Normal view MARC view ISBD view

Ethics and Governance of Biomedical Research : Theory and Practice.

By: Strech, Daniel.
Contributor(s): Mertz, Marcel.
Material type: TextTextSeries: eBooks on Demand.Research Ethics Forum Ser: Publisher: Cham : Springer, 2016Copyright date: ©2016Description: 1 online resource (223 pages).Content type: text Media type: computer Carrier type: online resourceISBN: 9783319287317.Subject(s): Public health lawsGenre/Form: Electronic books.Additional physical formats: Print version:: Ethics and Governance of Biomedical Research: Theory and PracticeDDC classification: 174.2 LOC classification: B1-5802Online resources: Click here to view this ebook.
Contents:
Intro -- Preface -- Contents -- Chapter 1: Introduction -- References -- Part I: Introducing New Domains of Research Governance -- Chapter 2: Should Research Ethics Encourage the Production of Cost-Effective Interventions? -- 2.1 Introduction -- 2.2 Cost-Effectiveness in the Development of New Interventions -- 2.3 Why Promote Cost-Effective Interventions at the Research Stage? -- 2.3.1 Appropriate Use of Scarce Resources -- 2.3.2 Supporting Downstream Actors -- 2.3.3 Social Value and Fairness to Research Subjects -- 2.4 Objections to Considering Cost-Effectiveness at the Research Stage -- 2.4.1 The Unpredictability of Effectiveness -- 2.4.2 The Unpredictability of Cost -- 2.4.3 Equity Concerns About Cost-Effectiveness Analysis -- 2.4.4 Freedom of Intellectual Inquiry -- 2.5 Who Should Ensure That Research Promotes the Development of Cost-Effective Interventions? -- 2.5.1 Research Ethics Committees -- 2.5.2 Research Advisory Committees -- 2.5.3 Sponsors -- 2.5.4 Investigators -- 2.5.5 Research Subjects -- 2.6 Conclusion -- References -- Chapter 3: From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers? -- 3.1 Introduction -- 3.2 Is Phase I Research a Form of Work? -- 3.2.1 Earnings-Based Conception of Work -- 3.2.2 Time-Based Conception of Work -- 3.2.3 Meaning-Based Conception of Work -- 3.2.4 The Relationship Between Earnings-Based, Time-Based, and Meaning-Based Conceptions of Work -- 3.3 Potentially Problematic Aspects of Phase I Research Work -- 3.3.1 Risk and Phase I Research Work -- 3.3.2 Shifting Phase I Research Work's Occupational Bucket -- 3.3.3 Occupational Flexibility/Authority and Phase I Research Work -- 3.4 Two Implications for Research Ethics -- 3.4.1 Payment Ceilings -- 3.4.2 Trial Data Transparency -- 3.5 Conclusion -- References.
Chapter 4: Nocebo Effects: The Dilemma of Disclosing Adverse Events -- 4.1 Introduction -- 4.2 Nocebo Effects and Lack of Adherence -- 4.3 Nocebo Effects and Framing Effects -- 4.4 Ethical Considerations -- References -- Part II: Challenges in Common Domains of Research Governance -- Chapter 5: Discriminating Between Research and Care in Paediatric Oncology-Ethical Appraisal of the ALL-10 and 11 Protocols of the Dutch Childhood Oncology Group (DCOG) -- 5.1 Introduction -- 5.2 Comparison of DCOG ALL-10 and ALL-11 -- 5.2.1 Research Is Designed to Develop Generalisable Knowledge -- 5.2.2 Research Requires Systematic Investigation -- 5.2.3 Research Potentially Presents Less Net Clinical Benefit and Greater Overall Risk Than Clinical Practice -- 5.2.3.1 Tailoring of Therapy -- 5.2.3.2 Total Body Irradiation -- 5.2.4 Research Introduces Burdens or Risks from Activities That Are Not Otherwise Part of Patient Care -- 5.2.5 Research Uses Protocols to Dictate Which Therapeutic or Diagnostic Interventions a Patient Receives -- 5.2.6 Summary -- 5.3 Discussion -- 5.4 Conclusion -- References -- Chapter 6: What Does the Child's Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany -- 6.1 Introduction -- 6.2 Empirical Approach -- 6.3 What Does the Child's Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany -- 6.3.1 What Do Parents Think About the Requirement of Seeking Assent? -- 6.3.2 How to Assess the Children's Competence to Give Assent? -- 6.3.3 Who Should Assess Assent Capacity? -- 6.3.4 How to Deal with a Child's Refusal to Participate? -- 6.4 Some Conclusions -- References -- Chapter 7: Assent in Paediatric Research and Its Consequences -- 7.1 Background -- 7.2 How Much Autonomy Is Needed to Give Assent? -- 7.3 Three Policies, Three Different Consequences.
