Acceptable Risk in Biomedical Research: European Perspectives

Acceptable Risk in Biomedical Research: European Perspectives


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 Europes 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

Front Matter....Pages i-xv
Front Matter....Pages 1-1
Introduction....Pages 3-9
Method and Material....Pages 11-14
Initial Conceptual Clarifications....Pages 15-29
Origins of the Requirement of ProportionalityOrigins of the requirement of proportionality ....Pages 31-44
The Purpose of the Requirement of Proportionalitypurpose of the requirement of proportionality ....Pages 45-77
Front Matter....Pages 79-79
Introduction....Pages 81-82
Which Risks, Burdens and Potential Benefits Are Relevant?....Pages 83-90
How to Estimate Risks, Burdens, and Potential Benefits....Pages 91-101
Front Matter....Pages 103-103
The Requirement of Proportionality Initial Clarifications....Pages 105-118
Therapeutic Research....Pages 119-142
Nontherapeutic Research....Pages 143-170
Nontherapeutic Research on Vulnerable Participants....Pages 171-219
Non-interference with Necessary Clinical InterventionsNon-interference with necessary clinical interventions and The No Harm Rule ....Pages 221-225
Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials....Pages 227-241
Acceptable Risks and Burdens to Others than the Participant....Pages 243-245
Later Developments During the Course of the Research....Pages 247-249
Legal Effects of the Requirement of Proportionality....Pages 251-253
Front Matter....Pages 255-255
Summary of Results....Pages 257-262
Recommendations....Pages 263-264
Perspectives....Pages 265-266
Back Matter....Pages 267-293


  • Author: Sigmund Simonsen (auth.)
  • Edition: 1
  • Publication Date: 2012
  • Publisher: Springer Netherlands
  • ISBN-10: 9400726775
  • ISBN-13: 9789400726772
  • Pages: 295
  • Format: pdf
  • Size: 3.3M
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