Before a clinical trial can begin, an institutional review board (IRB) must determine that the study is ethical and that participants’ rights are protected. This oversight step is crucial, but it can take a long time and delay studies from starting, particularly those at multiple sites.
Recognizing this translational barrier, NIH created the single IRB policy for multisite trials, and NCATS has spearheaded initiatives to implement this policy. Although these efforts have removed redundancy in the IRB process, roadblocks can still delay single IRB reviews. Investigators of the Clinical & Translational Science Institute of Southeast Wisconsin (CTSI) at the Medical College of Wisconsin (MCW) recognized this problem at their NCATS Clinical and Translational Science Awards (CTSA) Program hub. The investigators devised and piloted an innovative approach called Real-Time IRB that reduced the time from study submission to final approval by 70 percent.
It is common for IRB members to have questions or require small changes to a study before they can approve it. The back and forth between the IRB and researchers to resolve issues can take a lot of time. In fact, the MCW investigators found that studies that needed small changes took about 36 days longer to receive approval than studies that the IRB approved upon first review.
The Real-Time IRB approach requires the study team to attend the IRB meeting and discuss their proposed study with the committee. The team leaves the room while the IRB discusses any issues or modifications needed. The study team can then update its documents in a nearby room in “real time” while the IRB discusses other studies on the agenda. Later during the same meeting, the study team shares its changes with the committee for approval that same day.
Read more about this work in the October 2018 issue of the Journal of Empirical Research on Human Research Ethics.
Posted December 2018