In Reply. —
We thank Dr Leith for his interest in our article on informed consent in emergency research. Our article addressed a single question: Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? The article reviewed current federal guidelines for informed consent in this setting. It constructed a taxonomy of methods of obtaining informed consent in emergency research. Using as an example the case of thrombolytic therapy for myocardial infarction, we also described a novel two-step approach to obtaining informed consent.Our article, then, was not intended as a clinical trial, but as an effort to establish a conceptual framework for the study of informed consent in emergency research. As Feinstein1 has pointed out, the first question in designing clinical research is, "What is the question?" We stated in the article, "studies examining competency, risk aversiveness, and
Grim P, Singer P, Siegler M. Informed Consent in Emergency Research-Reply. JAMA. 1989;262(22):3129. doi:10.1001/jama.1989.03430220050016
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