Since 2003, strict rules have limited how long medical residents can work without a break. The rules are supposed to minimize the risk that these doctors-in-training will make mistakes that threaten patients' safety because of fatigue.
But are these rules really the best for new doctors and their patients? There's been intense debate over that and some say little data to resolve the question.
So a group of researchers decided to follow thousands of medical residents at dozens of hospitals around the country.
The study compares the current rules, which limit first-year residents to working no more than 16 hours without a break, with a more flexible schedule that could allow the young doctors to work up to 30 hours.
Researchers will examine whether more mistakes happen on one schedule or the other and whether the residents learn more one way or the other. The year-long study started in July.
"If we want to take the best care of patients now and in the future, we really need to understand much more about the intricate balance of hours, education and care," says David Asch, a professor of medicine at the University of Pennsylvania, who is leading the study.
But this study and a similar project have triggered objections from Public Citizen's Health Research Group, an advocacy organization based in Washington, D.C., and the American Medical Student Associ ation, which represents medical students.
The groups argue the studies put patients and residents at risk.
Sleep-deprived residents are more likely to injure themselves while doing procedures such as drawing blood, inserting intravenous lines or suturing wounds, says Michael Carome, who heads the health research group. The accidents could lead to infections with viruses such as hepatitis and HIV, he says. And tired residents tend to get into more car accidents after work.
He argues that the studies raise concerns about patients, too.
"Tired residents are more likely to make mistakes when they're caring for patients," Carome says. "And those mistakes in some cases can lead to catastrophic complications and even death."
A well-known example is the 1984 case of Libby Zion. Zion was a college freshman who died at a New York hospital while being cared for by residents. Other cases in which patients were harmed or even killed by mistakes made by tired residents finally resulted in the new work rules, which were adopted in 2003. These rules were revised in 2011, adding the 16-hour restriction for first-year residents.
Because longer hours are so risky, Carome argues, the studies are unethical, especially since the researchers are not being required to ask the residents or the patients for permission to include them.
"Patients are not being informed at all, so the patients are completely unwitting subjects of this research," Carome says. "The residents are aware that they are in this trial, but they have no choice to participate unless they want to leave the residency training program."
That's the case for David Harari, a first-year medical resident at the University of Washington Medical Center in Seattle. He knew his hours would be grueling but says he was shocked when he discovered he may have to work 30 hours straight.
"I can't see how anyone could work optimally with such little sleep," Harari says. "It's extremely difficult to stay awake, stay alert and function optimally at that level."
Harari was offended by the fact he had no choice in the matter.
"Being asked to partake in a study in which I never provided informed consent felt extremely unethical and really uncomfortable," Harari says.
Carome argues hospitals are pushing to relax the rules to save money. But Asch argues that the research is needed to determine which schedule is safest and teaches residents the best. Longer shifts may actually be safer than shorter shifts, he says, because shorter shifts can lead to more night shifts, which can be even more fatiguing than long shifts.
And, Asch says, mistakes often occur when residents have to hand off their patients to other doctors because a rigid schedule forces them to go home.
"The new doctor taking care of you never knows you as well as the doctor who was taking care of you before," Asch says. Information handoffs are "like in a relay race, where the baton gets dropped between two runners. And it's known as a critical point where medical errors are common."
Asch also maintains that it isn't practical to get consent from all the doctors and patients in the study. Some independent bioethicists agree.
"They're asking important questions that we need to answer in order to create competent doctors, and I think they're doing it in an ethically sound manner," says Mildred Solomon, who heads the Hastings Center, a bioethics think tank.
The federal Office for Human Research Protections is reviewing the complaints about the studies, according to a spokesperson.