One IRB receives process improvement help from a well-designed change management process (CMP) that provides information, implements new procedures, and addresses the revised Common Rule and its effects.
For instance, the IRB held a CMP session to address the core components of the Common Rule regulatory changes, says Lark-Aeryn Speyer, IRB senior associate regulatory analyst at the University of Michigan in Ann Arbor.
“In April 2017, when most of us were starting to get our hands into the Common Rule changes, we realized our standing processes were going to serve us pretty well,” Speyer says. “But this was such a big, time-sensitive matter, it needed a more intensive plan.”
The IRB held the two-day retreat for core members of the Team to Review E-research Enhancements (TREE). The retreat was held on a Thursday and Friday, from 8 a.m. to 5 p.m.
“We outlined the plan for the following year of the kinds of working groups we would expect to need for the changes and the kinds of deadlines we would expect,” Speyer says.
TREE addressed the need to educate the research community and set the tone for the following year of work.
“We planned to approach the Common Rule changes from all directions,” Speyer says.
Here are some of the ways TREE and the institution’s other committee, the Production Support Team (PST), worked to support education and change:
• Prioritize changes and effort. “One of the early steps is prioritizing,” Speyer says. “We decide if this is something we should proactively devote a lot of resources to, or should we make a note that people would favor some kind of change when we get around to it.”
The working groups, engaged in the Common Rule changes, contained study coordinators, principal investigators, and IRB members. Their work is to take charge of challenges faced by the IRB, viewing the challenges holistically.
“What is the overall outcome we want?” Speyer says.
• Include IT expertise. “We take IT’s advice on options for using the web-based smart form system for the IRB,” she says.
“Information technology support people are part of this,” Speyer adds. “They administer the system and are usually very inventive about looking for ways to make it fit any new needs that arise.”
For example, a new problem occurred in the protocol application process. The University of Michigan research pharmacy has an ancillary committee that reviews research projects, using the same electronic system as the IRB. They came to the IRB with concerns related to the documentation they need about investigational drugs and processes for storing drugs for a study, Speyer says.
In the last year, there was a new trend in which the protocols were less likely to include specific documents the research pharmacy committee needed. So the committee asked to discuss revisions to their section of the application or to ask for manuals of procedures in a way that would make it easier to obtain the necessary information, she explains.
“They brought this to TREE,” Speyer says.
The solution was to make it clear which information was needed and should be uploaded in the system.
“There’s a new way these research protocols are being prepared,” Speyer says. “We wanted our system to capture information in a way that works for us and for the study teams.”
• Education accompanies any change. When the IRB makes changes to processes, the change is announced to the research community.
“We had changes we were preparing for the Common Rule, over the course of the last year,” Speyer says. “It was an effort involving a huge number of people, and we were trying to spread the word very widely and repeatedly.”
Changes that involved the web-based system were communicated by website postings or email.
Some changes were turned into U-Mic presentations, which are short PowerPoints with voiceovers, posted on the IRB website and played for the boards as part of their continuing education, she says.
“For really big changes like the Common Rule efforts, we schedule seminars where we invite the research community to present on the changes,” Speyer says.
The information is targeted toward study teams and board members. But when the information is more general in nature, it can be more broadly useful — even outside of the institution, she adds.
One IRB receives process improvement help from a well-designed change management process that provides information, implements new procedures, and addresses the revised Common Rule and its effects.
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