Acceptable Risk in Biomedical Research (eBook)
XVI, 296 Seiten
Springer Netherland (Verlag)
978-94-007-2678-9 (ISBN)
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.
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.
1. Introduction2. Method and material3. Initial conceptual clarifications4. Origins of the requirement of proportionality5. The purpose of the requirement of proportionality6. Introduction: Part II 7. Which risks, burdens and potential benefits are relevant?8. How to estimate risks, burdens, and potential benefits9. The requirement of proportionality – initial clarifications10. Therapeutic research11. Nontherapeutic research12. Nontherapeutic research on “vulnerable” participants13. Non-interference with necessary clinical interventions and the no harm rule14. Especially on randomised clinical trials, including placebo controlled clinical trials15. 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 proportionality18. Summary of results19. Recommendations20. Perspectives21. Appendix
| Erscheint lt. Verlag | 4.1.2012 |
|---|---|
| Reihe/Serie | International Library of Ethics, Law, and the New Medicine | International Library of Ethics, Law, and the New Medicine |
| Zusatzinfo | XVI, 296 p. |
| Verlagsort | Dordrecht |
| Sprache | englisch |
| Themenwelt | Geisteswissenschaften ► Philosophie ► Allgemeines / Lexika |
| Medizin / Pharmazie ► Allgemeines / Lexika | |
| Naturwissenschaften ► Biologie | |
| Recht / Steuern ► EU / Internationales Recht | |
| Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht | |
| Sozialwissenschaften ► Soziologie | |
| Schlagworte | acceptable risk • biomedical research • biomedical research law • clinical trial directive • clinical trials and placebo use • Criminal Liability • estimating risks • human experimentation • Oviedo convention • patient autonomy • placebo clinic • placebo clinical trials • potential benefit and risk • randomized clinical trials • Requirement of Proportionality • research benefits and risks • risk assessment • the Nuremberg code • vulnerable research participants |
| ISBN-10 | 94-007-2678-3 / 9400726783 |
| ISBN-13 | 978-94-007-2678-9 / 9789400726789 |
| Haben Sie eine Frage zum Produkt? |
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