Skip to main content

All Access Subscription

Get unlimited access to our full publication and article library.

Get Access Now

Interested in Group Sales? Learn more

<p> Two clinical trials are under fire.</p>

Public Citizen: Resident Duty-hour Studies did not Obtain Informed Consent

Two clinical trials are under fire from watchdog group Public Citizen, stemming from what the group calls “highly unethical” practices that “fail to comply” with Department of Health and Human Services regulations to obtain informed consent from human subjects.

The trials – Flexibility in Duty Hour Requirements for Surgical Trainees Trial (FIRST) and Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) – are investigating whether longer, flexible duty hours (28 hours) for first-year medical residents have more negative effects on patient outcomes compared to the new, shorter 16-hour shift regulations. Public Citizen and the American Medical Student Association (AMSA) sent letters to the Office of Human Research Protections (OHRP), calling for investigation into both trials and for the ongoing iCOMPARE trial to be suspended.

In both studies, residents are put in either the control arm (16-hour shifts) or the experimental arm (up to 80 hours per week). Both trials included 190 hospitals and residency training programs nationwide, and several hundred residents. According to the Public Citizen/AMSA letters, neither study obtained voluntary informed consent from medical residents or the patients seen by the residents.

“These trials are among the most unethical research studies I have ever seen,” said Michael Carome, MD, director of Public Citizen’s Health Research Group and former associate director for regulatory affairs at OHRP, in a statement. “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” already shows that sleep deprivation due to long shifts can lead to needlestick injuries, exposure to bloodborne pathogens, increased risk of motor vehicle accidents, and other adverse outcomes, according to the Public Citizen statement.

“I can’t imagine this being done at all – the literature on sleep deprivation is alreadyvoluminous 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. Rose is also on the editorial advisory board of IRB Advisor. “Instead, there should have been a study seeing if fewer hours result in better performance all around -- that would make sense.”

The Northwestern University-based lead investigator of the FIRST trial – which completed data collection in June 2015 – determined that the study was exempt from institutional review board oversight as it did not constitute human subjects research. “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 [American College of Surgeons National Surgical Quality Improvement Program] (retrospective analysis of pre-existing data). Thus, we do not believe that local IRB approvals are needed, but we leave that up to each individual site to decide,” according to the FIRST trial information site. (A copy of the human subjects research determination form can also be found at that site.) The University of Pennsylvania IRB determined that the ongoing iCOMPARE study is minimal risk and waived informed consent requirements. Northwestern University representatives said patients were not informed of the clinical trial.

“This determination represents a colossal failure of Northwestern University’s human subjects protection system,” Carome said in the statement. “This same failure presumably occurred at many of the other institutions that participated in the FIRST trial.”

Despite the allegations, both trials had their share of supporters while in the recruiting stages last year. ICOMPARE required participating residency programs to inform potential interns of the trial and the randomization schemes. Other physicians applauded the studies, stating they are necessary to collect data on what is the best way to care for patients.

Look for more in-depth analysis and updates on this developing story in the January 2016 issue of IRB Advisor.