Indian Council of Medical Research (ICMR) will soon submit to the Union health ministry the survey reports which it conducted on 'understand the status, functioning and performance of Ethics committees of the research institutions' in the country. The survey, launched last year, was funded by World Health Organisation (WHO).
The survey, titled 'ICMR-WHO project: status of ethical review in registered clinical trials and clinical research in India', is complete and it will be submitted to the health ministry soon, a senior ICMR official said. However, the official refused to further discuss the findings of the survey.
The survey in the first phase focussed on the about 188 ongoing clinical trials and clinical research studies being funded by ICMR. In the second phase, the survey focussed on the projects being funded by other agencies to verify whether these research institutions have constituted ethics committees.
The main objective of the survey was to help understand and evolve ways of strengthening the ethical review processes in research institutions in the country. The foremost requirement before initiating any new research studies in human participants is to obtain sanction from the ethics committee. This ensures the scientific validity of the study and helps in the protection of right, safety and welfare of the human participants in research. It is the responsibility of the ethics committee to review and accord its approval to a research protocol as per the code of ethical norms.
The need for uniform ethical guidelines for research on human subjects, which is universally recognised, acquired a new sense of urgency as the critical issues in the areas of biogenetic research involving human subjects have become sensitive. 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 involving human subjects.
An appropriately constituted ethics committee should carry out the ethical review after holding a formal meeting involving discussions between the members before reaching a decision. This survey was planned to evaluate the function and the performance of ethics committees which have granted approval for ongoing clinical trials and clinical research in the country.
The survey was launched last year amid reports that several research institutions in the country were violating guidelines on the issue of constituting ethics committees. In many cases, the institutions have formed an ethics committee. But, there are several cases where the ethics committees are not working properly.
The ICMR has already drafted a bill called Biomedical Research Human Subjects Promotion and Regulation Bill which is gathering dust in the Union health ministry. Once the bill gets the Cabinet nod, it will become mandatory for all medical institutions conducting human research to get registered by a central agency. The ethics committees in individual institutions will also have to get registered with the agency.