Ten years of Central IRB review for an NIH-funded large clinical trial network by an academic IRB: The NIH StrokeNet experience

TL;DR

This paper describes how a university-based IRB successfully managed ethical reviews for a large NIH-funded stroke research network over ten years.

Contribution

Demonstrates the effectiveness of an academic-based Central IRB in managing a large clinical trial network.

Findings

The UC StrokeNet Central IRB approved 16 studies since 2014.

Review processes were refined to improve efficiency while protecting participants.

An academic IRB can effectively serve as a Central IRB for a large clinical trial network.

Abstract

In 2013, the National Institute of Neurological Disorders and Stroke established National Institutes of Health (NIH) StrokeNet to support multi-site clinical trials focused on stroke prevention, treatment, and recovery. The University of Cincinnati (UC) serves as the National Coordinating Center for StrokeNet. As part of the initiative, the UC StrokeNet Central IRB (SN-CIRB) was established at UC to serve as a single IRB to oversee StrokeNet trials. Since the SN-CIRB approved the first StrokeNet study in 2014, it has reviewed and approved 16 additional studies. Over this period, the UC Human Research Protection Program refined its review processes based on insights from earlier reviews. These improvements have improved efficiency while still ensuring the protection of study participants. The successful implementation and ongoing conduct of the SN-CIRB at UC demonstrate that an academic-based IRB can effectively serve as a Central IRB for a large clinical trial network.

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