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 The Indian Council of Medical Research (ICMR) has sought public consultation on Draft Operational Guidelines for Single Ethics Review of Multicentre Research in India.
Multicentre research involves conducting studies across multiple sites under a common protocol to address shared research questions, enabling strategic pooling of expertise, resources, and infrastructure. However, existing ethics review processes for multicentre studies in India often involve multiple site- specific reviews, resulting in duplication of effort, inconsistent ethics review decisions, and delays in study initiation.
To address these challenges, the ICMR Bioethics Unit has developed the Draft Operational Guidelines for Single Ethics Review of Multicentre Research in India. The document is being posted on the ICMR website for public consultation until March 06, 2026 (5:00 pm), and interest-holders may provide their comments, suggestions, or feedback.
Multicentre research spans a wide range of biomedical and health research domains, including basic or applied research, genetic and genomic research, epidemiological and population-based studies; implementation and health systems research; public health surveillance and survey-based research, and studies involving the secondary use of data and biological samples; multicentric clinical trials of drugs, biologics, vaccines, and medical devices; investigator-initiated clinical studies among others across institutions. Multicentre research is also increasingly conducted through national/ regional networks, often involving institutions with varying capacities and diverse socio-cultural contexts.
In India, multicentre biomedical and health research is being conducted after seeking ethics approval from the Ethics Committee (EC) at each participating site, a process that has often resulted in delays. To streamline this, the ICMR National Ethical Guidelines (2017) introduced a common ethics review approach, wherein a Designated Ethics Committee conducts the common ethics review and provides recommendations which are shared with site ECs.
The site ECs then conduct an expedited review focusing only on site-specific issues before issuing approvals at individual sites. Subsequently, the ICMR Joint Ethics Review Guidelines (2023) proposed a joint ethics review approach, in which a Designated EC and participating ECs convene in a single virtual meeting to reach a harmonised decision where individual ECs have an opportunity to utilise breakout rooms for discussions around site-specific issues.
To overcome these systemic barriers, a single ethics committee review mechanism for multicentre biomedical and health research, supported by clear and operational guidance, is warranted to streamline ethics review.
A single ethics committee, identified from among the participating sites, would undertake a comprehensive ethics review of the complete multicentre research protocol, including all core and site-specific documents. The review would consider national, regional, and local contexts, ensure scientific robustness while focusing on strengthening the ethical and participant-protection aspects of the study across all participating sites.
Following the review, the single ethics committee would provide consolidated comments and recommendations to the principal investigator who would address these comments, revise the protocol and related documents as required, and resubmit them for further consideration.
Upon receipt of satisfactory responses, the single ethics committee would grant an ethics approval, which would be applicable to all participating sites of multicentre research. This approach must be anchored in trust in the competence, independence, and impartiality of a single ethics committee, and in a shared commitment among participating sites to recognise, rely upon, and implement its decisions. Effective implementation requires mutual trust, cooperation, and coordination among all participating institutions, while noting the fact that the ethics committees are duly registered with the central authority and thereby have established composition with set ethics review procedures to undertake a quality ethics review.
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