In a recent post, 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-consent requirement, citing a provision in the U.S. federal regulations for the protection of human subjects in research. That provision is as follows: the IRB may “waive the requirement to obtain informed consent provided the IRB finds and documents that: (1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and (2) The research could not practicably be carried out without the waiver or alteration.”
Your patients are rating you online: How to respond. Manage your online reputation: A social media guide. Find out how.
No comments:
Post a Comment