Informed Consent in a Dangerous Medical Resident Hours Study

In a recent post in this space, I wrote about the iCOMPARE research study that is comparing the effects of increasing medical residents' consecutive duty hours with observing the currently prescribed limits on their shifts. According to the study protocol, the primary hypothesis of the research addresses the safety of patients: that mortality under the increased residents' duty hours will not significantly exceed patient mortality under the current mandated standard for medical residents on duty. I argued that the study design is unethical based on what is known about sleep deprivation. The study's goal -- seeing whether more patients die when residents get less sleep -- is ethically unacceptable because research has definitively shown that residents working very long shifts commit more medical errors than their well-rested counterparts. There is another reason why the study is unethical. Both the residents and the patients are considered research subjects, yet the researchers are not seeking informed consent from either group to participate in the research. The head of the Accreditation Council for Graduate Medical Education, one of the funders of the study, said that research ethics committees or Institutional Review Boards (IRBs) "at all the participating hospitals reviewed the trial protocols and determined that patients did not need to be informed." According to the study protocol, the IRB at the lead institution -- the University of Pennsylvania -- waived the informed...
Source: Healthy Living - The Huffington Post - Category: Consumer Health News Source Type: news