Indian Council of Medical Research (ICMR) has launched a survey to 'understand the status, functioning and performance of ethics committees of the research institutions' in the country. The World Health Organisation is expected to fund the project.
Titled 'ICMR-WHO project: status of ethical review in registered clinical trials and clinical research in India', the survey in its first phase will focus on the about 188 ongoing clinical trials and clinical research studies being funded by ICMR. In the second phase, the projects being funded by other agencies will come under the scanner of the ICMR to verify whether these research institutions have constituted ethics committees.
ICMR sources said that the main purpose of the survey is to help understand and evolve ways of strengthening the ethical review processes 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.
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 has been 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.
This research study is being conducted by the Bio-Ethics Cell of the ICMR and is funded by WHO (Country Office- India). In this study it is proposed to understand the status, functioning and performance of Ethics committees of institutions being funded by the Indian Council of Medical Research.
Without mincing words ICMR sources admitted that several research institutions in the country are violating the guidelines on the issue of constituting ethics committees. The ICMR has already sent more than 1000 forms to different research persons so far and it has received around 250 replies. In many cases, the institutions have formed an ethics committee. But, there are several cases where the ethics committees are not working properly, sources said.
The ICMR has already drafted a bill called Biomedical Research Human Subjects Promotion and Regulation Bill which is yet to be cleared by the Union Cabinet. 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.
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.