CDSCO seeks views on single ethics review model for multicentre trials

The consultations, scheduled for August 28, follow new ICMR guidelines proposing that a single Ethics Committee review all participating sites in multicentre research

The Central Drugs Standard Control Organisation (CDSCO) has announced stakeholder consultations later this month to obtain inputs and comments regarding the implementation of a single ethics review for multicentre research for clinical trials of new drugs.

 

An ethics review includes conducting a study across multiple institutions or sites using a common protocol to address shared research questions.

 

Scheduled for August 28, the consultations come against the backdrop of the Indian Council of Medical Research (ICMR) introducing new rules to lessen the operational and logistical challenges faced in the current model.

 

The new guidelines propose delegation of the responsibility for ethics review of all participating sites in multicentre research to a single Ethics Committee (EC) located at one mutually agreed-upon study coordinating site among all the participating sites.

 

Earlier, the ICMR’s National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, had introduced a common ethics review approach for multicentre research, suggesting that a designated EC conduct the common ethics review and provide recommendations that are shared with local ECs.

 

The local ECs could then conduct an expedited review focusing only on site-specific issues before issuing approvals at individual sites.

 

In 2023, the ICMR Joint Ethics Review Guidelines proposed a joint ethics review approach, in which a designated EC convenes a single virtual meeting to reach a harmonised decision, with the individual ECs having an opportunity to utilise breakout rooms for discussions around site-specific issues.

 

“However, significant operational and logistic constraints have made the widespread adoption of either of these models elusive,” the ICMR stated in its 2026 addendum to its ethical guidelines of 2017.

 

The addendum also pointed out that these models have other challenges, including multiple separate reviews of the same protocol leading to duplicative submissions, delayed approvals and wastage of resources.

 

Similarly, differences in risk categorisation, informed consent and protocol requirements have resulted in poor harmonisation and non-uniform implementation of study procedures.

 

The new single EC norm also comes at a time when the CDSCO has increased surveillance of clinical trials.

 

The central drug regulator had recently cancelled the registration of seven ECs across India over significant deficiencies and major regulatory non-compliance with the New Drugs and Clinical Trials (NDCT) Rules of 2019.

 

According to sources, several of these ECs had not correctly reported cases of serious adverse events (SAEs) in human trials conducted under their purview.

 

Experts add that a serious challenge for a single ethical review model could be the effective implementation of NDCT Rules across multiple ECs at local sites.