It all began with a tragedy. In March 1984, a fatal error occurred in a U.S. teaching hospital. Eighteen-year-old Libby Zion died because of a lethal drug interaction. The cause was serotonin syndrome — a rather obscure condition in 1984. The residents caring for Zion diagnosed a viral syndrome with “hysterical symptoms.”1 In the intense scrutiny that followed, their misdiagnosis was attributed in part to their exhaustion, since at the time they had been at work for 18 hours straight. But was exhaustion really the cause?

What if the problem stemmed from lack of supervision? What if the intern had not yet learned to distinguish “sick” from “not sick”? On the other hand, what if the young doctor, when prescribing the fateful dose of Demerol (meperidine), had been warned by a computer alert about potential adverse interactions between Zion's inpatient and outpatient medications (which included phenelzine)? Or could Zion's death have been avoided if the intern had had a nap?

Timeline of Changes in Residents' Work Hours.

Figure 1. Figure 1. Sample Schedule of Surgical Intern on Surgical Oncology Rotation, November 2011. The average number of hours worked by this intern is 79 per week, for a monthly total of 316 hours, 8.5 of which are spent in clinic and 10 in conference or didactics.

Though addressing the many potential sources of error remains relevant to both trainee education and patient safety, the regulatory changes since Zion's death have focused primarily on mitigating resident fatigue. In 1999, New York State implemented rules limiting residents to an 80-hour workweek, and in 2003, the Accreditation Council for Graduate Medical Education (ACGME) adopted a similar national standard2 (see text box 2-5). Still, public concern about patient safety escalated, leading Congress, in 2007, to commission a report from the Institute of Medicine (IOM) evaluating the effects of duty-hour reform and suggesting future directions. After a year-long review, the IOM recommended that interns' shifts not exceed 16 hours and that residents working up to 30 hours be allotted 5 hours for a nap (see Figure 1 for a sample resident's schedule).

Table 1. Table 1. Changes in Accreditation Council for Graduate Medical Education (ACGME) Work-Hour Requirements, and Comparison with Institute of Medicine (IOM) Recommendations.

In 2010, after a 16-member ACGME task force reviewed the IOM's recommendations, along with testimony from medical organizations, sleep researchers, and patient advocates, the rules were revised (Table 1). The most notable change was that interns' shifts were not to exceed 16 hours. “Strategic napping” was strongly suggested, and programs were required to teach residents “alertness management.” These rules were implemented in July 2011, and oversight was intensified.

The controversy surrounding work-hour reform spans decades, but a certain resignation seems to have settled over our profession. Physicians who believe that these rules are destroying our professional ethic are often perceived as curmudgeonly and have thus quieted their objections. Trainees who would prefer fatigue to unfinished patient care must nevertheless comply, or their programs will face steep fines and loss of accreditation. And program directors who aspire to design innovative educational environments must instead direct most of their energy toward the increasing administrative burden these requirements confer.

For us, the debate is irresistible. We are both trainees and third-generation physicians. We love being doctors but enjoy lives outside the hospital. And we've watched these rules transform our educational environments. But having spent the past year as editorial fellows at the Journal, becoming increasingly aware of the gaps between data and practice, we were struck by the disconnect between the duty-hour limits and the evidence base to support them. We therefore seek not to debate whether these rules are right or wrong, but to figure out how their effects can be rigorously assessed.

By interviewing members of the ACGME, patient advocates, program directors, educational experts, and trainees, we were exposed to both sides of the debate. Though we didn't always agree with one another, we emerged with a fundamental shared concern: the uniform implementation of the rules has left the profession without a mechanism for adequate evaluation. Our profession would never accept a new drug or device without clinical trials delineating benefit and risk. Why assume that any less is at stake in implementing a new training system?

As Sanjay Desai, director of the internal medicine residency program at Johns Hopkins, remarked, “Everybody says we're done with duty hours and we can't go back. That's a defeatist attitude. This is the future of American medicine, and the risk is too great. Creating more regulation in the absence of data is not a tenable solution.”

The path of least resistance is simply to accept the rules we've been handed. But to create delivery systems that are ultimately suited to meeting patients' diverse health needs, investigators must be able to study different approaches. Right now, such assessment is impossible. We therefore propose that the ACGME grant training programs a research exemption to permit such investigations.