HHS shuts down Michigan patient safety study

Physicians blast the move, saying it sets a precedent that could stifle a wide range of quality and safety initiatives.

By Kevin B. O’Reilly — Posted Feb. 4, 2008

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More than 100 Michigan intensive-care units cut their average catheter-related bloodstream infection rate 66% by implementing a simple checklist of proven infection-control practices such as hand washing and removing unnecessary catheters.

But the Dept. of Health and Human Services' Office for Human Research Protections last fall ordered the hospitals to suspend collecting data documenting the research project's success because researchers did not properly comply with federal regulations aimed at safeguarding patients.

Now each participating hospital must seek institutional review board approval for the project, which was organized by the Johns Hopkins University School of Medicine in Baltimore and whose results were published in the Dec. 28, 2006, New England Journal of Medicine.

The study already has been cited more than 20 times in other medical journals, with experts in one patient safety publication dubbing it an "instant classic." The safety effort reduced the median infection rate to zero per 1,000 catheter days, compared with national rates as high as 5.2 per 1,000 catheter days.

After receiving an anonymous complaint about the Michigan ICU project, the Office for Human Research Protections ruled it required IRB approval because researchers sought to test the effectiveness of infection-control protocols and involved patients and clinicians as subjects. Project investigators claimed their program was exempt from federal regulations because it did not involve experimental treatments that might harm patients.

Johns Hopkins officials were unavailable for comment at press time. But a spokesman for the Michigan Health & Hospital Assn. said the participating hospitals expect to complete the IRB approval process by March 1 and are seeking waivers of informed-consent requirements under criteria set out in federal regulations.

Impact on quality initiatives

Experts said the repercussions of OHRP's ruling are much broader.

"The impact is huge," said Atul Gawande, MD, a general surgeon at Brigham and Women's Hospital in Boston who brought attention to the case with an op-ed article in The New York Times.

The burgeoning quality movement already faces enough hurdles without having "to go through new bureaucracies," Dr. Gawande said. The ruling "does more harm than any kind of danger posed to patients by quality-improvement projects."

Robert Wachter, MD, a leading patient-safety researcher and chief of the medical service at the University of California, San Francisco, Medical Center, agreed. He said the OHRP ruling is "absolutely ludicrous" and could have a "huge chilling effect" on quality research initiatives.

The IRB process can take from four to six weeks, he said, and other experts have estimated that approval for large, multisite projects can take up to a year. Physicians and ethicists complain that IRBs are often underfunded and poorly trained and issue highly unpredictable recommendations.

But Matt Weinberg, a bioethicist in the New Jersey Dept. of Health and Senior Services, said the OHRP regulations are clear and that researchers tried to take the easy way out.

"It just seems to me a case of ethical laziness, which I think is unfortunately pervasive when it comes to getting consent for research projects," said Weinberg, who was not speaking on behalf of the New Jersey health department.

In a Jan. 4 letter to HHS Secretary Michael Leavitt, American Hospital Assn. CEO Rich Umbdenstock said OHRP rightly oversees clinical trials of new drugs and devices. But such investigations, he wrote, "are far different from the quality improvement efforts exploring the use of checklists, computerized reminders, teamwork training and other steps to ensure that the care we intend to deliver is actually delivered."

HHS spokeswoman Rebecca Ayer said in a statement that "not all efforts to improve quality are 'research' or subject to the regulations. How those rules apply to research to develop new quality initiatives is an important issue for HHS, providers and the public, and one that we are working actively to address."

OHRP may have correctly interpreted current law, but its decision "demonstrates the profound flaws in the ethics and policy of the whole federal research human-subjects review enterprise," said Lawrence O. Gostin, director of the Center for Law and the Public's Health at Johns Hopkins and Georgetown Universities.

Federal regulations impede many quality efforts where "the risks to human subjects are very low, and in fact, the activity itself is intended to increase the benefits to humans," Gostin said. "These are very concrete and routine activities that health professionals should be doing, using science to make better judgments and inform others about those better judgments."

A 2006 report published by the Hastings Center, a Garrison, N.Y., bioethics think tank, said organizations implementing minimal-risk quality initiatives should inform patients that consenting to receive care "includes consent to a minimum level of cooperation with ongoing [quality improvement]."

The American Medical Association collaborated on the Hastings report and has policy calling on OHRP "to develop clear guidelines to differentiate between quality improvement and human-subjects research."

AMA President-elect Nancy H. Nielsen, MD, PhD, said in a statement: "The AMA is deeply concerned about the lack of clarity around appropriate standards and procedures for overseeing quality improvement and patient safety activities in health care. We urge the Secretary's Advisory Committee on Human Research Protections to engage on these issues and work to provide guidance for physicians and others committed to improving the quality of care in this country."

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Success, but ...

More than 100 Michigan ICUs were able to reduce costly and deadly catheter-related bloodstream infections, going from a median rate of 2.7 infections per 1,000 catheter days to a rate of zero in only three months. But last fall, the Dept. of Health and Human Services' Office for Human Research Protections ordered the hospitals to stop collecting data related to the project because of a lack of proper institutional review board approval. Physicians and nurses at the participating ICUs had implemented the following interventions:

  • Washing hands.
  • Using full-barrier precautions during insertion of central venous catheters.
  • Cleaning the skin with chlorhexidine, a long-lasting liquid antiseptic soap.
  • Avoiding the femoral site when possible.
  • Removing unnecessary catheters.

Source: "An Intervention to Decrease Catheter-Related Bloodstream Infections," New England Journal of Medicine, Dec. 28, 2006

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Rules of research

Federal regulations governing research with human subjects are complicated and controversial. Experts even disagree on what qualifies as research. Regulations define it as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."

Even if federal officials consider a project involving human subjects to be research, an institutional review board may grant a waiver from the requirement to seek legally effective informed consent if the following criteria are met:

  • The research involves no more than minimal risk to the subjects.
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects.
  • The research could not practicably be carried out without the waiver or alteration.
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Sources: Title 45 of the Code of Federal Regulations, Part 46, Sections 102 and 116

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External links

"An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU," New England Journal of Medicine, Dec. 28, 2006 (link)

Michigan Health & Hospital Assn.'s Keystone: ICU project (link)

"The Ethics of Using Quality Improvement Methods in Health Care," Annals of Internal Medicine, May 1, 2007, (link)

Office for Human Research Protections determination letter sent to Johns Hopkins University School of Medicine, Nov. 6, 2007, in pdf (link)

"Office for Human Research Protections Compliance Oversight Procedures for Evaluating Institutions," Oct. 19, 2005, in pdf (link)

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