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December 8, 1989

Informed Consent in Emergency Research

JAMA. 1989;262(22):3129. doi:10.1001/jama.1989.03430220050015

To the Editor.—  The article on patient consent for in-ambulance thrombolytic therapy1 describes the authors' ideas on a new way to get patient consent for clinical research. There is no research conducted on this idea: it is just unilaterally executed on a captive population, with no control subjects and no analysis of its effectiveness in overcoming the defects of the standard method. Since this apparently was supposed to be research into methods of gaining consent, it should not have been approved without a "sound research design."2I agree that such ideas very much need to be tried, but it seems like a waste of scientific time (theirs and ours) to try such ideas without a randomized, controlled study comparing the proposed method with the standard, federally prescribed method. It seems premature to publish this nonresearch, consisting only of a description of the protocol without presenting any results or