All institutions conducting biomedical and health research are now required to have an ethics committee, according to the new rules specified by the Indian Council of Medical Research (ICMR).
These committees have to be constituted in line with the ICMR's National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. The idea is to “safeguard the safety, rights and welfare of research participants”.
The rules are part of the New Drugs and Clinical Trials Rules, 2019, notified earlier this week. The requirement for having a ethics committee will apply to all institutions including medical colleges, research institutions, universities, public- or private-funded institutions and non-governmental organisations.
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“The ethics committees shall review the research before initiation, and oversee the process through the entire duration of the research,” an ICMR statement said. 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 inclusions of clauses to govern biomedical and health research in the New Drugs & Clinical trials Rules, 2019, will bring the much-needed transparency and accountability in the regulation of biomedical and health research in India,” said Dr Balram Bhargava, Secretary, Department of health research and director general, ICMR. Bhargava said that this would help improve the "quality of research outcomes" and ensure protection for research participants.
