Georgia hospital patients and patients at other hospitals around the country were unwittingly enlisted in clinical trials aimed at finding out if their rates of death and serious complications were higher when medical residents caring for them were forced to work extremely long shifts, Public Citizen is reporting.
"These are among the most unethical research studies I have ever seen," Dr. Michael Carome, director of Public Citizen's Health Research Group, says in a release today.
Among the disturbing aspects, he said, was that patients were forced to be part of the experiment. Public Citizen and the American Medical Student Association are calling for an immediate suspension of the research of a federal investigation.
The two trials enrolled tens of thousands of patients at some of the nation's most prestigious hospitals and doctor training programs, including Emory University Program, Morehouse School of Medicine Program, Johns Hopkins University and Duke University Hospital, according to the news release.
Credit: Lois Norder
Credit: Lois Norder
For the studies, the Accreditation Council for Graduate Medical Education granted waivers on the cap for the number of consecutive hours the first-year medical residents could work. Some of the residents in the study had experimental work shifts of 28 consecutive hours or more, while a control group worked 16 consecutive hours, the ACGME limit.
Public Citizen's website shows that Emory and Morehouse were in the experimental group of the studies.
Sleep-deprived residents can expose patients to an increased risk of medical errors, the critics said. They also said that excessively long work shifts increases the residents' risk of motor vehicle accidents, needle-stick injuries and depression.
Normally, under federal rules, informed consent is required to enroll patients in clinical trials.
Emory University officials could not immediately be reached for comment. Come back later for more on this controversy.
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