Nov. 19, 2015
Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts, Placing Them and Their Patients at Risk of Serious Harm
Public Citizen and American Medical Student Association Call on Federal Regulators to Investigate and Immediately Stop Research, Urge Accrediting Body to Reinstate Work-Hour Limits for All Resident Doctors
WASHINGTON, D.C. – Two highly unethical clinical trials that have allowed first-year medical residents to work shifts of 28 consecutive hours or more — nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education (ACGME) for such residents — should be investigated. One of the trials, which is ongoing with funding from the National Institutes of Health (NIH), should be suspended immediately, Public Citizen and the American Medical Student Association (AMSA) told the U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) today in two letters.
In a separate letter to the ACGME, Public Citizen and AMSA urged the accrediting organization to rescind waivers of most of its 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.
Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needle-stick injuries and exposure to blood-borne pathogens and depression in medical residents. It also exposes their patients to an increased risk of medical errors, sometimes leading to patient injuries and deaths.
Together, the trials involved nearly 190 hospitals or residency training programs throughout the country, including such prestigious institutions as the Cleveland Clinic Foundation, Duke University Hospital, Emory University, George Washington University, Johns Hopkins University, Tufts University School of Medicine, UCLA Medical Center and the University of Pennsylvania. An estimated total of at least several hundred residents were enrolled in the experimental groups for both trials combined, and at least tens of thousands of patients were or will be under their care.
The primary goal of the two trials isto determine whether the rates of death and serious complications for the patients unwittingly enrolled in the trials at the hospitals where first-year residents are forced to work significantly longer work shifts (28 or more hours) than permitted under current ACGME rules (the experimental group) are higher than the rates of death and serious complications in patients enrolled at hospitals where residents’ work shifts comply with the ACGME limit of 16 consecutive hours (the control group). The investigators have not obtained the voluntary informed consent of the medical residents or their patients.
“These trials are among the most unethical research studies I have ever seen,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and former associate director for regulatory affairs at OHRP. “Among the many disturbing aspects of the trials is the researchers’ failure — in violation of fundamental ethical principles and federal regulations for the protection of human subjects — to seek the voluntary informed consent of either the resident doctors or the patients who are forced to be part of these disturbing experiments.”
The ACGME’s awareness of the known harm caused by excessively long work hours led it in 2011 to tighten restrictions on resident physicians’ work hours, including limiting shifts for first-year residents to a maximum of 16 hours.
The Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, which started on July 1, 2015, and is ongoing, involves internal medicine residents at 63 institutions. The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial, which ran from July 1, 2014, until June 30, 2015, took place at approximately 159 hospitals and involved general surgery residents.
Both trials are highly unethical and fail to comply with key requirements of HHS regulations for protecting human subjects, Public Citizen and AMSA said. The researchers for both trials are knowingly exposing both first-year residents and their patients to increased risks of avoidable serious harms, including medical errors and death for patients. The potential harm outweighs any possible benefits of the research.
Because of serious flaws in how the studies were designed and conducted, the trials are susceptible to substantial bias. As a result of these flaws, the trials may not be capable of detecting any effect of the dangerously long shifts on the rates of death and complications among experimental group patients.
Public Citizen and AMSA are calling on OHRP to investigate both trials and sanction all the institutions that ran them. They also are urging OHRP to immediately suspend the iCOMPARE trial.
In addition, according to a recent media report, the University of Pennsylvania’s institutional review board (IRB) – the designated lead IRB that reviewed and approved the iCOMPARE trial – incorrectly found that the trial involves only “minimal” risk and waived the requirements for obtaining informed consent for all subjects.
In the FIRST trial, the IRB at Northwestern University, the lead institution for that trial, determined that the FIRST trial did “not constitute research with human subjects” and, therefore, that IRB review and approval was not required. As a result, there was no opportunity for the IRB to discuss the risks of the research and the need for obtaining the voluntary informed consent of both the medical residents and their patients.
“This determination represents a colossal failure of Northwestern University’s human subjects protection system,” Carome said. “This same failure presumably occurred at many of the other institutions that participated in the FIRST trial.”
Inexplicably, even though the FIRST trial ended on June 30, 2015, the ACGME waivers for the trial remain in effect until June 2016, allowing hospitals assigned to the experimental group in that trial to continue forcing first-year residents to work the longer shifts for a full year after the trial ended. Similarly, the ACGME waivers for the iCOMPARE trial extend at least one year — and perhaps three years — after the scheduled end of that trial.
“The 2011 work-hour restrictions were put in place because of clear evidence of risk to resident physicians and were in line with the ACGME’s mission to improve health care and advance the quality of resident physicians’ education,” said Dr. Deborah Hall, national president of AMSA. “The ACGME’s decision to waive most of its 2011 work-hour standards for these studies, without any protections from dangerously long shifts for trainees, is both shocking and deeply disappointing.”
“The FIRST researchers have been very transparent about their underlying agenda in conducting this unacceptable research: to have the ACGME rescind its 2011 work-hour requirements that placed more restrictive limits on maximum shift duration and minimum time off between scheduled work hours for all residents, but particularly those affecting first-year residents,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group.
According to a 2010 survey of the general public, 81 percent of the 1,200 respondents believe that patients should be informed if a treating resident physician has been working for more than 24 hours, and 80 percent would then want a different doctor caring for them.
“The public will be outraged when it fully understands what the iCOMPARE and FIRST researchers, with the blessings of the ACGME and NIH, are doing,” Carome added. “Few patients would voluntarily agree to be enrolled in such trials if given the opportunity to choose.”