Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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Ezekiel J. Emanuel (ed.)
Johns Hopkins University Press (2003)
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.
|Keywords||Human experimentation in medicine Moral and ethical aspects Clinical trials Moral and ethical aspects Medical ethics Ethics, Research Research Subjects|
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|Buy the book||$22.96 new (52% off) $22.96 used (52% off) $42.96 direct from Amazon (9% off) Amazon page|
|Call number||R853.H8.E825 2003|
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Citations of this work BETA
Mark A. Rothstein & Abigail B. Shoben (2013). Does Consent Bias Research? American Journal of Bioethics 13 (4):27 - 37.
James M. DuBois, John T. Chibnall & John Gibbs (forthcoming). Compliance Disengagement in Research: Development and Validation of a New Measure. Science and Engineering Ethics.
Paul Litton & Franklin G. Miller (2005). A Normative Justification for Distinguishing the Ethics of Clinical Research From the Ethics of Medical Care. Journal of Law, Medicine & Ethics 33 (Fall 2005):566-74.
Katherine Wasson (2009). Direct-to-Consumer Genomics and Research Ethics: Should a More Robust Informed Consent Process Be Included? American Journal of Bioethics 9 (6):56-58.
Debora Diniz (2008). Research Ethics in Social Sciences: The Severina's Story Documentary. International Journal of Feminist Approaches to Bioethics 1 (2):23 - 35.
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