Refuting that it gave a green light to “highly unethical” research, the Accreditation Council for Graduate Medical Education (ACGME) will not rescind waivers of 2011 duty-hour requirements for physician training that allowed controversial clinical trials to test the effect of doctors working 28 consecutive hours — almost double the 16-hour current limit, IRB Advisor has learned.
Facing a similar call for action due to the lack of informed consent to patients in the trials, the Office of Human Research Protections (OHRP) is taking a more cautious tack. “OHRP is reviewing the allegations,” the agency said in response to requests for comment on the highly charged accusations by the watchdog group Public Citizen and the American Medical Student Association (AMSA).
The two advocacy groups jointly issued a series of complaints and allegations in strongly worded letters to OHRP and ACGME on Nov. 19. They demanded ACGME immediately rescind the organization’s waivers of its 2011 duty-hour standards (16 hours) for internal medicine and general surgery training for the ongoing Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, and the recently completed Flexibility in Duty Hour Requirements for Surgical Trainees Trial (FIRST). Overall, the trials have involved some 220 hospitals and thousands of patients.
“Neither of these unethical trials could have proceeded without the ACGME’s waivers,” the advocacy groups charged.
Not guilty
ACGME CEO Thomas J. Nasca, MD, strongly refuted both the premise of the allegations and some of the basic facts cited in the publicly made demands.
“The ACGME does not consider either the FIRST or the iCOMPARE trials to be unethical, and has no plans to rescind the waivers,” he tells IRB Advisor. “Both study protocols were reviewed and approved by the applicable institutional review boards, and the iCOMPARE trial was reviewed and funded by the National Institutes of Health [NIH].”
Among the research issues is whether longer, flexible duty hours (28 hours) for first-year medical residents have more negative or positive effects on patient outcomes compared to the 16-hour work shift regulations. Public Citizen and the AMSA argue that the negative effects of longer hours on patient and physician safety are well established — and were the very reason the accreditation council scaled back duty hours in 2011. “Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needlestick injuries and exposure to blood-borne pathogens, and depression in medical residents,” they stated in the complaint letter. “It also exposes their patients to an increased risk of medical errors, sometimes leading to patient injuries and deaths.”
A member of the editorial board of IRB Advisor also questioned the rationale for the research.
“I can’t imagine this is being done at all — the literature on sleep deprivation is already voluminous and clear, especially in high-risk jobs such as pilots, doctors, and residents,” says Susan L. Rose, PhD, executive director of the Office for the Protection of Human Subjects at the University of Southern California Los Angeles, in reaction to initial reports on the trials. “Instead, there should have been a study seeing if fewer hours result in better performance all around — that would make sense.”
Is it safe?
New research is raising questions about duty hours and whether the issue is as clear-cut as perceived. Some studies are finding little significant difference in patient outcomes related to sleep deprivation of physicians. For example, a recently published study looking at 38,978 daytime elective surgical patients treated by 1,448 physicians found no significant difference in patient outcomes whether the physician had just come in that day or had been working since 12 a.m. the night before.1
“While the [current 16-hour requirements] were built on the best available evidence at the time, in the intervening years various studies have been conducted comparing the 2011 to the 2003 ACGME [24 consecutive hours on-site; six additional for other activities] duty hour requirements,” Nasca says. “The preponderance of this new research evidence suggests that the 2011 requirements have not improved patient safety from the 2003 levels, and that there might be negative impacts on the quality of physician training.”
Thus, the ACGME granted the waivers to allow for the collection of data to ensure that the current duty hour requirements are achieving “the highest possible standards” for both patient and physician safety and the education and training needs of residents and fellows, he says. Moreover, the Institute of Medicine’s (IOM’s) Resident Duty Hours report2 — which formed the basis of the 2011 requirements — said prospective studies were needed so that any future changes to duty hours could be based on more comprehensive research, Nasca says.
The 2009 IOM report cited a growing body of research linking clinician fatigue and errors in recommending eliminating extended-duration shifts of more than 16 hours. In addition, the IOM recommended increasing days off, reducing night duty and providing more scheduled sleep breaks. The IOM recommendations were considered a compromise between the competing priorities of improving patient safety, reducing resident workload and fatigue, and maintaining the quality of resident education.3 The IOM also estimated that approximately $1.7 billion would be required to hire additional staff to allow residency programs to adhere to the recommendations. Some skeptics say this is the real issue — the sticking point with hospitals that cannot or will not fully fund the recommendations by hiring additional staff.
