In a move that pleased many researchers, the Office of Human Research Protections (OHRP) in mid-February reversed its decision to shut down a Johns Hopkins Quality Improvement study in Michigan.
On the heels of an SHM-led coalition’s efforts, a letter to the Hopkins researchers said the OHRP decided to move on and would immediately lift its ban on data collection by the Michigan hospitals participating in the study.
At first glance the new decision appeared to be a victory for researchers and others who worried the OHRP’s earlier ruling might have a chilling effect on quality improvement (QI) studies. A closer examination of the agency’s response shows that while officials at the OHRP heard and reacted to the loud outcry from the medical community, they haven’t significantly changed their approach to regulating QI research.
In fact, the OHRP’s director explains the apparent about-face wasn’t really a reversal. It simply was a determination that the time for regulation already had passed—that essentially the horse already left the barn.
“Because the five-part intervention (including the checklist) has now been adopted by the Michigan hospitals as a proven effective standard of practice, the intervention no longer represents a research intervention with the patients at the hospitals, and is therefore not research involving human subjects,” says OHRP Director Ivor Pritchard, PhD. “And because Johns Hopkins is not receiving private, identifiable data from the Michigan hospitals, but rather de-identified data about the frequency of infections in the ICUs, this research activity is not research involving human subjects.”
What this means is the OHRP again may decide to step in if it were to receive a complaint about an ongoing QI study, like the Johns Hopkins project.
“Assuming [Health and Human Services] had the authority to regulate the activity, and the regulations had not changed, we would continue to advise institutions that such a QI study would fall under the U.S. Department of Health and Human Services (HHS) protection of human subject regulations,” Dr. Pritchard says. “Whether we would take a compliance action in response to a complaint about such a research activity is a different matter, however, and would depend on the specific facts of the case.”
The most recent letter to Johns Hopkins and Dr. Pritchard’s responses show there really hasn’t been any resolution to the problem, says Mary Ann Baily, PhD, an associate for ethics and health policy at the Hastings Center in Garrison, N.Y.
In fact, the letter to Johns Hopkins suggests a study with the exact design might again run afoul of the OHRP, Dr. Baily says.
Still, Dr. Pritchard’s comments show there have been some changes in the way the OHRP views its role when it comes to QI studies and this may impact the way the agency responds next time, Dr. Baily says.
Although Dr. Pritchard didn’t rule out the possibility a future study might be shut down, the agency appears to have become sensitized to the concerns of the research community. “Our current efforts are directed toward finding better ways to communicate the relationship between quality improvement and research to both the healthcare and research communities,” he explains. “At the same time we are also reviewing the application of these rules to QI activities like the Johns Hopkins project and whether any changes are needed to encourage such work.”
This is a good sign, Dr. Baily says. It shows an openness to outside opinions that hasn’t been obvious in the past, she adds.
QI researchers and healthcare experts also have been heartened by that newfound openness at the OHRP. It’s a solid signal that voices of protest were successful in grabbing the attention of OHRP officials, they say.