I must admit, I didn’t hold out high hopes that a ragtag band of committed clinicians and other quality improvers could change federal policy. But we’ve done just that. If the Feds are capable of rectifying this mistake, who knows what might be next!
For those unfamiliar with the Hopkins-Michigan-OHRP checklist story, it is described on my prior blogs here and here. Through it all, our concern has not been just with one ICU safety study (notwithstanding its importance), but with the ruling’s chilling effect on quality improvement and safety activities in healthcare everywhere. Starting with a powerful op-ed in the NY Times by Atul Gawande, and followed by protests that began with this blog but spread like wildfire, pressure began to mount on the OHRP to remove their bureaucratic straightjacket on the field of quality improvement. And yesterday, a consortium of hospital-based medical societies (led by the Society of Hospital Medicine) issued a strongly worded statement and began an aggressive Congressional letter-writing campaign to overturn the OHRP decision.
While I was immensely proud of my colleagues for all this energy on behalf of our patients’ welfare, on my blog yesterday I fretted that:
the OHRP thinks that – because this is just about patient welfare and not about our economic self-interest – they can wait us out and we’ll let it go. Let’s prove ‘em wrong.
Well, we did! Yesterday afternoon, the OHRP issued the following statement on their official listserv:
OHRP CONCLUDES CASE REGARDING JOHNS HOPKINS UNIVERSITY RESEARCH ON HOSPITAL INFECTIONS
… Encourages Continuance of Work to Reduce Incidence of Catheter-Related Infections; Offers New Guidance for Future Research…
The Office for Human Research Protections (OHRP) – part of the U.S. Department of Health and Human Services – has concluded that Michigan hospitals can continue implementing a checklist to reduce the rate of catheter-related infections in intensive care unit settings (ICUs) without falling under regulations governing human subjects research. Dr. Kristina C. Borror, director of the office’s Division of Compliance Oversight, sent separate letters to the lead architects of the study, Johns Hopkins University and the Michigan Health & Hospital Association, outlining findings and offering researchers additional guidance for future work.
“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Dr. Ivor Pritchard, acting director of OHRP. “HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects.”
The Johns Hopkins study demonstrated that a comprehensive five-step program can dramatically reduce the incidence of catheter-borne infections in ICUs. HHS strongly encourages hospitals nationwide to adopt the program, which can save thousands of lives and millions of dollars each year.
OHRP noted that the Johns Hopkins project has evolved to the point where the intervention, including the checklist, is now being used at certain Michigan hospitals solely for clinical purposes, not medical research or experimentation. Consequently, the regulations that govern human subjects research no longer apply and neither Johns Hopkins nor the Michigan hospitals need the approval of an institutional review board (IRB) to conduct the current phase of the project.
In addition, the letters offer new guidance for future quality improvement research that poses minimal risk to human subjects, such as the Johns Hopkins study. Dr. Borror wrote that such research would likely have been eligible for both expedited IRB review and a waiver of the informed consent requirement.
In response to a written complaint about this research, OHRP opened a compliance oversight evaluation with the Johns Hopkins University and the Michigan Health & Hospital Association, regarding allegations of non-compliance with HHS regulations for the protection of human subjects (45 CFR part 46, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). The complainant alleged that the research was conducted without prior review and approval by an IRB and without the informed consent of the human subjects who participated.
HHS is 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.
This is a seminal moment for quality improvement in the United States. The prior OHRP decision, if left standing, could have mandated regulatory approval and the need to obtain patient and provider consent every time one wanted to improve a process and measure its impact. Today’s decision recognizes the need to balance traditional “research” regulations against the harm that will result if good people are forced to leap over unnecessary bureaucratic hurdles every time they seek to implement a safety or quality practice and see if it worked.
Moreover, as more and more regulations – many sensible but some asinine – are promulgated in the name of safety and quality, I hope the OHRP story kickstarts a process in which the regulators and the regulated collaborate to ensure that the ultimate goal of better patient care is being served.
Finally, it shows that we – when we put our minds to it – have the power to make change happen. We, it seems, are the ones we’ve been waiting for.
Boy, that line has a nice ring. I wonder if anybody else has used it yet.