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Risk: Moving from aversion to management
Create a continuous review process
IRBs should move toward risk management rather than risk aversion, and one way to do this is by obtaining information that provides deeper institutional memory of review outcomes in studies, one expert says.
"One issue is that IRBs are very skilled at imagining the possibility of risk, but we're not basing that assessment on actual data," says Moira A. Keane, MA, CIP, executive director in the human research protection program at the University of Minnesota in Minneapolis, MN.
"So the solution would be to look at research as it is implemented," Keane says. "We could take a realistic look at where the risks are and what's actually happening to individuals who participate in research projects."
As IRBs gather this real-time feedback, rather than waiting for the continuing review or a data safety monitoring board (DSMB) report, they'll be better informed about whether or not their decision-making process accomplished its objectives.
"Through the standard continuing review process we get some information on how a study is going, but it's very one-dimensional," Keane notes. "It's a self-report with completed forms and giving the IRB numbers, but it's not the same thing as having a brief conversation with the researcher about how it's going."
Direct communication will lead to a data-driven decision-making process, Keane says.
"We'll make decisions about a new research proposal based on similar proposals in our previous experience," she adds.
"Rather than assuming all the risk we can imagine, [what] is a probable risk for a study? We can say, 'We worried about this in the past, but here's what actually happened,'" Keane explains.
The human research protection program at the University of Minnesota is just beginning to build this type of data-driven making process, she notes.
"We've just begun exploring some possibilities of starting this risk tolerance initiative," Keane says. "We need to assess how and when we'd like to do this because IRBs have limited time."
This approach might also make IRBs more comfortable with studies that pose an unknown type of risk.
"Recently, we had a couple of projects that appeared to be not approvable because of the relative risk," Keane says.
"We worked with researchers and saw that the steps they were taking seemed reasonable, so we let them go ahead," she explains. "But we asked them to come back after they conducted the research and talk with the IRB about the experience to better inform the IRB about reviewing future projects."
This type of communication to advance continuous review of studies could be done in a more formal fashion, she suggests.
Keane offers these ideas for how IRB offices could do such an initiative:
Build individual IRB member experience: Research programs are better served by experienced IRB members who might see a new study and recall that 10 years ago the board had a similar issue arise, and it was resolved in this way, Keane says.
"Some rotation is healthy on an IRB, but I think institutional memory and experience is vital," she says. "We don't have term limits, and if our IRB members are willing to consider serving renewable terms, then that's what we do."
As a result, the IRB's collective experience level is deep, and individual board members can make observations based on outcomes they witnessed with previous studies.
Create a continuous review process: "The continuing review of research projects should be robust enough communication that we can reassure ourselves about our risk assessment and measure whether we overemphasized or under anticipated a particular study's risk," Keane says.
The key is to open the lines of communication with researchers as their studies are underway.
IRBs should encourage investigators to let them know about problems as they occur in the research project and to provide occasional feedback about how the study is doing.
"Some of that can come in post-approval monitoring of research projects when we anticipate they'll have some risk," Keane says.
"We need to look at a study to see if we got the risk and benefit ratio right," she adds.
Ask investigators to meet with IRB post-approval: After a study is approved and one or more subjects have begun to have study visits, it'd be helpful for the investigator to meet with the IRB to provide a report about the initial experiences of research participants, Keane suggests.
And this meeting could take place earlier than the formal continuing review session.
One idea might be to have a researcher meet with the IRB to explain what transpired in the project.
"We spend a lot of time in continuing review looking for the timeliness of reports and looking at whether we're using the right version of a particular document, and that's the easy stuff," Keane says. "This idea is to step back and look at the actual experience that would tell us more about risks."
For instance, IRBs can ask investigators these kinds of questions:
- How were the risks described to subjects?
- Did these adverse events occur?
- How were benefits described?
- Did you see anything that was unexpected?
"The basic experience of individuals informs the IRB," Keane says. "By the time we normally receive that data, we've reviewed dozens of other studies."
Think in terms of individual experience, not group outcomes: Data safety monitoring boards (DSMBs) will analyze data points of high risk clinical trials, but the IRB should be concerned about the experience of individuals in the study, Keane says.
"This is a qualitative approach to reviewing what's going on and not a number-crunching activity," she says. "We want to look at the study and experience of a particular research participant."
The key is to think of ways to formalize this process to obtain qualitative information that can be communicated to the IRB.
"You have to have researchers who are willing to think about these things and to give feedback to the IRB," Keane says. "This information becomes part of a report that is part of the research file, but it'd also be the kind of information that an IRB could draw from when the IRB is assessing risk in future studies."
The goal would be to seamlessly incorporate the risk tolerance process into the IRB's work so in the long run the extra time the IRB spends on mid-study communication with investigators would be offset by shorter review sessions with future challenging studies.
"If we invested the time in this kind of exercise, then we'd get time payoffs down the road when we're reviewing other studies," Keane says.