Updated on 15 October 2012
Therefore, in holding clinical trials are essential, its' equally important to ensure that there is no abuse of the process. Perhaps, historically this goes back to World War II and the Holocaust when various atrocities were carried out on dwarfs and children in the name of clinical experiments. The Nuremberg Code is the outcome of this horrifying experience in the first instance making voluntary consent of the human subject imperative. It requires that experiment should be such that it should yield fruitful results for the betterment of the society and be based on the results emanating from the previous experimentation and knowledge of the disease.
There have been since other similar initiatives, such as, ‘Declaration of Helsinki' being one which seeks to address issues not covered otherwise that of patients undergoing have to be guaranteed the best proven diagnostic and therapeutic methods. One of the greatest aberrations of more recent times is the ‘Tuskegee' incident where 399 black men who were misled that they were being treated for the disease, while clinical studies were conducted for syphilis, leading to death of 28 of these men, and others including their wives and children.
The ‘Tuskegee' incident led to further awareness and concern about the vulnerable populations and groups being identified, such as mentally and emotionally disabled persons, children and requiring that protecting human rights and dignity, full disclosures in the process of individual consent should form the basis of this regime.
In India, the first Indian Ethics Committee was constituted more than 30 years ago when the Indian Council for Medical Research (ICMR) in February 1980 issued the first official guidelines for the formation of Ethic Committees laying down membership criteria and ethical standards for review.
Appendix V to Schedule Y of the Drugs & Cosmetics Act, 1940 contains the provisions which prescribes a procedure and format by which prior informed consent of the volunteer is to be obtained. Rule 5 of the Schedule Y provides for the responsibilities of the Ethics Committee to ensure rights, safety and well being of all trial subjects Before carrying out the trials, the protocol for the same has to be reviewed and approved by the Ethics Committee of the institution in which the volunteers are being subjected to the trial (for example, patients in a hospital).