The Ethics of Medical Data Donation (Philosophical Studies Series Book 137)

This Open Access Book Presents An Ethical Approach To Utilizing Personal Medical Data. It Features Essays That Combine Academic Argument With Practical Application Of Ethical Principles. The Contributors Are Experts In Ethics And Law. They Address The Challenges In The Re-use Of Medical Data Of The Deceased On A Voluntary Basis. This Pioneering Study Looks At The Many Factors Involved When Individuals And Organizations Wish To Share Information For Research, Policy-making, And Humanitarian Purposes. Today, It Is Easy To Donate Blood Or Even Organs, But It Is Virtually Impossible To Donate One's Own Medical Data. This Is Seen As Ethically Unacceptable. Yet, Data Donation Can Greatly Benefit The Welfare Of Our Societies. This Collection Provides Timely Interdisciplinary Research On Biomedical Big Data. Topics Include The Ethics Of Data Donation, The Legal And Regulatory Challenges, And The Current And Future Collaborations. Readers Will Learn About The Ethical And Regulatory Challenges Associated With Medical Data Donations. They Will Also Better Understand The Special Nature Of Using Deceased Data For Research Purposes With Regard To Ethical Principles Of Autonomy, Beneficence, And Justice. In Addition, The Contributors Identify The Key Governance Issues Of Such A Scheme. The Essays Also Look At What We Can Learn In Terms Of Best Practice From Existing Medical Data Schemes. Chapter 1. Introduction (jenny Krutzinna And Luciano Floridi) -- Part I: Conceptualising The Ethics Of Medical Data Donation -- Chapter 2. Data Donation: How To Resist The Ileviathan (barbara Prainsack) -- Chapter 3. Data Donations As Exercises Of Sovereignty (patrik Hummel, Matthias Braun And Peter Dabrock) -- Chapter 4. The Ethics Of Uncertainty For Data Subjects (philip J. Nickel) -- Chapter 5. Incongruities And Dilemmas In Data Donation: Juggling Our 1s And 0s (kerina H. Jones) -- Part Ii: Governance And Regulation Of Medical Data Donation -- Chapter 6. Posthumous Medical Data Donation: The Case For A Regulatory Framework (edina Harbinja) -- Chapter 7. Medical Data Donation, Consent And The Public Interest After Death: A Gateway To Posthumous Data Use (annie Sorbie) -- Part Iii: Implementing Ethical Medical Data Donation -- Chapter 8. The Personal Data Is Political (bastian Greshake Tzovaras And Athina Tzovara) -- Chapter 9. Personal Data Cooperatives - A New Data Governance Framework For Data Donations And Precision Health (ernst Hafen) -- Chapter 10. Defining Data Donation After Death: Metadata, Families, Directives, Guardians And The Road To Big Consent (david M. Shaw) -- Part Iv: An Ethical Code For Posthumous Medical Data Donation -- Chapter 11. Enabling Posthumous Medical Data Donation: A Plea For The Ethical Utilisation Of Personal Health Data (jenny Krutzinna, Mariarosaria Taddeo And Luciano Floridi) -- Chapter 12. An Ethical Code For Posthumous Medical Data Donation (jenny Krutzinna, Mariarosaria Taddeo And Luciano Floridi). . Edited By Jenny Krutzinna, Luciano Floridi. Preface and Acknowledgments 6 Contents 7 Contributors 9 Chapter 1: Ethical Medical Data Donation: A Pressing Issue 11 1.1 Background 11 1.2 Current Debates 13 1.3 This Volume and Its Chapters 14 References 15 Part I: Conceptualising the Ethics of Medical Data Donation 17 Chapter 2: Data Donation: How to Resist the iLeviathan 18 2.1 Data Use in the Era of GAFA 18 2.2 What Does It Mean to Donate Data? 21 2.2.1 Donation as a Relational Practice 21 2.2.2 Can We Donate Data? 22 2.3 Considerations for Frameworks for Data Donation 23 2.3.1 Relationality 23 2.3.2 Indirect Reciprocity 25 2.3.3 Multiplicity 27 2.4 Resisting the iLeviathan? Politicising the Ethics of Data Donation 28 References 29 Chapter 3: Data Donations as Exercises of Sovereignty 32 3.1 Introduction 33 3.2 Donations and Sovereignty 35 3.3 Reasons in Favour of Data Donations 41 3.3.1 Solidarity 41 3.3.2 Beneficence 42 3.3.3 Participation 43 3.4 Challenges with Data Donations 43 3.4.1 Trust 43 3.4.2 Future Use 44 3.4.3 Invasiveness 45 3.4.4 Ownership 46 3.4.5 Affected People 47 3.4.6 Voluntariness 48 3.5 Donations, Consent and Control 50 3.5.1 Consent 51 3.5.2 Representation 52 3.5.3 Organizations 53 3.5.4 Observation I 53 3.5.5 Observation II 54 3.6 Conclusion 56 References 59 Chapter 4: The Ethics of Uncertainty for Data Subjects 64 4.1 Uncertainty and Data Ethics 64 4.2 What Features of Data Practices Create Unknowns? 