June 21, 2016: Streamlining the Institutional Review Board Approval Process to Accelerate New Treatments for Patients

A colleague here at NCATS received devastating news last year: Her 4-month-old grandson had been diagnosed with a rare brain tumor. The cancer failed to respond to first- and second-line chemotherapy, but molecular testing of the tumor revealed a target for which there was a potential treatment. The drug, however, was not widely available to children so young, so the boy would need to be enrolled in a clinical trial. The good news came that there was such a trial, raising the family’s hopes for an effective treatment. But then they learned the bad news: The trial was stalled due to problems getting multisite institutional review board (IRB) approvals. The child’s mother crystalized the issue with her response: “I don’t understand. Don’t they know brain tumors don’t wait for IRBs?”

One of the longstanding challenges for clinical research is the process of obtaining human-subjects approval from multiple IRBs for clinical studies. Researchers cannot begin recruiting participants until an IRB reviews and approves the protocol for conducting research on human subjects. When the same protocol is reviewed by many different IRBs in a multisite study, the redundancy of this process can lead to long delays. No disease waits for IRBs or other obstacles that slow clinical research. Time, for my colleague and her family — and so many others — really can mean a life.

NCATS’ mission is to develop solutions to these kinds of systemic, previously intractable translational science problems. Through its Clinical and Translational Science Awards (CTSA) Program, NCATS develops, demonstrates and disseminates approaches to improve and streamline clinical studies. One way to do this and to provide more consistent, high-quality IRB reviews is for all sites participating in a multisite clinical study to rely on the review of a single IRB. Such “IRB reliance” would mitigate a major roadblock to the translation of research discoveries into health benefits.

Given its potentially transformational impact, we at NCATS made the creation of a national single-IRB platform a top priority, and I am now proud to announce the fruit of these labors: the launch of the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform. The SMART IRB Reliance Platform is designed to provide a flexible prototype that can easily be used by any clinical research network or even a single investigator wishing to conduct a multisite clinical study. It will serve as a roadmap to help implement NIH’s requirement that all NIH-funded multisite clinical studies use a single IRB.

SMART IRB Reliance Platform builds on the successful experiences of several NIH central IRB initiatives and those of multiple regional CTSA Program networks, including a CTSA Program demonstration project called IRBrely. The bold, game-changing SMART IRB concept never could have come to fruition without the collaborative, team and trust-based relationships that CTSA Program investigators have built over many years in their efforts to improve clinical and translational science. As we like to say around here, “translation is a team sport,” and never was this more true than in the development of SMART IRB.

NCATS will continue to collaboratively develop, test and disseminate SMART IRB as a trusted national standard for single IRB reliance for clinical studies. This advance promises to help the countless patients — such as my colleague’s grandson — who so desperately need new therapies.

Christopher P. Austin, M.D. 
National Center for Advancing Translational Sciences