Acceptable Risk in Biomedical Research

European Perspectives

  • Sigmund Simonsen

Part of the International Library of Ethics, Law, and the New Medicine book series (LIME, volume 50)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Initial Issues

    1. Front Matter
      Pages 1-1
    2. Sigmund Simonsen
      Pages 3-9
    3. Sigmund Simonsen
      Pages 11-14
    4. Sigmund Simonsen
      Pages 15-29
    5. Sigmund Simonsen
      Pages 31-44
  3. Which Risks, Burdens, and Potential Benefits Are Relevant, and How Should They Be Estimated?

    1. Front Matter
      Pages 79-79
    2. Sigmund Simonsen
      Pages 81-82
  4. The Assessment of Proportionality

  5. Summary and Conclusions

    1. Front Matter
      Pages 255-255
    2. Sigmund Simonsen
      Pages 257-262
    3. Sigmund Simonsen
      Pages 263-264
    4. Sigmund Simonsen
      Pages 265-266
  6. Back Matter
    Pages 267-293

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.


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

Authors and affiliations

  • Sigmund Simonsen
    • 1
  1. 1.StadsbygdNorway

Bibliographic information

  • DOI
  • Copyright Information Springer Science+Business Media B.V. 2012
  • Publisher Name Springer, Dordrecht
  • eBook Packages Medicine Medicine (R0)
  • Print ISBN 978-94-007-2677-2
  • Online ISBN 978-94-007-2678-9
  • Series Print ISSN 1567-8008
  • Buy this book on publisher's site