Acceptable Risk in Biomedical Research: European Perspectives

Medical Law

Acceptable Risk in Biomedical Research: European Perspectives

By Sigmund Simonsen
Springer-Verlag February 2014

Specifications

ISBN-13
9789400795532
Publisher
Springer-Verlag
Publication
February 2014
Format
Paperback
Jurisdiction
Netherlands ? Countri(es) for reference only

Details

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

1. Introduction
2. Method and material
3. Initial conceptual clarifications
4. Origins of the requirement of proportionality
5. The purpose of the requirement of proportionality
6. Introduction: Part II
7. Which risks, burdens and potential benefits are relevant?
8. How to estimate risks, burdens, and potential benefits
9. The requirement of proportionality - initial clarifications
10. Therapeutic research
11. Nontherapeutic research
12. Nontherapeutic research on "vulnerable" participants
13. Non-interference with necessary clinical interventions and the no harm rule
14. Especially on randomised clinical trials, including placebo controlled clinical trials
15. Acceptable Risks and Burdens to Others than the Participant
16. Later developments during the course of the research
17. Legal effects of the requirement of proportionality
18. Summary of results
19. Recommendations
20. Perspectives
21. Appendix
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