Public Citizen and the American Medical Student Association express dismay at the failures of the Office for Human Research Protections (OHRP) to suspend the unethical iCOMPARE trial and to launch an investigation into the research. Newly obtained government documents regarding the trial, which forces some first-year medical residents to work dangerously long shifts, provide further evidence that the trial violates basic ethical principles and federal regulatory requirements for the protection of human subjects.
View the following iCOMPARE documents obtained under the Freedom of Information Act:
- December 13, 2015, email from the National Institutes of Health to OHRP transmitting iCOMPARE documents
- iCOMPARE IRB review certification documents
- October 6, 2015, iCOMPARE Data and Safety Monitoring Plan
- October 9, 2015, iCOMPARE Statistical Analysis Plan
- iCOMPARE process for identifying adverse events among resident physicians in participating programs
- Minutes of the October 13, 2015, iCOMPARE Data and Safety Monitoring Board meeting