Small IRBs should add networking to their toolkit
Keeping a small IRB in the know on the latest regulatory requirements, technological advances, etc., is a huge challenge. Some smaller IRBs have found that one cost-effective way to increase their knowledge of current requirements and trends is to be part of a networking group.
"We talk about the issues and concerns that are common to IRBs," says Eric Allen, CIP, director of research compliance at the University of North Carolina at Greensboro.
Among the common themes identified by Allen's IRB networking group are the topics of how technology is evolving, cyber security and regulatory issues, and informed consent, he says.
"We talk about how we struggle with an issue from a compliance perspective or from an institutional support perspective and discuss how you address this," Allen says.
Small IRB offices need the support and information that is possible through networking with peers, says Bonnie Frisard, MBA, director of the human research protection program at Catholic Medical Center in Manchester, NH.
"There are so many organizations that participate in research and have a very small IRB office," Frisard says. "I'm a department of one."
Directors of small IRBs often have no one within their organization to turn to when there's an in-depth question or problem, she notes.
"There are several people within the organization who I can contact for assistance, including the IRB chair, IRB members, corporate compliance, and medical staff director," Frisard adds. "But for in-depth understanding or interpretations, my peers at outside organizations are most helpful."
Small IRBs are different from an IRB at an academic hospital, as many smaller IRBs do not deal with phase I or phase II studies, she says.
Another benefit of a networking group is that it fills in educational needs and gaps, Frisard and other IRB managers say.
"Part of the problem is, a small research institution has a very limited budget so education is hard to come by other than online opportunities," says Erica Tauriello, CIP, manager, human research program at Wentworth-Douglass Hospital in Dover, NH.
Tauriello is part of the mentoring group that Frisard started in 2011. Six New Hampshire human research protection managers or IRB directors meet each quarter to share ideas, concerns, and knowledge.
"We've helped each other understand a change in regulations for IRBs or a change in regulations for clinical research," Tauriello says. "Some of us have draft standard operating procedures [SOPs] and have developed SOPs, and we were sharing ideas."
The networking group also shared their strategies on specific topics such as informed consent, she notes.
While any IRB director might find some IRB tools and information online, these general templates might not be a perfect fit for smaller research institutions, she adds.
"It's easier when you're sitting with a group of people from similar institutions, looking at each other's procedures to see what's working and helping each other with it," Tauriello explains.
The local IRB networking group operates a little like the online IRB Forum, providing information and support, she adds.
In North Carolina, a grant helped fund a networking consortium that lasted a few years, Allen says.
"When it died off, it gave us contact information so we could form our own little network," he says. "I'm on a local IRB here and they've started another small consortium and have included me in their network."
The new networking group has 16 to 20 people who aim to meet quarterly, he adds.
Face-to-face networking groups have more confidentiality and greater flexibility, Allen and Frisard say.
"You can ask questions on the IRB Forum, which is wonderful, but there might not be an immediate response for follow-up," Frisard explains.
Sometimes a person who would like to see templates for certain forms will ask people to send them samples to their private email accounts, which means the other people on the forum do not get to see the information, she adds.
For directors of small IRBs, the networking group also can improve morale, the experts note.
For instance, in New Hampshire many hospitals were hit hard with budget cuts in recent years. Hospitals responded by reducing or eliminating travel to conferences and professional educational opportunities, Frisard says.
"So most of us didn't get to go to the PRIM&R meeting, which is where you see your peers and hear about what they're doing," Frisard says. "Meetings are where you see that you're not alone in the world."
The networking meetings, held at each participant's organization, are relatively inexpensive while still providing the social and professional reward of a face-to-face meeting or session, she adds.
The main benefit of networking is to help IRB directors find different ways of looking at problems and addressing regulatory and other issues, Allen says.
"Once you've been in the human subjects protection business for a while you know the rules, but this helps you look at them from different perspectives and explain them to different groups," he says.
"Overall, the networking group is one of the most beneficial things you can do," Allen says. "You are part of a group that brings you information so you don't have to seek it out."
Networking meetings spark discussions and allow people to work on possible ways to resolve issues that arise, he adds.
It also gives IRB directors who work solo another person with whom to discuss their issues and ideas.
"When we are having a problem or issue or are trying to develop something new, we have somewhere to turn," Tauriello says. "We have somebody to ask a question and bounce off our ideas."
Tauriello works alone in her IRB office. Her only peers are the IRB chair, IRB members, and clinical research personnel.
"We talk things through, but nobody else covers the IRB end of it except me, and this is true of most of the people in this IRB network," she explains.
"We send each other emails or call each other and say, 'Hey, can you help me?'" she adds. "We're glad to have the network where we can get help from each other."