Acceptable Risk in Biomedical Research: European Perspectives
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