66 4.2.1 Open-Endedness 67 4.2.2 Opacity 68 4.2.3 Persistence 69 4.2.4 Endemic Uncertainties Combined 71 4.3 Two Epistemic Interests of Data Subjects 71 4.3.1 Interests in Trust 72 4.3.2 Interests in Knowing Our Own Obligations 74 4.4 Strategies for Mitigating Uncertainty 76 4.4.1 Systemic Resilience Through Flexible Systemic Oversight 77 4.4.2 Hazard Reduction Through Privacy-by-Design 78 4.4.3 Concluding Reflections 79 References 80 Chapter 5: Incongruities and Dilemmas in Data Donation: Juggling Our 1s and 0s 84 5.1 Introduction 84 5.2 Hast Thou Which Art but Data, a Touch, a Feeling? 85 5.3 What We Might Be Donating 86 5.4 Are We at Least with Socrates? 88 5.5 Legal Position – Data vs Tissue 88 5.6 No Man Is an Island Entire of Itself 89 5.7 Data, Data Everywhere, nor any Chance to Think 90 5.8 Up in the Air 91 5.9 Through a Glass Darkly 92 5.10 Life Through a Lens (Or Several) 94 5.11 Minding Our Ps and Qs 95 5.12 The Need for Innovation in Data Governance 97 5.13 Who Are You, Who, Who, Who, Who? 98 5.14 Finding the Black Cat in the Dark Room 98 5.15 Conclusion 99 References 100 Part II: Governance and Regulation of Medical Data Donation 103 Chapter 6: Posthumous Medical Data Donation: The Case for a Legal Framework 104 6.1 Introduction 105 6.2 Legal Protection of Health-Related Data of the Living and the Dead in the UK 107 6.2.1 The Protection of the Data of the Deceased in the Health Sector 108 6.3 Some Issues Around Ownership, Privacy, Control and Succession of Data 110 6.4 A Comparable Regime: Organ Donation 112 6.5 International Framework – Code or Law? 115 6.6 Conclusion 117 References 118 Chapter 7: Medical Data Donation, Consent and the Public Interest After Death: A Gateway to Posthumous Data Use 121 7.1 Data Governance and the Promise of PMDD 122 7.2 Timing, Interests and the Limits of Consent 125 7.2.1 A Matter of Timing 125 7.2.2 Interests in PMDD 127 7.2.3 Models of Consent 128 7.3 Authorisation and the Role of the Public Interest 131 7.4 Conclusion 134 References 135 Part III: Implementing Ethical Medical Data Donation 137 Chapter 8: The Personal Data Is Political 138 8.1 Introduction 138 8.2 Sharing Genomic Data 139 8.3 Sharing Neurobiological Data 140 8.4 Data Sharing as a Social Movement 141 References 142 Chapter 9: Personal Data Cooperatives – A New Data Governance Framework for Data Donations and Precision Health 146 9.1 The Unique Features of Personal Data 146 9.2 The Need – Aggregated Datasets on Millions of People 147 9.3 The Opportunity – The Legal Right of Citizens to Obtain Copies of Their Personal Data and Their Willingness to Contribute These Data to Research 148 9.3.1 The European General Data Protection Regulation (GDPR) – Data Portability 148 9.3.2 The Willingness and the Right to Citizen Science 148 9.4 The Challenge 149 9.5 The Solution – Data Cooperatives and Personal Data, a Perfect Match 150 9.5.1 Data Cooperatives, Business Model, Non-profit, Financial Incentives 150 9.5.2 Challenges to the Cooperative Model 151 9.5.3 Example: MIDATA Data Cooperative 152 9.5.4 The Data Platform and Governance Form the Core of a New Innovation Ecosystem 152 9.6 Data Cooperatives and Data Donations 153 References 154 Chapter 10: Defining Data Donation After Death: Metadata, Families, Directives, Guardians and the Route to Big Consent 155 10.1 Introduction 155 10.2 Defining Data Donation After Death 156 10.3 Data Donation Metadata 157 10.4 Data Advance Directives 159 10.5 Posthumous Data Guardians 159 10.6 Objections 160 10.7 Other Governance Mechanisms 161 10.8 Conclusion 162 References 162 Part IV: An Ethical Code for Posthumous Medical Data Donation 164 Chapter 11: Enabling Posthumous Medical Data Donation: A Plea for the Ethical Utilisation of Personal Health Data 165 11.1 Introduction 166 11.2 What Is Posthumous Medical Data Donation? 166 11.3 Why We Should Enable PMDD 168 11.4 How Does PMDD Compare to Other Biomedical Donations? 