Recent trials that investigated the impact of long physician shifts on patient care may have been unethical and put both medical residents and patients in danger, according to Public Citizen and the American Medical Student Association.
The two organizations wrote to HHS' Office for Human Research Protections both in November 2015 and February 2016 to call attention to two studies, iCOMPARE and FIRST, which they claim are highly unethical because they require first-year residents to work shifts lasting longer than 28 hours, nearly twice the current maximum consecutive shift hours allowed.
Representatives from the two organizations claim that documents obtained from the National Institutes of Health, which funded the trial in part, reflect at least 56 of 63 internal medicine programs across the country participating in the programs either do not have required institutional review board approvals or were reviewed in an expedited fashion they weren't qualified for. Additionally, the organizations claim that the Office for Human Research Protections received the same NIH records that called iCOMPARE's practices into question almost three months ago and took no action.
"[D]ocuments indicate that the iCOMPARE researchers recognized that the trial's experimental intervention could be exposing the resident subjects to increased risks of motor vehicle accidents, needle-stick injuries that can expose the residents to bloodborne pathogens and depression due to sleep deprivation," the Public Citizenand ASMA statement reads. "These events needed to be carefully monitored during the trial to ensure the safety of the resident subjects. But there is no evidence that the IRBs that reviewed the trial were informed of these risks and the details of the monitoring plan."
The organizations have requested an urgent meeting with HHS' Acting Assistant Secretary for Health and the director of the OHRP to discuss the nature of trials.