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Networks help physicians research practice-based care
Group has research network, IRB devoted to studies
Primary care practice-based research networks (PBRNs) bring together physicians and clinicians in practices across the country to research how patients are treated in a primary care setting.
Although many of the studies conducted in these networks are of relatively low risk, PBRNs have reported difficulties working with IRBs, particularly on large, multisite studies.
IRBs in different locations can require changes to applications and consent forms, and different IRBs can categorize the same protocol as exempt, expedited or requiring full board review.
Deborah G. Graham, MSPH, associate research director for the American Association of Family Physicians (AAFP), based in Leawood, KS, says that, often, IRBs simply don't understand the type of research they're dealing with.
"Generally, it's multisite research that's conducted in family physicians' offices," she says. "It could be survey-type research, or it could be the implementation of a new type of care. It's a very low-risk type research, on a different scale from what most academic IRBs are used to."
Instead of acting as principal investigators, participating physicians send their data along to the network.
In order to help those individual physicians navigate the IRB system, the AAFP has created its own National Research Network, a PBRN that collaborates with investigators and practices to help conduct research.
The AAFP National Research Network includes about 350 clinicians and study coordinators from 180 practices across the U.S. and Canada.
Graham reports that that about 40 percent of the active members are not required to report to a local IRB, as well as use the AAFP's own IRB, created last year. The AAFP IRB is composed of members who understand practice-based research and its specific needs, she says.
AAFP IRB oversight
Physicians who want to use the AAFP's IRB sign an agreement to allow oversight by the board. The IRB also has an arrangement with the Collaborative Institutional Training Initiative (CITI) to provide online courses in required human subjects protection for those physicians and their staff.
The AAFP IRB also serves as a HIPAA privacy board for the research network's studies.
Unaffiliated members who use the AAFP IRB need not fill out any additional IRB applications or HIPAA forms.
But for physicians who are attached to a medical center, or other institution that requires local IRB review, the process is more cumbersome, Graham says.
Individual practices, which may not have staff dedicated to research activities, must cope with local forms, as well as turn in the submissions themselves, although they are not principal investigators.
To help these physicians, the AAFP research network has taken on much of the burden of dealing with individual IRB forms.
Individual IRBs' demands can vary, Graham says.
"Sometimes they want more protection for a low-risk study than it really calls for," she says. "Sometimes it's just that each local IRB wants their say in it — they want a change in the consent form, either because they have their own templates or their own information they want.
"If you're dealing with 20 different IRBs, and they all want to change it just a little bit, that's a lot of bureaucracy and a lot of problems," Graham says. "At these practices, many of whom don't have a research coordinator, either the central (AAFP research network) office needs to complete all the IRB forms, or the practice just isn't able to participate."
Even with the AAFP research network's help, the bureaucracy involved in getting a number of IRBs to approve a study can delay its implementation.
"For most of our studies, because of that, we have to kind of roll things out as IRBs approve it," she says. "It's very difficult to roll out a study across the board at the same time. You kind of do it in one location as you get approval."
She says the AAFP research network has asked individual IRBs if they would be willing to accept a centralized application from the network, or the AAFP IRB's approval, but few have agreed.
"I don't think they're equipped to go outside of their system for now," Graham says. "I think a lot of them feel the responsibility that they need to review everything and they're not set up to accept the approval of another IRB."
IRBs: Open to education?
Graham says the research network encourages local physicians to educate their IRBs about the specifics of practice-based research. She recommends that IRBs be open to this education.
"There's definitely different types of research with different types of challenges, and they need to be open to working with the needs of different types of groups," she says.
For example, Graham notes that physicians and their staff, at their individual practices, often are required by their IRBs to go through hours of human subjects protection training, much of which is irrelevant to the studies they do.
The AAFP IRB requires completion of only four CITI modules, which have been geared specifically toward practice-based research.
"They are not principal investigators, they are not co-investigators — they're just the local staff," she says. "The AAFP IRB understood that, so they set up a special section just for them."
She says many investigators who report to local IRBs now are trying to convince those boards to accept a similar training program.
Graham says she also would encourage IRBs to be willing to work with groups such as the AAFP NRN and its IRB. She says she's optimistic that more IRBs will be open to this type of arrangement, particularly considering OHRP's recent interest in alternate models of IRB review.
"They've had a couple of conferences now on alternate models of review, so it does seem that different places are investigating different options," she says. "I would hope so."
She says the AAFP and its IRB plan to bring together stakeholders in the research process to discuss various possibilities for streamlining review of multisite practice-based research.
Those options could include IRBs allowing review by another institution's IRB or by a centralized IRB such as the AAFP IRB. Sites also could form a consortium and elect one IRB to serve as the reviewing body.
"A goal down the road would certainly be to have a kind of centralized process that local IRBs would accept," she says.