ICMR moves to speed up approvals for clinical trials. A look at key guidelines

In a bid to reduce delays and duplication in clinical trials conducted across multiple hospitals and institutions, the Indian Council of Medical Research (ICMR) has introduced a new framework to streamline ethics approvals for clinical research in India.

The new Single Ethics Review (SER) model allows one designated Ethics Committee to approve a clinical study on behalf of all participating sites, replacing the current practice where each institution conducts its own independent review of the same study. The framework is an addendum to ICMR’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

ICMR said the existing system often led to “duplicative submissions, delayed approvals and wastage of resources”, particularly in studies spanning multiple institutions and states. The guidelines noted that in multi-centre research, “repeated ethical review of the same protocol by multiple Ethics Committees often leads to inconsistencies, inefficiencies and delays without substantial additional protection to research participants.”

The council also observed that ethics committees had increasingly become engaged in coordination work rather than core ethical oversight, with limited additional value for participant protection.

This is not the first attempt at reform. ICMR’s Joint Ethics Review Guidelines issued in 2023 had proposed a model under which multiple ethics committees would participate in a common virtual review process to arrive at a harmonised decision. However, operational and logistical constraints limited wider adoption. The new framework goes a step further by placing the review responsibility entirely with one designated committee.

The framework covers a wide range of biomedical and health research, including clinical trials of drugs, vaccines, biologics and medical devices, as well as genomic studies, epidemiological research, public health surveys, and studies involving health data and biological samples. Regulatory clinical trials will continue to remain governed by the Drugs and Cosmetics Act and the New Drugs and Clinical Trial Rules, 2019.

Under the new system, a coordinating principal investigator will submit a common proposal to the designated ethics committee, which will conduct the review, issue a consolidated decision, and oversee monitoring, protocol deviations and adverse event reporting across all participating sites. Committees taking on this role must meet eligibility criteria related to trained members, digital infrastructure and prior experience in handling large multi-centre studies.

“The SER mechanism seeks to streamline the ethical review process while maintaining participant protection and regulatory compliance,” the guidelines stated.

The framework is also expected to improve participation from underserved and geographically remote populations in clinical research. Field units, community health centres and outreach locations that previously lacked access to multi-centre studies because they did not have their own ethics committees can now participate under the approval of a central committee. ICMR said this would help generate more representative evidence for healthcare policy and treatment decisions.

The council added that participant safety, informed consent, privacy safeguards and continuous monitoring would remain important to the review process despite the move towards a centralised approval mechanism.