“Concern about costs almost certainly has been a motivating factor for those people who seek to roll back the resident work hour restrictions that were put into place by the ACGME in 2011,” says Michael A. Carome, MD, director of Public Citizen’s Health Research Group and former associate director for regulatory affairs at OHRP.
Another looming factor is a projected physician shortage, which could eventually make it difficult to limit hours even if funding is available. The Association of American Medical Colleges estimates that by 2025 demand for physicians will exceed supply by a range of 46,000 to 90,000 — depending on what interventions are taken. (See more at http://bit.ly/1PRhgDJ.)
A ‘shocking’ move
Public Citizen and AMSA said the council’s decision to grant the waivers is “shocking and deeply disappointing. Particularly disturbing is the ACGME’s apparent disregard of the evidence that justified its appropriate decision in 2011 to increase the restrictions on resident physicians’ duty time, including limiting duty periods for PGY-1 residents to a maximum of 16 hours.”
In addition to citing new research since the 2011 requirements in granting the waivers, Nasca emphasized that some fundamental requirements were not waived for the clinical trials.
“The statement [in the letter] reflects a misunderstanding of the requirements for first PGY-1 residents,” Nasca says. “The fundamental ACGME duty hour requirements were not waived. Those requirements limiting the total number of hours worked per week remain in effect, and PGY-1 residents are all required to have on-site, direct supervision, in which a more experienced clinician bears the ultimate responsibility for patient care. The type of clinical trials underway represent the ‘gold standard’ for evaluating outcomes, and will be used to assist in the calibration of duty hour requirements as recommended by the IOM.”
Informed consent
The lack of informed consent — not telling patients their physician is working long consecutive hours as part of a clinical trial — is a volatile issue that could easily become politicized in the wake of the allegations. A single, highly publicized case of a patient death linked to “overworked” physician trainees in 1984 shaped the tenure and text of current work duty requirements. The death of 18-year-old Libby Zion within 24 hours of emergency admission to a New York City hospital set off a national debate on doctors being overworked in understaffed hospitals.
A 2010 public survey4 found that 81% 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 researchers found that 81% of respondents believed reducing resident physician work hours would be very or somewhat effective in reducing medical errors. In addition, 68% favored an IOM proposal that resident physicians not work more than 16 consecutive hours over an alternative IOM proposal permitting 30-hour shifts with at least five hours protected sleep time.
“The American public overwhelmingly favors discontinuation of the 30-hour shifts without protected sleep routinely worked by U.S. resident physicians,” the authors noted. “Strong support exists to restrict resident physicians’ work to 16 or fewer consecutive hours, similar to limits in New Zealand, the U.K. and the rest of Europe,” they concluded.
Given this background, the public will be “outraged” when they fully understand the nature of this research, Carome says. In addition, he maintains that physicians have also not given informed consent, though published comments suggest that at least some of the doctors know they are in the trial.
“The fact that the residents may know they are in these trials does not mean their legally effective, voluntary informed consent was obtained,” Carome tells IRB Advisor. “Under federal regulations and basic ethical principles related to human research, researchers must obtain the voluntary informed consent of human subjects enrolled in research like the iCOMPARE and FIRST trials.”
In obtaining such consent, the researchers must provide subjects with several basic elements of information, including descriptions of the purpose of the research, the procedures involved, and the reasonably foreseeable risks to the subjects, he explains. “There should be a statement that participation is voluntary and refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled,” he says.
Thus, Public Citizen and AMSA call for OHRP to suspend all research and investigate the trials. In particular, exposing one study group to residents working longer hours violates basic ethical principles by putting subjects at a serious risk that has been previously established, they contend.
The IRB at Northwestern University in Chicago — the lead institution of the FIRST trial — reviewed the proposal and granted an informed consent waiver for the study because they did not consider the trial to be human subjects research, according to the NU website (http://bit.ly/1NRbFwL). Additional IRB applications will be filed at the time of the data analyses, according to the FIRST trials website.
“This study was found to be exempt as it is not human subjects research, the intervention is at the hospital level, no resident or patient identifiable information is collected, and the data being analyzed are already being collected by the institutions for ACS NSQIP (retrospective analysis of pre-existing data),” the Northwestern researchers stated. “Thus, we do not believe that local IRB approvals are needed, but we leave that up to each individual site to decide.”
