To understand the quality of informed consent and the processes involved in taking the informed consent in the ongoing clinical trials in the country, the Indian Council for Medical Research (ICMR) has launched a survey on 'quality of informed consent in clinical trials in India'.

The survey assumes significance in the light of mushrooming of research firms and other contract research organisations in the country during the past couple of years. Continuing flow of the drug research business to India from abroad is mainly because of the availability of investigators and human subjects for trials at much cheaper rates than abroad.

Though there are ICMR guidelines to be followed for procuring human subjects for trials, it is reported that the research firms in collusion with the agents are conveniently forgetting the guidelines. Around 200 drug trials are going in at different parts of the country at present. The agents operating hand in glove with the large companies and CROs recruit illiterate and uninformed subjects for the drug trials just for some money. It is also reported that the human subjects procured for trials are rarely informed about its adverse and sometimes fatal effects of the trials.

The ICMR survey is an attempt on the part of the country's premier medical research institution to understand and evaluate the processes and the quality of informed consent obtained from the participants enrolled in the ongoing clinical trials in the country. The obligation of the researcher is to provide all relevant information in detail to the participants about the study. The process of the informed consent is not merely taking signature of the participants but to ensure proper understanding about the study.

The study will be funded by "World Health Organization" (India Country Office), and is being conducted by the Bio-Ethics Cell of the ICMR.

About 10 clinical trials funded by ICMR have been identified as the participants. The study will facilitate the ICMR to better understand the process, acknowledge the difficulties faced by the researcher and formulate strategies to improve upon the same. The study would be useful in improving the understanding of informed consent process and evolve better strategies for future. The survey comes close on the heels of another survey on 'ethics committees of the research institutions in the country'.