Improve the IRB with an annual evaluation
Retain members with salary offset
Serving on an IRB is a very important role that requires commitment and training. Yet, many research institutions that have very good training and evaluation programs for their staffs lack any sort of ongoing oversight of their IRB members.
"I did a literature search on IRBs and formal evaluations and their effectiveness, and I found almost nothing," says Andrew Bertolatus, MD, IRB chair of the biomedical IRB and director of the human subjects office in research services administration at the University of Iowa in Iowa City, IA.
However, research organizations seeking accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), are beginning to initiate or improve IRB member evaluation processes, he says.
"I tried using Google to ask this question, and I got pages and pages of individual institutions' policies on evaluating their IRB members," Bertolatus says. "I could see they all conform to what they think AAHRPP would expect, and they're all accredited places."
AAHRPP published a tip sheet (available online at http://www.aahrpp.org/Documents/D000264.PDF) on the evaluation of IRB chairs, members, and staff in January, 2011. Prior to this publication, human subjects programs might not have seen that as a priority.
"We went through two rounds of accreditation without having too much in this area," he says.
AAHRPP's tip sheet says that the periodic assessment of IRB chairs, vice-chairs, members, and staff is essential to a well-functioning IRB, and evaluations should be performed periodically and be scheduled when a member is up for re-appointment. The type of assessment performed is left up to the institution.
The human subjects office at the University of Iowa recently improved its evaluation process, adding an evaluation form that is completed each year by IRB chairs.
"We have several chairs on each of our boards," Bertolatus says. "These evaluations are forwarded to organizational officials, including the vice president of research."
IRB chairs evaluate each member's meeting attendance, participation, and the thoroughness and quality of their reviews, he says.
"I'm looking for people who are speaking up and making comments and contributions to the review process, even if they're not the primary reviewer," Bertolatus explains. "We don't have a requirement for a written report, but we have a checklist for primary review of new projects, and we're rigorous about making people turn that in."
The AAHRPP tip sheet lists these criteria for evaluating IRB members:
- Number of meetings attended out of total number of meetings
- Number of exempt determinations made
- Number of protocols reviewed by the expedited procedure
- Number of protocols reviewed that went to the convened IRB
- Number of reviews completed as the primary reviewer
- Timeliness of reviews
- Completion of required checklists
- Completion of educational requirements
- Attendance at educational sessions
- Number of educational sessions conducted.
"We track IRB members' meeting attendance electronically," Bertolatus says. "The reason we do this is because attendance leads to another aspect tied to evaluation, which is enhancing IRB member commitment to the IRB."
AAHRPP also lists subjective criteria, including being prepared for meetings, contributing to meetings, performing quality reviews, knowing the regulations, organizational polices, and being able to identify areas for improvement. It also lists communication with investigators and IRB staff and the ability to work with IRB staff.
Research programs need to offer educational opportunities to IRB staff and members as part of meeting this objective.
"We have a strong requirement for people to do continuing education," Bertolatus says. "We have an online educational sessions or program that is sent out electronically to all of our members," he says. "This online system will present a several-page document about a particular issue."
Issues are chosen based on the knowledge needs identified at any particular time, he adds.
"The system tracks whether or not they have completed the online course and taken the quiz," he says. "It's been surprisingly well-received."
Along with a greater focus on IRB members' performance, there might be ways research institutions could compensate IRB members in a way that recognizes their generous time commitment to the boards.
For example, two years ago, the University of Iowa began paying physician IRB members a salary offset. Their departments receive 10% of their salaries, Bertolatus says.
"But that comes with a commitment of their doing a certain number of meetings per year because they are expected to meet that attendance requirement, which we track fairly accurately," he says.
The idea is that the IRB members who have this 10% salary offset are being given time in their departments to attend to IRB business, he adds.
"The 10% salary offset is considered compensation for freeing up 10% of your time to work on the IRB, and it's up to the individual department to decide how this is being honored," Bertolatus says.
"The IRB members feel this is a worthwhile thing, and I think it has raised the level of commitment considerably," Bertolatus says. "We now have more consistency in who is attending meetings each week."
It's important to have IRB members who are consistent, more invested, and interested in the process, he adds.
Serving on an IRB is a very important role that requires commitment and training. Yet, many research institutions that have very good training and evaluation programs for their staffs lack any sort of ongoing oversight of their IRB members.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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