Ethics in clinical research-Indian scenario

In this era of globalisation, owing to multi-factorial reasons, India has emerged as a preferred destination for various clinical trials in recent times. As per rough estimates, the money transactions involved in these clinical trials are in the range of $1 billion. Cases alleging unethical practices followed by the doctors in connivance with the pharmaceutical companies have made headlines. About 2000 deaths have also been reported in the last 4 years during various clinical trials, albeit there may be even more owing to number of unreported deaths. Although there exist many regulatory bodies that take care of various ethical issues pertaining to clinical trials, yet it is evident from the recent reporting that these bodies have miserably failed in achieving their objectives. As per the prevailing guidelines in the area of clinical research, every research institute should have an institutional ethics committee and every research proposal should have prior clearance before undertaking the study. The basic principles of ethics are openly violated, not only by the researchers, but also by the ethics committees, which are otherwise supposed to act as a watchdog against any unethical act.

The Medical Council of India has enforced the ‘Indian Medical Council Regulations (Professional Conduct, Etiquette and Ethics)’in 2002 and amended further in 2009. Now, the proposed undergraduate curriculum for medical students ‘Graduate Medical Education-2012’ lays down much emphasis on teaching the topic of ‘ethics’ right from the first year, extending till the final year of medical education. The paper discusses these intricate issues in light of various clinical trials conducted recently in the Indian subcontinent, which allegedly followed different unethical practices. There is a dire need to understand these complicated issues by all the researchers involved in clinical research on human subjects as well as inculcating highest ethical and moral values right from the formative years of education.