Acceptable Risk in Biomedical Research

1. Introduction
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2. Method and Material
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3. Initial Conceptual Clarifications
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4.
Origins of the Requirement of ProportionalityOrigins of the requirement of proportionality


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5. The Purpose of the Requirement of Proportionalitypurpose of the requirement of proportionality


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6. Introduction
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7. Which Risks, Burdens and Potential Benefits Are Relevant?
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8. How to Estimate Risks, Burdens, and Potential Benefits
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9. The Requirement of Proportionality – Initial Clarifications
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10. Therapeutic Research
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11. Nontherapeutic Research
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12. Nontherapeutic Research on “Vulnerable” Participants
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13.
Non-interference with Necessary Clinical InterventionsNon-interference with necessary clinical interventions
and The No Harm Rule

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14. Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials
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15. Acceptable Risks and Burdens to Others than the Participant
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16. Later Developments During the Course of the Research
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17. Legal Effects of the Requirement of Proportionality
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18. Summary of Results
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19. Recommendations
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20. Perspectives
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Keywords: Medicine & Public Health, Theory of Medicine/Bioethics, Medical Law, Biomedicine general