Critical Care
Volume 8
Issue 2 |
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This article is part of a series on Ethics, edited by Dr Laura Hawryluck.CommentaryThe ethical analysis of risk in intensive care unit researchCharles Weijer  Associate Professor of Bioethics and Surgery, Adjunct Professor of Philosophy, Dalhousie University, Halifax, Canada. At the time of writing, Visiting Scholar, Department of History and Philosophy of Science, University of Cambridge, and Visiting Fellow, Clare Hall, Cambridge, UK  author email corresponding author email
Critical Care 2004,
8:85-86doi:10.1186/cc2822
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13 February 2004 |
Abstract
Research in the intensive care unit (ICU) is commonly thought to pose 'serious risk' to study participants. This perception may be at the root of a variety of impediments to the conduct of clinical trials in the ICU setting. Component analysis offers a promising approach to the ethical analysis of ICU research. Because clinical trials commonly involve a mixture of study interventions, therapeutic and nontherapeutic procedures must be analyzed separately. Therapeutic procedures must meet the requirement of clinical equipoise. Risks associated with nontherapeutic procedures must be minimized consistent with sound scientific design, and be deemed reasonable in relation to the knowledge to be gained. When research involves a vulnerable population, such as adults incapable of providing informed consent, nontherapeutic risks are limited to a minor increase over minimal risk. Understood in this way, the incremental risk posed by participation in ICU research may be minimal. This realization has important implications for review by institutional review boards of such research and for the informed consent process. | 
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