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HMO group uses alternate IRB model to review low-risk studies
Facilitated review used for data-only studies now; expansion plans in works
IRBs continue to work toward streamlining the handling of multisite studies through alternative models of review. But they can sometimes struggle with a process that requires them to accept the review of another board in place of their own.
IRBs involved in the HMO Research Network (HMORN) a consortium of 16 HMOs from across the country that work together on research projects have risen to the challenge. They have been using facilitated review for more than two years for data-only studies, creating a structure in which IRBs can choose to cede review of a study to the IRB of the lead investigator.
The project has been so successful that HMORN is now looking to expand it to more challenging studies, says Sarah Greene, MPH, research associate with Group Health Research Institute in Seattle, WA, which belongs to the network.
"In October, we decided to expand our facilitated review model to other kinds of research, not just data-only," Greene says.
She says starting with less complicated studies was one of the keys to the success of the HMORN model. The data-only studies didn't involve an exchange of personally identifiable health information.
"I think that was crucial," Greene says. "There's no way we would have started with a drug trial. By finding the kind of research that was inherently minimal risk that was a way to ease everybody into the process."
Greene says the facilitated review project was part of a larger effort to create efficiencies in HMORN. She says the focus on IRB review came about the same time as a 2005 workshop on alternative IRB review models led by the National Institutes of Health (NIH) and the federal Office for Human Research Protections (OHRP). That conference identified 10 potential models that IRBs could use to review multisite studies.
The HMORN group originally proposed a centralized IRB for network research projects. "However, our IRBs quickly disabused us of that as a prospect, at least in the near term," Greene says.
Face to face is key
In an effort at building consensus, the group held a face-to-face meeting of all of the IRB administrators in the network to try to work out a solution. Greene says this was another important factor in the success of the project.
"I think that was really foundational," she says. "You just can't get the same sense from a conference call or a series of e-mails, however well-intentioned they are. You just can't build that same sense of 'we're all in this together, let's problem-solve it together.'"
In the facilitated model that the IRB administrators finally agreed to, the IRB associated with the principal investigator's HMO would take the lead for a study. The other IRBs in the group could choose to cede review to the lead IRB or could opt for separate local review.
"We found that that model was definitely the most tractable with everybody, with researchers as well as with IRBs," Greene says.
An example of a study that might employ this review method would be aggregating health care data to look at the outcomes of heart disease for patients using a particular drug.
"We can do all of that without touching individual-level data," she says. "It's all deidentified and all aggregated. Those kinds of summary-level analyses are the kinds of things that we can do as data-only, minimal-risk projects."
The group made early decisions designed to ease the process further. For example, the lead IRB would use its own application form, which would be distributed to the other IRBs in the group.
"We don't have a common IRB application form," Greene says. "We talked about whether it was feasible to create a common form and decided that it was not the best use of our resources at that time."
The group has developed standard operating procedures to guide the process, and tweak them from time to time as they gain more experience with it.
Local IRBs are always allowed to opt out of the facilitated review process for a particular study, although Greene says she doesn't believe an IRB in the network has ever taken advantage of that option.
"We always allow the local IRB to say, 'you know, I'm not comfortable ceding this study,'" she says. "I think that's pretty instrumental you can't just thrust an edict on someone and expect that they will comply. You shouldn't. The culture varies, the context varies and you have to honor that."
Since HMORN began using the facilitated model in 2008, the group has continued to hold meetings of its IRB administrators to maintain a dialogue and work out any problems that come up.
As the network gears up to take on projects other than data-only studies, it will have to deal with new issues, including informed consent.
"We haven't actually tackled the issue of consent forms," Greene says. "We have a couple of sites in our network that have developed consent form templates for minimal-risk research. So I think our next frontier is seeing if we could take a template and adopt it or adapt it for a network-wide consent form template and see if that would fly."
She notes that even with a network-wide form, there may need to be site-specific supplements to the informed consent.
In the meantime, the group is looking at the experiences of members who are involved in other collaborative projects, such as the Clinical and Translational Science Awards (CTSA), to refine its procedures.
"We're trying to be open to what's going on around us," Greene says. "If there are things we can impart to the CTSA community, we're certainly trying to do that. And likewise, if we can learn from their experience and build that into the HMO Research Network, we're doing that as well. We're trying to be bi-directional and adaptive and fluid as much as we can."