One key to resolving the issue may be for healthcare experts to come up with a definition of what constitutes “human subjects research.”
“This is where issues keep coming up,” Hodge says. “Is QI just an extension of clinical care or is it research? The answer to that question will tell you whether it implicates the rule or not.”
Researchers, ethicists, and legal experts hotly debate these issues. No one appears to know exactly where to draw the line that divides human subjects research from QI studies.
Even before the checklist controversy arose, HIPAA was already having a deleterious impact on the exchange of QI information, says Mary Ann Baily, PhD, an associate for ethics and health policy at the Hastings Center in Garrison, N.Y.
Loathe to run afoul of the OHRP, at least one of the larger managed-care providers decided against publishing results of its QI studies, Dr. Baily says. “They’re just trying to stay out of the OHRP’s way,” she explains. “At a recent workshop, researchers said, ‘We don’t publish our data. We make our own system work better and keep our heads down. That way we don’t run into any problems. It’s safer that way.’ ”
This means nobody benefits from that company’s research. “What a waste that is,” Dr. Baily asserts.
Not everyone has taken such a defensive position. But there is a wide range of opinions among QI researchers around the country.
“Certainly as someone who is involved in QI research on an operational level and who is also interested in conducting research looking at the effects of QI interventions I struggle with this regularly,” says Peter Lindenauer, MD, MSC, associate professor of medicine at the Tufts University School of Medicine in Boston and associate medical director, Division of Healthcare Quality, at Baystate Medical Center.
“QI officers don’t look at the work they do as being research,” Dr. Lindenauer notes. “They’re often translating research into practice and implementing and developing strategies designed to improve care. So, when you think about it in those terms, it would never dawn on a typical QI officer to seek IRB approval or to get consent from patients to participate.”
Some researchers avoid the issue by looking only at data with patient identifiers stripped. The assumption is that HIPAA rules apply only to medical records with identifiers intact.
Under that assumption, Lakshmi Halasyamani, MD, has performed two heart failure studies without getting into issues of patient consent. But she sees potential problems with future research.
“Because we were looking at the impact of interventions across the whole population of heart failure patients, it wasn’t a problem,” says Dr. Halasyamani, vice chair for the department of medicine at St. Joseph Mercy Hospital in Ann Arbor, Mich., and a member of SHM’s Board of Directors. “So long as you’re looking at global outcomes, the regulations don’t have much impact.”
But Dr. Halasyamani and her colleagues may want to start looking at the benefits of interventions on subgroups. And this is where things can get messy, she says.
Healthcare professionals really need to figure out a working definition for what constitutes research—and they need to do it soon, Dr. Halasyamani says. Without a good definition, Dr. Halasyamani can see a slowdown of QI research and the possibility of researchers using a QI loophole to get around IRBs. “I could see where some researchers might be tempted to call their studies QI to avoid bureaucratic hassles and IRB oversight,” she says.
Some experts think the minute you decide to publish, by definition you’re doing research.