects. As a result of the stringent associated laws, clinical research has mostly been restricted to institutes and has been out of the reach of individual medical practitioners. Given this, the Indian Medical Association has now initiated the set up of an Independent Ethics Committee of IMA which would not only help all private practitioners who are presently not associated with any institute initiate clinical trials, get the necessary approvals and guidance, but also ensure the safety and rights of the patients involved. The committee will comprise of a total of 20 members from across fields including research, sociology, theology, health care, communications, social sector as well as education. As a first step towards setting up the committee, IMA held a ICHGCH training program for all the members in accordance with the Drug and Control Rules 1945 yesterday. During the training session, the members were educated on the protocols of what members should and should not do, the history of clinical trials in India, ICMR guidelines for bio-medical research on human subjects, the process of informed consent, ethics in clinical trials. The roles and responsibilities of all the members were also decided along with basic guidelines and framework within which the ethics committee would function. Sharing details, Dr SS Agarwal, National President IMA & Padma Shri Awardee Dr KK Aggarwal, President HCFI and Honorary Secretary General IMA said, “As per the Bulletin report of the World Health Organization (WHO) there are less than 40 ECs in our country, which are duly constituted and functioning. India continues to have a high burden of diseases despite the various health program and policies, which have not been able to achieve the desired goals and objectives. The reasons for this include the dearth of in-depth research, which has been carried out on the Indian population. Understanding the crucial role of research and clinical trials and keeping in mind the need to preserve the rights and well-being of clinical trial subjects, IMA has decided to set up its own ethics committee in this regard. The aim of this committee will be to promote research initiatives by independent medical professionals in the most patient-friendly and transparent manner. The rights of the clinical subjects will be of topmost priority and a systematic process will be put in place to ensure no errors." Clinical Research is a systematic investigation in human beings designed to discover or contribute to a body of generalizable knowledge. Since it involves human participants, researchers are ethically obligated to protect them. The two principal protections offered to an individual taking part in clinical research are Written Informed Consent and Ethics Committee (EC) review. The purpose of an EC review of biomedical research is to safeguard the dignity, rights, safety, and well-being of the research participants. The EC review comprises of ethical principles and decision-making to solve actual or anticipated dilemmas in the conduct of human research The speakers of the ethics committee training session held at IMA included Dr K K Aggarwal Hony Secretary General – IMA; Mr Vinay Singh - Research Scholar and employee of Novo Nordisk; Denmark; Dr Sanjeev Khowal - Asst. Manger-Training, Dabur; Mr Rahul Singh Bisen - Senior Associate, Kinapse India; Prof (Dr) N P Singh - Former-Director Prof Medicine, MAMC College, Medical Advisor Director, Medicine & Allied Specialties and Senior Consultant in Internal Medicine Max Super Speciality Hospital, Vaishali Gbd; Ms Ira Gupta - Legal Advisor; Dr S Anuradha - Director-Professor of Medicine Maulana Azad Medical College and Dr Vandana Roy - Director-Professor and Head of Pharmacology, Maulana Azad Medical College The sessions were followed by a discussion and an evaluation.

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