AMSA and Public Citizen Send Complaint Letters Concerning FIRST and iCompare Trials

August 13, 2017

Public Citizen and the American Medical Student Association have jointly sent letters of complaint calling on the Office for Human Research Protections (OHRP)  and and the Accreditation Council for Graduate Medical Education (ACGME).

AMSA calls on the OHRP to launch compliance oversight investigations of the NIH-funded iCOMPARE trial and the related FIRST trial, and to immediately suspend the ongoing iCOMPARE trial.

AMSA also calls on ACGME to immediately rescind the organization’s waivers of most of its 2011 duty-hour standards for internal medicine and general surgery training programs randomly assigned to the experimental groups in the ongoing iCOMPARE trial and the recently completed FIRST trial, respectively.

Both trials — neither of which was possible without the ACGME waiving of its current duty-hour restrictions — fail to materially comply with key requirements of the Department of Health and Human Services regulations for the protection of human subjects at 45 C.F.R. Part 46.

Read the letters below:

Media Coverage

Advocacy groups want 30-hour shifts for novice doctors halted, saying they pose ‘serious health risks’  Washington Post
Med Students Call Resident Work Trials Unethical
– MedPageToday
Northwestern-led study of medical residents working 28-hour shifts decried – Chicago Tribune
Groups protest trials with medical residents working 28 hours straight – Milwaukee Journal Sentinel
Studies on resident work hours ‘highly unethical,’ lack patient consent– Modern Healthcare
US-Backed Experiments Involving 30-Hour Shifts For Medical Residents Must End, Advocacy Groups Say – International Business Times
Medical students to HHS, ACGME: Stop research on 30-hour shifts for 1st year physicians – Becker’s Hospital Review
Are Clinical Trials Resulting in 28-Hour Shifts for Medical Residents Putting Patients and Doctors at Risk? – EHS Today
Advocacy groups call for immediate end to 30-hour shifts for new docs– Fierce Healthcare