Preliminary review reaps quick benefits for health system IRB
Deferrals dropped 30% in three months
A large health system IRB found that incomplete study submissions were clogging up the IRB review system, resulting in long waits — up to three months — for approval.
More than 40% of IRB submissions were deferred for substantive issues, says Dorean J. Flores, CIP, IRB manager, North Shore-Long Island Jewish (LIJ) Health System in New Hyde Park, NY.
With 2,100 open studies that the IRB reviews, the high deferral rate was causing long delays in IRB approvals and wasting staff time, she notes.
Also, the IRB's workload was growing. Prior to 2013, the IRB office had two IRB committees to oversee. Last year, a third committee was added, says Hallie Kassan, MS, CIP, director of the office of the human research protection program at North ShoreLIJ.
The IRB solved these issues by developing a thorough preliminary review process, Kassan and Flores say.
Within three months of initiating the preliminary review process, there was a 30% reduction in the deferral rate of initial full board studies.1
Also, the turnaround rate on study approvals dropped from three months to 1.5 or two months, Flores says.
"We looked at how we could review effectively without having to hire a lot of staff and how to get protocols reviewed and approved in an efficient manner," Flores says. "We're very customer service-oriented and wanted to cut down on our turnaround time, and we wanted to mitigate any substantive issues that would result in the study being deferred."
The pre-review process has case managers reviewing studies two weeks prior to a convened IRB meeting. The case managers' comments and concerns are sent to the IRB reviewers and principal investigators. The purpose is to aid reviewers' evaluation of the study prior to the full board meeting. Also, the principal investigator is given enough time to resolve issues before the meeting.1
"The way the IRB office operates is if a study has the minimum requirements for a full review, it's put on the agenda even if it would result in a deferral," Flores says. "These deferrals were sent back to investigators."
The main purpose of the preliminary review process is to decrease time to IRB approvals and to decrease work on both sides, Kassan says.
"It makes us more efficient," she adds. "First of all, it makes the IRB meeting minutes easier to write."
When case managers find problems with a study submission that would result in a deferral, they contact the investigator and obtain additional information prior to the IRB meeting, she explains.
"Having these answers ahead of time saves time at these meetings," Kassan says. "If we can avoid deferrals, then the study doesn't have to come back to the full committee for a re-review, and it saves IRB members' time."
Kassan and Flores describe how the project works:
Assign cases to IRB case managers. The IRB office divides the pre-review workload to fairly distribute it.
"We have five IRB case managers, and those five case managers have specific departments that they oversee," Flores says. "Not all of these departments submit studies every month, so we balance the workload so everyone has a study to review."
If a case manager has a light caseload one month, then she or he might pitch in to help another case manager, she adds
Implement a pre-review process. The IRB started the pre-review process in 2013, Flores says.
IRB case managers review the protocol, informed consent form, sponsor documents, and other sections of the submissions, looking for major issues that could result in a deferral, she explains.
They spend about three hours on more complex, sponsor-initiated studies when they are conducting the pre-reviews, she adds.
"We look at whether the risks are minimized," Flores says. "We look at every major issue that would have prevented it from being approved or contingently approved."
Other questions a pre-review covers include:
- What are confidentiality protections?
- Is there an appropriate risk-benefit ratio?
- Are we protecting vulnerable populations?
"We want answers to each and every item that needs to be addressed," Flores says. "If we have a basic answer that is not as detailed as possible, then we communicate that concern to the investigator."
Send comments to IRB reviewers and investigators. "We send our pre-review comments and documents to the IRB reviewers about 1.5 weeks before the meeting, so they'll have a week to look at the documents," Flores says.
They also send their findings to investigators and request a fast turnaround on responses so that these also can be given to IRB reviewers, Kassan explains.
"Sometimes the investigator responds close to the meeting time, and we bring the response with us to the meeting and discuss it with the committee," Kassan adds.
Typically, investigators have two or three days to respond to questions and comments, Flores says.
"Investigators have been very responsive to us, and they might send a quick email to clarify additional issues," she adds.
Adjust the program when obstacles appear. When the IRB started the pre-review process, the staff found that the first three months were the most difficult because case managers were not receiving timely answers from investigators, Flores says.
"We crunched numbers and ended up with six deferrals in one meeting, and it wasn't working," she recalls.
Something had to change. "The pre-review process won't work if investigators don't know to look for a quick email from us within the first two days of submission," she explains. "So we spoke with research coordinators, who are the eyes and ears of the study."
They told the coordinators to watch for an email from the IRB and to make certain the email's questions and comments were answered immediately.
"We email research coordinators directly and cc [carbon copy] the investigator," Flores says. "We let them know that when they are having a full board review they will get pinged by us for a couple of days, and so they need to look for those emails."
Once the IRB office began to work more closely with research coordinators, the rapid response rates greatly improved, Flores notes.
Another obstacle involved the IRB reviewers' perceptions of the pre-review.
During the first few months of the pre-review process' launch, IRB case managers were reviewing all the issues, including those that were not necessarily deferral issues, Flores explains.
As a result, some IRB reviewers felt the case managers were doing their work for them, Flores notes.
"This caused a bump in the road," she says.
The IRB office resolved this by having the pre-review focus on issues that could result in a deferral and leaving the big issues and scientific issues for the IRB reviewers, she adds. "We had to tweak the pre-review process to not review everything."
The last change was to do a better job of letting IRB reviewers know more about the pre-review process and what to look for in the information sent their way, she says.
Reduce IRB office and staff workflow. The IRB office has made staff workflow much more efficient since the pre-review process began and deferral rates dropped, Flores says.
"Overall, we could have needed seven to eight people to handle 2,100 studies," she says. "Now that we have this efficient process going on, those studies are coming in and reviewed in a manner to address all concerns and only leave minor issues."
This leaves a reduced burden on IRB committee and staff to get everything ready to bring to the committee, Flores adds.
"The initial time we spend in the beginning with the pre-reviews actually saves time in the end," she says.
- Flores DJ, Ramdeo R. Comparative study on the effectiveness of a preliminary review process in the reduction of study deferrals. Poster presented at the 2013 Advancing Ethical Research Conference, held by the Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston.