For one IRB, splitting up is easy to do

Smaller boards bring smaller workloads

For IRBs at mid-sized institutions, monthly meetings can go for hours and involve many protocols. This can be very time-consuming and cumbersome for IRB members and investigators alike. Protocol discussions may not get the time they need, and members simply may not have enough time to review all the agenda items.

The human research protection program and IRB at Wake Forest School of Medicine in Winston-Salem, NC, was no exception. While the average 45-day turnaround for full board review was right at the national average, the board’s productivity was not where it could have been. They had four boards with an average of 18 members who met once per month for four or more hours, and usually had an agenda of 16 to 20 protocol actions to consider. Many IRB members did not have the time to review the full agenda before meetings. Maintaining the quorum of 10 people for each meeting was often difficult, as members were sometimes late from seeing patients or were paged away for emergencies. Tabled studies had a month-long wait before reconsideration. Wake Forest IRB leaders decided to look for a more practical solution.

Productivity inspiration

“When you have agendas that are sometimes 16 to 20 protocols or actions long, the meetings were often three to four hours long and we were concerned because if board members were paged away, they would miss things later in the meeting,” says Joseph Andrews, PhD, CIP, director of the Wake Forest School of Medicine IRB. Developing questions and writing minutes from four-hour meetings were also particularly cumbersome.

Andrews and colleagues looked to commercial IRBs for productivity inspiration. “One question we had was how they were able to be so efficient and have high-quality reviews,” he says.

After careful review, they decided to split the four existing IRB boards into eight smaller boards that would meet every two weeks instead of once per month. Protocols are divided among the smaller boards so that each has only four or five protocols to review in much shorter, one-hour meetings. Boards meet on days that accommodate everyone’s availability. Meeting minutes are shorter and far less cumbersome, and everyone has time to fully review all agenda actions prior to meetings.

“Board members are able to more easily look at and retain the information and ask more thoughtful questions with four of five items than with 16 items,” Andrews says. “Faculty on the board have been extremely supportive of the model because they don’t have to block the whole afternoon out for the meeting — now they can go back and see patients or teach a class after the meetings.”

The Wake Forest administration granted the IRB a four-month pilot to test the new model. The idea was met with some concerns, including whether board members would agree to two meetings per month rather than one, and that fewer experts would be on each board.

“I think the staff were eager to try it,” Andrews says. There were some concerns from staff, but “once they got the first set of [meeting] minutes in and there were only four or five items to note, it was such a relief from the 16 or 17 actions they had before.”

To form the new boards, the vice chairs were promoted to chair positions for the four new ones. IRB board members were given copies of the schedules of the new boards and selected their top three choices based on their individual schedules. Members were assigned boards based on their availability. Those who had scheduling conflicts with all the new meeting dates were offered alternate positions. Overall, attendance has been increased to 100%, or close to it, for all meetings.

The smaller boards also solved issues with facilities. Squeezing 15 to 20 board members in one room for meetings was a challenge, and the room did not have much audio-visual equipment. “We had a hard time finding a room to accommodate everyone comfortably,” says Brian Moore, MS, CIP, assistant director of the Wake Forest IRB. “We would have a lot of tables set up with 15-20 staff members in the room. The facilities didn’t allow for video and teleconference in rooms that size. By splitting up the boards, we were able to put them in a more hospitable area with audio-video and more equipment.” For those who are unable to attend in person, they can now be present via telephone or video conference. “We can now get close to 100% attendance,” Moore says.

Turnaround time

Turnaround time for protocol approval has decreased by nearly 50%, Andrews says. And with shorter meetings and fewer protocol actions in each, board members are able to have investigators present in person or by remote conference to further explain a protocol and clarify and questions. “Previously, with heavy agendas and a long meeting it would throw everything behind when the [investigators] came to the meetings. With the new model, they can call in and answer questions about the protocol, or pop into the room and talk, and with only four or five agenda items, we don’t fall behind.” Discussion time for each item has increased 33%, he says.

And the IRB was able to implement the model without any additional costs to the university.

“We haven’t changed the ratio of staffing and no additional resources were required from the institution to do this,” Moore says. “There was no cost added, but a lot of value was added.”

“Many institutions are facing budget crunches, so increasing costs by ramping up staff members are prohibitive in some cases,” Andrews says. “We used the same four-analyst mode, and now each analyst is assigned to two different boards. Workload has gone down because instead of having 16 actions and four-hour sets of minutes, there are four items to write up and time for questions to send back to investigators. We haven’t had any negative impacts at all.”