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checklist) has now been adopted by the Michigan hospitals as a proven effective standard of practice, the intervention no longer represents a research intervention with the patients at the hospitals, and is therefore not research involving human subjects,” says OHRP Director Ivor Pritchard, PhD.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.

“The fact that they rescinded a prior ruling based on pushback from the field is quite important,” says Robert Wachter, MD, professor and chief of the division of hospital medicine at the University of California at San Francisco, a former SHM president, and author of the blog “Wachter’s World” (www.wachtersworld.com). “It says that they have at least heard and responded to pressure from people doing this work.”

Unless there is a clear-cut set of rules that allow researchers to easily figure out when a study might catch the attention of the OHRP, many simply may decide against pursuing QI studies.

Dr. Wachter and others hope the latest communications from the OHRP are a sign officials at the agency are open to outside opinions and ready to start a dialogue.

That would be an important change, says Michael A. Matthay, MD, a professor of medicine and anesthesia at the University of California San Francisco. Up until now, the agency has been unfettered.

Dr. Matthay has had the experience of being second-guessed by the OHRP. In 2003, he was a researcher on a study sponsored and overseen by the National Institutes of Health. The research was brought to a screeching halt when officials at the OHRP decided they didn’t like the study’s design.

Although that study eventually was allowed to resume, the down time wasn’t without its costs, since it delayed results that eventually had a significant effect on patient care, says Dr. Matthay.

The Hopkins case is just another example of what happens when a government agency like the OHRP is allowed to act without oversight of its own actions, experts contend.

It highlights the agency’s ineffectiveness and inability to protect patient interests, Dr. Matthay suggests. “It’s not going to result in a better quality of care, and it’s not protecting patient rights,” he concludes.

“I’m a hopeful guy,” Dr. Wachter says. “If you’d asked me three months ago, when the ruling first came out, whether we would be able to get people an agency that had previously been impervious to public pressure to notice and pay attention, I might not have believed it.

“I think we’ve already gotten somewhere. This is just the first step. And it’s not a trivial first step. Federal agencies tend to turn off the phone and e-mail in response to pressure. We’ve shaken them by the shoulders. They have to realize how much turmoil they’re creating in the field and why this is going to be harmful to quality care of patients.”

In one of the clearest signs that the “pushback” from researchers has had an effect, officials at the OHRP admitted the Hopkins case might have caused confusion among QI researchers. The agency would like to help clear things up, Dr. Pritchard says.

“Our impression is that many institutions are currently grappling with the challenges of determining when QI studies require [internal board review] and when informed consent should be required or waived,” he allows. “You should also be aware that, going forward, HHS officials will make a sincere effort to improve communications with medical providers and researchers so that quality improvement initiatives that pose minimal risks to subjects are not inhibited by the regulations. We’re also encouraging any providers or researchers with questions about these regulations to contact us for guidance. In addition, we’re reviewing the application of these rules to evidence-based quality improvement activities, like the Johns Hopkins project, and whether any changes are needed to encourage such work while safeguarding the rights and welfare of human subjects in research.”

Dr. Wachter and others hope there will be much more communication between researchers and the OHRP.

“My hope is that this is not done, that this is the beginning of a very important conversation,” Dr. Wachter says. “If it is done, then this has simply been a Pyrrhic victory.” TH

Linda Carroll is a medical writer based in New Jersey.

A Boost for QI Research