Research institutions sometimes struggle with retaining experienced IRB members as the workload can be significant and there are so many competing duties and projects for these scientists, professors, bioethicists, and other professionals.
This was a major problem a decade ago at the University of California, Berkeley (UC Berkeley), when two-thirds of the IRB members would leave each year. The most common complaint was, "It’s too much work," says Rebecca Armstrong, DVM, PhD, director of the research subject protection program.
The high IRB member turnover rate was only part of the problem: Principal investigators levied many complaints in those years, and the IRB process lacked the consistency that Armstrong was certain could be achieved.
What she felt was needed most was a pre-review process, conducted by well-trained and well-educated IRB professionals. This meant changes to the IRB office’s staffing level and skills mix.
"I started with the hiring process, advocating for new positions to add to staff to speed up the IRB review turnaround, which was very important to investigators," Armstrong says. "This was a process over a number of years, and it was critical that we hire the right people."
Her strategy was to trust her staff and empower them to conduct IRB pre-reviews.
"We’ve established a professional workforce and empowered them to make decisions, speaking for the unit, the IRB, and the office," Armstrong adds.
Her goal was to hire people who had advanced degrees, who could become certified, and to provide them with the training and support they would need to succeed. (See story about maintaining a successful IRB office workforce, page 127.)
"When a new staff member comes on board, there’s a lot of mentoring," says Tani Prestage, MA, MPH, CIP, assistant director in the Office for the Protection of Human Subjects at UC Berkeley.
"There are so many nuances to the IRB review process, and issues might not come up every day, but they might come up every few weeks," Prestage says. "So we make sure we’re available for a consult with new IRB staff. Once they are past their probationary period, we do weekly staff meetings because we want to make sure there is consistency."
The policy and staff changes have resulted in a number of improvements, including the following:
- IRB members’ satisfaction has increased, and now only one or two members leave each year.
- Complaints from investigators have decreased, and when there is a problem, IRB staff are able to resolve these on their own most of the time.
- The IRB submission process now includes a pre-review conducted by very well-trained IRB staff, leading to greater consistency.
- A federal regulatory audit in 2010 had no findings.
"The big end result is, we’ve reduced the workload for IRB members," Armstrong says. "I think that has a trickle-down effect, enabling us to have stable committee membership."
The pre-review process evolved from a simple checkbox for submission completeness, Armstrong says.
Before the staffing changes, the IRB office was unable to handle analytical work, she notes.
"It has evolved over time, but since 2006, we’ve had a high-caliber, in-depth, administrative, pre-review process at both expedited and full committee levels," she says.
If an IRB analyst encounters something he or she does not know how to handle, the analyst will consult with a colleague or contact Prestage for advice.
"Tani is very good at recognizing what kind of issues should be sent to me for interpretation," Armstrong says. "Then we may have a three-way meeting with the staff member, Tani, and me."
These issues are considered in the context of the IRB office’s institutional memory of how something similar was handled. If it hasn’t been addressed consistently, then a standard operating procedure (SOP) might be written for it, she says.
Once a resolution is found, it might be shared at staff meetings so others can learn from their colleague’s experience.
"One of the ways we’ve developed consistency is through sharing information at staff meetings and making sure we’re all on the same page on this," Armstrong says.
Sharing information at staff meetings is a great educational tool, Prestage says.
"Regulations and guidance can be open to interpretation, so different institutions’ policies may vary," she says. "This openness provides flexibility, and it is very helpful that we have regular weekly meetings where new UC Berkeley employees can learn different interpretations."
IRB leadership and staff continue to create and revise guidelines and policies.
"Tani and I draft policies that are circulated to staff for review, and then they go to the full committee for policy approval," Armstrong says.
"If a staff member has a particular interest in a subject, then they take the role of drafting guidance and obtaining feedback from their colleagues," she adds. "We get them involved in writing guidelines on how the IRB views these issues."
Principal investigators can use the guidance as they prepare their IRB submissions.
IRB members appreciate the pre-review analyses by the staff, Prestage says.
"At every meeting, there is at least one member who will thank our analyst for giving the board clear comments," she adds. "The board appreciates having that extra reviewer looking at the submission."
