Dec. 16, 2015
Accreditation Council Fails to Address Ethical Lapses That Put Resident Doctors and Patients at Risk
Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts
WASHINGTON, D.C. – The Accreditation Council for Graduate Medical Education (ACGME) has failed to address, or even acknowledge, the serious ethical lapses in two clinical trials that have allowed first-year medical residents to work dangerously long shifts, Public Citizen said today.
On Nov. 19, Public Citizen and the American Medical Student Association called on the Office for Human Research Protections to investigate two highly unethical trials – iCOMPARE and FIRST – that allowed hundreds of first-year medical residents to work shifts of 28 consecutive hours or more — nearly twice the current maximum number of hours allowed by the ACGME for such residents. The groups simultaneously called on the ACGME to rescind its waivers of important work hour limits that it granted to hospitals and residency training programs participating in the two trials. Neither trial could have proceeded without the ACGME’s waivers. Learn more about the unethical trials.
On Dec. 7, the ACGME sent Public Citizen a three-page response (PDF) denying culpability.
“We are hardly surprised by the ACGME’s response to our request,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “As an important funder, facilitator and endorser of the iCOMPARE and FIRST trials, the organization no doubt is reluctant to acknowledge that it erred in supporting such unethical research.”
In a letter sent today to the ACGME, Public Citizen points out that strikingly absent from the ACGME’s response is any acknowledgement of the well-documented risks posed by sleep deprivation resulting from excessively long shifts to the medical residents — particularly the first-year medical residents — who have been randomly assigned to the experimental groups of both trials; the lack of informed consent of the subjects of the trials; and the serious deficiencies in the scientific design of the trials.
In addition to not addressing the main ethical concerns of the trials, the ACGME wrongly asserts that the waivers were granted only for the length of each research trial. However, as Public Citizen notes, documentation provided on the trials’ own websites indicates that the waivers will extend beyond the duration of the study periods.
Additionally, the ACGME’s letter attempts to downplay the potential adverse impact of the waivers on both the resident and patient subjects randomly assigned to the experimental groups of both trials. Its letter emphatically states that the ACGME “did NOT waive the central requirements for duty hours that have been in place since 2003 … (i.e., 80 hours per week—averaged over four weeks; one day off in seven—averaged over four weeks; and 24-hour in-house call duty no more frequently than every third night).” But the ACGME fails to mention provisions that it waived, including the most stringent 2011 requirement for first-year residents: the maximum 16-hour limit, the elimination of which allowed first-year residents in the experimental groups to work shifts of 28 consecutive hours or more.
Finally, the ACGME seeks to avoid culpability for its decision to grant waivers that allowed these unethical trials to proceed by claiming that the trials were “reviewed by the Institutional Review Board (IRB) of the institution affiliated with each principal investigator” and that “the iCOMPARE trial was funded by the National Institutes of Health (NIH).”
Public Citizen refutes this, noting, “neither IRB review nor NIH funding of research is sufficient to establish that research is ethical.” Moreover, the assertion that the FIRST trial underwent IRB review at Northwestern University, the lead institution, is inaccurate. For that trial, the IRB administrator at the university made a colossal error by determining that the trial did not involve human subjects research and therefore did not need to be reviewed by the IRB, Carome said.
Public Citizen renewed its call for the ACGME to immediately rescind the waivers of key provisions of its 2011 work hour standards for the internal medicine and general surgery residency training programs in the iCOMPARE and FIRST trials.