7.4 Conclusion -- References -- Chapter 8: Ethical Principles in Phase IV Studies -- 8.1 Introduction -- 8.1.1 Informed Consent -- 8.1.2 Risk/Benefit Assessment -- 8.1.3 Therapeutic Orientation in Phase IV Studies -- 8.2 Ethical Principles in Phase IV -- 8.3 Conclusion -- 8.4 Further Research -- References -- Chapter 9: Fate of Clinical Research Studies After Ethical Approval-Follow-Up of Study Protocols Until Publication -- 9.1 Introduction -- 9.2 Materials and Methods -- 9.2.1 Cohort of Study Protocols -- 9.2.2 Data Collection and Definitions -- 9.2.3 Identification of Corresponding Publications -- 9.2.4 Data Analyses -- 9.3 Results -- 9.3.1 Characteristics of Included Studies -- 9.3.2 Course of Studies and Publication Outcome -- 9.4 Discussion -- 9.5 Conclusions -- References -- Chapter 10: Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals -- 10.1 Introduction -- 10.2 Methods -- 10.3 Results -- 10.3.1 Information and Requirements Regarding International Guidelines on Publication Ethics -- 10.3.2 Information and Requirements Regarding Ethics Review -- 10.3.3 Information and Requirements on Informed Consent -- 10.4 Discussion -- 10.5 Conclusion -- References -- Part III: Improving Common Domains of Research Governance -- Chapter 11: Ensemble Space and the Ethics of Clinical Development -- 11.1 Introduction -- 11.2 The Risk/Benefit Landscape of Early Phase Research -- 11.3 Critical Points on the Landscape -- 11.4 Elucidating Ethical and Scientific Aspects of Early Phase Trials -- 11.4.1 Initiation of Early Phase Testing -- 11.4.2 Subject Selection in Early Phase Research -- 11.4.3 Initiation of Randomized Trials -- 11.4.4 Ethical Justification of Risk in Early Phase Research -- 11.4.5 Reporting Trials -- 11.5 Potential Problems and Limitations -- 11.6 Conclusion -- References.
Chapter 12: Rethinking Risk-Benefit Evaluations in Biomedical Research -- 12.1 Background -- 12.2 The Need for a Better Framework for Risk-Benefit Evaluations -- 12.3 The Fundamental Question: What Justifies Exposing Participants to Risk? -- 12.4 Rethinking Risk-Benefit Evaluations: The Importance of the Social Value of Research -- 12.5 Conclusion -- References -- Chapter 13: Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research -- 13.1 Introduction -- 13.2 Interpretations of the "Minimal Risk" Threshold -- 13.2.1 "Risks of Daily Life" Standard -- 13.2.2 The "Routine Examinations" Standard -- 13.2.3 The "Charitable Participation" Standard -- 13.3 An Alternative Approach -- 13.4 Conclusion -- References -- Chapter 14: Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses -- 14.1 Introduction -- 14.2 Informed Consent, Broad Consent, and Variation of the Rules -- 14.2.1 Informed Consent and Broad Consent -- 14.2.2 Varying the Rules -- 14.2.3 Taking Stock -- 14.3 The Responsibility to Give Feedback -- 14.3.1 The Meaning of a "No Feedback" Rule -- 14.3.2 The "Reasonable Expectations" of Participants -- 14.4 Public Interest -- 14.4.1 Health Research and Informed Consent -- 14.4.2 Participants' Consent and the Public Interest -- 14.5 Conclusion -- References -- Chapter 15: Ethical Dimensions of Dynamic Consent in Data-Intense Biomedical Research-Paradigm Shift, or Red Herring? -- 15.1 Introduction -- 15.2 Consent and Biobank-Based Biomedical Research -- 15.3 Dynamic Consent and Personalised, Integrated Healthcare Research -- 15.4 Criticisms of Dynamic Consent -- 15.5 Conclusion: Emerging Principles? -- References -- Chapter 16: Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement -- 16.1 Introduction: Reversing the "Race to the Bottom" Effect.
16.2 Patenting: A Cultural Invention -- 16.3 Ethical Enhancement of IP Systems -- 16.4 Discussion of Objections -- 16.4.1 Patent Law Was Not Intended to Encompass Moral or Ethical Judgments on Inventions -- 16.4.2 Unbiased Information Is Difficult to Come by, Which May Not Matter -- 16.4.3 The Reasonability of Improving What Might Nevertheless Remain Harmful -- 16.4.4 Political Capacities or the Basis on Which a Strategy of Incremental Change Could Be More Pragmatic -- 16.5 Conclusion -- References.
Tags from this library: No tags from this library for this title. Log in to add tags.
Item type Current location Call number URL Status Date due Barcode
Electronic Book UT Tyler Online
Online
B1-5802 (Browse shelf) https://ebookcentral.proquest.com/lib/uttyler/detail.action?docID=4526240 Available EBC4526240

