Academic medical centers engaged in clinical and translational research have traditionally faced a major dilemma when looking to conduct clinical trials.
“Since centers often don’t have enough study subjects on their own to be able to answer a research question definitively, they need to partner with other centers,” says Alan I. Green, MD, principal investigator (PI) and director of SYNERGY, Dartmouth’s Clinical and Translational Science Institute. SYNERGY is supported by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, which is led by the NIH’s National Center for Advancing Translational Science (NCATS).
But in multisite research, the institutional review board (IRB) approval process, which is in place to ensure that research subjects are appropriately protected, often differs from institution to institution.
“As a result, an enormous amount of time and money can be burned up as centers work to find common terms of agreement—and there’s no evidence that research subjects are protected any better than they would be if a single IRB represented all the institutions involved,” explains Green.
SMART IRB Joinder Now Available
With the recent release of the SMART (Streamlined, Multisite, Accelerated Resources for Trials) IRB Joinder software platform, Green and his team at SYNERGY, in close collaboration with the Catalyst CTSA group at Harvard Medical School, and the CTSA team at the University of Wisconsin-Madison, have taken a major step towards helping the NIH and NCATS reach their goal of centralizing IRB review among the 64 CTSA research centers nationally.
“The SMART IRB Joinder application guides IRB administrators through the process of entering a legal agreement to be part of the SMART IRB network, so that they can use SMART IRB’s standardized platform in future studies,” says Will Haslett, PhD, principal developer of the application and team member of SYNERGY’s Informatics Collaboratory for Design, Development and Dissemination (ic3d)—part of the Biomedical Data Science department at the Geisel School of Medicine.
This application was released on September 15, 2016, and can be found at: https://smartirb.org.
Release of the Joinder application completes the first of two main phases of the SMART IRB project. “The second phase, being led by the Harvard Catalyst group and in partnership with the University of Wisconsin and Dartmouth, is aimed at developing what’s called a cede review tool, which will help PIs establish an ‘IRB of record’ in future multisite studies,” explains Steven Andrews, PhD, director of strategy for ic3d and project director for Geisel’s department of Biomedical Data Science.
A Roadmap for Streamlining, Accelerating Research
The SMART IRB initiative builds on the work of its predecessor project, called IRBrely, which Green and the Dartmouth team led (in collaboration with the teams from Harvard and Wisconsin) from the fall of 2014 to the spring of 2016.
“We were given a supplement to our main CTSA award by NCATS to organize a system for harmonizing and streamlining IRB review across the country,” says Green. “In a highly collaborative effort involving a number of different centers, we were able to establish a master agreement and standard operating procedures which informed our work on the Joinder application.”
As the SMART IRB platform becomes fully implemented it will serve as a roadmap for the country, helping the NIH implement its policy of eventually having all NIH multisite studies use a single IRB, says Green.
“You know, in order to successfully implement the really astonishing discoveries that are going on in medicine, we have to change the way we do things,” he says. “And that’s where an initiative like SMART IRB can really make a difference. It can be part of a major thrust to dramatically speed up, simplify, and hopefully make more efficient, clinical research.”
