Overview
- First major (indepth) publication in European biomedical research law
- Elaborates on and clarifies the main legal and ethical theme in the assessments of biomedical research projects
- Practical approach (applied legal research) – describes how what the law says with the use of practical case examples
Part of the book series: International Library of Ethics, Law, and the New Medicine (LIME, volume 50)
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Table of contents (20 chapters)
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Front Matter
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Initial Issues
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Front Matter
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Which Risks, Burdens, and Potential Benefits Are Relevant, and How Should They Be Estimated?
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Front Matter
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Which risks, burdens, and potential benefits are relevant, and how should they be estimated?
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The Assessment of Proportionality
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Front Matter
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The assessment of proportionality
Keywords
- Oviedo convention
- Requirement of Proportionality
- acceptable risk
- biomedical research
- biomedical research law
- clinical trial directive
- clinical trials and placebo use
- criminal liability
- estimating risks
- human experimentation
- patient autonomy
- placebo clinical trials
- potential benefit and risk
- randomized clinical trials
- research benefits and risks
- risk assessment
- the Nuremberg code
- vulnerable research participants
About this book
This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science.
This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.
Authors and Affiliations
Bibliographic Information
Book Title: Acceptable Risk in Biomedical Research
Book Subtitle: European Perspectives
Authors: Sigmund Simonsen
Series Title: International Library of Ethics, Law, and the New Medicine
DOI: https://doi.org/10.1007/978-94-007-2678-9
Publisher: Springer Dordrecht
eBook Packages: Medicine, Medicine (R0)
Copyright Information: Springer Science+Business Media B.V. 2012
Hardcover ISBN: 978-94-007-2677-2Published: 05 January 2012
Softcover ISBN: 978-94-007-9553-2Published: 22 February 2014
eBook ISBN: 978-94-007-2678-9Published: 04 January 2012
Series ISSN: 1567-8008
Series E-ISSN: 2351-955X
Edition Number: 1
Number of Pages: XVI, 296
Topics: Theory of Medicine/Bioethics, Medical Law, Biomedicine general