Protecting genetic privacy in biobanking through data protection law / Dara Hallinan.

Format:

Book

Author/Creator:

Hallinan, Dara, author.

Series:

Oxford scholarship online.

Oxford scholarship online

Language:

English

Subjects (All):

European Parliament. General Data Protection Regulation.

European Parliament.

Medical records--Law and legislation--European Union countries.

Medical records.

Data protection--Law and legislation--European Union countries.

Data protection.

Biobanks--Law and legislation--European Union countries.

Biobanks.

European Union countries.

Physical Description:

1 online resource (304 pages).

Edition:

First edition.

Place of Publication:

Oxford, England : Oxford University Press, [2021]

Summary:

Biobanks are critical infrastructure for medical research but they are also the subject of considerable ethical and legal uncertainty. Given that biobanks process large quantities of genomic data, questions have emerged as to how genetic privacy should be protected. What types of genetic privacy rights and rights holders should be protected and to what extent? Since 25th May 2018 the General Data Protection Regulation (GDPR) has applied and now occupies a key position in the European legal framework for the regulation of biobanking. This book takes an in-depth look at the function, problems, and opportunities presented by European data protection law under the GDPR as a framework for the protection of genetic privacy in biobanking in Europe.

Contents:

Cover

Half title

Protecting Genetic Privacy in Biobanking through Data Protection Law

Copyright

Contents

Abbreviations

Table of Cases and Legislation

1. Introduction

2. Genetic Data, Genome Understanding, and Socially Relevant Information

A. Introduction

B. Types of Genetic Data

C. Types of Socially Significant Information Revealed via Genetic Analysis

D. The Range of Genetic Analyses Potentially Applicable to Genetic Data

E. The Accuracy of Information Produced via Genetic Analysis

F. The Range of Parties Implicated by Genetic Analyses

G. Conclusion

3. The Context and State of the Art in European Biobanking

B. The Human Genome Project: Where It All Began

C. Organisational Legacies of the Human Genome Project

D. Methodological Legacies of the Human Genome Project

E. The Promises of Genomic Research

F. The Unfulfillable Promises of Genomic Research?

G. Defining Biobanks: A Loose Definition for a Heterogeneous Class

H. Variations in European Biobanking: Scientific Approach

I. Variations in European Biobanking: Organisational Structure

J. Variations in European Biobanking: Substance Ownership and Intellectual Property

K. Variations in European Biobanking: Approach to Research Subjects

L. Future Trends in European Biobanking

M. Conclusion

4. Genetic Privacy and Other Interests in Biobanking: Conflict and Confluence

B. Privacy: As a Condition and as a Right

C. Genetic Privacy Rights: A Subset of Privacy Rights

D. Mapping Genetic Privacy Rights Engaged by Biobanking: The Research Subject's Genetic Privacy Rights on the Transactional Axis

E. Mapping Genetic Privacy Rights Engaged by Biobanking: Genetic Relatives' and Genetic Groups' Genetic Privacy Rights on the Relational Axis.

F. Genetic Classes and Genetic Categories: Two Different Kinds of Genetic Groups

G. Mapping Other Interests Engaged by Biobanking: Interests Tied Up with the Conduct and Outcome of Biobank Research

H. Mapping Other Interests Engaged by Biobanking: Third-​Party Non-​Research Interests in Accessing Biobanking Substances

I. Mapping the Relationships between Genetic Privacy Rights and Other Interests: Conflicts

J. Mapping the Relationships between Genetic Privacy Rights and Other Interests: Confluences

K. Conclusion

5. The Protection of Genetic Privacy in Biobanking at International Level: Establishing a Baseline Standard for Genetic Privacy Protection in Biobanking

B. The Structure of the International Framework

C. Common International Principles Regarding Research Subjects' Genetic Privacy on the Transactional Axis

D. Common International Principles Regarding Genetic Relatives' and Groups' Genetic Privacy on the Relational Axis

E. Emerging International Principles Regarding Research Subjects' Genetic Privacy on the Transactional Axis

F. Emerging International Principles Regarding Genetic Relatives' and Groups' Genetic Privacy on the Relational Axis

G. Problems of Structure: The International Framework Is Not Hard Law

H. Problems Along the Transactional Axis: The International Framework Does Not Provide Protection for the Full Range of Research Subjects' Genetic Privacy Rights

I. Problems Along the Relational Axis: The International Framework Does Not Provide Protection for the Full Range of Genetic Privacy Rights Holders

J. Problems with the Standard of Protection: The International Framework Provides Incomprehensive Protection

6. Do we Need Data Protection at All? Evaluating Protection for Genetic Privacy in Biobanking in Europe Excluding Data Protection.