172 11.4.1 Key Differences Among Existing Biomedical Donation Schemes 172 11.5 The Need for an Ethical Code 175 11.6 How to Implement Ethical PMDD 177 11.6.1 Learning from Mistakes and Codifying Best Practice 177 11.6.2 Deriving Relevant Ethical Principles 179 11.7 Conclusion 180 References 181 Chapter 12: An Ethical Code for Posthumous Medical Data Donation 183 12.1 Preamble 183 12.2 Considerations 184 12.3 Definitions 185 12.4 Overview 185 12.4.1 Objectives 186 12.4.2 Scope 186 12.5 Foundational Ethical Principles 186 12.5.1 Human Dignity and Respect for Persons 187 12.5.2 Promotion of the Common Good 187 12.5.3 The Right to Citizen Science 187 12.5.4 Quality and Good Data Governance 188 12.5.5 Transparency, Trust, and Integrity 188 12.6 Obtaining PMRs for Research Purposes 189 12.6.1 Obtaining Consent 189 12.6.2 Persons Unable to Give Consent 190 12.6.3 Changing or Withdrawing Consent 190 12.6.4 Refusing Donations 191 12.6.4.1 Refusing a PMDD on Grounds of the Data’s Nature 191 12.6.4.2 Refusing a PMDD on Grounds of the Data Source 191 12.6.4.3 Other Grounds for Refusing a PMDD 191 12.7 Research Approval, Conduct and Oversight 192 12.7.1 General Principles 192 12.7.1.1 Prohibition of Financial Gain 192 12.7.1.2 Confidentiality 192 12.7.1.3 Data Custody 193 12.7.1.4 Data Protection 193 12.7.1.5 Directly Identifiable Data 193 12.7.1.6 Information on Health and Hereditary Disease 193 12.7.2 Research Access 194 12.7.2.1 Access Requests 194 12.7.2.2 Research Results 195 12.7.3 Research Oversight 195 12.7.4 Contingency Planning 195 References 197 Index 198 Front Matter ....Pages i-x Ethical Medical Data Donation: A Pressing Issue (Jenny Krutzinna, Luciano Floridi)....Pages 1-6 Front Matter ....Pages 7-7 Data Donation: How to Resist the iLeviathan (Barbara Prainsack)....Pages 9-22 Data Donations as Exercises of Sovereignty (Patrik Hummel, Matthias Braun, Peter Dabrock)....Pages 23-54 The Ethics of Uncertainty for Data Subjects (Philip J. Nickel)....Pages 55-74 Incongruities and Dilemmas in Data Donation: Juggling Our 1s and 0s (Kerina H. Jones)....Pages 75-93 Front Matter ....Pages 95-95 Posthumous Medical Data Donation: The Case for a Legal Framework (Edina Harbinja)....Pages 97-113 Medical Data Donation, Consent and the Public Interest After Death: A Gateway to Posthumous Data Use (Annie Sorbie)....Pages 115-130 Front Matter ....Pages 131-131 The Personal Data Is Political (Bastian Greshake Tzovaras, Athina Tzovara)....Pages 133-140 Personal Data Cooperatives – A New Data Governance Framework for Data Donations and Precision Health (Ernst Hafen)....Pages 141-149 Defining Data Donation After Death: Metadata, Families, Directives, Guardians and the Route to Big Consent (David M. Shaw)....Pages 151-159 Front Matter ....Pages 161-161 Enabling Posthumous Medical Data Donation: A Plea for the Ethical Utilisation of Personal Health Data (Jenny Krutzinna, Mariarosaria Taddeo, Luciano Floridi)....Pages 163-180 An Ethical Code for Posthumous Medical Data Donation (Jenny Krutzinna, Mariarosaria Taddeo, Luciano Floridi)....Pages 181-195 Back Matter ....Pages 197-198 Ethical Medical Data Donation : A Pressing Issue / Jenny Krutzinna And Luciano Floridi -- Data Donation : How To Resist The Ileviathan / Barbara Prainsack -- Data Donations As Exercises Of Sovereignty / Patrik Hummel, Matthias Braun, And Peter Dabrock -- The Ethics Of Uncertainty For Data Subjects / Philip J. Nickel -- Incongruities And Dilemmas In Data Donation : Juggling Our 1s And 0s / Kerina H. Jones -- Posthumous Medical Data Donation : The Case For A Legal Framework / Edina Harbinja -- Medical Data Donation, Consent And The Public Interest After Death : A Gateway To Posthumous Data Use / Annie Sorbie -- The Personal Data Is Political / Bastian Greshake Tzovaras And Athina Tzovara -- Personal Data Cooperatives : A New Data Governance Framework For Data Donations And Precision Health / Ernst Hafen -- Defining Data Donation After Death : Metadata, Families, Directives, Guardians And The Route To Big Consent / David M. Shaw -- Enabling Posthumous Medical Data Donation : A Plea For The Ethical Utilisation Of Personal Health Data / Jenny Krutzinna, Mariarosaria Taddeo, And Luciano Floridi -- An Ethical Code For Posthumous Medical Data Donation / Jenny Krutzinna, Mariarosaria Taddeo, And Luciano Floridi. Jenny Krutzinna, Luciano Floridi, Editors. Includes Bibliographical References And Index.