Acceptable Risk in Biomedical Research

European Perspectives

Authors:

ISBN: 978-94-007-2677-2 (Print) 978-94-007-2678-9 (Online)

Table of contents (20 chapters)

  1. Front Matter

    Pages i-xv

  2. Initial issues

    1. Front Matter

      Pages 1-1

    2. No Access

      Book Chapter

      Pages 3-9

      Introduction

    3. No Access

      Book Chapter

      Pages 11-14

      Method and Material

    4. No Access

      Book Chapter

      Pages 15-29

      Initial Conceptual Clarifications

    5. No Access

      Book Chapter

      Pages 31-44

      Origins of the Requirement of ProportionalityOrigins of the requirement of proportionality

    6. No Access

      Book Chapter

      Pages 45-77

      The Purpose of the Requirement of Proportionalitypurpose 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. No Access

      Book Chapter

      Pages 81-82

      Introduction

    3. No Access

      Book Chapter

      Pages 83-90

      Which Risks, Burdens and Potential Benefits Are Relevant?

    4. No Access

      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. No Access

      Book Chapter

      Pages 105-118

      The Requirement of Proportionality – Initial Clarifications

    3. No Access

      Book Chapter

      Pages 119-142

      Therapeutic Research

    4. No Access

      Book Chapter

      Pages 143-170

      Nontherapeutic Research

    5. No Access

      Book Chapter

      Pages 171-219

      Nontherapeutic Research on “Vulnerable” Participants

    6. No Access

      Book Chapter

      Pages 221-225

      Non-interference with Necessary Clinical InterventionsNon-interference with necessary clinical interventions and The No Harm Rule

    7. No Access

      Book Chapter

      Pages 227-241

      Especially on Randomised Clinical Trials, Including Placebo Controlled Clinical Trials

    8. No Access

      Book Chapter

      Pages 243-245

      Acceptable Risks and Burdens to Others than the Participant

    9. No Access

      Book Chapter

      Pages 247-249

      Later Developments During the Course of the Research

    10. No Access

      Book Chapter

      Pages 251-253

      Legal Effects of the Requirement of Proportionality

  5. Summary and conclusions

    1. Front Matter

      Pages 255-255

    2. No Access

      Book Chapter

      Pages 257-262

      Summary of Results

    3. No Access

      Book Chapter

      Pages 263-264

      Recommendations

    4. No Access

      Book Chapter

      Pages 265-266

      Perspectives

  6. Back Matter

    Pages 267-293