FYI.

This story is over 5 years old.

28 Hours on the Clock: ‘Unethical’ Trial May Have Put Med Students at Risk

In what one watchdog group calls a “highly unethical” trial, first-year medical residents worked 28 hours at a stretch or longer.
Image: Shutterstock

Medical residents were put at risk of car accidents, needle-stick injuries, and depression in a "highly unethical" trial that forced some to work 28 hours at a stretch, to see whether it would harm their ability to care for patients, according to documents released Wednesday by the American Medical Student Association (AMSA) and Public Citizen, a watchdog group.

The study is still ongoing, but Public Citizen and AMSA are now urging that it be suspended and investigated. Researchers say not so fast, however, saying that longer shifts can actually improve resident training, even patient care.

Advertisement

For any working doctor, long hours are part of the deal, and nobody goes to medical school expecting a 40-hour work week. But there's growing momentum to curb doctors' hours to prevent burnout, depression, sleep deprivation and other serious problems—not to mention medical error, which can have a huge impact on patients. Limiting a doctor's shift can force them to walk out in the middle of surgery, or leave right when a patient needs them the most. On the other hand, nobody wants a doctor who hasn't slept, and slips up on the job.

Research on how doctors' long working hours affect patients is actually mixed, and in some cases suggests it's fine

The way it stands now, first-year medical residents in the US are limited to working 16-hour shifts. In iCOMPARE, researchers wanted to test out a more "flexible" arrangement that saw them working as many as 28 hours at a time. Residents in the study followed certain rules: they could only work 80 hours a week at most, and had to take one day off per week. The documents, obtained from the National Institutes of Health through a Freedom of Information Act request, show that iCOMPARE's designers recognized residents might be injured in a car accident, accidentally poke themselves with an infected needle, or succumb to depression because of sleep deprivation—risks that Dr. Michael Carome, director of Public Citizen's Health Research Group, calls significant.

One of the most important issues, as he sees it, is consent. Residents essentially were required to participate. "They know they're in the trial, but have no choice unless they want to leave their training program," he explained. Patients, meanwhile, don't realize they're participating at all. Carome sees glaring problems with how the study was approved at most of the 63 participating training programs. The principal investigator, Dr. David Asch of the University of Pennsylvania, wasn't available to comment for this piece by deadline.

Research on how doctors' long working hours affect patients is actually mixed, and in some cases suggests it's fine—even good for them. When doctors hand off people in their care, confusion or miscommunication can lead to medical errors. A similar study, called FIRST, showed that surgical residents with flexibility to work longer hours didn't pose a greater risk to patients. (FIRST has also been a target of Public Citizen and AMSA.) "It was safe for patients," countered Dr. Karl Bilimoria of Northwestern University, who led that study. "Residents told us they thought it was better for patient safety and continuity of care," although they had some concerns about not having enough time off to see friends and family. "They understand this trade-off," he maintained. "It's one a lot of professionals make."

The Office for Human Research Protections, at the US Department of Health and Human Services, is reviewing the allegations, a spokesperson said. Carome hopes for an investigation. "We want this study to stop," he said. As long as it continues, "residents and their patients will continue to be put at risk, without their consent."