Intro -- Preface -- Contents -- Chapter 1: Introduction -- References -- Part I: Introducing New Domains of Research Governance -- Chapter 2: Should Research Ethics Encourage the Production of Cost-Effective Interventions? -- 2.1 Introduction -- 2.2 Cost-Effectiveness in the Development of New Interventions -- 2.3 Why Promote Cost-Effective Interventions at the Research Stage? -- 2.3.1 Appropriate Use of Scarce Resources -- 2.3.2 Supporting Downstream Actors -- 2.3.3 Social Value and Fairness to Research Subjects -- 2.4 Objections to Considering Cost-Effectiveness at the Research Stage -- 2.4.1 The Unpredictability of Effectiveness -- 2.4.2 The Unpredictability of Cost -- 2.4.3 Equity Concerns About Cost-Effectiveness Analysis -- 2.4.4 Freedom of Intellectual Inquiry -- 2.5 Who Should Ensure That Research Promotes the Development of Cost-Effective Interventions? -- 2.5.1 Research Ethics Committees -- 2.5.2 Research Advisory Committees -- 2.5.3 Sponsors -- 2.5.4 Investigators -- 2.5.5 Research Subjects -- 2.6 Conclusion -- References -- Chapter 3: From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers? -- 3.1 Introduction -- 3.2 Is Phase I Research a Form of Work? -- 3.2.1 Earnings-Based Conception of Work -- 3.2.2 Time-Based Conception of Work -- 3.2.3 Meaning-Based Conception of Work -- 3.2.4 The Relationship Between Earnings-Based, Time-Based, and Meaning-Based Conceptions of Work -- 3.3 Potentially Problematic Aspects of Phase I Research Work -- 3.3.1 Risk and Phase I Research Work -- 3.3.2 Shifting Phase I Research Work's Occupational Bucket -- 3.3.3 Occupational Flexibility/Authority and Phase I Research Work -- 3.4 Two Implications for Research Ethics -- 3.4.1 Payment Ceilings -- 3.4.2 Trial Data Transparency -- 3.5 Conclusion -- References.

Chapter 4: Nocebo Effects: The Dilemma of Disclosing Adverse Events -- 4.1 Introduction -- 4.2 Nocebo Effects and Lack of Adherence -- 4.3 Nocebo Effects and Framing Effects -- 4.4 Ethical Considerations -- References -- Part II: Challenges in Common Domains of Research Governance -- Chapter 5: Discriminating Between Research and Care in Paediatric Oncology-Ethical Appraisal of the ALL-10 and 11 Protocols of the Dutch Childhood Oncology Group (DCOG) -- 5.1 Introduction -- 5.2 Comparison of DCOG ALL-10 and ALL-11 -- 5.2.1 Research Is Designed to Develop Generalisable Knowledge -- 5.2.2 Research Requires Systematic Investigation -- 5.2.3 Research Potentially Presents Less Net Clinical Benefit and Greater Overall Risk Than Clinical Practice -- 5.2.3.1 Tailoring of Therapy -- 5.2.3.2 Total Body Irradiation -- 5.2.4 Research Introduces Burdens or Risks from Activities That Are Not Otherwise Part of Patient Care -- 5.2.5 Research Uses Protocols to Dictate Which Therapeutic or Diagnostic Interventions a Patient Receives -- 5.2.6 Summary -- 5.3 Discussion -- 5.4 Conclusion -- References -- Chapter 6: What Does the Child's Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany -- 6.1 Introduction -- 6.2 Empirical Approach -- 6.3 What Does the Child's Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany -- 6.3.1 What Do Parents Think About the Requirement of Seeking Assent? -- 6.3.2 How to Assess the Children's Competence to Give Assent? -- 6.3.3 Who Should Assess Assent Capacity? -- 6.3.4 How to Deal with a Child's Refusal to Participate? -- 6.4 Some Conclusions -- References -- Chapter 7: Assent in Paediatric Research and Its Consequences -- 7.1 Background -- 7.2 How Much Autonomy Is Needed to Give Assent? -- 7.3 Three Policies, Three Different Consequences.

