IN Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.
A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.
Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
There seemed to be no question that the the quality improvement (QI) project involved an intervention on physicians, not patients. The project involved use of a simple checklist by intensive care unit (ICU) physicians designed to reduce hospital-acquired infections. The items on the check-list, described in a New England Journal of Medicine article [Pronovost P, Needham D, Berenholtz S et al. An intervention to decrease catheter-related bloodstream infections in the ICU. New Engl J Med 2006; 355:2725-2732. See link here.] consisted of "hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters."
The prospective cohort study apparently collected data from the charts of patients hospitalized after use of the check-list was begun to determine their clinical outcomes.
The main objection by the OHRP seemed to be that the project did not get permission from patients to use information from their clinical records. Research involving collecting data from patients' clinical records usually is considered to be extremely low risk to patients if the information collected is not sensitive, and the researchers protect the confidentiality of the data.
The decision to shut down this observational research project appeared to be extreme and based on, to be charitable, exceedingly narrow and nit-picking ground. The data collected did not appear to be sensitive; there was no question about protection of its confidentiality; the QI intervention could have been carried out without associated research and without patient informed consent (since the intervention affected physicians directly, not patients); and the study was apparently approved by local institutional review boards (IRBs). (See two letters by Kristina C. Borror, Ph.D., Director of the Division of Compliance Oversight at OHRP, to Johns Hopkins University officials, here and here.)
Gawande called the government's decision "bizarre and dangerous." On the Health Beat blog, Maggie Maher speculated, "someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is." On the Health Care Organizational Ethics blog, Dr Jame Sabin cited the Hastings Center report on the ethics of QI research, and wrote, "it is hard to avoid suspicion about the motives of the OHRP for scuttling the project. But whatever the motivation behind OHRP’s actions, it is important for the agency to reverse course promptly."
While doctors are endlessly criticized for medical errors and poor quality care, there has been little financial support for quality improvement research available from government, foundations, or commercial sources. Thus it is galling to see an apparently worthwhile and very low risk quality improvement study shut down, especially when much more risky interventional studies are allowed to continue.
For example, while this study was shut down, the US Food and Drug Administration (FDA) let a poorly designed controlled trial of gene therapy administered into individually inflamed joints of patients with inflammatory arthritis, a trial which already saw the unexpected and unexplained death of one subject from overwhelming infection, restart (see post here). Maybe it is time for conspiracy theories...
ADDENDUM (2 January, 2008) - also see comments on the Effect Measure blog, and by MedInformaticsMD on Health Care Renewal.
The research published by Pronovost and colleauges meets the
government's definition of research:
"Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge."
By publishing their results, they document that it was
a systematic investigation that were meant to be generalizable.
The research design was looking at incidence rates before and after
the intervention, not a randomized controlled trial.
The research design wasn't the problem. It was the failure to have Institutional Review Board (ethics board) review and approval
before conducting the research. How such a failure occurred is unclear. Whatever the reason for this oversight, OHRP is charged with upholding the laws governing research and the citation is simply a consequence of that responsibility.
But it seems that the study was submitted to the Johns Hopkins IRB. The July letter from OHPR (http://www.hhs.gov/ohrp/detrm_letrs/YR07/jul07d.pdf)
referred to the application made by the researchers to the IRB.
So failure to submit the study to the IRB was not the issue.
Furthermore, this was apparently an observational study of outcomes after an "intervention" which was not made directly on patients, which at most could be considered a quality improvement project, but could very well also be considered a standard of medical care to which all intensive care physicians should aspire. This was not a randomized controlled trial. No experimental interventions were done on any patients, as best as I can tell.
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