Public Citizen and the American Medical Student Association have jointly submitted letters of complaint urging the Office for Human Research Protections (OHRP) and the Accreditation Council for Graduate Medical Education (ACGME) to take immediate action.
AMSA requests that the OHRP initiate compliance oversight investigations into the NIH-funded iCOMPARE trial and the related FIRST trial and calls for an immediate suspension of the ongoing iCOMPARE study.
Additionally, AMSA urges the ACGME to promptly revoke the waivers it granted from most of its 2011 duty-hour standards for internal medicine and general surgery residency programs assigned to the experimental groups in the ongoing iCOMPARE trial and the recently concluded FIRST trial, respectively.
Both trials—possible only due to the ACGME’s waiver of its current duty-hour restrictions—do not adequately comply with critical requirements set forth by the Department of Health and Human Services regulations for protecting human subjects, outlined in 45 C.F.R. Part 46.
Read the letters below:
- Letter to OHRP concerning FIRST trials
- Letter to OHRP concerning iCOMPARE trials
- Letter to ACGME concerning FIRST and iCOMPARE trials
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