File #2466: "2018_Book_PublicRegulationOfTumorBanks.pdf"
Testo
1|Foreword|5
1|Contents|9
1|List of Abbreviations|11
1|List of Editor and Contributors|13
1|Part I: Tumor Banks or the Valorization of a Complex Object|15
2|Chapter 1: Is Putting Cancer in Banks a Patrimony To Be Developed?|16
3|1.1 Purpose of the Project|17
3|1.2 Project Method|18
3|1.3 Architecture of the Publication|19
2|Chapter 2: Biological Samples and Their Sampling Degrees|21
3|2.1 From a Full Body to a Biological Element|22
4|2.1.1 The Act of Detachment Circumscribed by the Respect of Human Body|23
4|2.1.2 The Act of Detachment Materializes the Legal Existence of Biological Samples|24
3|2.2 The Transition from Biological Elements to Biological Samples|25
4|2.2.1 A Specification Process Turning a Thing into a Good|25
4|2.2.2 A Conditional Use of Biological Samples|27
3|References|28
2|Chapter 3: Personal Data Protection in Tumor Banks|30
3|3.1 Consent as an Uncertain Requirement for the Collection of Personal Data by Tumor Banks|33
4|3.1.1 Uncertainties Surrounding the Necessity and Modalities of Consent|33
4|3.1.2 Uncertainties Surrounding the Extent and Effects of Consent|35
3|3.2 Confidentiality as an Illusory Requirement for the Transmission of Personal Data by Tumor Banks|36
4|3.2.1 A Relative Requirement for the Transmission of Personal Data|37
4|3.2.2 An Artificial Requirement for the Transmission of Personal Data|38
3|References|39
2|Chapter 4: The Policies of Tumor Biobankers: Main Strategies and an Example of the Policies Adopted by the Nice Hospital Bioba...|41
3|4.1 Introduction: Present and Future Issues|41
3|4.2 What Policy(ies) for a ``Biobanker´´?|42
4|4.2.1 The Collection´s Target Pathology/Pathologies, If Any|43
4|4.2.2 The Type of Bioresource Collected|43
4|4.2.3 The Biobanker´s Field of Expertise|43
4|4.2.4 The Hospital´s or Institution´s Policies and General Organization|44
3|4.3 Choosing a Policy for a Biobank|45
3|4.4 The Policy Drawn Up for the Nice University Hospital Biobank (BB-0033-00025, Nice, France)|45
3|4.5 Conclusion: One or Several Policies for Biobankers?|47
3|References|48
2|Chapter 5: The Concept of Biological Samples Collection|50
3|5.1 Introduction|50
3|5.2 Definition of Biological Sample and Biological Collection|50
4|5.2.1 Biological Sample|50
4|5.2.2 Biological Collection|51
3|5.3 How Are Collections Established and Used in 2017?|51
4|5.3.1 Establishment of a Biological Collection|51
4|5.3.2 Use of a Biological Collection|51
5|5.3.2.1 Collections Regulated by the Jardé Law|51
5|5.3.2.2 Collections Not Regulated by the Jardé Law|52
3|5.4 Clinical Research and Biological Samples Regulation|52
4|5.4.1 Prior to the Jardé Law|52
5|5.4.1.1 Interventional Studies|52
5|5.4.1.2 Non-interventional Studies|54
4|5.4.2 New Regulation: The Jardé Law|54
5|5.4.2.1 Category 1 Studies: Interventional Studies Exceeding the Minimal Risks Standard (Former Biomedical Studies)|55
5|5.4.2.2 Category 2 Studies: Interventional Studies Presenting Minimal Risk and Not Involving Medication|56
5|5.4.2.3 Category 3 Studies: Non-interventional Studies Involving the Human Person and Corresponding to Purely Observational St...|56
3|5.5 Function of a Biological Resource Centre (BRC): Its Collections, Its Missions: Example BRC-Cancer Toulouse University Inst...|56
4|5.5.1 Missions of a Biological Resource Centre|56
4|5.5.2 Example: BRC-Cancer Toulouse University Institute for Cancer (TUIC)|57
4|5.5.3 Modus Operandi|58
3|5.6 Conclusion|58
3|References|59
2|Chapter 6: Does Tumor Bank Regulation Promote the Valorization of Tumor Collections?|60
3|6.1 What Does a Simplification of the Regulation of Biobanks Activity Entail for Their Valorization?|63
4|6.1.1 Simplifying the Management of Biobanks Activity for Specific Research Purposes|64
4|6.1.2 The Simplification of Procedures Regarding the Build-Up of Biological Sample Collections|65
3|6.2 Are We Moving Towards a Simplification of Data Access?|67
4|6.2.1 The Simplification of the Implementation of Data Processing Procedures|68
4|6.2.2 Is It an Effective Simplification?|69
3|References|71
2|Chapter 7: Economic Modeling and Valorization of Biobanks|72
3|7.1 Economic Operation of a Biobank|73
