Binding order: IRB book improves communication
Leadership group gets handle on information
Keeping IRB chairs and members updated and well informed can be challenging when an institution's human subjects research is rapidly expanding.
The University of Medicine and Dentistry of New Jersey in Newark, NJ, grew from about four staff members to 12 in two years. Also, new IRB submissions increased to nearly 75 per month. So the IRB director knew she'd have to come up with an efficient way to keep IRBs updated on the latest regulations and other news.
"We have more than 75 IRB members and four different IRB committees," says Carlotta M. Rodriguez, BS, CIP, director of the IRB Newark Campus.
Each IRB has a vice-chair, and one chair handles all four boards.
"Sometimes the vice chairs wouldn't see each other, and I started noticing that something new would come up, and I couldn't get the information to them as quickly as I'd like," Rodriguez says. "So we established an IRB leadership committee with me, the IRB chair, the four vice chairs, and the assistant director in my office."
The leadership committee meets at least monthly and discusses trends in IRB submissions, IRB staff and members and training, regulations, and any topical issues that arise.
These meetings have improved communication between vice chairs and ensure each IRB receives any new information that's available, Rodriguez says.
"Every month we give out educational items," she adds.
As the educational sheets piled up and sometimes were torn and crumpled, Rodriguez decided it would be a good idea to give each member of the leadership committee a binder, called the IRB chair reference book, to contain the information.
"So I put in each binder what we always needed, like the regulations, the Belmont Report, vulnerable subjects codes, our institution's own policies on conflicts of interest, guidance for confidentiality, elements of informed consent, and any new topics or laws," Rodriguez says.
An essential item
Other items in the binders include Robert's Rules of Order, IRB membership roster, State of New Jersey Access to Medical Research Act, HIPAA, and categories of research reviewable by expedited review procedure.
It took Rodriguez about a month to assemble the binders, and then she presented them at the next leadership committee meeting.
Eventually the binders grew to 2.5 inches thick, and they became an essential item carried to each IRB meeting.
"In my office there are two staff members who attend every IRB meeting, and they bring the IRB chair books with them," Rodriguez says. "So if a chair needs to reference something, they can see the information right there."
The IRB chair and vice-chairs also keep their IRB chair books in their offices to refer to as they read protocols.
The binders have evolved over time and now are tabulated for easier reference, she says.
"I didn't want a book that would sit on the shelf," Rodriguez says. "It should be a living document that you add to and update all the time."
IRB members sometimes discuss issues at meetings that eventually will find their way into the IRB chair book.
"Sometimes someone will have a question or an issue that comes before their IRB meeting, and they say it would be helpful if we had that information on hand," Rodriguez says.
For example, IRB members recently discussed how to assess risk in studies and how to assign the labels of "minimal risk" or "greater than minimal risk," she explains.
"IRB members might be on the fence in deciding whether a study has minor risk or greater than minimal risk," she adds. "So we're working with the chairs to create scenarios as examples of minimal risk; minor, but not greater than minimal, risk, and then greater than minimal risk."
Once Rodriguez receives feedback, she'll have this added to the binders.
The IRB chair and vice chairs use the binders to inform their own protocol reviews and to update other IRB members, Rodriguez notes.
"The chair and vice chairs love it," she says. "They find it useful."
Keeping IRB chairs and members updated and well informed can be challenging when an institution's human subjects research is rapidly expanding.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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