Ethics of Research Biobanking (eBook)

The Ethics of Research Biobanking 2
Part I Research Biobanking: The Traditional Approach 17
Consent to Biobank Research: One Size Fits All? 18
Informed Consent, the Ideal Solution to Biobank Research? 18
Special Research: Special Requirements 19
Moot Material 20
Exceptional Information 20
Special Risk 21
Special Outcome 21
Practical Considerations: Kind of Research 22
New Names: Same Problems 23
Biological Material 23
Unknown Consequences 24
Information and Risk 25
Unexpected Consequences 26
Different Kind of Research 26
Alternatives to Informed Consent in Biobank Research 27
Undetermined Consent 28
Not Autonomy, but Privacy and Confidentiality 29
Consent to Submit to the Researcher 30
Conditional Authorization 32
Conditional Consent? 34
Conclusions 35
References 36
What No One Knows Cannot Hurt You: The Limitsof Informed Consent in the Emerging World of Biobanking 39
The Boom in Guidelines for Research Involving Biobanks 39
Relying on Informed Consent 40
Consent in Retrospective and Prospective Biobanks 41
Consent: Other Problems 43
Time to Abandon Consent in Favor of Anonymization 44
Conclusions 45
References 45
Users and Uses of the Biopolitics of Consent:A Study of DNA Banks 47
Introduction 47
Field Approach and Method 50
Types of Physician–Subject Interactions Observed 52
Consent as Seen by Its ``Subjects'' 54
Responsibilities 55
Counter-Intuitive Asymmetry 57
Conclusions 59
References 60
Information Rights on the Edge of Ignorance 62
Introduction 62
The Concepts of ``Information'' and ``Data'' 63
The Concept of ``Right'' 63
The Right to Information in Research Biobanking 65
The Right Not to Be Informed 67
Conclusions 68
References 69
The Dubious Uniqueness of Genetic Information 70
Introduction 70
The Potential Risk to the Donor 71
Genetic and Other Health Information as Research Datain Biobanks 74
The Interests of the Donor 75
The Dubious Uniqueness of Genetic Information 76
The Generalizability of Non-genetic Health Information 78
Conclusions 79
References 79
Duties and Rights of Biobank Participants:Principled Autonomy, Consent, Voluntariness and Privacy 81
The Assumption of Rights 81
Principled Autonomy 82
Justifying Consent by Principled Autonomy 84
Autonomy, Perfection, and Neutrality 85
Trust and Negatively Informed Consent 87
Authorisation and Voluntariness 88
Patients' Duties and Privacy Rights 90
Conclusions 95
References 95
Biobanking and Disclosure of Research Results:Addressing the Tension Between ProfessionalBoundaries and Moral Intuition 97
Introduction 97
Disclosure of Research Results in the Context of Biobanking 98
Tensions Between Professional Boundaries and Social Responsibility 99
When Do Research Data Constitute Information that ShouldBe Communicated to the Subject? 99
What Do We Mean by the Term ``Disclosure of Research Results''? 100
Aggregate Data vs. Individual Data 100
Disclosure of Individual Research Results 101
Arguments for and Against Disclosure of Results 102
What Motivates the Decision to Disclose or Not? 103
Disclosure of Research Results vs. Duty to Warn 104
From the Clinical Setting to the Research Setting 105
An Emerging International Ethic of Duty to DiscloseGenetic Research Results 105
When Do Research Data, in General, Constitute Informationthat Should Be Communicated to an Individual ResearchSubject? 106
Policy Suggestions and Next Steps 108
Requirements for Biobankers and Investigators 108
Elements of the Disclosure Process 109
Next Steps 109
References 110
Biobanks and Our Common Good 112
Introduction 113
Communitarianism, Society and Biobanks 113
Liberalism, Equality and Biobanks 116
Biobank Research and Informed Consent 120
Conclusions 122
References 123
Trust, Distrust and Co-production:The Relationship Between Research Biobanks and Donors 126
Introduction 126
The Discourse of Public Trust 127
What is Trust? 128
Natural and Obvious Donor Trust in Biobanks and Biobankers 129
When Natural Trust Is Missing: Distrust and Virtual Trust 132
The Group Between 133
Trust, Distrust or Co-Production: Towards an AlternativeDesign of Biobanks 135
Efficiency or Empowered Citizenship 136
Switching from Trust via Virtual Trust to Distrust 137
From Trust to Co-production 138
References 140
Scientific Citizenship, Benefit, and Protectionin Population-Based Research 142
Introduction 142
Protecting Participants 143
Benefiting Participants 144
Engaging Citizens 147
Guiding Vision 149
References 151
Part II Research Biobanking: Towards a New Conceptual Approach 153
Mapping the Language of Research Biobanking:An Analogical Approach 154
Introduction 155
Analogies 156
Epistemic Normativity of Analogies 156
Moral Normativity of Analogies 157
Analogical Analysis 159
What Is a Good Analogy? 160
The Analogy Is Dead: Long Live the Analogy 160
Old Analogies for New Technologies? 161
Exploration by Analogy 162
Moral Argument by Analogy 163
Old Dogs and Old Tricks: Are Analogies Doomedto Be Conservative? 163
Recycling and Reshaping Analogies 164
