Acceptable Risk in Biomedical Research

European Perspectives


ISBN: 978-94-007-2677-2 (Print) 978-94-007-2678-9 (Online)
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Table of contents (20 chapters)

  1. Front Matter

    Pages i-xv

  2. Initial issues

    1. Front Matter

      Pages 1-1

    2. Book Chapter

      Pages 3-9


    3. Book Chapter

      Pages 11-14

      Method and Material

    4. Book Chapter

      Pages 15-29

      Initial Conceptual Clarifications

    5. Book Chapter

      Pages 31-44

      Origins of the Requirement of Proportionality

    6. Book Chapter

      Pages 45-77

      The Purpose of the Requirement of Proportionality

  3. Which risks, burdens, and potential benefits are relevant, and how should they be estimated?

    1. Front Matter

      Pages 79-79

    2. Book Chapter

      Pages 81-82


    3. Book Chapter

      Pages 83-90

      Which Risks, Burdens and Potential Benefits Are Relevant?

    4. Book Chapter

      Pages 91-101

      How to Estimate Risks, Burdens, and Potential Benefits

  4. The assessment of proportionality

    1. Front Matter

      Pages 103-103

    2. Book Chapter

      Pages 105-118

      The Requirement of Proportionality – Initial Clarifications

    3. Book Chapter

      Pages 119-142

      Therapeutic Research

    4. Book Chapter

      Pages 143-170

      Nontherapeutic Research

    5. Book Chapter

      Pages 171-219

      Nontherapeutic Research on “Vulnerable” Participants

    6. Book Chapter

      Pages 221-225

      Non-interference with Necessary Clinical Interventions and The No Harm Rule

    7. Book Chapter

      Pages 227-241

      Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials

    8. Book Chapter

      Pages 243-245

      Acceptable Risks and Burdens to Others than the Participant

    9. Book Chapter

      Pages 247-249

      Later Developments During the Course of the Research

    10. Book Chapter

      Pages 251-253

      Legal Effects of the Requirement of Proportionality

  5. Summary and conclusions

    1. Front Matter

      Pages 255-255

    2. Book Chapter

      Pages 257-262

      Summary of Results

    3. Book Chapter

      Pages 263-264


    4. Book Chapter

      Pages 265-266


  6. Back Matter

    Pages 267-293