Many researchers are already familiar with the process of submitting a proposal to the Institutional Review Board (IRB) before starting their work, a process that takes some time before the project can officially begin. A study that was recently published in the Journal of Clinical and Translational Science suggests adding another step before IRB approval could actually help the process move along more efficiently.
The study, called “Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards,” included the Indiana CTSI as one of its sites. During the six-month study, researchers submitted their proposals to a Scientific Review Committee (SRC) before passing it along to the IRB. The SRCs look at scientific quality issues, such as study design, statistical analysis plans, specific outcomes and endpoints. They are meant to complement the regulatory guidelines set by the IRB.
The SRCs reviewed proposals at ten CTSAs across the country. The SRC which was made up of Indiana University faculty (including key members with backgrounds in biostatistics and other specialties) reviewed 18 studies between October 2016 and April 2017 that were tied to research at IU campuses.
Christine Caldwell, program manager of Regulatory Knowledge and Support for the Indiana Clinical and Translational Sciences Institute (CTSI), was one of the authors in the study, and admits she was skeptical at first, because she was concerned it would add too much time to the initial review. Her viewpoint since then has changed.
“The IRB has given us really positive feedback about the impact the SRC is having on these non-reviewed studies,” said Caldwell. “We’ve been pleasantly surprised. It certainly does add some time to the overall review, because it happens prior to IRB review, but overall the IRB thinks the tradeoff is worth it because of the positive impact. Since they hadn’t been peer reviewed, these are the kinds of studies that would go to the IRB and may get provisionally approved or tabled more often, so the impact to timeline is not as great as we thought it may have been.”
Since the pilot, Caldwell says they have kept the SRC going for studies that are investigator-initiated, require biomedical review, greater than minimal risk, and that haven’t been peer-reviewed, with the exception of federally-funded or industry-funded studies. She says they have adjusted the process a bit since then to make it a little more streamlined, but they plan to continue using SRCs, since studies that go through the process will have had scientific quality addressed by the time they reach the IRB.