The American Medical Student Association and Public Citizen, a nonprofit consumer advocacy group, jointly called on HHS and the Accreditation Council for Graduate Medical Education to put an end to trials testing shift lengths of resident physicians that pose risks for both physicians and patients.
One trial, called FIRST, involved randomly assigning a flexible duty-hour schedule for surgery residents among 166 hospitals with training programs. The hospitals in the experimental group allowed first year residents a maximum of 80 hours per week and one day off per week, all averaged over a four week period. They were also limited to in-house calls a maximum of every three nights. The research team recommended 24-hour, rather than 16-hour shifts, followed by rounds.
In a letter to HHS' Office for Human Research Protections, the advocacy groups called the FIRST trials "highly unethical," adding that it "failed to materially comply with essentially all requirements of HHS regulations for the protection of human subjects."
The second trial, called iCOMPARE, is ongoing. It involves random assignment among 63 internal medicine residency training programs. Those assigned to the experimental group have similar rules to those in the FIRST trial. However, in another letter to HHS, the groups noted residents in the iCOMPARE trial reported working shifts up to 30 hours, nearly double ACGME's maximum shift length.
AMSA and Public Citizen cited concerns about patient safety and "avoidable risks of serious harm" to residents, including depression, increased stress and car accidents due to lack of sleep. They also note subjects have no option to consent to the experiment.
The groups called on ACGME to rescind its waivers of its 2011 standards for resident shift length that allowed the trials to be conducted. In the letter to ACGME, the groups said "...an independent body needs to investigate the process that allowed these inappropriate waivers to be granted in the first place, in the face of the strong evidence of resident and patient harm that caused ACGME to issue the duty-hour standards in 2011."
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