3|7.2 Challenges Affecting Valorization|75
4|7.2.1 Information Asymmetries|75
4|7.2.2 Biobank Decisions|76
5|7.2.2.1 Strategic Positioning|76
5|7.2.2.2 Conditions of Transfer|78
5|7.2.2.3 Networking|79
3|7.3 Conclusion|80
3|References|80
2|Chapter 8: Socializing Tumors: From the Conservation of Tumors in Banks to Their Ontological Variations|82
3|8.1 The Socialization of Living Organisms as a Focus of Research?|83
3|8.2 A Sociological Fieldwork on Tumor Biological Resources|83
3|8.3 The Sociotechnical Chain of Biobanking|85
4|8.3.1 Scene 1: Collection|85
5|8.3.1.1 Selecting Tumors|85
5|8.3.1.2 Collecting|86
5|8.3.1.3 Conditioning|87
5|8.3.1.4 Delivering|87
4|8.3.2 Scene 2: The Exploitation in the Hospital Laboratory|88
4|8.3.3 Scene 3: Managing Tumor Entities|89
3|8.4 Making Biological Resources: An Ontological Plurality|90
3|References|92
1|Part II: The Issues Related to Tumor Collections Valorization|94
2|Chapter 9: The Valorization of Tumor Collections: Reconciling the Interests of the Different Actors|95
3|9.1 Patients´ Rights: A Central Concern When Valorizing Collections|96
4|9.1.1 Respecting Patient Autonomy in the Medical Relationship|96
4|9.1.2 Biological Resource Centers: In Charge of the Quality and Safety of Samples and Associated Data|98
5|9.1.2.1 The Need for BRCs to Meet Biobanking Standards|99
5|9.1.2.2 Providing Biological Resources|99
3|9.2 Reconciling Individuals´ Rights with Scientific and Economic Imperatives|100
4|9.2.1 Developing a ``Market´´ in Human Biological Material and Associated Data|100
4|9.2.2 The Effectiveness of Laws Governing the Non-Commercialization of the Human Body and the Lack of Property Rights on Biolo...|103
3|References|104
2|Chapter 10: The Development of Tumor Collections: The Interest of the European Union|106
3|10.1 The Union´s Policy: A Policy That Encourages Research|108
4|10.1.1 The Competence of the Union in the Field of Research: A Specific Shared Competence|108
4|10.1.2 European Infrastructures for Research Excellence: From ERIC to BBMRI-ERIC|109
3|10.2 The Union´s Regulation with Regards to Access to Biological Samples and Data for Research Purposes|110
4|10.2.1 The Inherent Limitations in the European Research Infrastructure|111
4|10.2.2 Better European Governance as an Asset for the Development of Collections|112
3|References|116
3|Reports|117
1|Part III: The Means for Tumor Collections Valorization|118
2|Chapter 11: Academic Valorization of Biobanks|119
3|11.1 The Intrinsic Value of Collections|119
4|11.1.1 The Historical Value of Collections Held by Public Establishments|119
5|11.1.1.1 Census of Biological Collections|120
5|11.1.1.2 The Legal Framework for Existing Collections|121
4|11.1.2 The Scientific Value Added by Research|122
5|11.1.2.1 Academic Research|123
6|Cohorts and Registers|123
5|11.1.2.2 Commercial Research|124
3|11.2 Valorization of Collections|125
4|11.2.1 Academic Valorization Through Practice|125
5|11.2.1.1 Measure 1 of the ``Cancer Plan´´: Strengthen Multidisciplinary Research|125
5|11.2.1.2 The IBiSA Scientific Interest Group|126
5|11.2.1.3 Biobanking and Biomolecular Resources Research Infrastructure|126
5|11.2.1.4 Public Population Project in Genomics and Society (P3G)|127
3|11.3 Scientific Valorization Through Publications|127
4|11.3.1 Academic Credit for Bioresources|128
4|11.3.2 Citing Bioresources: The CoBRA Guidelines|129
4|11.3.3 Publishing a Bioresource: A New Type of Journal|130
3|References|130
2|Chapter 12: Commercialization Through the Use of Private Law Contracts|132
3|12.1 Introduction|132
3|12.2 The Marketability of the Object|135
4|12.2.1 A Complex Object, the Asset Nature of Which Is Discussed|135
4|12.2.2 A Complex Object, the Marketability of Which Is Limited|137
3|12.3 The Efficiency of the Chosen Legal Tool|139
4|12.3.1 The Capacities of the Parties|139
4|12.3.2 The Terms of the Contract|142
3|References|145
2|Chapter 13: The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork|146
3|13.1 Introduction|146
3|13.2 Canada|147
4|13.2.1 Legal Framework|147
5|13.2.1.1 Free and Informed Consent|147
5|13.2.1.2 Free and Informed Consent in Québec Civil Law|148
5|13.2.1.3 Ethics Policies|149
4|13.2.2 Privacy|150
