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Acute care research: is it ethical?

K V Iserson1, M B Mahowald

  • 1University of Arizona College of Medicine, Tucson 85724.

Critical Care Medicine
|July 1, 1992
PubMed
Summary

Acute care research faces ethical hurdles. Modifying usual requirements, including informed consent, and enhancing Institutional Review Board (IRB) oversight can facilitate vital patient benefit research.

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Area of Science:

  • Medical Ethics
  • Critical Care Research
  • Patient Safety

Background:

  • Acute care research presents significant challenges for Institutional Review Board (IRB) approval and informed consent processes.
  • Ethical and legal ambiguities in acute care research have impeded scientific progress and the realization of patient benefits.

Purpose of the Study:

  • To address the ethical and practical difficulties in conducting research within acute care settings.
  • To propose modifications to standard research ethical requirements to accommodate the unique circumstances of acute care patients.

Main Methods:

  • Defining acute care patients as those experiencing unexpected, high-mortality/morbidity events requiring immediate intervention.
  • Arguing for the justification of acute care research through adapted ethical standards.

Main Results:

  • Acute care research is ethically justifiable when standard requirements are modified.
  • Proposed modifications include a distinct definition of acute care and revised informed consent procedures.

Conclusions:

  • Establish a clear definition differentiating acute care from other critical care.
  • Eliminate the conventional informed consent requirement for acute care research.
  • Implement stringent IRB oversight, including review by a panel representing potential study participants.
Keywords:
Biomedical and Behavioral Research

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