---

This volume is the first major work to address acceptable risk -- a question at the core of biomedical research. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics.

---

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. 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

---