The trial’s lead investigator, Dr. Karl Bilimoria of Northwestern, says that while FIRST wasn’t classified as human research, an independent data monitoring board was established to check for safety concerns.
He adds that aside from programs in New York, which regulates resident hours by law, only six sites declined to participate. All sites were free to run the trial through their individual IRBs.
“We left it up to everybody to do what was best for them locally,” he says.
In a letter to Public Citizen and the American Medical Student Association, ACGME noted that tired residents can hand off patients at any time, are advised to nap after 16 hours and are given adequate sleep facilities and/or safe transportation options.
Two JAMA editors, Drs. Julie Ann Sosa and Howard Bauchner, write in a commentary published with the paper, “We recognize the controversy about the ethics of the study and believe that transparency about the way in which it was approved and conducted should be reviewed and discussed.”
The ethical issues are complex, agreed Dr. Robert Klitzman, director of the Masters of Bioethics Program at Columbia University in New York City.
He noted that a 2014 report in JAMA showed no improvement in patient outcomes after the 2011 ACGME resident hour restrictions were imposed. While he’s sympathetic to the concerns of Public Citizen, Klitzman says, “I think it’s very powerful evidence that there was no danger to patients” before then.
He agrees with Public Citizen and the American Medical Student Association, however, that the trial should be considered human research.
“It’s much more complicated than a short shift and long shift,” says Dr. Sanjay Desai, residency program director at Johns Hopkins Hospital in Baltimore.
For example, he says, shorter shifts lead to more transitions or “handoffs” in care, which are known to contribute to miscommunication and errors.
Desai, who is not involved with FIRST, but is involved with iCOMPARE, also says shorter shifts are often worked at night and can be as tiring as longer shifts.
“The logic of the argument makes sense only at the surface, but when you consider night shifts and handoffs, the complexity becomes immediately clear,” Desai says.
Although the study is done, Klitzman says the Office for Human Research Protections, which was contacted by Public Citizen and the American Medical Student Association, may still take action or decline to act on the complaint.
