Clinical Trials of Resident Duty Hours Come Under Fire


On Nov. 19, Public Citizen and the American Medical Student Association (AMSA) sent letters to the federal Office of Human Research Protection asking for an investigation into two trials that waived limits on first year resident doctors’ working hours. The groups also called on the ACGME to rescind the waivers it has provided to 222 academic medical centers which allow first year residents to work 28-hour shifts, rather than the 16-hour maximum established in the 2011 duty hours regulations.

CIR has submitted a letter in support of the complaint by Public Citizen and AMSA.

The FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial, involving first year surgery residents, was recently completed, and the iCompare trial, focusing on internal medicine residents and funded by the National Institutes of Health, is scheduled to be completed in June 2016. The primary outcome of both trials is patient deaths within 30 days. The waivers for participating internal medicine programs are in place until 2019.

Criticism of the trials centers around the design of the studies and the failure of investigators to obtain informed consent from the residents who are subjects of the studies, as well as their patients.


From Medscape:

“As reported last month by the Washington Post, the IRB of the University of Pennsylvania classified FIRST as a “minimal risk” study, a designation “critical to the decision to waive the usual requirement to inform patients and doctors they would be participating in an experiment.” The newspaper quoted a university official as saying that it would be impractical to obtain informed consent from “every internal medicine patient at all of the participating hospitals.”

The website for iCOMPARE sets forth a version of informed consent for residents. Internal medicine residency programs “will inform their applicants” of their participation in iCOMPARE. By completing study surveys later on, trainees will provide their consent.

However, that protocol apparently has not always been followed, according to the Washington Post. It quoted two first-year residents in psychiatry at the University of Washington School of Medicine as saying that nobody told them they might pull 30-hour shifts when they applied. The university said it notified internal medicine residents about the trial, but not psychiatry residents, who study internal medicine in their first year, according to the Washington Post.

Other press coverage:

Doctors underwent “extreme sleep deprivation” in studies of effect on patient deaths, The BMJ

Studies on resident work hours ‘highly unethical,’ lack patient consentModern Healthcare

When your doctor is on a 30-hour shift, The Daily Beast


Residents, CIR wants to hear from you about this issue. Please email with your thoughts and experiences in this area.