The Ethics of Research Biobanking

The Ethics of Research Biobanking

Part I Research Biobanking: The Traditional Approach

Consent to Biobank Research: One Size Fits All?

Informed Consent, the Ideal Solution to Biobank Research?

Special Research: Special Requirements

Moot Material

Exceptional Information

Special Risk

Special Outcome

Practical Considerations: Kind of Research

New Names: Same Problems

Biological Material

Unknown Consequences

Information and Risk

Unexpected Consequences

Different Kind of Research

Alternatives to Informed Consent in Biobank Research

Undetermined Consent

Not Autonomy, but Privacy and Confidentiality

Consent to Submit to the Researcher

Conditional Authorization

Conditional Consent?

Conclusions

References

What No One Knows Cannot Hurt You: The Limitsof Informed Consent in the Emerging World of Biobanking

The Boom in Guidelines for Research Involving Biobanks

Relying on Informed Consent

Consent in Retrospective and Prospective Biobanks

Consent: Other Problems

Time to Abandon Consent in Favor of Anonymization

Conclusions

References

Users and Uses of the Biopolitics of Consent:A Study of DNA Banks

Introduction

Field Approach and Method

Types of Physician–Subject Interactions Observed

Consent as Seen by Its ``Subjects''

Responsibilities

Counter-Intuitive Asymmetry

Conclusions

References

Information Rights on the Edge of Ignorance

Introduction

The Concepts of ``Information'' and ``Data''

The Concept of ``Right''

The Right to Information in Research Biobanking

The Right Not to Be Informed

Conclusions

References

The Dubious Uniqueness of Genetic Information

Introduction

The Potential Risk to the Donor

Genetic and Other Health Information as Research Datain Biobanks

The Interests of the Donor

The Dubious Uniqueness of Genetic Information

The Generalizability of Non-genetic Health Information

Conclusions

References

Duties and Rights of Biobank Participants:Principled Autonomy, Consent, Voluntariness and Privacy

The Assumption of Rights

Principled Autonomy

Justifying Consent by Principled Autonomy

Autonomy, Perfection, and Neutrality

Trust and Negatively Informed Consent

Authorisation and Voluntariness

Patients' Duties and Privacy Rights

Conclusions

References

Biobanking and Disclosure of Research Results:Addressing the Tension Between ProfessionalBoundaries and Moral Intuition

Introduction

Disclosure of Research Results in the Context of Biobanking

Tensions Between Professional Boundaries and Social Responsibility

When Do Research Data Constitute Information that ShouldBe Communicated to the Subject?

What Do We Mean by the Term ``Disclosure of Research Results''?

Aggregate Data vs. Individual Data

Disclosure of Individual Research Results

Arguments for and Against Disclosure of Results

What Motivates the Decision to Disclose or Not?

Disclosure of Research Results vs. Duty to Warn

From the Clinical Setting to the Research Setting

An Emerging International Ethic of Duty to DiscloseGenetic Research Results

When Do Research Data, in General, Constitute Informationthat Should Be Communicated to an Individual ResearchSubject?

Policy Suggestions and Next Steps

Requirements for Biobankers and Investigators

Elements of the Disclosure Process

Next Steps

References

Biobanks and Our Common Good

Introduction

Communitarianism, Society and Biobanks

Liberalism, Equality and Biobanks

Biobank Research and Informed Consent

Conclusions

References

Trust, Distrust and Co-production:The Relationship Between Research Biobanks and Donors

Introduction

The Discourse of Public Trust

What is Trust?

Natural and Obvious Donor Trust in Biobanks and Biobankers

When Natural Trust Is Missing: Distrust and Virtual Trust

The Group Between

Trust, Distrust or Co-Production: Towards an AlternativeDesign of Biobanks

Efficiency or Empowered Citizenship

Switching from Trust via Virtual Trust to Distrust

From Trust to Co-production

References

Scientific Citizenship, Benefit, and Protectionin Population-Based Research

Introduction

Protecting Participants

Benefiting Participants

Engaging Citizens

Guiding Vision

References

Part II Research Biobanking: Towards a New Conceptual Approach

Mapping the Language of Research Biobanking:An Analogical Approach

Introduction

Analogies

Epistemic Normativity of Analogies

Moral Normativity of Analogies

Analogical Analysis

What Is a Good Analogy?

The Analogy Is Dead: Long Live the Analogy

Old Analogies for New Technologies?

Exploration by Analogy

Moral Argument by Analogy

Old Dogs and Old Tricks: Are Analogies Doomedto Be Conservative?

