Acute care research: is it ethical?
BACKGROUND
Research in acute care is a troubling area for Institutional Review Board (IRB) approval and informed consent. Confusion about ethical and legal requirements has hampered research efforts and subsequent patient benefits.


METHODS
Acute care patients are the relatively few critical care patients who have suffered unexpected events that carry a high probability of mortality or severe morbidity unless immediate medical intervention is provided. We argue that acute care research is justified if the usual ethical requirements for research are modified to reflect the uniqueness of the situation.


CONCLUSIONS
Our recommendations are to: a) use an explicit definition of acute care as distinct from other modes of critical care; b) eliminate the requirement for informed consent (as it is usually understood); and c) require stringent IRB oversight, regarding the unique ethical problems raised by this area of research. We further suggest that IRB oversight includes review of the protocol by a panel of individuals who represent possible enrollees in the proposed study.
Iserson
K V
KV
University of Arizona College of Medicine, Tucson 85724.
Mahowald
M B
MB
D026686:Beneficence; D003422:Critical Care; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D033281:Nontherapeutic Human Experimentation; D026684:Personal Autonomy; D011367:Professional Staff Committees; D012106:Research; D035842:Research Subjects; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014342:Truth Disclosure; D035501:Uncertainty; D014481:United States