CTSA programme sites sign NIH’s SMART agreement for single IRB model

26th March 2017 (Last Updated March 26th, 2017 18:30)

All sites in the clinical and translational science awards (CTSA) programme have signed on to the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS) streamlined, multisite, accelerated resources for trials (SMART) institutional review boards (IRBs) authorisation agreement.

All sites in the clinical and translational science awards (CTSA) programme have signed on to the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS) streamlined, multisite, accelerated resources for trials (SMART) institutional review boards (IRBs) authorisation agreement.

The policy and programmatic initiative for one IRB is expected to streamline the delay of trials that might be caused due to the presence of different IRBs at different sites of a multi-centre clinical trial.

The SMART IRB authorisation agreement includes a total of more than 150 medical research institutions and will enable all participating study sites to depend on the review of single IRB for each study.

The initiative could be beneficial for patients waiting to enrol in a study due to the possibility that the initiation of multisite trials can be completed within weeks instead of months.

"This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly."

NCATS director Christopher Austin said: “This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly.

“It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”

The agreement will serve as a model to assist investigators in adhering to the NIH’s policy on single IRB use for multisite studies.

Designed to improve IRB efficiencies, the policy will ensure the protection of the participants and expedite the research process.

The agreement will additionally offer the foundation for NCATS’ trial innovation network central IRBs.