Here are steps to improve IRB member compliance
Discuss issue with members
Research institutions with concerns about an IRB’s preparation for reviews and regulatory compliance could learn a few lessons on how to assess their performance and improve any problems from the experience of the IRB at WellSpan Health in York, PA.
The WellSpan IRB discovered through a study of data from its electronic IRB submission database that IRB members were not reviewing all of the submission and review documents each month. This suggested the members were not well prepared for discussions and votes on board agenda items, which is a regulatory compliance issue. So the IRB began a quality improvement project, using the Lean Process and Methodology. It has resulted in improved training, better compliance, and more submission review files being opened each month.
Here’s how the continuous quality improvement process works:
• Assess compliance: A couple of years ago, the WellSpan IRB began using and electronic IRB submission and review program that made it possible to identify whether IRB members were opening their review documents each month. A report generated by the software showed a high rate of noncompliance, says Melissa Schlenker, MS, CCRC, CIP, an IRB and clinical trials manager at WellSpan Health.
• Learn more: “We took the news to our director and IRB chair and vice chair and talked about it,” Schlenker says. “We had discussions with the IRB.”
They found that IRB members were very busy professionals, often running out of time to review a submission before the next IRB meeting and not knowing how best to prioritize the IRB review packet information they needed to read.
“Usually, they say they didn’t have time — that’s the biggest factor,” says Tara Moore, quality assessment specialist for research at WellSpan.
In other cases, members had difficulty using the IRB electronic system with their electronic devices, such as iPads, for instance, Moore says.
“And we came to the conclusion that one thing that was not being taken into consideration is we have many different levels of computer literacy,” she says.
“We received a lot of good suggestions, and we took the feedback to board members and said, ‘Here’s what we found out, so how can we help you fix the problem?’” Moore recalls. “By allowing them to give us feedback, we helped them become a solution to the problem, and we took everything into consideration.”
• Develop solutions: Some monthly packages would have 20 files, but not all of these would require careful review, Schlenker says.
“We came up with one solution of simply flagging the items that most needed to be reviewed,” Moore says. “That was an easy fix.”
Also, Moore met individually with IRB members, at their request, to review their IRB material and help them go through the process of reviewing it. She taught them how to scroll down a page and move to the next items.
“I gave them individualized attention, which made them feel special and gave them assurance that they’re doing it the right way,” Moore says.
• Continue tracking: Each month, Schlenker checks data to see whether IRB members are opening their packets. “I run their numbers, checking their performance against what we expected them to open in the packet, and I give that information to them,” Schlenker says.
“We still have a couple of people who were maybe too busy, so they don’t open the documents, and I’ll go back to them and say, ‘Hey, I noticed there was a problem, is there anything you need to tell us?’” Moore says.
Moore and Schlenker address any concerns the members raise.
“Over time, we have reached a certain level of compliance and have maintained that compliance over time, and that’s been a good thing,” Schlenker says.
• Address limitations: “The only caveat and limitation of the study was we could tell whether IRB members opened the document because the system tells us this, but we don’t know how long they stay on each document,” Schlenker says.
“We had very open discussions with IRB members about how we calculate data and graph it for them, but we can’t tell how long they kept that document open.”
An IRB member who wants to appear compliant could open each file, even if he or she didn’t take time to read them.
“But we educated members on why it was important to open these specific documents because it would increase their knowledge,” Schlenker explains. “And we addressed the regulatory component of approving or reapproving a project.”