A. Introduction

B. Selection of European Legal Systems to Analyse

C. EU Law Excluding Data Protection

D. Estonian Law Excluding Data Protection

E. German Law Excluding Data Protection

F. UK Law Excluding Data Protection

G. Problems of Structure: No System-​Excluding Data Protection-​ Is Optimally Structured to Protect Genetic Privacy in Biobanking

H. Problems with the Protection of Research Subjects' Genetic Privacy: Excluding Data Protection, Only Estonia Protects the Full Range of Genetic Privacy Rights

I. Problems with the Protection of Genetic Relatives' and Genetic Groups' Genetic Privacy: No System-​Excluding Data Protection-​Protects Genetic Relatives or Groups

J. Problems with the Adequacy of Protection: No System-​Excluding Data Protection-​Provides Comprehensive Protection

K. Problems of Harmony: Systems-​Excluding Data Protection-​ Are Neither Harmonised, Nor Necessarily Compatible

L. Looking to Data Protection and the GDPR

7. Testing the GDPR in Relation to Biobanking: When Does the GDPR Apply to Biobanking?

B. The GDPR's General Applicability Principles: Article 2 and Biobanking

C. Personal Data and Its Constituent Criteria

D. Which Biobanking Substances Could Potentially Be Personal Data?

E. Biological Samples as Personal Data? Practical Parallels Between Biological Samples and Sequenced Genomic Data

F. Biological Samples as Personal Data? Biological Samples Can Be Considered in Terms of Information

G. Biological Samples as Personal Data? Biological Samples Can Be Considered as Information as the Term Is Used in the GDPR

H. Which Biobanking Links Qualify as Identified or Identifiable?

I. Conclusion

8. Testing the GDPR in Relation to Biobanking: How Does the GDPR classify the Biobanking Process?

A. Introduction.

B. Two Classifications Systems: The Actor Classification System and the Personal Data Classification System

C. The Applicability of the Actor Classification System to Biobanking

D. The Applicability of the Personal Data Classification System to Biobanking

E. Conclusion

9. Testing the GDPR in Relation to Biobanking: How Do the GDPR's Substantive Provisions Apply to Biobanking?

B. Biobanking and Oversight under the GDPR

C. Biobanking and Legitimate Processing under the GDPR

D. Biobanking and Data Subject Rights under the GDPR

E. Biobanking and Data Controller Obligations under the GDPR

F. Biobanking and Transfers to Third Countries under the GDPR

G. Biobanking and Sanctions under the GDPR

H. Biobanking and Derogations under the GDPR

10. A Critical Analysis of the Efficacy of the GDPR as a Framework for the Protection of Genetic Privacy in Biobanking

B. A Framework for the Critical Analysis of the GDPR

C. Problems Concerning the Structure of the GDPR

D. Problems Concerning the Protection of Research Subjects' Genetic Privacy Rights on the Transactional Axis

E. Problems Concerning the Protection of Genetic Relatives' and Genetic Groups' Genetic Privacy Rights on the Relational Axis

F. Problems Concerning the Substantive Protection Offered by the GDPR

G. Problems Concerning the Technical Applicability of the GDPR's Provisions to Biobanking

H. Problems Concerning the Disproportionate Impact of the GDPR on Research

I. Problems Concerning the Practical Applicability of the GDPR to Biobanking

J. Problems Concerning the Degree to Which the GDPR Harmonises Protection

11. Conclusion

References

Index.

Notes:

This edition also issued in print: 2021.

Includes bibliographical references and index.

Description based on print version record.

Description based on publisher supplied metadata and other sources.

ISBN:

0-19-265039-4

0-19-265038-6

0-19-191891-1

OCLC:

1247122922