What Effect Will the New NIH Policy Have On Multi-Site Research?
In June 2016, the National Institutes of Health (NIH) released a new policy on the use of a single institutional review board for multi-site clinical research. According to the policy, the goal of this policy is to “enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.” The policy goes on to say that they expect this process will “reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects’ protections” as well as “allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.”
Right now, this process is only effective for “non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States,” but the implications of this policy could be far-reaching in the industry. In an interview for CenterWatch Weekly, Cami Gearhart, CEO of Quorum Review IRB said, “This policy only affects NIH-sponsored trials, so its immediate impact will be limited. On the other hand, this could well be the first in a series of regulatory changes.”
Supporters of the policy seem to see the single IRB method as a way to save time and money because it removes duplicate processes that offer no additional protection for clinical research volunteers. Those who are not as staunch in their support question whether the policy will actually reduce costs and shorten timelines because the responsibility for management of the process may be more of a burden on clinical sites and hospitals.
Both sides of the argument seem to agree on one thing, though, patients will benefit the most from this policy because IRBs acting as a central IRB have more power to protect volunteers from consent forms through the trial process.
What impact is this going to have on the industry as a whole in the future?
Right now, there is no concrete evidence; however, this may be a step toward an industry-wide requirement for the use of centralized IRBs in the future. If the policy proves to be as effective as people are hoping by reducing costs and shortening timelines, then we may see it rolled out on a much broader scale. As with everything in the ever-changing biopharmaceutical industry, only time will tell.