References 165
The Use of Analogical Reasoning in UmbilicalCord Blood Biobanking 168
Introduction 168
Big Challenges with Small Amounts of Blood 169
Analogies Applied 171
Analogical Reasoning 173
Analogies Explored 175
Commercial Banking 175
Insurance Analogy 176
Gambling Analogy 177
Membership Analogies 178
Concluding Remarks on Analogies to Analyse and to Argue 179
References 180
The Alexandria Plan: Creating Librariesfor Human Tissue Research and Therapeutic Use 182
Introduction 182
Case 1: Human Embryonic Stem Cell Collections 185
The Ethics of Histocompatibility 185
Case 2: NUGene and Genomic Population Studies 190
Why is Collection an Ethical Issue? 190
Case 3: Ovarian Tissue: Disclosure, Fidelity,and Privacy 191
Endemic Problems: Money and the Secret Body 194
Moral Philosophy Means Many Arguments are Valid 195
The Alexandria Solution: What We Have in Common. A Theory of Libraries as a Theory of Justice 197
The Great Library in Alexandria 199
The Carnegie Libraries 199
References 201
The Art of Biocollections 203
Introduction 203
Overview 206
Problems Related to Terminology 207
Similarities Between Biobanks and Art Galleries 209
Some Differences Between ``Biobanks'' and Art Galleries 211
The Relationship Between Collectors and Collectables 212
Altruistic Donations 213
Deposits 215
Power 217
Appropriations–Extractions–Confiscations 220
Contributing Valuables: Seen from Different Positions 223
Conclusion 224
References 226
The Health Dugnad: Biobank Participationas the Solidary Pursuit of the Common Good 227
A General Duty to Participate in Medical Research 228
Perfect and Imperfect Duties 229
The Dugnad Concept 231
Biobank Participation 233
Is HUNT a Dugnad? 235
The Opinion of Biobank Participants 236
The Importance of Solidarity 237
Normative Recruitment and the Helsinki Declaration 238
When Normative Recruitment is Not Justified 240
Accounts of Duties 241
Citizenship and the Ethics of Belonging 242
Conclusions 243
References 243
Embodied Gifting: Reflections on the Roleof Information in Biobank Recruitment 245
Introduction 245
Prevailing Assumptions: Two Traditions in Medical Ethics 247
The Contribution from the Social Sciences: Empirical Studies 250
The Importance of Political Context: A Swedish Example3 252
Lagerlöf and Sacrifice as Power 255
Conclusions 257
References 259
Conscription to Biobank Research? 262
Introduction 262
What Is the General Justification for Conscription? 264
The Moral Obligation to Participate in Biomedical Research 265
Conscription for Biobank Research? 266
Conclusions 268
References 269
Ownership Rights in Research Biobanks:Do We Need a New Kind of `Biological Property'? 270
Introduction 271
The Classical `Controversy': Questioning the `Non-Commercialisation Principle' 272
The Fear of `Private Property' in Human BiologicalMaterial for Research 273
The Problem with Property Rights and the Human Body: `Accepting or Not Accepting It': That Is the Question 275
The Portuguese Case: Considerations on the LegalConsequences of a Property Right Over One's Body 276
The Legal and Bioethical Construction of a New `Biological Property' 279
Conclusions 281
References 281
Legal Challenges and Strategies in the Regulationof Research Biobanking 284
Introduction 285
Human Research Biobanks: What Are They? 286
General Comments 286
Human Material Removed and Stored for Various Purposes 287
Type of Research Use Intended 288
Policy Makers Are Still Struggling 289
Legal Analogies and Comparative Law 290
External and Internal Legal Comparisons 290
Human Material as Biological Waste 291
Human Material as Raw Material 291
Human Material as Part of the Human Being 292
Human Material as Health-Related Personal Data 293
Human Material as Non-Identifiable Health Data 294
Human Material as a Public Resource 295
Summing Up the Analogies: The Biobank a Legal Anomaly 296
Some Areas of Controversy 298
Biological Samples Are Not Data 298
Genetic Exceptionalism 299
The Ambiguity of Anonymity 300
Varying Strategies in Domestic Regulation: Some Examples from the Nordic Countries 302
Is There a Nordic Approach to Biobank Legislation? 302
Type and Scope of Nordic Biobank Legislation 304
Issues of Consent and Withdrawal 305
Access and Benefit Sharing 307
The Challenge of International Harmonisation 308
Regulatory Tools and Competency 308
Hard Law and Soft Law 308
International Regulation 309
The Council of Europe 310
The European Union 312
Addressing the Regulatory Challenges 313
References 315
Annexation of Life: The Biopolitics of Industrial Biology 321
Introduction 321
The Knowledge-Based Economy 323
Industrial Biology 327
The Political Concept of Biocolonialism 329
Discussion: ``Things Fall Apart'' 332
References 334
In the Ruins of Babel: Should Biobank Regulations be Harmonized 336
Introduction 336
The Thrust for Harmonization: Industrial Biology 338
Weaker Ethics for Stronger Technoscience 341
The Biobank of Babel: Should Biobank Regulations be Harmonized? 343
Conclusion: Back to Babel 346
References 347
Index 349