New NIH policy calls for a single IRB for multi-site clinical research
A newly issued policy from the NIH requiring a single institutional review board (IRB) for NIH-funded multi-site research may be a step toward an industry-wide mandate of centralized IRB review in the future.
The goal of the policy, which will take effect May 25, 2017, “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,” according to the NIH. When the policy was proposed last December, it garnered more than 150 comments, most in favor and some against.
“This policy only affects NIH-sponsored trials, so its immediate impact will be limited,” said Cami Gearhart, CEO of Quorum Review IRB. “On the other hand, this could well be the first in a series of regulatory changes,” including the pending Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule and the 21st Century Cures Act.
The NIH policy states: “Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects’ protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.”
But the extent to which this enhancement will occur is somewhat unclear. Those who support the policy say a single IRB will save time and money by eliminating duplication of effort, and that no additional subject protection is gained by having multiple IRB reviews. Those who question the policy say it is too broad in scope, that there is no firm evidence a central IRB review will save time and money and that the administrative burden on sites may increase rather than decrease.
“I see small and medium-sized IRBs who are participating in NIH-funded studies to be more negatively impacted. Their workload will supposedly shrink, but in actuality, it may not be,” said Parker Nolen, IRB manager at Community Health Network IRB. “You have to have somebody on the inside coordinating these reviews and maintaining the proper approvals. What is perceived to be more of a streamlining process is going to turn into perhaps a burden for the smaller institutions.”
Academic centers and hospital networks may be most affected by the new policy and have to make the most adjustments for the federally funded studies, experts say. Some are preparing to build their own central IRB programs, but “it’s a very complex and expensive undertaking to oversee clinical trials in multiple jurisdictions,” Gearhart pointed out.
“I think this really is the start of some seismic changes in our industry and how we are going to be able to engage at an institutional level for human subject protection,” Nolen said. “I think we’re going to see a lot of IRBs pop up onto the landscape. I think we’re going to see many of those IRBs institutionally based, if that institution is a large academic center or a hospital healthcare network.”
Although larger IRBs may be at an advantage with the new policy, some say certain smaller IRBs could also fare well. Ellen Kelso, executive director of Strategic Development at Chesapeake IRB, points to IRBs that are well-positioned with the communication systems and infrastructure in place to handle review in multiples across different geographical regions in the U.S.
“Not every tiny IRB is without agility,” she said. “IRBs have picked the places that they serve. There may be a small IRB that has served across a broad scope, and I wouldn’t want to take them off the map. There are a lot of very capable organizations out there.”
Most observers agree that the primary beneficiaries of the single-IRB concept will be patients. “Study subjects will benefit the most,” Gearhart said. “As an independent IRB, we sometimes participate in multi-site trials as the central IRB and at other times we act as just one of the local IRBs—and we clearly have more power to protect study participants when we’re acting as the central IRB.”
Kelso said the NIH requirement also presents an opportunity to review some of the legal focus in the consent form, a document intended to inform subjects about the study’s benefits and risks but is time-consuming to develop when it becomes burdened with legalese.
“Now that we have a call for a single IRB from the NIH, which touches the academic research institutions, an IRB will be right at the center,” she said. “The ability to exert some influence will be likewise strengthened. I think we have an opportunity as a research community to remove, as much as possible, that additional unnecessary legality from the consent document.”
This article was reprinted from Volume 20, Issue 27, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »