Michigan patient safety study gets HHS approval to resume

The decision raises hopes the agency will re-examine how regulations on human research subjects apply to quality improvement studies.

By Kevin B. O’Reilly — Posted March 10, 2008

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A patient safety project that helped more than 100 Michigan hospital intensive care units cut their average catheter-related bloodstream infection rate by 66% can start collecting outcomes data again. That was the ruling last month from the Dept. of Health and Human Services' Office for Human Research Protections.

The move was viewed widely as a reversal of OHRP's controversial decision last fall to order the hospitals to suspend data collection. OHRP acted then because researchers had misclassified the project as being exempt from federal human research subject regulations and did not obtain informed consent from ICU patients.

More broadly, the decision seemed to signal a new willingness by the agency to re-evaluate whether rules designed to protect patients involved in high-risk biomedical experiments should also be applied to minimal-risk, evidence-based quality improvement research activities.

Results of the Michigan project were published in the New England Journal of Medicine in December 2006. They demonstrated how systemic changes improved clinicians' adherence to U.S. Centers for Disease Control and Prevention guidelines shown to reduce catheter-related bloodstream infections.

Previously, the intervention had been shown to work at Johns Hopkins Hospital, home to lead study author and principal investigator Peter J. Pronovost, MD, MPH, director of the adult critical care division.

OHRP said in a statement the project had "evolved" since it was first studied from 2003 to 2005, because the intervention is now proven and thus no longer qualifies as experimental research subject to federal rules. Similar projects probably could proceed with expedited institutional review board approval and qualify for a waiver of the informed-consent requirement, the agency said. Expedited reviews average about six weeks and can take up to a year, studies show.

Dr. Pronovost said the argument about what qualifies as human subjects research misses the point.

"Trying to label what is quality improvement or what is research isn't going to be very productive," he said. "There ought to be some way to look at this using a risk-based framework."

Researchers raise issue elsewhere

The Michigan study is far from being an isolated case. David Korn, MD, chief scientific officer of the Assn. of American Medical Colleges, has received dozens of complaints, questions and concerns about OHRP regulations from researchers the last few years.

"The Hopkins case crystallized in a very visible way exactly why clarification has to take place," he said.

Ezekiel J. Emanuel, MD, PhD, bioethics chair at the National Institutes of Health, said the new OHRP decision "essentially acknowledges they made a mistake." He added that what is needed now is "a fix for the whole system, a rethink for review of zero-risk research."

A wide-ranging review of how OHRP regulations apply to quality improvement research is already under way, according to OHRP Acting Director Ivor Pritchard, PhD.

"HHS is going to look at this issue from top to bottom," he said. Options include issuing new guidance, asking for regulatory changes and seeking a waiver of the rules from the secretary of HHS for certain low-risk quality studies. A March 27-28 meeting of the Secretary's Advisory Committee on Human Research Protections will examine the issue.

Physicians and ethicists welcomed the change of heart.

"OHRP seems to be recognizing how important it is to do this quality improvement work," said Mary Ann Baily, PhD, associate for ethics and health policy at the Hastings Center, a Garrison, N.Y., bioethics think tank. "They are recognizing how important it is to let it go forward without saddling it with very heavy procedural burdens really designed for risky medical research, not for minimal-risk activities that are designed to improve the delivery of health care."

In a Feb. 21 letter to HHS Secretary Michael Leavitt, American Medical Association Board of Trustees Chair Edward L. Langston, MD, said the OHRP decision "must serve as a building block for a broader effort to establish mechanisms for appropriate, timely and robust ethical oversight of quality improvement activities."

An invitation-only meeting set for May 1 and sponsored by the Institute of Medicine and the American Board of Internal Medicine Foundation will focus on the ethical and regulatory implications of quality initiatives.

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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)

Office for Human Research Protections determination letter sent to Johns Hopkins University, Feb. 14, pdf (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 human subject regulations decision charts, Sept. 24, 2004 (link)

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