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Accredited human research protection programs (HRPPs) are required to meet a seemingly simple standard that requires a quality improvement program to be focused on efficiency and compliance.
These are two different requirements, and the issue for most IRBs is determining how to do both simultaneously, says John R. Baumann, PhD, executive director of the HRPP, office of vice president for research at Indiana University in Indianapolis.
"Sometimes there’s a strain between those two things, as you can imagine," Baumann says.
Indiana University has found a successful balance between efficiency and compliance while meeting the accreditation standards set by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
The research institution has seven IRBs and approximately 5,000 active studies, so a lot of paperwork, emails and forms go through the IRB office, Baumann notes.
"In being consistent with AAHRPP standards, our quality improvement activities revolve around questions of efficiency and questions of quality," Baumann says. "Metrics indicate it has made a noticeable difference, resulting in a shorter submission to review time."
The IRB’s review time is below AAHRPP’s mean review time, he adds.
Here are a few tips on how to meet this QI standard:
1. Identify processes that can be made more efficient without sacrificing quality.
"Look at what you can do differently without sacrificing quality," Baumann suggests.
A good starting point is shortening the time between when a submission is received and when it’s complete. One factor is finding missing information in submissions, he says.
Questions to ask include:
• What kind of outreach and guidance can we do to eliminate those problems?
• What’s missing and how can we get the message out to decrease the number of submissions that are incomplete?
"At this stage of the game, so much of what we’re dealing with is to improve the completeness and quality of what comes in," Baumann says. "And we want to reduce the back-and-forth between our office and the researcher because that takes time."
Another initiative is to move submissions to review and approval more quickly, Baumann says.
"The way we’re trying to do that is by reducing the back-and-forth between our office and the research team to get it ready to be reviewed," Baumann says.
When the IRB office used the standard of making the submission perfect before sending it to the IRB reviewer, they found it caused a significant time delay because they would send questions to investigators who would seek sponsor approval, and then finally return the answers to the IRB office, he explains.
"Then we’d send it to the reviewer, who in a high percentage of cases wants other questions answered, and then we’d have to repeat the whole process," he says.
The solution was simple: "Instead of asking the researcher to make changes before we send the submission to the reviewer, we send our critique to the IRB reviewer," Baumann says. "The IRB accepts, revises, or adds on to our review, and so there is only one review that goes back to the sponsor."
Then the IRB office notifies the researcher that certain items need to be changed. The researcher makes the changes, sends the revised submission to the IRB, and that usually is the end of the back-and-forth process.
2. Analyze protocol deviations and noncompliance.
"We’re initiating a process for reviewing collectively all protocol deviations and noncompliance that comes into the office," Baumann says.
"All too often we treat deviations and noncompliance as individual cases," he adds. "We treat them very seriously, but have not up until now learned as much as we could of the review of them."
Questions to ask include the following:
• Where are the protocol deviations coming from?
• What are the deviations and what can we do to help researchers avoid them?
• Are there particular patterns to the noncompliance?
• Do the IRB’s education and guidance need to be beefed up?
Sometimes the problem is that an investigator is being too specific in the protocol, Baumann notes.
"The appointment occurs 24 hours later than scheduled," he says. "Does it matter whether it’s a Tuesday or Wednesday when the participant comes in?"
This is easily resolved by just writing the protocol with more flexible language, as long as it’s consistent with best interests of the subject’s well-being and the purpose of the research, he adds.
3. Address provisional approvals.
Provisionally approved studies are ones that have met all of the criteria for approval, but the IRB wants some changes.
"We’re launching an investigation to see what those changes are and whether there is any way we can catch them before they go to review," Baumann says. "The IRB office will hopefully catch them."
The goal is to reduce the number of studies that are provisionally approved.
Questions to ask include the following:
• What did we do right for those studies that are fully approved at the IRB meeting?
• What did we miss on the provisionally approved studies?
• What happened with studies that were not approved or were tabled?
Often, studies that are tabled have questions of science, which is not something the IRB office can address, Baumann notes.
"We had one tabled today because the reviewers did not like the statistical method they were using to answer the question," he says.
"This is not something the staff can generally catch," he adds.
"We will look at what we can put in place that we didn’t catch beforehand or see what kind of training is needed for the IRB," Baumann says.
4. Form IRB collaborative review agreements.
"We are increasingly open to sharing, deferring, or accepting deferred IRB reviews," Baumann says.
Researchers sometimes have three IRBs looking at the exact same study. So Indiana University is forming agreements with other institutions to develop collaborative reviews.
"We’ve established many collaborations with many accredited organizations with IRB review," he says.
Questions to ask include:
• When can we make such an agreement?
• Which institution should be the IRB of record?
• Which institution has the risk or lead investigator?
"We make a decision based on which institution is home to the lead investigator and the location of the risks," Baumann says.
All of these quality improvement changes are fairly simple and move an IRB out of the parochial ideal that each IRB has to review everything, Baumann adds.