7.4 Conclusion -- References -- Chapter 8: Ethical Principles in Phase IV Studies -- 8.1 Introduction -- 8.1.1 Informed Consent -- 8.1.2 Risk/Benefit Assessment -- 8.1.3 Therapeutic Orientation in Phase IV Studies -- 8.2 Ethical Principles in Phase IV -- 8.3 Conclusion -- 8.4 Further Research -- References -- Chapter 9: Fate of Clinical Research Studies After Ethical Approval-Follow-Up of Study Protocols Until Publication -- 9.1 Introduction -- 9.2 Materials and Methods -- 9.2.1 Cohort of Study Protocols -- 9.2.2 Data Collection and Definitions -- 9.2.3 Identification of Corresponding Publications -- 9.2.4 Data Analyses -- 9.3 Results -- 9.3.1 Characteristics of Included Studies -- 9.3.2 Course of Studies and Publication Outcome -- 9.4 Discussion -- 9.5 Conclusions -- References -- Chapter 10: Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals -- 10.1 Introduction -- 10.2 Methods -- 10.3 Results -- 10.3.1 Information and Requirements Regarding International Guidelines on Publication Ethics -- 10.3.2 Information and Requirements Regarding Ethics Review -- 10.3.3 Information and Requirements on Informed Consent -- 10.4 Discussion -- 10.5 Conclusion -- References -- Part III: Improving Common Domains of Research Governance -- Chapter 11: Ensemble Space and the Ethics of Clinical Development -- 11.1 Introduction -- 11.2 The Risk/Benefit Landscape of Early Phase Research -- 11.3 Critical Points on the Landscape -- 11.4 Elucidating Ethical and Scientific Aspects of Early Phase Trials -- 11.4.1 Initiation of Early Phase Testing -- 11.4.2 Subject Selection in Early Phase Research -- 11.4.3 Initiation of Randomized Trials -- 11.4.4 Ethical Justification of Risk in Early Phase Research -- 11.4.5 Reporting Trials -- 11.5 Potential Problems and Limitations -- 11.6 Conclusion -- References.

Chapter 12: Rethinking Risk-Benefit Evaluations in Biomedical Research -- 12.1 Background -- 12.2 The Need for a Better Framework for Risk-Benefit Evaluations -- 12.3 The Fundamental Question: What Justifies Exposing Participants to Risk? -- 12.4 Rethinking Risk-Benefit Evaluations: The Importance of the Social Value of Research -- 12.5 Conclusion -- References -- Chapter 13: Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research -- 13.1 Introduction -- 13.2 Interpretations of the "Minimal Risk" Threshold -- 13.2.1 "Risks of Daily Life" Standard -- 13.2.2 The "Routine Examinations" Standard -- 13.2.3 The "Charitable Participation" Standard -- 13.3 An Alternative Approach -- 13.4 Conclusion -- References -- Chapter 14: Big Biobanks: Three Major Governance Challenges and Some Mini-constitutional Responses -- 14.1 Introduction -- 14.2 Informed Consent, Broad Consent, and Variation of the Rules -- 14.2.1 Informed Consent and Broad Consent -- 14.2.2 Varying the Rules -- 14.2.3 Taking Stock -- 14.3 The Responsibility to Give Feedback -- 14.3.1 The Meaning of a "No Feedback" Rule -- 14.3.2 The "Reasonable Expectations" of Participants -- 14.4 Public Interest -- 14.4.1 Health Research and Informed Consent -- 14.4.2 Participants' Consent and the Public Interest -- 14.5 Conclusion -- References -- Chapter 15: Ethical Dimensions of Dynamic Consent in Data-Intense Biomedical Research-Paradigm Shift, or Red Herring? -- 15.1 Introduction -- 15.2 Consent and Biobank-Based Biomedical Research -- 15.3 Dynamic Consent and Personalised, Integrated Healthcare Research -- 15.4 Criticisms of Dynamic Consent -- 15.5 Conclusion: Emerging Principles? -- References -- Chapter 16: Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement -- 16.1 Introduction: Reversing the "Race to the Bottom" Effect.

16.2 Patenting: A Cultural Invention -- 16.3 Ethical Enhancement of IP Systems -- 16.4 Discussion of Objections -- 16.4.1 Patent Law Was Not Intended to Encompass Moral or Ethical Judgments on Inventions -- 16.4.2 Unbiased Information Is Difficult to Come by, Which May Not Matter -- 16.4.3 The Reasonability of Improving What Might Nevertheless Remain Harmful -- 16.4.4 Political Capacities or the Basis on Which a Strategy of Incremental Change Could Be More Pragmatic -- 16.5 Conclusion -- References.

Description based on publisher supplied metadata and other sources.

Author notes provided by Syndetics

<p><br></p> <p><br></p>

There are no comments for this item.

Log in to your account to post a comment.