Since the Affordable Care Act was signed in 2010, health systems have merged and grown, and with their geographic sprawl, so have IRBs grown and spread out. This raises the challenge of convening an IRB meeting in a central location when IRB members live and work within a wide radius.
“Our health system was founded in 1997 with the merger of North Shore and LIJ,” says Jon Newlin, CIP, assistant director of the Office of the Human Research Protection Program, Feinstein Institute for Medical Research at North Shore–LIJ Health System in New Hyde Park, NY.
The health system has grown from a small group of hospitals to 21 hospitals. Five of those hospitals were added within the past five years, notes Hallie Kassan, MS, CIP, director of the office of the human research protection program, North Shore-LIJ Health System IRB.
“We have geographically separate committees,” Kassan says. “We have 21 hospitals in the New York metro area.”
As the health system grew, it became clear that the traditional IRB model was too inefficient. The institution decided in July 2014 to restructure the local IRB into a flexible IRB model, and use videoconferencing instead of the typical board meetings in person, Newlin says.
The IRB’s turnaround time was around 98 days, and the goal was to cut that down. Now the turnaround time is 45 days for full board reviews of new studies, Newlin says.
“It has made a big difference for us in full board turnaround time,” he adds.
The flexible IRB model also was designed to solve some major issues that arose as the health system grew, including the following:
- Many of the acquired hospitals had IRBs and their committee members were not enthusiastic about driving a long distance to regular IRB meetings, and
- the overall IRB membership grew to be large and cumbersome.
With the flexible model, the human research protection program (HRPP) had all IRB members listed on one roster for regulatory purposes. But in practice, the 60-plus IRB members were divided into four small IRB committees, each with seven to 15 members who would meet on a bi-weekly basis. The second big change was that meetings were conducted by videoconference instead of in a board room.
New IRB member orientations are held in a separate videoconference, followed up with the new members’ attendance at the bi-weekly videoconference board meetings.
The videoconference meetings are not recorded, although the technology makes this possible. Each person engaged in the meeting uses his or her own computer or electronic device to sign on via the Internet. The IRB provided inexpensive video cameras to each member for use during the conferences. The technology also makes it possible to block a particular member if the person is recused from a portion of the meeting’s discussion, Newlin says.
“For most people, it’s a hands-free experience where they use the computer speakers and Web camera,” he says. “It allows everyone to be on the screen at the same time, which gives it a group feel.”
The convenience of videoconferencing has made it possible to convene boards on short notice, he adds.
“One unique experience we had with videoconferencing was we were designated by the state of New York to be an Ebola treatment center, and they — health system administration and clinicians — wanted to open a compassionate use treatment center for people who came into the hospital with Ebola,” Newlin says.
This was part of a protocol that needed a quick IRB review. So the IRB held an ad hoc meeting, sending out an email to all members, and 25 members joined in the videoconference, which lasted about an hour, he recalls.
“This system was functioning at a very high level, while with an in-person system we would have had to exclude most members from attending,” Newlin says.
“Each committee meets every other Tuesday or Thursday, and the meetings are limited to five to seven items,” Newlin says. “Meetings never go over an hour.”
Previously, meetings would have 20-30 attendees and last much longer, he adds.
Each group is designed to be a generalist group, with expertise in various areas of research: “Each group has one or two oncologists, surgeons, and each group should be able to review most types of studies that come in,” Newlin explains. “We use consultants if we really have to.”
But most of the time, any needed expertise can be found within the larger IRB member group, he says.
“For instance, if we didn’t have someone on Group A with scientific expertise, we can ask Group B to send someone over to Group A,” Newlin says. “Everyone is on the same roster, so it’s not like that person would be prohibited from attending the meeting.”
Each IRB group’s meeting minutes show the names of all of the IRB members and who was present at that particular group’s meeting, he adds.
Also, there are never more than nine voting members at any meeting. “We want diverse expertise present, so we limit the number of voting members from each particular expertise,” Newlin says. “So, for instance, we generally don’t have meetings with eight doctors and one community member, although that is theoretically possible.”
Instead, each board includes a nonscientist/community member and a variety of other members, including a statistical member.
Each of the four groups has two or three of these nine people present. Then for the remaining voting spots, IRB members on the group are designated as alternate voting members, so there always are nine voting members at each meeting, Newlin explains.
Each group has an IRB chair, but there also is a super-chair for the entire IRB, and the IRB has 60-plus alternates, Kassan says.
“That’s the beauty of the flex model,” Newlin says. “It’s always been allowable under the regulations.”
The flexible model passes regulatory muster and has been presented at national conferences, so it’s a well-established model, he adds.
Minutes from each of the group meetings are sent to every person on the IRB roster, regardless of whether they were present, Kassan says.
After 90 days of using the flexible model, the IRB conducted a survey to assess what stakeholders thought of the change. Most appeared to be happy, Newlin says.
“We retained three-quarters of our IRB members, and 95% said on the survey that it was easy to use the videoconferencing,” he says. “Even members who are not that technically advanced find it easy to use and most say the picture and audio quality are good.”
One interesting finding with the flexible model change was that IRB staff, who also was surveyed at 90 days, mostly found that the new model resulted in the same workload, Newlin notes.
“We had three people who said there was a minor increase in work, one said minor increase, and three said the same workload,” Newlin says.
For IRB staff, the workload under the flexible model includes having people attend more IRB meetings, but no one has complained that they should go back to the old model, he adds.
Most IRB members said the new system was as efficient or more so than the old system and they appreciated the smaller agendas, he adds.
“Before the change, they’d have to drive an hour to an IRB meeting and then settle in for a 2.5 hour meeting,” Newlin says.
One of the reasons why the videoconferences are shorter and more efficient is because there are fewer side conversations at meetings, he notes.
Some IRBs previously had centered their meetings around dinner, but those dinner sessions were ended before the IRB moved to videoconferencing, Newlin says.
Acknowledging that some IRB members might miss face-to-face interactions, the IRB asked members if they would like to occasionally get together in person, and there was a mixed response, Newlin says.
“Some people didn’t want to get together ever, and some wanted to get together four times a year,” he says. “We settled on having an in-person meeting twice a year, and they can do this if they want.”
The chief disadvantage to videoconferences is that it reduces social interaction, he notes.
While the amount of time spent discussing progress reports, modifications, and new studies is roughly the same as before, with the in-person meetings, the camaraderie of a Web meeting is different, Newlin says.
“So we definitely lose something in the social sphere, but I don’t think — and the IRB member surveys agree — that it has any effect on how well the IRB is doing its central job of applying regulations and protecting subjects,” Newlin adds.
North Shore-LIJ Health System decided in July 2014 to restructure the local IRB into a flexible IRB model, and use videoconferencing instead of the typical board meetings in person.
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