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Cutting response time for expedited review
Here's how they went from 14 to 5 days
Human research protection program staff at the VA Medical Center in Tuscaloosa, AL, knew there was a problem with the IRB's expedited review process. It was taking 14 or more days to get information back to research assistants.
"We noticed that several people had used delays to get expedited reviews turned around," says Darlene S. Knox, program analyst and human research protection program administrator at the VA Medical Center.
"Expedited reviews took 14 days on average from submission to correspondence to investigator," she adds. "We made a goal of turning expedited reviews around in five days."
This was an ambitious goal because the office had no electronic system for tracking expedited reviews at that time. There were mountains of reviews collected in a folder.
To even determine how fast or slow the review system was, they had to look at the dates research assistants turned in the proposals and compare these to the dates when the IRB chair signed them, says Julie R. Wakefield, MA, administrative officer of research and development at the Tuscaloosa VA Medical Center.
"We discussed them in a [R&D] research and development meeting and tried to come up with a process that would allow more than just the IRB chair and vice chair review these documents," Knox says. "We wanted to establish a process where the chair and vice chair could delegate the responsibility of reviewing the expedited protocol to someone else."
They decided an experienced IRB member could handle expedited reviews. Experienced members were those who had been on the board for at least six months. The change was called a "delegation of authority for the expedited review process of experienced IRB members."
The next step was to explain this change in a memo, along with a list of people who now could review and make a decision on expedited review submissions.
When a new expedited review request came to the IRB office, IRB staff would send out an email to the list of qualified reviewers and ask for a volunteer to handle the new submission.
"Whoever was the first to respond received the expedited review," Knox says.
IRB staff then sent the reviewer a package that included standard operating procedures for the expedited review process and a separate list of categories of what qualifies for an expedited review, she adds.
They also began to send the results in an attachment to principal investigators, notifying them that a hard copy was available to be picked up.
"Recently, we've added an electronic systemIRBNet, a program that will help streamline the process even more," Knox says. "Investigators can submit their projects through IRBNet and will receive a notification that it has been submitted."
The change has been straightforward and fairly seamless, she adds.
"There were sometimes situations where submissions didn't make the criteria, and reviewers would refer them to the full board," she says. "But outside of that, there were no other issues."
The change accomplished its goal: the expedited review process was reduced to five or fewer days. Plus there was an added benefit in that IRB members involved in the new process were satisfied with the extra work, Knox says.