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Ethical Issues in Clinical Research

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Principles of Research Methodology

Abstract

From the earliest prebiblical writings to modern day, concern for and debate on the appropriate conduct by caregivers toward patients have been a central theme of appropriate (“ethical”) medical practice. Resulting from awareness of World War II German atrocities performed on prisoners, the mentally deficient, and defenseless civilians, the Nuremberg Code and Belmont Report were devised to protect patients and society from inappropriate assault on their body and psyche. Later to be followed by regulations set forth by HIPAA regarding the importance of patient privacy. Central to acceptable ethical behavior in human research are three main principles: respect for persons, beneficence, and justice. When possible, a fully informed written consent based on protocol comprehension must be obtained and preserved from each subject. With reservation and caution, parental consent may be sufficient for child participation in a study of low risk but potential importance to society. Currently, international guidelines for ethical human research require prior approval of research protocols by an Institutional Review Board (IRB). The IRB must document its views in writing, clearly identifying the trial being assessed, which documents were reviewed, and the dates of its reaching decisions for approval, disapproval, or need for restructuring. The National Institutes of Health (NIH) names the principles governing acceptable human research: social and clinical value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled subjects.

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Authors and Affiliations

  1. Department of Medicine, Sate University of New York, Downstate Medical Center, Brooklyn, NY, 11203, USA

    Eli A. Friedman MD

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  1. Eli A. Friedman MD
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Correspondence to Eli A. Friedman MD .

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Editors and Affiliations

  1. , Cardiovascular Medicine, SUNY Downstate Medical Center, Clarkson Avenue, box 1199 450, Brooklyn, 11203, USA

    Phyllis G. Supino

  2. , Cardiovascualr Medicine, SUNY Downstate Medical Center, Clarkson Avenue 450, Brooklyn, 11203, USA

    Jeffrey S. Borer

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Friedman, E.A. (2012). Ethical Issues in Clinical Research. In: Supino, P., Borer, J. (eds) Principles of Research Methodology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3360-6_12

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  • DOI: https://doi.org/10.1007/978-1-4614-3360-6_12

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