Recycling and Reshaping Analogies

References

The Use of Analogical Reasoning in UmbilicalCord Blood Biobanking

Introduction

Big Challenges with Small Amounts of Blood

Analogies Applied

Analogical Reasoning

Analogies Explored

Commercial Banking

Insurance Analogy

Gambling Analogy

Membership Analogies

Concluding Remarks on Analogies to Analyse and to Argue

References

The Alexandria Plan: Creating Librariesfor Human Tissue Research and Therapeutic Use

Introduction

Case 1: Human Embryonic Stem Cell Collections

The Ethics of Histocompatibility

Case 2: NUGene and Genomic Population Studies

Why is Collection an Ethical Issue?

Case 3: Ovarian Tissue: Disclosure, Fidelity,and Privacy

Endemic Problems: Money and the Secret Body

Moral Philosophy Means Many Arguments are Valid

The Alexandria Solution: What We Have in Common. A Theory of Libraries as a Theory of Justice

The Great Library in Alexandria

The Carnegie Libraries

References

The Art of Biocollections

Introduction

Overview

Problems Related to Terminology

Similarities Between Biobanks and Art Galleries

Some Differences Between ``Biobanks'' and Art Galleries

The Relationship Between Collectors and Collectables

Altruistic Donations

Deposits

Power

Appropriations–Extractions–Confiscations

Contributing Valuables: Seen from Different Positions

Conclusion

References

The Health Dugnad: Biobank Participationas the Solidary Pursuit of the Common Good

A General Duty to Participate in Medical Research

Perfect and Imperfect Duties

The Dugnad Concept

Biobank Participation

Is HUNT a Dugnad?

The Opinion of Biobank Participants

The Importance of Solidarity

Normative Recruitment and the Helsinki Declaration

When Normative Recruitment is Not Justified

Accounts of Duties

Citizenship and the Ethics of Belonging

Conclusions

References

Embodied Gifting: Reflections on the Roleof Information in Biobank Recruitment

Introduction

Prevailing Assumptions: Two Traditions in Medical Ethics

The Contribution from the Social Sciences: Empirical Studies

The Importance of Political Context: A Swedish Example3

Lagerlöf and Sacrifice as Power

Conclusions

References

Conscription to Biobank Research?

Introduction

What Is the General Justification for Conscription?

The Moral Obligation to Participate in Biomedical Research

Conscription for Biobank Research?

Conclusions

References

Ownership Rights in Research Biobanks:Do We Need a New Kind of `Biological Property'?

Introduction

The Classical `Controversy': Questioning the `Non-Commercialisation Principle'

The Fear of `Private Property' in Human BiologicalMaterial for Research

The Problem with Property Rights and the Human Body: `Accepting or Not Accepting It': That Is the Question

The Portuguese Case: Considerations on the LegalConsequences of a Property Right Over One's Body

The Legal and Bioethical Construction of a New `Biological Property'

Conclusions

References

Legal Challenges and Strategies in the Regulationof Research Biobanking

Introduction

Human Research Biobanks: What Are They?

General Comments

Human Material Removed and Stored for Various Purposes

Type of Research Use Intended

Policy Makers Are Still Struggling

Legal Analogies and Comparative Law

External and Internal Legal Comparisons

Human Material as Biological Waste

Human Material as Raw Material

Human Material as Part of the Human Being

Human Material as Health-Related Personal Data

Human Material as Non-Identifiable Health Data

Human Material as a Public Resource

Summing Up the Analogies: The Biobank a Legal Anomaly

Some Areas of Controversy

Biological Samples Are Not Data

Genetic Exceptionalism

The Ambiguity of Anonymity

Varying Strategies in Domestic Regulation: Some Examples from the Nordic Countries

Is There a Nordic Approach to Biobank Legislation?

Type and Scope of Nordic Biobank Legislation

Issues of Consent and Withdrawal

Access and Benefit Sharing

The Challenge of International Harmonisation

Regulatory Tools and Competency

Hard Law and Soft Law

International Regulation

The Council of Europe

The European Union

Addressing the Regulatory Challenges

References

Annexation of Life: The Biopolitics of Industrial Biology

Introduction

The Knowledge-Based Economy

Industrial Biology

The Political Concept of Biocolonialism

Discussion: ``Things Fall Apart''

References

In the Ruins of Babel: Should Biobank Regulations be Harmonized

Introduction

The Thrust for Harmonization: Industrial Biology

Weaker Ethics for Stronger Technoscience

The Biobank of Babel: Should Biobank Regulations be Harmonized?

Conclusion: Back to Babel

References

Index