Public Citizen and the American Medical Student Association are calling on federal regulators to investigate and immediately stop research trials that will result in shifts as long as 28 hours for medical residents and that could put patients at higher risk of death.
The two new trials are requiring hundreds of medical residents nationwide to work dangerously long shifts, a move that a number of organizations claim place both the doctors and their patients at risk. The clinical trials allow 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. Voluntary informed consent to participate in the trials was not sought from either the residents or their patients.
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) urged the U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) Nov. 19 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.
“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.”
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. Several hundred residents were enrolled in the experimental groups for the trials, and thousands of patients potentially could be impacted.
Are Patient Death Rates Higher?
The primary goal of the two trials is to determine whether the rates of death and serious complications for the patients unwittingly included in the trials at the hospitals where first-year residents are working significantly longer shifts 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.
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 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 Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, which started on July 1 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.
According to Public Citizen and AMSA, both trials are highly unethical and fail to comply with key requirements of HHS regulations for protecting human subjects. 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, according to Public Citizen.
Public Citizen and AMSA believe that flaws in how the studies were designed and conducted make 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.
Waiving Informed Consent
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.”
What’s the Reason for the Studies?
Even though the FIRST trial ended on June 30, 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 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.”