Leveraged wisely by those who understand when and how to best use it, single institutional review board (IRB) review for multisite studies can be employed by clinical trial practitioners to garner faster approvals for clinical studies of vital drugs and other treatments, says Barbara E. Bierer, MD, director of the Regulatory Foundations, Ethics, and the Law Program for Harvard Catalyst, the Harvard Clinical and Translational Science Center.
However, it’s not a path to be taken lightly or without adequate preparation. It’s vital for all involved to ensure principal investigators (PIs) and others on the study team understand their unique roles and responsibilities, explains Bierer, who is also faculty director for the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard and a professor of medicine with Harvard Medical School.
“Some PIs may be involved in a limited number of protocols or studies, and [single IRB scenarios for multisite studies] can be a rarer situation for them where they may not be clear” on the scope of their responsibilities, compared to working with an IRB at their home institution, Bierer says.
She’s a big advocate of SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials), designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.
SMART IRB is not an IRB; rather, it’s a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB’s Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Investigators and their study teams, together with institutional and IRB/human research protection program (HRPP) offices, use the SMART IRB platform to initiate single IRB review of a study.
Through smartirb.org, investigators, study team members, and IRB/HRPP administrators and staff can access essential education as well as flexible tools and resources designed to support the adoption and implementation of single IRB review for a range of studies.
Launched in 2016, SMART IRB is funded by the National Institutes of Health’s (NIH’s) Clinical and Translational Science Awards Program. The platform serves as a roadmap for institutions to implement the NIH’s Policy on the Use of a Single Institutional Review Board for Multisite Research, effective since January 2018, though SMART IRB may be used for any study that is eligible for IRB reliance, regardless of funding source, size, or status.
“It’s all about getting medications and treatments to patients faster without compromising patient protections,” Bierer says. “With adequate oversight, it can decrease the burden on the clinical trial workforce” and produce more efficient trials, she adds.
Author: Michael Causey