All institutions wanting to conduct biomedical and health research will now be required to have an ethics committee that will monitor it and review the study before initiation, according to new guidelines issued by the Indian Council of Medical Research (ICMR).

The aim is to safeguard safety, rights, welfare of research participants, a senior official said. The ICMR National Ethical Guidelines for Biomedical Research have become mandatory and need to be followed for all biomedical research in the country as per the New Drugs and Clinical Trials Rules, 2019, released recently by the Ministry of Health, the official said.

This is for the first time the biomedical and health research is going to be regulated through the ethics committee and a system is being set up by the ministry. The Ministry of Health has designated the Department of Health Research as the authority for registration of ethics committee that reviews such research works and thereby helps in safeguarding the safety, rights, welfare of research participants.

The committee shall be required to register with the authority and the registration would remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the authority. The ICMR National Ethical Guidelines will guide the ethical requirements for all institution that are engaged in such research works whether it is medical colleges, research institutions, universities, public or private funded institutions, non-governmental organisation or others.

Dr Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR, said these inclusions of clauses to govern biomedical and health research in the New Drugs & 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 protection of research participants and responsiveness to the health needs of our people," he said.