Clinical research sector is facing newer and newer challenges and students in medical sciences have to keep abreast of the national and international guidelines in this regard, according to Dr A N Rai, director, National Assessment and Accreditation Council (NAAC).

He was delivering a lecture on “Ethics and responsible conduct of clinical research” organised by Sri Ramachandra University, Chennai in association with Collaborative International Training Initiative (CITI), USA, with participation from ICMR and MCI.

With increasing clinical research based on genomics, molecular biology and using humans as models, concerns for patient safety are genuine, so, responsible conduct in clinical research is constantly encouraged.

He said NAAC will closely watch the outcome of this international conference being held in Chennai and use it to develop benchmarks in quality education.

Dr S P Thyagarajan, Dean Research, SRU said, in India both basic medical research involving experimentation with animals and clinical research involving clinical trials for evaluation of newer drugs and pharmaceuticals, devices, implants and other bio-materials are being critically looked at both by the regulatory agencies like Drugs Controller General of India, Indian Council of Medical Research and other appropriate agencies. The clinical trials are criticised very often by mass-media as well as judiciaries. It is thus important to provide research ethics education, training and certification to all researchers on the prevailing international and national level norms and guidelines.

Since March 2014, SRU is designated by University of Miami as the Centre of Excellence in Research Ethics Education, Dr. Thyagarajan added.

This conference is conducted mainly for focusing the basic concepts and principles in research ethics and responsible conduct of research. ICMR has given ethical guidelines for studies on human subjects and the guidelines are being updated periodically, sources informed.