The Indian Council of Medical Research (ICMR) has announced a significant reform to expedite ethics approvals for clinical research across India. Through its new Single Ethics Review (SER) model, the ICMR seeks to reduce the prevalent delays and duplication in trials conducted at multiple institutions.
Under the existing system, each participating institution in a multi-center study was required to conduct its own independent ethical review. This often resulted in repetitive submissions, prolonged approval times, and inefficient resource allocation, particularly for studies spanning various states and hospitals.
Addressing Inefficiencies in Multi-Centre Studies
The ICMR observed that the previous multi-committee review process frequently led to inconsistencies and delays without substantially enhancing participant protection. Ethics committees were increasingly burdened with coordination tasks rather than focusing solely on core ethical oversight.
This isn't the first attempt at reform. In 2023, the ICMR's Joint Ethics Review Guidelines proposed a virtual common review. However, operational and logistical challenges hindered its widespread adoption.
How the Single Ethics Review (SER) Model Works
The new SER framework, an addendum to the ICMR’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, assigns the full review responsibility to a single designated ethics committee. A coordinating principal investigator will submit a common proposal to this committee, which will then issue a consolidated decision and oversee monitoring, protocol deviations, and adverse event reporting across all participating sites.
Committees taking on this central role must meet specific eligibility criteria, including having trained members, robust digital infrastructure, and prior experience managing large multi-center studies.
Broad Scope and Expected Benefits
The framework encompasses a wide array of biomedical and health research, including clinical trials for drugs, vaccines, biologics, and medical devices, as well as genomic studies, epidemiological research, and public health surveys involving health data and biological samples. Regulatory clinical trials will continue to adhere to the Drugs and Cosmetics Act and the New Drugs and Clinical Trial Rules, 2019.
The SER mechanism is expected to streamline the ethical review process while maintaining strict participant protection and regulatory compliance. Moreover, it aims to boost participation from underserved and geographically remote populations by allowing field units and community health centers without their own ethics committees to join multi-center studies under a central approval. This will help generate more representative evidence for healthcare policy and treatment decisions.
Despite the move towards a centralized approval mechanism, the ICMR emphasized that participant safety, informed consent, privacy safeguards, and continuous monitoring will remain paramount throughout the review process.