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Personalized Medicine: Ethics for Clinical Trials

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Molecular Profiling

Part of the book series: Methods in Molecular Biology ((MIMB,volume 823))

Abstract

Modern ethical codes in medicine were developed following World War II to provide respect for persons, beneficence, and justice in clinical research. Clinical trial medicine involves greater scrutiny than most research activities. In every instance, clinical trials have institutional review boards to ensure the medical procedure under study complies with regulatory requirements, privacy, informed consent, good practices, safety monitoring, adverse events reporting, and is free of conflicting interests. Mandatory training in medical ethics for all clinical staff is becoming more common, and at some institutions, knowledgeable patient advocates play a watchdog role. In personalized medicine, each patient becomes a clinical trial of one, based on the uniqueness of the person’s illness and the relatively tailored treatment. These features imply a shared responsibility between the patient and the researchers because uncertainty exists over the outcome for each individual patient. This chapter introduces ethical considerations using case studies, with historical context, and describes general ethical guidelines for initiating a clinical trial.

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Author information

Authors and Affiliations

  1. Inova Health System, Inova Fairfax Hospital, Fairfax, VA, USA

    G. Terry Sharrer

Authors
  1. G. Terry Sharrer
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Correspondence to G. Terry Sharrer .

Editor information

Editors and Affiliations

  1. Center for Applied Proteomics and, George Mason University, University Blvd. 10900, Manassas, 20110, Virginia, USA

    Virginia Espina

  2. Center for Applied Proteomics &, George Mason University, University Blvd. 10900, Manassas, 20110, Virginia, USA

    Lance A. Liotta

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Sharrer, G.T. (2012). Personalized Medicine: Ethics for Clinical Trials. In: Espina, V., Liotta, L. (eds) Molecular Profiling. Methods in Molecular Biology, vol 823. Humana Press. https://doi.org/10.1007/978-1-60327-216-2_3

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  • DOI: https://doi.org/10.1007/978-1-60327-216-2_3

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  • Publisher Name: Humana Press

  • Print ISBN: 978-1-60327-215-5

  • Online ISBN: 978-1-60327-216-2

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