Special Report: Streamlining IRB Process
IRBs may improve efficiency with these tips
Improve expedited review process
Research institutions nationwide continue to look for ways to improve quality while eliminating redundancy, regulatory creep, and inefficiencies. The key to success is flexibility and considering changes in any type of process that is not working as efficiently as possible, experts say.
Areas that can be addressed for improvements and greater efficiencies are varied, ranging from revamping the board to improving the way expedited reviews are handled. Here are some ideas:
• Revamping the IRB board: For instance, some IRBs have found that adding more ethics boards can help reduce the time from protocol submission to an IRB decision. But one IRB has found that making the opposite change also can improve operations. The office of research compliance and biosafety at Texas A&M University (TAMU) in College Station condensed its IRB from four boards to one board to improve efficiency, says Catherine L. Higgins, PhD, IRB manager.
"We also increased the IRB's membership, and that seems to work quite well," she says. "We have 16 IRB members, and we are adding 10 more."
The institution made the change to one board last year with the goal of going back to basics while also engaging more IRB member enthusiasm and commitment, Higgins explains.
"One board makes sense for us; IRB members meet once a month for about five hours," she says. "The IRB meeting discussions are extremely interesting, and the group has become more vibrant and exciting over the past year."
The IRB has close to 2,500 active studies, and the number of submissions per month doubled from 150 to 300 after the consolidation of boards. Also, the IRB's processing time for submissions dropped from 17 days to two days in that same period of time, Higgins says.
• Using IRB liaisons: Credit for the improved processing time at TAMU is shared by several initiatives, including the board consolidation. One of the biggest contributors to the improvement is the IRB's adoption of an electronic submission system and the creation of IRB staff liaisons for pre-reviewing studies and working with researchers. Higgins looked for staff liaisons that would fit in well with particular colleges, and she sought people who were energetic and go-getters, she says.
"I wanted employees who have a lot going on outside of work because if they have a lot going on outside of work, they want to get their work done," Higgins says.
The liaisons meet regularly to discuss problem studies and to reinforce IRB management and processes. They also work directly with investigators and research departments, getting to know one particular department's needs, she adds.
Staff liaisons attribute much of their improved efficiency to the online system, but also to a variety of changes, including these: better meeting and minutes preparation, addressing specific application questions, using a pre-review checklist, easier revision requests online, less time spent finding files and submissions, improved communication with investigators, fewer crises, faster amendments and continue reviews online, and better knowledge of regulations and IRB expectations, Higgins says.
The change to a single IRB also involves board members participating on subcommittees to provide guidance on different topics. Each board meeting features a special topic that has been the focus of a subcommittee. Then subcommittee members discuss these with the full board at meetings.
Also, some IRB members mentor new investigators, helping them with study design and identifying their project's goals. The IRB consists of people from across the university so each can be a representative of his or her department and different types of studies, she adds.
The IRB members enjoy working with fledgling investigators to improve study applications, especially in the colleges of education and sociology and psychology, Higgins notes.
"An IRB member will say, I want to partner with investigators and help them fix this,'" she says.
• Use expedited reviews efficiently: Aurora Health Care Inc. of Milwaukee created a special process, application, and expedited review category 10 to streamline review of research activities that involve review of public health information. These include specific parameters for retrospective chart reviews, says Lori Roesch, manager of the research subject protection program.
The policy specifies how the IRB might grant a waiver of informed consent for the medical record/database request. According to the Aurora Health Care application, the criteria are these:
- The research involves no more than minimal risk and will not adversely affect the rights and welfare of subjects because the clinically indicated intervention or tests were already completed.
- The results would not affect clinical decisions about the individual's care because they are analyzed after the fact.
- The subjects are not deprived of clinical care to which they would normally be entitled.
- There are no conflicts of interest disclosed by investigators and key personnel.
The new expedited review policy applies to research that is not federally funded and excludes studies that are reviewed by the Food and Drug Administration (FDA) or which require contact with patients for research purposes. The organization was able to institute the policy only after unchecking the box on its Federalwide Assurance (FWA), Roesch notes.
The change, which applies only to research originating at the organization, has improved and streamlined the IRB application process, she adds.
• Track study timeline data: Whenever an IRB makes a change to processes, such as creating new policies for expedited reviews and informed consent waivers, it is a good idea to monitor and track outcomes to see what works and what falls short of expectations.
"We track when the study comes in and when we do our review. If there are questions that have to go back to the investigator, we track that as well," Roesch says. "Our average turnaround time is 15 days."
That is a decline from the initial turnaround time of 25 to 35 days as IRB staff and members first piloted the streamlining changes, she notes.
"There is a learning curve, and we've reduced the turnaround time for the most recent four studies to three to nine days," Roesch says. "Once we've completed the streamlining process, trained everyone on it, we're seeing a decrease in the turnaround time."
A next step would be to track the turnaround time after further changes are implemented, such as a possible change from annual continuing reviews to reviews every two years, she says.
"We have not made that change yet," Roesch says. "We take baby steps because you want to make sure as you do these changes and roll these out that you're not missing something."