Similarly, the IRB at the University of Pennsylvania in Philadelphia — one of the lead sites in the iCOMPARE study (http://bit.ly/1Cs5LIp) — said the research poses minimal risk and waived informed consent requirements. In a statement to IRB Advisor, a U. Penn official said the research is in part addressing concerns that limiting hours may hamper physician education.
“The goal of iCOMPARE is to determine if the current limitations on work hours for physicians in training should be changed,” says Susan E. Phillips, senior vice president for public affairs at the Penn Health System. “This NIH-funded study began because there is considerable concern among experts in the field that the current duty hour system of residency education may limit the nation’s ability to train physicians effectively.”
The study results will provide much-needed evidence to make “informed decisions” on these important clinical and educational issues, she says.
“The study was designed and vetted by regulatory bodies, research review boards, and established ethics panels,” Phillips says. “Importantly, at the study sites there are no changes to the existing and exhaustive supervision requirements for physicians in training.”
In any case, it is not clear at this writing whether other IRBs at participating hospitals revisited the issue of informed consent given that two of the lead institutions had deemed it unnecessary. The responsibility of local IRBs to do their own evaluation of such research may be addressed in the OHRP response to the allegations, but for now Carome’s contention is that most did not address the waiver of informed consent and allowed the research to proceed.
“To the best of our knowledge, for both the iCOMPARE and FIRST trials, the researchers have failed to obtain the voluntary informed consent of the residents or the patients at all research sites,” he says.
In addition to all this point-counterpoint, there are some complex and counterintuitive issues related to physicians’ engrained work culture and the old-school mindset that it is better to stay with patients longer than risk the possible errors and miscommunication of more frequent “handoffs” to the next doctor on duty. In this respect, some question whether medicine has essentially traded one hazard for another, shortening shifts but increasing handoffs. A third-year internal medicine resident posting a comment to a Washington Post article5 on the issue recalled that doing night coverage for multiple day shifts as an intern required “dangerous” handoffs. (See related story in this issue.)
“I think the study is necessary to evaluate what is the lesser of two evils,” the commenter said. “Yes, studies clearly show sleep deprivation makes decision making difficult. But are handoffs worse? We don’t know.”
Carome is not buying it.
“Such a tradeoff argument — that we must either have residents work excessively long shifts that lead to sleep deprivation, increased patient harms from medical errors, and resident harms, or have more handoffs leading to increased patient harms — represents a false dilemma,” he says. “Measures can be taken to ensure effective handoffs, such as standardized communication practices and decreased resident workload so the number of patients being handed off is limited. Going back to longer shifts, for which there is substantial evidence of harm to both residents and patients, is not an acceptable approach. Moreover, the argument about increased handoffs ignores the health risks that sleep deprivation has for the residents themselves.”
Physicians have a culture that honors working long hours as a commitment to patients and coworkers. “Those who trained before duty hour regulations often dismiss current physicians in training as lifestyle oriented and not committed to the profession,” researchers report.6 This pressure is such that residents will underreport hours and continue following patients at home, they warned.
Editor’s note: The letters of complaint and other documents on the two clinical trials are available at the Public Citizen website: https://www.citizen.org/icompare.
REFERENCES
- Govindarajan A, Kumar M, Murray BJ, et al. Outcomes of Daytime Procedures Performed by Attending Surgeons after Night Work. N Engl J Med 2015; 373:845-853.
- Ulmer C, Wolman DM, Johns MME, eds. Institute of Medicine. Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Washington, DC: The National Academies Press; 2008. ISBN: 9780309127721.
- Iglehart JK. Revisiting duty-hour limits — IOM recommendations for patient safety and resident education. N Engl J Med 2008;359:2633-2635.
- Blum AB, Raiszadeh F, Shea S, et al. US public opinion regarding proposed limits on resident physician work hours. BMC Medicine 2010;8:33.
- Bernstein L. Some new doctors are working 30-hour shifts at hospitals around the U.S. Washington Post, October 28, 2015. http://wapo.st/1NaGA5t.
- Arora VM, Farnan JM, Humphrey HJ. Professionalism in the Era of Duty Hours: Time for a Shift Change? JAMA. 2012;308(21):2195-2196.
Refuting that it gave a green light to “highly unethical” research, the Accreditation Council for Graduate Medical Education won't rescind waivers of 2011 duty-hour requirements for physician training.
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