|Flexibility In duty hour Requirements for Surgical Trainees Trial|
|"The FIRST Trial"|
|FIRST Trial Surgical Education Consortium|
The Institutional Review Board (IRB) at Northwestern University has reviewed the proposal and determined that the research activity does not meet the definition of human research. This study was found to not be human subjects research because the intervention is at the hospital/programmatic level, no individually identifiable resident or patient information is collected, and the patient-level data being analyzed are already being collected by the institutions for ACS NSQIP (retrospective analysis of pre-existing data). Moreover, the ACGME is charged with policy changes in this area, and they have sanctioned the rule changes. While the Northwestern IRB has made a determination of not human research and the study team does not believe local IRB is then required, each site can work with their own IRB to decide the status of the project at their institution. You can access the study on clinicaltrials.gov (NCT02050789).
Updates to the FIRST Trial protocol or statistical procedures can be found here.
FIRST Trial Statistical Analysis Protocol:
FIRST Trial IRB Non-Human Subjects Determination :