Public Citizen and the American Medical Student Association have jointly sent letters of complaint calling on the Office for Human Research Protections (OHRP) 听and and the Accreditation Council for Graduate Medical Education (ACGME).
蜜芽appcalls on the OHRP to听launch compliance oversight investigations of the NIH-funded iCOMPARE trial and the related FIRST trial, and听to immediately suspend the ongoing iCOMPARE trial.
蜜芽appalso calls on ACGME to immediately rescind the organization鈥檚 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 鈥� neither of which was possible without the ACGME waiving of its current duty-hour restrictions 鈥� 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
听鈥�听Washington Post听鈥� MedPageToday
听鈥� Chicago Tribune
鈥撎齅ilwaukee Journal Sentinel
鈥� Modern Healthcare
听鈥� International Business Times
听鈥� Becker鈥檚 Hospital Review
听鈥� EHS Today
鈥� Fierce Healthcare
