title: Re-evaluating ethical concerns in planned emergency research involving critically ill patients: an interpretation of the guidance document from the United States Food and Drug Administration.
abstract: BACKGROUND
  U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention.
  
  
  OBJECTIVE
  Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States.
  
  
  METHODS
  Review of the 2011 and updated FDA guidance document on exemption from informed consent.
  
  
  RESULTS
  The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document.
  
  
  CONCLUSIONS
  The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU.
  
  
  CONCLUSIONS
  We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill.
authors: Department of Anesthesiology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905 USA. smischney.nathan@mayo.edu.
authors: Nathan J
authors: NJ
authors: Smischney
authors: Department of Anesthesiology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905 USA. onigkeit.james@mayo.edu.
authors: James A
authors: JA
authors: Onigkeit
authors: Department of Anesthesiology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905 USA. hinds.richard@mayo.edu.
authors: Richard F
authors: RF
authors: Hinds
authors: Department of Anesthesiology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905 USA. nicholson.wayne@mayo.edu.
authors: Wayne T
authors: WT
authors: Nicholson
mesh_terms: D003422:Critical Care / Q000941:ethics*; D016638:Critical Illness; D004638:Emergency Treatment / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007362:Intensive Care Units; D028681:Moral Obligations; D061214:Patient Safety; D018579:Patient Selection / Q000941:ethics*; D017410:Practice Guidelines as Topic; D015203:Reproducibility of Results; D012107:Research Design; D035842:Research Subjects; D020458:Third-Party Consent / Q000941:ethics; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration