Reduce complaints with new policies and procedures
Make IRB office responses professional
The IRB at East Carolina University of Greenville, NC, was able to satisfy investigators' complaints and improve response times, partly through an overhaul of its policies and procedures.
"We put a lot of effort into turning paper around and providing service to investigators, and we tightened down on the regulatory items to make certain it was done right," says Kenneth De Ville, JD, PhD, a professor at the Brody School of Medicine in Greenville.
De Ville was hired by the university's vice chancellor to reorganize the IRB into a biomedical IRB and a behavioral/social science IRB. He started by hiring research professionals who could understand investigators' issues and regulatory requirements and put new policies and procedures in place.
As a result of the reorganization, the IRB's workload rose from 434 protocol submissions in 2003, to 662 in 2005, after the changes took place.1
Once investigators saw how the IRB office was run more efficiently, they stopped complaining when more was asked of them, De Ville notes.
"We'd send protocols back to have them redo items, and we would have them reshape the study or send more documents," De Ville says. "Previously, I think they resented the time loss, and they resented legitimate regulatory requests too."
One of the efficiencies enacted was an announced turnaround time of three to five days on queries and items that didn't need a full board review. But the IRB office has even improved on the committed turnaround time.
"I've done a number of audits, and they're always under two days," De Ville says.
The IRB office made the full committee review time more efficient by starting some new practices.
For example, the biomedical IRB, which meets every two weeks, would assign reviewers for a full committee review to a protocol, and the reviewers could write their comments in a secure Web site, 48 hours prior to the committee meeting, De Ville says.
"Our office staff would download those comments into a template for the minutes, and that would be projected during the meeting," he adds. "The discussions would be typed at the same time the meeting was going on."
This way, the IRB staff could return to the office and immediately generate letters based on the committee's decisions.
"So if there were queries, comments, or revisions, those could be out within 48 hours," De Ville says.
One of the benefits of this process is that the IRB has complete documentation by the time the meeting is complete, De Ville adds.
There was another benefit to having the IRB reviewers type in their comments two days before the IRB meeting.
"The skilled office staff could call investigators before the meeting and ask them to send in any missing information or make any changes," De Ville explains. "Then their changes would be taken to the committee and the investigator wouldn't need to wait until the subsequent meeting to have a response."
Reference:
- De Ville K, et al. Rejuvenating a foundering institutional review board: one institution's story. Acad Med. 2007;82:11-17.
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