Many quality improvement studies are research needing IRB review
Many quality improvement studies are research needing IRB review
Human subject QI projects may require IRB oversight
The line between quality improvement (QI) activities, which are intended to improve health care within an institution, and true research, which seeks to contribute knowledge to others outside the institution, has always been blurry. But quality experts say it’s getting harder to differentiate between the two, as QI studies become more rigorous and as projects that may have started as internal surveys end up get presented at conferences and written up in papers.
As a result, there may be a significant number of such studies going on at an institution without the IRB’s awareness or review, says Peter Lindenauer, MD, MSc, associate medical director in the division of health care quality at Baystate Medical Center in Springfield, MA.
Lindenauer was lead author of a 2002 survey in the American Journal of Medicine that found significant disparities between what QI officers and IRB chairs believed to be research that required IRB review.1 When asked about various QI scenarios, ranging from internal communications aimed at improving care to a plan to publish results, quality officers were less likely, in most cases, to believe that the project required IRB review.
Even at a single institution, the quality officer and IRB chair had differing ideas about the need for reviewing the proposal.
Lindenauer says he believes the problem likely has worsened in the past few years, thanks to a growth in QI projects and the greater participation of physician leaders who may wish to publish their results.
Jacqueline Byers, PhD, RN, CNAA, CPHQ, associate professor of nursing at the University of Central Florida in Orlando, and research editor for the Journal for Healthcare Quality, says she’s seen a noticeable increase in the scientific rigor of articles submitted for her publication.
Often, she says, when she asks for proof of human subjects protection review, the answer comes back: "Well, it’s QI, so we don’t need to go before an IRB."
"But an investigator can’t determine that," she says. "There needs to be some sort of institutional mechanism; and if it’s not the IRB, it needs to be designated to some other body."
Lindenauer says he believes many QI departments and IRBs rely on a mutual "don’t ask, don’t tell" arrangement to avoid hassles for either entity. QI officers may refrain from submitting their proposals to IRBs because they don’t want the projects delayed. And IRBs don’t press them for details of their studies because they worry about the increased workload.
But he adds that IRB review is important for these studies, which may include elements that could put patients at risk.
"What goes under the guise or the umbrella of quality improvement varies tremendously," Lindenauer says. "There are projects that are called quality improvement projects, which are focused on getting more people the standard measure of high-quality care. But you also may have a project where, say, we want to shorten length of stay by 50% because our hospital has to save money. Thinking as an advocate for patients, I would want to have some degree of comfort that it would be safe to shorten a patient’s length of stay."
Byers, who also serves as co-chair of her university’s IRB, says one of her goals is to educate quality professionals that they should submit their proposals to IRBs, even though most would be considered exempt or gain expedited review.
And she says IRBs need to figure out a practical way of dealing with those submissions, so that it doesn’t overburden the board or stymie QI efforts.
"I think the time to put it on the IRB professionals’ radar screen is now, and to start the dialogue," Byers says.
What’s QI; what’s research?
The Common Rule (45 CFR 46.102.d) defines research as the "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
The key term for assessing a quality improvement project’s status tends to be "generalizable," say Byers and Lindenauer. That is, do those planning the study intend only to disseminate it to their own staff, to let them know the best method of achieving results within their own institution? Or do they perhaps plan to use the information in a journal article, or for a poster at a conference, or even on a billboard to tout the hospital’s accomplishments to the public?
If the answer is the latter, it’s generalizable knowledge and must be reviewed by an IRB, Byers says.
Another important distinction is that research may open patients up to a different standard or method of care, which would make them human subjects and requires review, she says.
"For example, I did a study in a neonatal intensive care unit a few years ago, where we were piloting a different care delivery model so we were changing the standard of care," she says. "We sent that through IRB, because No. 1, we wanted to disseminate it with posters and publications, which is clearly generalizable knowledge, but secondly, because we were exposing the infants to a different type of care model."
Lindenauer adds that an attempt to provide a control group for an intervention — giving it to one unit, but not to another in order to compare results — is another red flag that an IRB should sign off on it.
Byers says the slope between QI and research can be a slippery one.
"As a QI professional, you go into it thinking, this is innocent, I’m only going to audit 30 charts and see how the pain management is being taken care of. And then you say, Well, we seem to have an issue here’; and you go into another study, and then the next thing you know, there’s a nurse executive presenting at a state conference talking about how they solved the pain management problem in their organization," she says.
Byers says the first example would fit clearly under a QI umbrella, but as you use knowledge from that study for other studies, it all becomes generalizable.
"It’s an extremely, extremely, gray area," she says.
All the better, Byers says, to overreport to IRBs rather than underreport.
Reaching out to QI
Byers says IRBs need to reach out to their QI teams to get a handle on the type of studies they’re doing. Because quality professionals often don’t have the same in-depth knowledge of human subjects regulations that IRBs do, they need to be provided with information to help them figure out when an IRB must review their work.
Checklists containing elements of the federal regulations, similar to those commonly given researchers, can be used to help determine whether a quality officer believes a study is exempt or expedited, Byers says.
"But they still need to submit it," she says. "The key thing is that the people who are performing the study are not determining its level."
In order to deal with what could be a significant increase in submissions to the IRB, Byers says an institution can create a subcommittee similar to the privacy boards that mete out HIPAA decisions.
At her institution, a subcommittee with expertise in quality improvement and risk management handles those proposals, and is authorized to designate studies as exempt.
"The IRB doesn’t have to do it all, and the IRB chair doesn’t have to do it all," she says. "But those people on the subcommittee need to have the same OHRP on-line instruction, all the stuff an IRB member would get."
Ultimately, Lindenauer says, he’d like to see leaders in the field of human subjects protection and quality improvement work together to hammer out a more standardized approach to deciding how quality improvement studies should be handled.
"Until that happens, there’s going to be huge variations across organizations about how quality improvement is overseen," he says.
Reference
- Lindenauer PK, Benjamin EM, Naglieri-Prescod D, et al. The role of the institutional review board in quality improvement: A survey of quality officers, institutional review board chairs, and journal editors. Am J Med 2002; 113(7):575-579.
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