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Editor's Correspondence
September 13, 2010

Is Emergency Research Without Initial Consent Justified? The Consent Substitute Model—Reply

Author Affiliations

Author Affiliations: Department of Bioethics Clinical Center, National Institutes of Health, Bethesda, Maryland.

Arch Intern Med. 2010;170(16):1508-1509. doi:10.1001/archinternmed.2010.296

In reply

Kierzek et al claim that we underestimated the role of community consultation in our article “Is Emergency Research Without Initial Consent Justified? The Consent Substitute Model.”1 The primary focus of our article was a general systematic framework justifying emergency research without informed consent, of which community consultation is but one component. Our model acknowledges the desirability of involving citizens and communities in emergency research and specifically supports their involvement in determining if an experimental intervention conflicts with potential subjects' values and interests. Emergency researchers have confronted many practical difficulties when implementing community consultation. We therefore support the call by Kierzek et al for further research in this important area and believe that empirical findings will only serve to strengthen the Consent Substitute Model and its relevance to emergency research regulations.

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