JIPMER Director Dr T S Ravikumar emphasised that the recent guidelines for registration of ethics committee in clinical trials of drugs be followed in order to protect the safety and welfare of the research participants.
Speaking at a one day workshop on Bioethics , organised by the Division of Research, JIPMER, he expressed the need for comparative effectiveness research.
Dr C Adithan Senior Professor, Pharmacology, and organising secretary, said that as per notification on registration of ethics committee, all ethics committees have to be registered for examining and approving clinical trial protocol. He also explained about the composition of ethics committee, forum for ethics committee and compensation clause for such committees that are mentioned in government notification.
Dr Nandini K Kumar who was closely involved in the finalisation of ICMR’s Ethical Guidelines of 2000 and 2006, spoke about the past unethical practices done in clinical trials that necessitated the framing of guidelines and rules for safeguarding the interest of clinical trial participants. This was followed by a talk by Dr Ramakrishnan, Scientist ‘F’ & Division Head, Health Systems Research and Bio-Ethics, National Institute of Epidemiology, ICMR, who explained the Indian guidelines on good clinical practice.
Dr Sridhar, member of JIPMER Ethics Committee and Professor of Biochemistry, highlighted the components of informed consent form and the problems in obtaining informed consent in vulnerable population.
The workshop was organised in the backdrop of recent concerns regarding clinical trial-related Serious Adverse Events (SAEs) and compensation provided to the research participants in case of clinical trial-related injuries or death. In view of this, Government of India had taken several steps to strengthen the regulatory mechanisms for the conduct of clinical trials in India.