Improve evaluation of IRB’s QI/QA processes
Track review times
IRB offices need a systematic approach to quality improvement (QI) processes. They also should have a way to evaluate performance, subjecting the office to internal scrutiny, an IRB expert says.
“There are simple ways to do this,” says Nichelle L. Cobb, PhD, director of the health sciences IRB office at the School of Medicine and Public Health, University of Wisconsin-Madison.
“There are simple projects and ongoing projects that every IRB office should have in place,” Cobb adds.
For instance, IRBs could track review times for IRB members who do expedited reviews, she says.
“You can see how long the reviews are for each type,” she says.
Whatever the current review time is, a new QI goal could be to lower that time, Cobb adds.
Cobb offers the following additional tips on improving IRB processes:
• Review individual staff data. Review processes can vary according to which IRB professional is handling them, and data on individual performance can be useful, Cobb says.
“We have to address variability, how many studies each person has, and how [long it takes them] to get through them,” she adds.
IRB directors can adjust workloads more efficiently once they have this information. Also, these data can be used to show leadership why the IRB needs additional staff, she says.
• Understand your processes for managing multisite studies. IRBs increasingly are being nudged into collaborative review models. When an IRB is the central IRB for a study or agreeing to accept another IRB’s review, there need to be processes in place to manage these collaborations, Cobb says.
Process improvement might focus on communication between the IRB of record and study sites, as well as address differences in state laws and institutional requirements, she adds.
“Spend time getting to know your colleagues at other institutions,” Cobb says.
When an IRB relies on another IRB for the protocol review, it should make sure its own institution’s study teams are complying with the IRB of record’s institutional policies. “They might have different policies and requirements for noncompliance reporting,” Cobb adds.
• Select something to improve and follow through with it. “I recommend that IRB offices consider picking a topic and following through with that area for a spot check project,” Cobb says.
For example, suppose an IRB is the IRB of record for another institution. Then the spot check project could be to make certain its policies and procedures, checklists, and consent documents comply with the revised policy handbook of the other institution, she explains.
The IRB could even assign a staff member to look at the other institution’s consent document from 10 recent studies — that occurred after the handbook change — and make sure the changes were in it, Cobb says.
A short evaluation form might be used to assess whether the IRB had approved consent documents with all updated requirements. If missing items are identified, the IRB can send an email to the study team, saying, “Hi, we did an internal audit and would you please change this,” Cobb says.
• Audit the IRB, as well as study teams. “IRBs need to have systems where someone can check on the IRB’s work,” Cobb says.
“For example, a quality control measure we use is reviewing IRB minutes,” she says. “Are we explaining our basis of determination in them so someone from the outside would know which regulation we’re basing this determination on?”
The goal is to make sure the IRB’s minutes are as consistent as possible with determinations and communication, she adds.
• Track IRB metrics and review weekly reports. Whether an IRB has an electronic system with easily generated reports or a paper system with manually pulled reports, metrics tracking and reporting is important. Someone on staff should be able to access and assess IRB metrics, including the time frame from protocol submission to IRB review and every step along the way, Cobb says.
The ideal person for this job is someone who understands metrics and their use in quality improvement. “We appointed someone who manages submissions and who became very good at metrics and quality improvement,” Cobb says. “She developed a template and would write up what the project would be, how it was done, and what the results were in case we needed to recreate it.”
It’s important for IRBs to employ quality improvement methods because it shows the research community that the IRB cares about the process, too, Cobb says.
“Like everyone else, you’re doing your best practices and making adjustments as needed,” she adds. “This helps you identify where to make changes.”
IRB offices need a systematic approach to quality improvement processes. They also should have a way to evaluate performance, subjecting the office to internal scrutiny, an IRB expert says.
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