“The fact that they rescinded a prior ruling based on pushback from the field is quite important,” says Robert Wachter, MD, professor and chief of the division of hospital medicine at the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.