The proposed Biomedical Research Human Subjects Promotion and Regulation Bill has been cleared by the Law Ministry and has reached the Health Ministry. The Union Health Minister has to review the bill and place it before the Cabinet, Dr Vasantha Muthuswamy, senior deputy director general of ICMR told Pharmabiz.

The guidelines and the bill have been drafted by the Indian Council of Medical Research (ICMR) and a Supreme Court judge, respectively. Once the bill is passed by the Cabinet, it will become mandatory for all institutions conducting human research to get registered by a central agency. The ethics committees in individual institutions would also have to get registered with the agency.

Though a specific time frame cannot be set at the moment, but things will progress once the Health Ministry will approach the Cabinet for its nod and the Bill is finally passed, Muthuswamy added.

The Council for International Organisations of Medical Sciences (CIOMS) brought out the 'International Guidelines for Ethical Review in Epidemiological studies' in 1991 and 'International Ethical Guidelines for Biomedical Research involving Human subjects' in 1993. Over the years, various bodies in national jurisdictions have also laid down general and specific principles in specific areas of scientific research entailing the use of human beings as subjects in medical research. These national codes (drawn from the international codes and the universal principles underlying them) sketch guidelines to be followed in their respective jurisdictions.

The need for uniform ethical guidelines for research on human subjects is universally recognised. Indeed, it has acquired a new sense of urgency as the critical issues in the areas of biogenetic research involving human subjects have become acute. Apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced which involve human subjects.

Further, the advent of new medical devices and radio-active materials, and therapeutic benefits of recombinant DNA products have added a new dimension to the ethical issues that need to be considered before evaluating these for their efficacy, utility and safety.

The Indian Council of Medical Research (ICMR) had brought out in February 1980, a document entitled 'Policy statement on ethical considerations involved in research on human subjects' prepared by the ethical committee under the chairmanship of Justice HR Khanna. This document is being widely used by not only ICMR but also by other government agencies, research institutions and scientists. The document, however, needs to be updated in view of the recent developments in modern biology as also in different branches of medical science so as to add to its contemporary relevance.

Therefore, a Central Ethics Committee on Human Research (CECHR) was constituted under the chairmanship of Justice MN Venkatachaliah by the then director general, Dr GV Satyavati to consider various issues related to the ethical, legal and social dimensions of research involving human subjects. The committee first met on 10th September, 1996 and identified major areas and set up sub-committees of experts for drawing up a set of guidelines that included clinical evaluation of drugs, devices, diagnostics, vaccines, herbal remedies, epidemiological research, human genetics research, transplantation research, including foetal tissue transplantation and assisted reproductive technologies.

The CECHR met on 10th August 1997 to consider the draft guidelines prepared by all the five groups and a draft consultative document was prepared for wide circulation and subsequent regional and national debates before finalisation. A series of four regional public debates at Kolkata, Mumbai, Hyderabad and New Delhi on the draft consultative document were conducted in the years 1998-99.

The Central Ethics Committee on Human Research (CECHR) of the Indian Council of Medical Research has laid down ethical guidelines for biomedical research on human subjects in September 2000. It is expected that all institutions in the country which carry out any form of biomedical research involving human beings should follow these guidelines and spirit to protect the safety and well being of all individuals who participate in such research for the progress of science through acquisition of new knowledge.