Professionalizing the IRB: One institution's plan
Hospital improves consistency of review
Like many other institutions, the Children's Hospital of Philadelphia often struggled to get and keep good IRB members. Its roster was full of busy physicians who couldn't make all the meetings, and some had to rotate off the board because of the demands of their work.
"To staff our three committees and ensure enough physicians would come, we wound up with committees that were 15 or 17 members," says Mark Schreiner, MD, chairman of the Committee for the Protection of Human Subjects at CHOP. "Often, we would just barely make quorum — we would have eight or nine people at a meeting.
"And the problem was that we needed to have a lot of physician members to ensure that we had three or four who were capable of reviewing new material."
CHOP's solution? They cut the number of boards to one, with 11 members and 11 alternates. And to ensure that those members would be there, the CHOP Research Institute pays for the members the equivalent of two days of salary support per month to compensate for their time and effort.
Each member is paired with a particular alternate. Someone from that pair is expected to attend 20 of the board's 24 scheduled meetings each year.
"If they don't make all the meetings, meet their quota, there's no pay," Schreiner says.
It's part of CHOP's initiative to "professionalize" the IRB, ensuring that the work members do part time for the IRB is valued by the members and their department heads.
To pay for it, the institution is using money paid by industry sponsors for protocol review.
Previously, "we hadn't looked at how much money was being generated from industry-related work — it was just going into the research institute, but it wasn't really coming back to the IRB," Schreiner says.
In addition, he says, the institution found it wasn't billing industry for all of the work it had been doing. Initial fees were being charged, but CHOP was often failing to bill for continuing reviews and amendments, which were in the industry contracts.
Valuing the IRB
One goal of this approach is to have department heads and division chiefs see IRB service as valued, since they're the ones who must give the members non-clinical time to serve.
"Often, department chairs provide individuals who have time available, but they're often not people who are engaged in research," he says. "To get specialty expertise but not research expertise doesn't help the committee. And then other people who are busy researchers and who don't have time don't help either."
To form the new, smaller board, Schreiner picked the best members from his three previous boards, as well as a few members who had left the IRB because of time constraints.
"From the three boards, we were able to identify individuals who we thought were good members but also who represented the diversity that we needed to make decisions."
Community members were not left out of the initiative. They are paid a stipend for their work on the board.
"When I joined the committee, our community members were largely elderly people who were retired — they were the people who had time," he said. "They didn't really represent the community we served. We've made an effort over the last five years to get younger people, a little more diverse, people with training in medical ethics.
"The problem with younger people is that they're working and they have to rearrange their time. So a lot of our community members would last with us only a year or so. They'll get a stipend, to help make it possible for them to serve and compensate them somewhat for their time."
High expectations
For Schreiner, professionalizing the IRB isn't just about paying members, but raising expectations. In order to make meetings go more smoothly, board members are expected to be familiar with all of the protocols, not just the ones for which they were the primary reviewer.
"One of the things that can take a lot of time at a meeting is for the primary reviewer to go through the protocol in laborious detail," he says. "Well, our assumption is that everybody will be familiar with every study, so we can focus on the issues."
His office also is taking other steps to reduce unnecessary work for the full board, engaging in cooperative IRB review and making use of flexibility in the regulations to exempt or expedite reviews. When membership on a board is consistent, the same types of studies are likely to be handled in the same way each time, without having to continually revisit issues, saving work for the board and hassle for investigators.
Schreiner says staffing in this department hasn't changed. He will run one of the monthly IRB meetings, while his vice-chair, Barbara Engel, will lead the other.
The new system has only been in place a few months. The first meeting in the new format was July 1.
"The first meeting was efficient, and took less time than many," he says.
And he's already seen one positive effect of the change.
"As soon as there was salary support for the time, we had one department that was proposing additional members," he says. "Instead of begging for members, we're going to be able to choose people who are really good."
Schreiner says the biggest obstacle to a change of this kind is getting the money to fund it. In his case, he went to the director of his research institute to propose the new arrangement.
"We wanted to fund people for two days a month, but you could fund people for part of their time," he says. "Maybe you could only be able to afford to fund them for the equivalent of one day a month."
The ultimate goal is an IRB that holds together over time and can reach consistent decisions, he says. "The only way to do that is to have the same people come each month and do it for a period of time."
Like many other institutions, the Children's Hospital of Philadelphia often struggled to get and keep good IRB members. Its roster was full of busy physicians who couldn't make all the meetings, and some had to rotate off the board because of the demands of their work.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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