Human research protection rules and regulations evolve and change, and it’s difficult for even the most experienced IRB members and chairs to keep up with them. So as one IRB has found, the best practice is to create an educational program that provides orientation, training, and continuing education for IRB chairs and members, the director says.
“It’s hard to keep a huge number of IRB members familiar with all of the nuances to regulations and guidance,” says Rebecca Rousselle, CIP, director of the Emory University IRB in Atlanta. The Emory University IRB has more than 110 members across eight panels.
The following are the Emory IRB’s educational strategies:
- Keep chairs aware of new regulations, guidance. “Fortunately, our chairs tend to be long-standing members and are very experienced,” Rousselle adds. “The issue with them is making sure they get information about new guidance that comes out and new policies we have.”
So the IRB has an informal way of keeping chairs and vice-chairs up to date: “We meet monthly in the lounge at the university’s conference center,” Rousselle says. “We can sit outdoors or by the fireplace, ordering snacks and drinks.”
Chairs receive the meeting’s agenda in advance, and attendance is voluntary. Meetings are held the first Thursday of each month from 4:30 to 6 p.m.
The meetings focus on new federal guidance or institutional policies, as well as examples of problems other research institutions have had and that the IRB would like to prevent, Rousselle says.
“We use these meetings as an opportunity to get their input on changes to our standard operating procedures [SOPs] and to gain their input on anything we can do to make our members happier and more productive,” she adds. “We talk about what we can do to retain and educate members.”
- Train and prepare new IRB members. Education of new IRB members begins with an initial email exchange with the IRB office in which an IRB coordinator lets the prospective member know what the board’s expectations are, says Shara Karlebach, WHNP-BC, CIP, quality assurance and education consultant at Emory IRB.
If the prospective board members continue to show interest, then they go through multiple steps, including submitting necessary documentation and attending an in-person, two-hour training, Karlebach explains.
“We spend half the time going over regulations, logistics of meetings, requirements, and expectations for reviews on all levels,” she says. “The second part of training is familiarizing them with an online system on how to complete the review, and we talk them through every type of review and amendment.”
New members learn how to access IRB resources, which human research protection materials are recommended reading, and observe an IRB meeting, she adds.
“They watch how other people discuss studies at the meeting, so they can have a sense of what’s expected of them and ask questions as they need to,” Rousselle says.
This is followed by the formal appointment process, in which they become official IRB members. This appointment is signed off by an institutional official, and the new member is told that there will be ongoing training, as well.
“For their first reviews, we provide technical guidance if they need it and have a staff member help them,” Karlebach says. “There’s a small team that’s in charge of onboarding members, and we control for that content and process.”
In the future, the IRB plans to add a mentorship program for new members, as well. “There’s so much to know about regulations that we think they’d benefit from having an experienced member be there for them,” Rousselle says.
The IRB is supported by a highly trained professional staff that takes care of most of the new member onboarding, she notes.
But IRB chairs welcome new members and help facilitate their transition to the role. For instance, the vice chairs will turn to community members to make certain they have input, Rousselle says.
- Provide various continuing education opportunities. Continuing education for IRB members includes an annual, half-day, catered retreat that covers the most important topics at that time and older topics where members might need a refresher course, she says.
“We bring in a researcher to talk about specific research, and we plan to have a research participant come in and talk about that perspective,” Rousselle says.
The IRB also provides members with a 30-minute, monthly educational webinar and an educational newsletter. Hard copies of the newsletter are brought to meetings, and it’s also sent out by email. (See sample items from newsletter in this issue.)
A third educational strategy is the “Take Five” at IRB meetings. This refers to a five-minute educational update.
“We’re sensitive to the fact that meetings go from 4 p.m. to overlapping with dinner time, so the Take Five is a change of pace in the middle of the meeting or at the beginning,” Rousselle notes. “We go over something in the IRB review process that people have trouble with or if there are new policy changes or guidance, and we present it in five minutes.”
Take Five topics typically are provided by meeting facilitators, who are IRB staff.
The IRB member education program is for all members, and there are no specific education sessions for just the community members, Karlebach says.
“But obviously, they might not be as familiar with research as faculty in the research world, so we do our best to highlight for them how their input is critical and why it’s so important,” she explains. “We like to remind them how they add value; it’s not additional training, per se, but there’s a focused discussion when we’re onboarding a community member about how it’s important they add their thoughts, speak up in meetings, and not let themselves be intimidated by clinicians and experts.”
Also, the IRB has a semi-annual community member luncheon for networking and discussing resources and their particular concerns. There is also a member page on the IRB’s website. Plans are to enhance it with practical tools to assist with completing reviews and guidance, tailored to what IRB members need to know, Rousselle says.
Human research protection rules and regulations evolve and change, and it’s difficult for even the most experienced IRB members and chairs to keep up with them.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content