QI projects aim to prevent problems, improve processes
Use a QI feedback loop
The best quality improvement (QI) projects at research institutions have multiple goals and can quickly identify problematic trends while also preventing regulatory noncompliance. They can improve IRB and investigator education and training. They can make existing processes more efficient and revamp IRB forms and templates. They also can be seen as beneficial to the whole research experience, rather than being viewed simply as punitive.
How do they achieve all of these objectives?
A first step is to frame the QI program in a constructive way, experts say.
For instance, call the oversight process "study review" instead of "audits," says Susie Corl, MSW, MPH, CIP, CCRP, quality improvement specialist at Boston Children's Hospital's office of clinical investigation, Education and Quality Improvement program (EQuIP).
"We look at principal investigators and their research and how it's going, and we give individual feedback," Corl says. "We give a report to the investigator, and it's confidential."
Data from these reports are used to identify noncompliance trends or problems serious enough to require reporting them to the IRB or regulatory agencies. But the typical minor findings are given only to the research site.
"We make sure the IRB doesn't know about the reviews and findings," Corl explains. "The only caveat is if we go out and find that someone is doing something that puts subjects at risk."
Corl calls it a "feedback loop," which means the information is used to educate researchers about problem areas and what they can do to fix and prevent these issues.
Educating both IRB members and investigators is another significant step toward improving a QI program.
"I always tell people you have to have some education in there to enable the improvement to happen and to show how you are a support mechanism for investigators," says Sarah White, MPH, CIP, director of the human research quality improvement program at Partners HealthCare in Boston.
Partners HealthCare has a quality improvement program with a particularly strong focus on education, White says.
"The scope of our QI program is larger than some others," White says. "We focus on ensuring compliance with components of research and educating investigators; we range from auditing or onsite reviews, as we like to call them — both for-cause and not-for-cause, and doing education at a study start-up."
Partners HealthCare QI program also works with investigators whose work is subject to Food and Drug Administration (FDA) rules to assist them and educate them about registering with the federal site ClinicalTrials.gov.
"We assist investigators in understanding and doing an analysis of whether they need to register and how to understand the results," White says.
Research institutions need both the auditing/review oversight piece and the education piece, she notes.
"You need the study review to understand what's going on in the field," she adds. "You need education to improve the quality of research documentation and compliance on site."
On-site reviews can be a rich source of QI data, but they need to be conducted consistently and systematically to be useful, White observes. White spoke about setting up quality improvement programs at the 2013 Advancing Ethical Research Conference, held by Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston.
To improve the data-mining possibilities of on-site reviews, White led an initiative to develop a database and observation index for use by all reviewers. The observation index lists more than 100 different observations that may be made at an on-site review. It links observations to a regulatory reference and corrective action, and it ensures consistency across the review team and from site to site and review to review, White explains. (See story about Partners' observation index, page 4.)
"The database is one of those behind-the-scenes tools that has made the Partners quality improvement program very efficient and very consistent," White adds.
Once the QI process identifies a problem, the next step is to provide feedback to the research site and to develop a plan for corrective action and continuous monitoring, Corl says.
"The one thing we need to be really careful about is whether to close out the issue or provide continuous monitoring after we give feedback to the director and we get a response," she explains. "It's complicated."
Corl presented a poster at the PRIM&R meeting about a QI project in which continuous monitoring proved to be very important to improving not only one research site's human research protection activities, but the entire program's processes. In this case, an on-site review discovered discrepancies in how some informed consent forms were signed. But through a more in-depth investigation and continuous monitoring, Corl and the QI team also found that the problem was systemic due to a problem with the IRB-approved template for informed consent. (See story about improving IC signature documentation on this page.)
Continuous monitoring of specific problems contributes to the feedback loop, Corl explains.
For instance, when a review showed that one research site only had one parent permission signature on its informed consent forms that require two signatures, the QI office asked the investigator to correct the problem and then went a step further by reporting the issue to the director of research compliance, who decided they should review all IRB records to see if there might be a trend involving missing parent permission signatures on IC forms, she says.
"This was the feedback loop," Corl says. "We reported the problem to the director, did a larger report on the findings and then gave that back."
Then the QI office shared information about an identified trend with the IRB and continued to look, intermittently, at records to make certain the suggested changes were made and that they resulted in compliance, she adds.
The resulting efforts led to a QI project that improved the overall research protection program, while preventing what might have been an unfair focus on a single site's noncompliance issues.
"I find that in this role of QI at the institution, we are able to focus heavily on education and then use the knowledge we've gained to do the reviews," Corl says. "Even if we find minor problems, it's still important in the long run, and we're gathering information that we can share with principal investigators."