iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents
On November 19, 2015, Public Citizen and the American Medical Student Association (AMSA) called on federal regulators at the Office for Human Research Protections to investigate two highly unethical clinical trials, known as the iCOMPARE and FIRST 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. Public Citizen and AMSA also urged OHRP to immediately suspend the ongoing iCOMPARE trial, which is funded by the National Institutes of Health.
In a separate letter to the ACGME, Public Citizen and AMSA urged the accrediting organization to rescind waivers of its work-hour limits that it granted to hospitals and residency training programs participating in the two experimental trials. Neither trial could have proceeded without the ACGME’s waivers.
Read a brief summary of the major issues with the iCOMPARE and FIRST triails.
More Information on the iCOMPARE and FIRST Trials
- Press Statement: Keeping Limits on Medical Resident Work Hours Is the Right Thing to do, but the Unethical FIRST Trial Must End, May 18, 2016
- Letter to the HHS
Acting Assistant Secretary for Health Regarding the Unethical iCOMPARE Trial, March 9, 2016
- Second Follow-up
Letter to OHRP Regarding the Unethical iCOMPARE Trial, March 9, 2016
- Follow-up Letter to OHRP Regarding the Unethical iCOMPARE Trial Comparing Standard and Long Work Schedules for Internal Medicine Residents, February 11, 2016
- Press Statement: New England Journal of Medicine Violates Its Own Policy, Publishes Results of Unethical FIRST Trial That Put Resident Doctors at Risk, February 2, 2016
- Letter Responding to the ACGME's Defense of the iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents, December 16, 2015
- Letter to Office for Human Research Protections Regarding the iCOMPARE Trial, November 19, 2015
- List of Institutions Participating in the iCOMPARE Trial (PDF)
- Letter to Office for Human Research Protections Regarding the FIRST Trial, November 19, 2015
- List of Institutions Participating in the FIRST Trial (PDF)
- Letter to the Accreditation Council for Graduate Medical Education Regarding the iCOMPARE and FIRST trials, November 19, 2015
- Press Release: Unethical Trials Force Hundreds of Resident Doctors Nationwide to Work Dangerously Long Shifts, Placing Them and Their Patients at Risk of Serious Harm, November 19, 2015