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Prehospital Thrombolytic Therapy for Acute Myocardial Infarction

Pamela S. Grim, MD; Peter A. Singer, MD, FRCPC; Gregory P. Gramelspacher, MD; Ted Feldman, MD; Rory W. Childers, MD; Mark Siegler, MD

JAMA. 1989;262(2):252-255.

Abstract
Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.

(JAMA. 1989;262:252-255)

Author Affiliations
From the Section of Cardiology (Drs Grim, Feldman, and Childers) and the Center for Clinical Medical Ethics (Drs Gramelspacher and Siegler), University of Chicago (III) Hospitals; and The Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine, New Haven, Conn (Dr Singer).

Footnotes
The opinions expressed in this article are those of the authors and do not necessarily represent those of the supporting foundations.

Reprint requests to University of Chicago Hospitals, 5841 S Maryland Ave, Box 161, Chicago, IL 60637 (Dr Grim).

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