A while back I wrote about how the Office of Human Research Protection (OHRP) had blocked the implementation of a checklist for ICUs that would most likely prevent roughly 20,000 deaths from infectious disease annually. ScienceBlogling Revere reports that the OHRP has reversed its decision (italics mine):
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.htm). 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.
What I what to know is who is the stupid fucknozzle who filed the written complaint? I’ve checked through all of the publicly available documentation, and that’s not listed. Maybe it’s time for an FOIA (I really need new hobbies….).