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Kentucky IRB office has mentoring program and other education strategies
Information on-demand helps with training
IRB members often begin their new role with many questions and concerns. While these may be answered during a formal training program, there is another way to help ease new members into the role, and that's through a formal mentoring program.
"If you're coming in as a new IRB member, we have a series of training sessions for you, but in addition we will contact another IRB member who is experienced and ask if this person will be the new member's mentor," says Ada Sue Selwitz, MA, director of the Office of Research Integrity at the University of Kentucky in Lexington, KY. Selwitz also is an adjunct professor in the College of Medicine.
The institution recently received full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington, DC.
When AAHRPP officials visited the office, they complimented the mentoring program, Selwitz notes.
The institution has four medical IRBs and one non-medical IRB, all with more than 10 members and alternates, says Helene Lake-Bullock, PhD, JD, a research compliance officer in the Office of Research Integrity.
Several years ago, when Selwitz and Lake-Bullock began working on improving training and education for IRB members, they checked with 10-15 other institutions to see how they educated their IRB members.
"One of them had a mentoring program in the past, but they had not continued it," Lake-Bullock recalls. "But when I talked to people about IRB member education, they thought it was a great idea to provide mentoring."
The institution's IRB members also liked the idea and said their own transitions might have been easier if they had been mentored, she recalls.
"They were happy to do that for new members," Lake-Bullock says.
The institution also provides updated education and training for IRB members through what amounts to information on-demand.
For example, when a protocol is submitted that involves a vulnerable population, such as children, the IRB office will send IRB members a set of materials that addresses the ethical review of studies involving children, Selwitz says.
"One thing I believe is that adult learners learn best by doing," Selwitz says. "So one thing we do here is if we receive a protocol that requires raising issues either because of ethical concerns or regulatory ones, then we have a set of materials that helps users address those issues."
The office sends IRB members the additional material in their protocol packets, calling this protocol-specific training.
"If I attach those materials to a protocol you're reviewing, then you're more likely to read them then," Selwitz says. "That's a very effective tool."
The additional information is sent to IRB members, but it is shared with investigators when they request more information, Selwitz notes.
"If investigators come to me and say, 'What kind of questions might the IRB raise?' we'll say, 'Why don't you look at what we'll be sending the IRB members,'" Selwitz says.
With experience, IRB members eventually may not need to read the packets of information. But at the beginning this is the second part of their additional training. Mentoring has become a major part of their initial training.
Matching members with similar backgrounds
Because the university has five IRBs, there is continuous turnover and mentoring of new members, but most of the changes occur in the fall, Lake-Bullock says.
"When we get our new assignments in the fall, I set up the mentoring pairs," Lake-Bullock says. "I call on seasoned members and usually try to match them with new members who have the same background."
For example, a medical IRB member will mentor a new medical IRB member, and if someone has a specialty in pediatrics, he or she might be paired with someone else who has that specialty, she explains.
"I've come to find that's pretty important," Lake-Bullock says. "They'd rather be paired with another community member if they're a community member."
Even the IRB alternates are provided with mentoring since they will need to be ready to step into the IRB role when needed, she says.
Mentors are asked to provide assistance to new members for at least a few months. If they feel they cannot handle the time commitment, they can pass and volunteer to mentor later.
"They make a phone call to the new member and introduce themselves and accompany the new member to a meeting," she says. "The mentor will introduce the new member at the meeting and try to make the person feel comfortable."
Once the IRB office decided to start the mentoring program, Selwitz and Lake-Bullock came up with guidelines.
"So we started developing the outline of what we would expect them to do," Lake-Bullock says.
The result is a three-page tool that includes a checklist for the mentor (see box below for sample items from the Welcome Checklist).
Lake-Bullock is available if the mentors or new IRB members have any questions once they've been paired, but she says there have been few issues arise.
"It's been very low maintenance," she says. "Once the mentoring pairs are set-up, it's been a self-run program."
Anecdotal evidence suggests that IRB members are pleased with the mentoring program and that the IRBs benefit from new members' faster assimilation on the board, Lake-Bullock says.
"Our intent is to send out a survey and see how it's doing," she says. "But I've asked people what they thought of the program, and, overall, they thought it was great."