Backlash
The Hopkins researchers figured they wouldn’t have problems with OHRP because they weren’t studying a new, unproven intervention. They were simply trying to discover the impact of providing a checklist of proven procedures.
Just to be on the safe side, though, the researchers presented their plans to the Hopkins IRB, which determined that the study was exempt from review.
So it was a surprise to everyone when the OHRP, acting on an anonymous complaint, weighed in and shut down data collection after ruling that IRBs from each of the 103 hospitals participating in the study would need to separately evaluate and approve the study.
“Most people read about this and their jaws dropped,” Dr. Wachter says. “They couldn’t believe that the federal government would restrict research on the use of a checklist. It’s wacky.”
This is a perfect example of regulatory overreach, Dr. Wachter says.
“It can be challenging to draw the line,” he adds. “But, to me, it defies common sense to say that a program in which we are going to implement a checklist and then collect data to see if it works constitutes research and therefore requires the same amount of patient protection as a study of a new device or a potentially toxic medication.”
What made the OHRP ruling seem even more odd was the fact that another division of the HHS, the Agency for Healthcare Research and Quality, had added Dr. Pronovost’s study to its list of “classic” papers shortly after the research was published.
Making matters worse in many researchers’ minds was the fact the OHRP didn’t stop with this study. An official letter to officials at Johns Hopkins extended the agency’s reach to all Hopkins “quality assurance/quality improvement proposals for which federal funding is being sought.”
The OHRP ordered that these proposals be “examined to determine if IRB review was conducted or if exempt status was not granted inappropriately. If these are not the case, the [principal investigators] for the proposals will be contacted and informed that prospective data collection requires IRB review and that an application for exempt status will not be accepted for these projects.”
And the OHRP went even further. The November letter suggested that even quality assurance/quality improvement studies that included retrospective reviews might be construed as “human subjects research.”
In essence, that means any attempt to evaluate the impact of any type of change in procedures meant to improve quality of care would require IRB scrutiny and—quite likely—patient consents, says Mary Ann Baily, PhD, an associate for ethics and health policy at the Hastings Center in Garrison, N.Y.
“I think it’s very maddening,” Dr. Baily says. “The OHRP has created an impossible situation. Why in heavens name would the OHRP want to tie QI researchers up in knots?”
Despite multiple requests from The Hospitalist, officials at the OHRP declined to comment and clarify the issue.
Some QI researchers see the need for regulation. There should be some oversight, even when it comes to QI, says Lakshmi Halasyamani, MD, 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. While the intervention involved in the Johns Hopkins case seems relatively benign, this isn’t always the case with QI.
It comes down to evaluating the level of risk to patients, says Dr. Halasyamani. And there needs to be someone, somewhere in the process evaluating the risks to patients of each intervention, Dr. Halasyamani says.
“We shouldn’t be creating a whole new level of bureaucracy that will slow down low risk interventions that could have a huge impact,” she adds. “But, you want someone looking at whether the interventions could have a downside.”