International Library of Ethics, Law, and the New Medicine

Acceptable Risk in Biomedical Research

European Perspectives

Authors: Simonsen, Sigmund

  • 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
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eBook $139.00
price for USA (gross)
  • ISBN 978-94-007-2678-9
  • Digitally watermarked, DRM-free
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  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.00
price for USA
  • ISBN 978-94-007-2677-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $179.00
price for USA
  • ISBN 978-94-007-9553-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the ebook  
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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.

Table of contents (20 chapters)

  • Introduction

    Simonsen, Sigmund

    Pages 3-9

  • Method and Material

    Simonsen, Sigmund

    Pages 11-14

  • Initial Conceptual Clarifications

    Simonsen, Sigmund

    Pages 15-29

  • Origins of the Requirement of ProportionalityOrigins of the requirement of proportionality

    Simonsen, Sigmund

    Pages 31-44

  • The Purpose of the Requirement of Proportionalitypurpose of the requirement of proportionality

    Simonsen, Sigmund

    Pages 45-77

Buy this book

eBook $139.00
price for USA (gross)
  • ISBN 978-94-007-2678-9
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $179.00
price for USA
  • ISBN 978-94-007-2677-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $179.00
price for USA
  • ISBN 978-94-007-9553-2
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Rent the ebook  
  • Rental duration: 1 or 6 month
  • low-cost access
  • online reader with highlighting and note-making option
  • can be used across all devices
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Bibliographic Information

Bibliographic Information
Book Title
Acceptable Risk in Biomedical Research
Book Subtitle
European Perspectives
Authors
Series Title
International Library of Ethics, Law, and the New Medicine
Series Volume
50
Copyright
2012
Publisher
Springer Netherlands
Copyright Holder
Springer Science+Business Media B.V.
eBook ISBN
978-94-007-2678-9
DOI
10.1007/978-94-007-2678-9
Hardcover ISBN
978-94-007-2677-2
Softcover ISBN
978-94-007-9553-2
Series ISSN
1567-8008
Edition Number
1
Number of Pages
XVI, 296
Topics