By Melinda Young
Academic institutions are grappling with ensuring their IRBs are prepared for the January 2020 deadline to move multisite research to a single IRB. This deadline looms over all policy and procedural changes.
“There are plenty of institutions out there that are not ready for this change,” says Ann Johnson, PhD, MPH, CIP, IRB director and adjunct professor at the University of Utah
The evolution to a single IRB will be tough on human research protection programs (HRPPs) and IRBs for a while, predicts Julie Ozier, MHL, CHRC, CIP, director of the HRPP at Vanderbilt University and Medical Center.
“I think it’s going to be a mass of confusion for a while, until it gets settled down,” Ozier says. “Last year, you were allowed to transition studies that met certain criteria to the new Common Rule. But in January, when a single IRB review requirement goes into effect, all those studies will have to comply.”
Until 2020, the transition will involve exempt or expedited studies. Starting on Jan. 20, 2020, those studies will need to use a single IRB. IRBs might not be prepared for the January deadline, Ozier says.
“There are a lot of people who got caught in wanting to transition studies to the new Common Rule because it results in fewer reviews for investigators,” she says. “But now they’re at that point and have to go backward and convert that to a single IRB.”
Even if researchers are not enrolling participants in a study, they will have to transfer the study to a single IRB, Ozier says. “It’s a narrow niche that will trip up a lot of people,” she adds.
Several groups representing research institutions wrote to the Office for Human Research Protections (OHRP), expressing concern that OHRP’s deadline for cooperative research and use of a single IRB will apply to studies that began before that date.
“In the absence of prompt and clear guidance, institutions will be forced to begin complying with an interpretation that runs counter to the best interests of the federal government and the U.S. research enterprise or will be out of compliance beginning Jan. 20, 2020,” reads the May 1, 2019, letter written by the Association of American Medical Colleges, the Association of American Universities, and the Association of Public and Land-grant Universities to OHRP’s Jerry Menikoff, MD, JD. (The letter is available online at: http://bit.ly/2osViRp.)
Over the years, the University of Utah has focused on single IRB processing, Johnson says. “We’re ready and have been ready for a while, so we’re not afraid of this transition,” Johnson adds. “We have the infrastructure and skills, and we know how to do this.”
The single IRB and Common Rule changes also affect how IRBs handle informed consent. “One of the things we did because of the revised Common Rule and single IRB is we got rid of our consent template, which is a very bold thing to do,” Johnson says. “We don’t need a consent template to be a compliant IRB. The reason we got rid of our consent template is because we wanted to get rid of this notion that a consent form is supposed to look a certain way. It’s not.”
The idea is to re-engineer notions and ideas about informed consent so that study personnel do not believe consent forms should look one precise way, Johnson explains.
“As long as the informed consent document says the things the Common Rule says it needs to say, then you have a consent form and it works,” she says.
Under the Common Rule changes, IRBs should make decisions about informed consent up front, Ozier suggests. “Decide how it’s going to be handled and be flexible because it could change over time,” Ozier says. “You have to decide who is going to do what and when, on a study-by-study basis, which is different from what institutions are used to.”
In the new Common Rule era, it would be helpful for IRBs to let go of preference-based changes to the informed consent document, Johnson notes. Preference-based changes involve how an informed consent form looks or how certain sentences and paragraphs are structured, she explains.
“These preferences don’t have any basis in criteria for approval or federal regulations, or are related to institutional policies,” Johnson says. “These preferences are just how the IRB likes it.”
It is more efficient to let go of those personal preferences and focus on what is important. “At Utah, we help our staff, research personnel, and other reviewing IRBs understand there is a difference between policy vs. preference on what the informed consent says,” Johnson says. “It’s easier for my staff to review an informed consent if it looks like the ones they’re used to, but that doesn’t mean it shouldn’t be approved by the IRB.”
Instead, IRBs can give investigators research language that is specific to policies and teach IRB members and HRPP staff how to understand the difference between quality and preferences, she adds.
For IRBs that are not ready for the single IRB world, there are modifications they might need to make, Johnson says. “We needed to modify our electronic system for submissions, and we had to retrain all of our staff and investigators,” she explains. “It took a lot of time. It’s a daunting task.”
Keep in mind that no one is expected to make this transition perfectly on day one, Johnson notes. “We’re all in a learning process of what best practices for a single IRB are, and it’s OK if we’re still learning and making things better after that effective date,” she says. “I’m hopeful that people will take courage that we’re all in this together, even after the effective date, and we’ll still work on this and make it a good process.”
The takeaway message is to be prepared as well as possible, but to accept the need to keep learning more about the transition after the effective date, Johnson adds.