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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
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