Indian Medical Association (IMA) will set up an independent ethics committee which would help private practitioners, who are currently not associated with any institute, initiate clinical trials, get the necessary approvals and guidance, and also ensure safety and rights of the patients involved.
The committee will comprise of 20 members from various fields, including research, sociology, theology, healthcare, communications, social sector and education.
"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 towards India, given its rich technical resource pool, ease of patient recruitment and the sheer diversity inherent in our country's genetic texture.
"However, the migration of international clinical trial projects has brought concerns about the quality of clinical research, deficiencies found in functioning of ethics committees and an unethical approach to the recruitment of trial subjects," KK Aggarwal, Secretary General of IMA, said.
"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," Aggarwal said.
As a first step towards setting up the committee, IMA held a training programme for all the members in accordance with the Drug and Control Rules 1945 yesterday.
During the training session, the members were educated about the protocols of they should and should not follow, 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 the members were also decided along with basic guidelines and framework within which the ethics committee would function.
"India continues to have a high burden of diseases despite various health programmes and policies, which have not been able to achieve the desired goals.
"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 trial subjects, IMA has decided to set up its own ethics committee in this regard," said SS Agarwal, National President of IMA.
The aim of the committee will be to promote research initiatives by independent medical professionals in a patient- friendly and transparent manner. The rights of the clinical subjects will be the topmost priority and a systematic process will be put in place to ensure no errors occur, he said.
