The Ethics of Research Biobanking

von: Jan Helge Solbakk, Soren Holm, Bjorn Hofmann

Springer-Verlag, 2009

ISBN: 9780387938721 , 357 Seiten

Format: PDF, OL

Kopierschutz: DRM

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The Ethics of Research Biobanking


 

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