One of the more sweeping changes in the revised Common Rule is the single IRB policy, which is designed to reduce unnecessary and duplicative review by several IRBs over a multisite human research trial.
However, there will be exceptions to this requirement when the regulations become effective, and there has been some confusion about the difference between a single and a “common” IRB. To address these and other issues, the National Institutes of Health (NIH) recently held a webinar meeting to explain this new approach.
To be compatible with the final revised Common Rule, the requirement to use single IRBs for multisite studies was to go into effect in 2020. However, the rule has been subject to delays and its fate is in question in the current antiregulatory political climate. On Jan. 4, 2018, HHS submitted a notice of “Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.” The implementation of the rule is delayed until July 19. (The notice can be found at: http://bit.ly/2DmNtmT.)
The single IRB policy has become a major theme of the rule revisions, and would likely remain an important aspect in the finalized version.
“All NIH-funded multisite domestic studies involving nonexempt human subjects research are expected to use a single IRB,” said Deysi Duque, PhD, with the NIH Office of Extramural Research. “Sites must be conducting the same protocol. It applies to all human subjects, not just clinical trials. It applies to all new and recompeting applications and proposals currently being funded. Also, for research funded through grants and development contracts.”
Exceptions to the Rule
The single IRB rule does not apply to foreign sites and institutional training, she said, noting there are three types of exceptions. These include “policy-based” exceptions, when federal, state, tribal, local laws, regulations, and policies require local review.
“For example, tribal regulations and policies are given specific consideration in order to ensure the importance of their role is recognized,” Duque said. “They do not require NIH exceptions review committee approval.”
There also are “time-limited” exceptions, typically when ancillary studies are part of ongoing or parent studies. “These exceptions do not require a single IRB until the parent study is expected to comply with the single IRB policy,” she said. “This is to ease some concerns about ongoing research without a single IRB.”
The third exception is when there is “compelling justification” for local IRB review, which must be approved by an NIH exceptions review committee, Duque said.
“With the compelling justification exception, you want to identify the sites that are impacted and provide the justification,” said Petrice Brown-Longenecker, PhD, an extramural Human Research Protection Officer at the NIH. “When you create your budget, you want to budget as if there was no compelling justification exception because you have not been granted one yet. The compelling justification exception must be approved by NIH. Once it has been approved by NIH and granted the award, the budget can then be adjusted.”
Single or Central?
Two terms that have been used interchangeably and with some confusion are a “single” IRB and a “central” IRB, Brown-Longenecker said.
“A single IRB is typically selected on a study-by-study basis,” she said. “It’s usually an existing IRB at an institution that agrees to serve as the IRB of record for a particular study.”
Conversely, a central IRB is typically “set up or created” to review all sites that are participating in a study, she noted.
“The central IRB is usually created specifically for the study as opposed to a single IRB, which is an existing IRB that has agreed to be the IRB of record,” she said. “So, unless the funding opportunity announcement or contract solicitation that you are applying to specifies the creation of a central IRB, you do not have to create one.”
Some of the basic single IRB models include an existing IRB that is participating in the study or was awarded funding for the multisite study.
“Or, the investigator can decide to use an independent or unaffiliated IRB,” Brown-Longenecker said. “We typically refer to these as commercial IRBs. Please note that the single IRB of record that’s chosen does not have to be the parent site. It can be any of the sites or a commercial IRB, as we’ve mentioned. It’s really the best IRB for the study. NIH will not select the IRB for the award unless it’s a cooperative agreement or a contract that is determined to do so.”
The single IRB selected must be registered with OHRP and must have membership for the study.
“When choosing the single IRB of record, it’s important to keep in mind the type of study and the sites that are conducting the research,” she said. “So again, the NIH isn’t usually going to select the IRB — it’s the best IRB for the study. And how do you know which is the best IRB? That’s a study-by-study decision. But we suggest that participating sites work together ahead of time to determine the best IRB for the study. Make sure that all reliance agreements and communication plans are in place and up to date, either while you are writing the application or soon after the ‘just-in-time’ area of award.”