A common challenge for IRBs is educating board members who come from a variety of backgrounds and levels of experience.
“By nature, they’re a mix of individuals on the committee of varying expertise and all that is by design,” says Jonathan M. Green, MD, professor of medicine Washington University (WU) in St. Louis. Green is an executive chair of the Washington University IRB at and an associate dean for human studies.
“Sometimes it’s a challenge to provide sufficient education to all members and to help them to fully understand the criteria for approval and how to apply them to studies,” Green says. “IRBs strive for consistency in their decisions, but there is a lot of subjectivity.”
To find new IRB members, the IRB reaches out to community organizations, churches, disease-related groups, and others.
“We have a waiting list,” Green says. “We’re setting up a new member training and have at least 30 people that want to be on the board, and we don’t have a lot of turnover.”
To help improve consistency, the WU IRB revamped its education training system to provide 10 hours of up-front education for each IRB member. There is face-to-face instruction prior to becoming full committee members, in addition to required online CITI modules.
The 10 hours of instruction are tiered with some parts specific to nonscientific IRB members, including an Introduction to Research module, Green says.
Nonscientific members also can learn more about how research is conducted, different study designs, interventional studies, and what controls are about.
“Everyone goes through a two-hour 101 course about the basic criteria for approval and what the Belmont Report is,” Green says. “Then for our scientific members, we have a separate session where we get into more advanced topics in IRB review: the subparts, FDA regulations, and those sorts of things.”
IRB education sessions are scheduled in two-hour blocks with each session repeated once to help people find a time that works with their schedule. There usually is one week between each new session, and new members typically complete the training within a month and a half, Green says.
The program includes a mock IRB session in which new members can have a trial experience at reviewing and presenting, and there’s a buddy system that pairs experienced members with new members for ongoing support, Green says.
“A lot of times people are thrown into the frying pan, and we’ve found the buddy system helps a lot,” he says. “It gives everyone a baseline level of knowledge.”
WU IRB has six meetings per week, each with one chair who leads discussions of cases and provides guidance. Since the committee has seven members with 160 alternates, no one has to attend all of the weekly meetings, and they can commit to any particular meeting through online scheduling, Green says.
Ongoing education also includes a 10-minute module at the beginning of every meeting. These educational short sessions include a PowerPoint narration on a broad range of topics, including the following from 2015 and 2014:
- therapeutic misconception;
- keeping focused on the criteria for approval;
- IRB oversight modules,
- study initiation program,
- conflict of interest and IRB review,
- documenting risk findings,
- myIRB tips and tricks,
- changing the human subjects regulations,
- reviewing data and safety monitoring plans,
- keeping focused on the criteria for approval,
- research and the cognitively impaired,
- IRB evaluation of placebo controlled trials,
- HIPAA & research,
- research with healthy volunteers,
- changes to the HRPO reviewer sheet, and
- informed consent documents and health literacy.
“We’ve developed the curriculum in house, and it’s evolved over time — pulled from experience,” Green says.
Each year, IRB members have an evaluation accompanied by a survey that asks them about their experience serving on the board. “Generally, feedback is positive,” Green says.
“People want to learn and stay engaged in the process, and we have member outreach — particularly for unaffiliated members,” he adds. “We stay in close contact with them so they don’t feel like we’re just using them for warm bodies in the meeting.”