| ETHICS, AMBIGUITY AVERSION, AND THE REVIEW OF COMPLEX TRANSLATIONAL CLINICAL TRIALS. | |
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MedLine Citation:
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PMID: 21241343 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Clinical trials of novel agents often present several layers of ethical challenge. Because time and resources for ethical and safety review are limited, how investigators, IRBs, and regulators allocate attention to a trial's various safety dimensions itself represents a critical ethical question. In what follows, I use the example of a Parkinson's disease gene transfer trial to show how risks involving unknown probabilities or outcomes (ambiguity), might sometimes draw attention away from risks that involve known probabilities or outcomes. This potentially undermines the goal of 'systematic and nonarbitrary analysis of risk' during ethical review. To counteract the possible effects of such attention biases, I propose that reviewers develop 'cognitive aids' like lists and, where appropriate, set aside time to discuss non-ambiguous risks. I also propose further research for addressing and understanding how attention allocation, emotion, and ambiguity influence ethical decision-making. |
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Authors:
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Jonathan Kimmelman |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-1-17 |
Journal Detail:
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Title: Bioethics Volume: - ISSN: 1467-8519 ISO Abbreviation: - Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2011-1-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8704792 Medline TA: Bioethics Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2011 Blackwell Publishing Ltd. |
Affiliation:
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McGill University. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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