There might be a simple solution to IRB workflow issues that stem from graduate student research cycles: A party.
At least, this strategy worked for the Yale University IRB in New Haven, CT, which created “approval parties” to handle the influx of fellowship students’ IRB applications each spring.
“We had a lot of fellowship applications come in at the same time and going out at the same time,” says Brandy Lagner, CIP, senior regulatory analyst, research administration, RESHRP human subjects committee at Yale.
It was challenging for the IRB office to handle these applications while keeping up with the usual workload, so they decided to ask IRB committee members to handle student applications, which mostly resulted in expedited or exempt determinations, she adds.
“The root of the problem was that there are a lot of fellowships awarded in the spring to students, who, mostly, want to do their research immediately, in the summer,” says Stephen Latham, JD, PhD, chair of the human subjects committee at Yale University.
Having projects that were time-sensitive, students needed a quick decision from the IRB. This placed considerable pressure on the IRB office and led to workflow bottlenecks, Latham says.
“Everyone on the human subjects committee was aware that we were having problems because of the fellowship study load,” Latham adds. “And I had a sense from discussions at committee meetings that most of the committee members would like to help out.”
The IRB decided to improve the issue through a two-pronged solution: First, it worked with the university’s fellowship office, and, secondly, it asked for committee volunteers to handle some of the expedited/exempt determinations at an “approval party.”
The process improvement project also benefited from the committee having a fellowship office representative on the board, Latham notes.
Previously, the fellowship office was unaware of the burden their decision-making timetable placed on the IRB office, he explains.
Once the fellowship office staff learned of how difficult it was for the IRB office to handle all of those additional protocols, they wanted to help out, Latham adds.
“We ended up working closely with the fellowship office, which staggered their review times for rewards,” says Carrie McDaniel, CIP, senior regulatory analyst, human subjects committee, Yale University.
“Everything in the past was in April, and now they started having fellowship deadlines and awards earlier, from as early as late December and early January through April,” McDaniel explains.
The goal was to prevent the springtime bottleneck. Also, the fellowship office’s online application form now includes three questions related to human subjects research. A “yes” answer to any of these questions alerts the student that an IRB review is required, and the application links students to the IRB website for submission information.
“We work closely with the fellowship office to find out how many students we can expect,” McDaniel says.
This change reduced the workload to a more manageable level over a four-month period. The second change of asking for IRB members to help with handling the fellowship applications reduced the IRB office’s workload even more.
When there are fellowship projects coming in, Latham announces that it is fellowship season and volunteers are needed for reviews.
“It doesn’t take many of these to significantly reduce the staff’s load,” Latham notes. “If we had five people together and each looked at three protocols, that takes away one-third of one month’s load from the IRB staff, and it means they can handle the rest.”
The approval parties, which might have five attendees and feature breakfast or lunch, serve as an overflow mechanism for the expanded demand, Latham adds.
The parties involve a small group of IRB members sitting around a table, looking at exemption requests and expedited review forms to make sure the right boxes are checked, the right information is gathered, and that principal investigators have answered all questions, Latham explains.
For example, a project might appear to be exempt, but if the investigator did not say that people under age 18 are excluded, then someone would have to call the investigator and ask this question, Latham says.
“When the principal investigator says, ‘Right,’ we take that box and check it,” he explains. “This is easy to do in a group while you’re sipping coffee and eating a bagel.”
Often, the reviewing committee members will get in touch with student investigators in advance of the meeting, but there have been times when the IRB group has called investigators during the approval party, he adds.
The atmosphere at the approval parties is relaxed, and members find it to be a relaxing and positive experience, Lagner says.
From the student investigators’ perspective, it has been a great change. They receive their approvals quickly, enabling them to begin their projects without frustrating delays, McDaniel notes.
There might be a simple solution to IRB workflow issues that stem from graduate student research cycles: A party.
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