All 64 member institutions of the NIH's Clinical and Translational Science Awards program have agreed to a common framework for running multisite trials under the umbrella of just one Institutional Review Board. The NCI has long offered a centralized review board option. Come September, single Institutional Review Boards will be mandatory for all NIH-backed studies.
The NIH has taken a major step toward ensuring that all multisite trials funded by the agency, including those involving patients with cancer, no longer have duplicative and often superfluous oversight.
The NIH's National Center for Advancing Translational Sciences (NCATS) announced last month that all 64 medical research institutions funded through the agency's flagship Clinical and Translational Science Awards (CTSA) program—a $500 million per year effort to move biomedical discoveries into the clinic—had agreed to a legal structure for ceding reviews of human studies conducted at multiple sites to a single Institutional Review Board (IRB). Nearly 100 other medical centers in the United States have also signed on to NCATS's SMART IRB initiative.
Short for “Streamlined, Multisite, Accelerated Resources for Trials,” the SMART IRB platform is aimed at reducing administrative red tape and ensuring consistency in study plans and consent forms across all sites involved in a study. “Time can be life in this instance, especially in cancer,” says Petra Kaufmann, MD, director of both the Division of Clinical Innovation and the Office of Rare Diseases Research at NCATS. “We want to move away from that multiple review process to a single IRB.”
Streamlining IRB oversight isn't an entirely new idea. For more than 15 years, NCI-funded trials have had the option of going through the agency's Central Institutional Review Board (CIRB). Initially developed for phase III adult oncology trials, the CIRB has expanded to include pediatric, early-phase, and prevention trials.
The NCI review board has yielded considerable savings, in both time and money, for participating institutions. However, CIRB participation has always been voluntary, and investigators of NCI-sponsored trials can choose to go through their own institution's oversight board instead.
Beginning in September, the NIH is scheduled to enact a policy that all agency-funded multicenter clinical studies will have to abide by one IRB, and smoothing that transition is a task that's fallen to NCATS (available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html).
In addition to the SMART IRB platform—which Kaufman describes as something akin to a treaty or general framework—NCATS is also copying the NCI model and offering centralized IRB services of its own for CTSA-funded investigators. Last year, the center funded three Trial Innovation Centers: one at Johns Hopkins and Tufts Universities, one at the University of Utah, and one at Duke University and Vanderbilt University Medical Center. As with the NCI CIRB, researchers can opt to use one of the centers' IRBs. Alternatively, they can meet the new NIH mandate by picking any other IRB of record to review a particular trial, such as one at an institution participating in that clinical trial, or, for cancer trials, the NCI.
Many cancer researchers applaud the effort to bring ethics reviews for every trial under one umbrella. “When you have a well-designed, well-constructed, multicenter clinical study with a model consent form that's been carefully crafted, the likelihood that a local IRB makes any substantive changes to either the protocol or the consent form is extremely small,” says Richard Schilsky, MD, chief medical officer of the American Society of Clinical Oncology.
However, Bruce Gordon, MD, a pediatric hematologist-oncologist and executive chairman of the University of Nebraska Medical Center's IRB in Omaha, worries that the NIH is rushing to implement its single IRB policy—which had been slated to go into effect in May but has been pushed back to September 25—without giving institutions the time to figure out how best to integrate off-site IRBs with other considerations of their Human Research Protection Program, such as biosafety, conflicts of interest, and patient privacy.
“With that said, I'm in favor of cooperative review and single-IRB models,” adds Gordon, who once chaired the NCI's pediatric CIRB. “For the most part, it's going to be better than the system we have now, but it's not a panacea, and it does require thinking about these other considerations.” –Elie Dolgin
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.