ICMR Makes Ethical Guidelines for Biomedical Research Mandatory - ACRI India

The Indian Council of Medical Research (ICMR) has issued certain National Ethical Guidelines for Biomedical Research, which has now become mandatory. Every biomedical research in the country needs to adhere to these guidelines, as per the New Drugs and Clinical Trials Rules 2019. These new rules had been recently released by the Ministry of Health and Family Welfare, Government of India.

This compulsion will be effective after 180 days from the date of publication of Gazette. The details are included under clauses 15, 16, 17, and 18 under Chapter IV of the New Drugs and Clinical Trial Rules. It is for the first time that biomedical and health research will be regulated through the ethics committees. The system is being set up by the Ministry of Health and Family Welfare, which has designated the Department of Health Research as the authority of registration of the ethics committee that review such research. This helps to safeguard the rights, safety, and welfare of the research participants.

It is important that any institution or organization that intends to conduct biomedical and health research should be required to have an ethics committee that has been established. This ethics committee will be required to function and maintain records in accordance to the National Ethical Guidelines for Biomedical and Health Research, involving human participants, 2017. The ethics committee is required to review the research before initiation, while also overseeing throughout the duration of the research. They are also required to register with the authority, with the registration remaining valid for a period of five years from the date of issue. However, this registration may be suspended or cancelled by the authority, which means a stop on the five year period.

The National Ethical Guidelines for Biomedical Research will guide the ethical requirements for all institutions that are engaged in such research, may it be medical colleges, universities, research institutions, public or private funded institutions, or non-governmental organizations. Dr. Balram Bhargava, Secretary at the Department of Health Research, and Director General at ICMR commented on the move saying, “The inclusions of clauses to govern biomedical and health research in the New Drugs and Clinical Trials Rules, 2019 will bring about the much-needed transparency and accountability in the regulation of biomedical and health research in India. This would help to improve the quality of research outcomes while ensuring the protection of research participants and responsiveness to the health needs of our people.

With such improvement in quality of research outcomes, the entire outlook of the clinical research industry in India is set to change. With such changes, the clinical research career scenario for Indian students is also set to change. So, if clinical research interests you and the healthcare of your Indian fellowmates happens to be your passion, make sure you get top clinical research training in Bangalore at the earliest from a reputed organization like Avigna Clinical Research Institute. This training will give you an official certification that will help you earn the best careers in clinical research in the future.