Two ongoing studies meant to determine the patient impact of longer than recommended work shifts for doctors are unethical and being done without their informed consent, according to complaints sent to HHS.
The studies, one of which assigns first-year medical residents from 58 internal medicine programs to potentially more than 30 consecutive hours, have “egregious ethical and regulatory violations,” said Public Citizen and the American Medical Student Association in letters sent Tuesday to HHS.
This exposes patients to greater than minimal risk of harm, the organizations said in the letters sent to Dr. Jerry Menikoff and Kristina Borror of HHS' Office for Human Research Protections. The OHRP is reviewing the allegations, an HHS spokesperson said in an e-mail.
Both studies look at the impact of the non-standard “flexible-duty” hours on patients' 30-day mortality outcomes. One is being conducted by Dr. David Asch at the University of Pennsylvania and Dr. Sanjay Desai at Johns Hopkins University. ">That study
">That studybegan collecting data in July and will last a year.
The other is led by Dr. Karl Bilimoria, professor of surgery at Northwestern University. Data collection is expected to end in June.
None of the researchers were available for comment by deadline.
In the letters sent Tuesday, Public Citizen and the AMSA argue that the research design forces hundreds of residents across the nation to work “dangerously long shifts,” placing them and their patients at risk of serious harm.
They also did not seek voluntary informed consent from the participating resident doctors, nor from patients who “are forced to be part of these disturbing experiments,” said Dr. Michael Carome, director of Public Citizen's Health Research Group.
“I think they're right on this one,” said Art Caplan, director of the Division of Medical Ethics in New York University's Langone Medical Center's Department of Population Health. His main concern is the endpoint.
If the studies had looked at self-reported fatigue or near-misses rather than patient death and injury, it might be different. “Anything that involves putting patients at serious risk, especially by going against the recommendations … demands more consent from patients.”
Not to mention, it's a pretty well established fact that staying up too long leads to errors, Caplan said. According to the National Sleep Foundation, when on-call residents work overnight, they have twice as many attention failures, commit 36% more serious medical errors than those who work a 16-hour shift. Various other studies have shown similar conclusions.
“We don't need to reconfirm it,” Caplan said. “Is this really necessary if we already have guidelines and data that shows you get more errors with less sleep?”
Work-hour restrictions have been hotly debated among those wanting to restructure postgraduate medical education. Medical residents had previously been allowed to work shifts of up to 30 consecutive hours. In 2011, the Accreditation Council for Graduate Medical Education (ACGME) updated its standards, limiting first-year residents to 16-hour shifts and other residents to 24-hour shifts.
But there were mixed feelings about the change, with particular disagreement from current clinicians who had been through and liked the rigorous schedules. Supporters of the change countered that sleep-deprivation is a known issue and that limiting hours was “common sense.”
In the Northwestern study in question, called the Flexibility In Duty Hour Requirements for Surgical Trainees Trial, medical residents from 152 hospitals who participate in the American College of Surgeons National Surgical Quality Improvement Program were randomly assigned to work the 16-hour standard, or “an intervention arm that eliminates several ACGME duty hour requirements.”
The design was reviewed by the institutions Data Safety Monitoring Board in March, which voted to allow the trial to continue.