4|13.2.3 Fiduciary Duties|151
5|13.2.3.1 Fiduciary Relationships and the Common Law Trust|151
5|13.2.3.2 The Québec Fiducie|152
5|13.2.3.3 The Duty of Good Faith|153
4|13.2.4 Property Rights in Biospecimen|154
5|13.2.4.1 Property Rights in Biospecimens in Jurisprudence|154
5|13.2.4.2 The CCQ Rejection of Property Rights in the Human Body|155
5|13.2.4.3 Patents|156
3|13.3 The US|157
4|13.3.1 The Common Rule|158
5|13.3.1.1 Biobanking in the US|159
4|13.3.2 Legal Framework|159
5|13.3.2.1 Free and Informed Consent|159
6|Federal Legislative Framework|159
5|13.3.2.2 Jurisprudence|160
4|13.3.3 Privacy|161
5|13.3.3.1 Federal Privacy Laws|161
6|Common Rule/Final Rule|162
6|HIPAA|163
4|13.3.4 Fiduciary Duties|163
4|13.3.5 Property Rights in Biospecimens|164
5|13.3.5.1 Property Rights|164
5|13.3.5.2 Patents|165
5|13.3.5.3 Jurisprudence|166
3|13.4 Conclusion|168
4|13.4.1 Lingering Questions|168
3|References|169
2|Chapter 14: Biobank Expertise and the Research Unit-Biobank Relationship|170
3|14.1 Modeling|171
4|14.1.1 The Research Unit|171
4|14.1.2 The Biobank|172
4|14.1.3 The Project´s Social Value|172
4|14.1.4 Sharing the Project´s Value|173
3|14.2 Results|174
4|14.2.1 The Sample Tariff|174
4|14.2.2 Participation, Contracts, and Expertise|175
4|14.2.3 Effort, Contracts, and Expertise|176
4|14.2.4 What Level of Expertise?|178
3|14.3 Economic Challenges of Networking|178
3|14.4 Public Policy Recommendations|179
3|References|179
2|Chapter 15: Extra-Patrimoniality for the Patient|180
3|15.1 A Tumor Is Part of a Human Body|181
4|15.1.1 An Element of the Human Body Is Not Part of a Person´s Property|182
4|15.1.2 A Bodily Element Is Part of a Person: It Can Only Be Collected from Their Body|183
3|15.2 A Tumor Is Different from Other Elements: It Is Harmful to the Person|184
4|15.2.1 No Circulation Is Possible from Body to Body|184
4|15.2.2 A Necessary Removal|185
3|References|186
2|Chapter 16: The Moment of Patrimonialization|187
3|16.1 Introduction|187
3|16.2 The Sources of Supply|188
4|16.2.1 The Main Supply: Bodies Without Legal Personality|189
5|16.2.1.1 Surgical Residues: A Simple Absence of Opposition|189
5|16.2.1.2 Samples from Deceased Persons|191
5|16.2.1.3 Embryos|192
4|16.2.2 The Subsidiary Resource: Samples on Persons|194
5|16.2.2.1 In the Context of a ``Classical´´ Biomedical Study|194
5|16.2.2.2 In the Context of a Simplified Regime|195
3|16.3 The Rights on Elements Once the Bank Has Been Established|198
4|16.3.1 The Almost Non-existent Rights for Natural Persons|198
4|16.3.2 The Rights of the Bank on the Elements|200
3|References|204
2|Chapter 17: The Patrimonial Specificities of Public Persons|205
3|17.1 Specificities Regarding Public Property|206
4|17.1.1 An Increased Protection: The Exemption from Seizure|206
4|17.1.2 A Limited Flexibility: Non-assignment at a Low Price|207
3|17.2 The Specificities Regarding the Public Service of Biobanks|209
4|17.2.1 The Techniques of De Facto Universality and ``Administrative Fund´´ in the Service of Tumor Banks|209
4|17.2.2 The Challenges of the Biobank Public Service|211
3|References|213
2|Chapter 18: Biological Sample Collection in the Era of Genomic Medicine: A New Example of a Public Commons?|215
3|18.1 The Commons, a Theoretically Relevant Model|216
3|18.2 The Commons, Tested by Practices|220
3|References|224
1|Erratum to: Public Regulation of Tumor Banks|226
2|Erratum to: X. Bioy (ed.), Public Regulation of Tumor Banks, https://doi.org/10.1007/978-3-319-90563-1|226
1|Contents|9
1|List of Abbreviations|11
1|List of Editor and Contributors|13
1|Part I: Tumor Banks or the Valorization of a Complex Object|15
2|Chapter 1: Is Putting Cancer in Banks a Patrimony To Be Developed?|16
3|1.1 Purpose of the Project|17
3|1.2 Project Method|18
3|1.3 Architecture of the Publication|19
2|Chapter 2: Biological Samples and Their Sampling Degrees|21
3|2.1 From a Full Body to a Biological Element|22
4|2.1.1 The Act of Detachment Circumscribed by the Respect of Human Body|23
4|2.1.2 The Act of Detachment Materializes the Legal Existence of Biological Samples|24
3|2.2 The Transition from Biological Elements to Biological Samples|25
4|2.2.1 A Specification Process Turning a Thing into a Good|25
4|2.2.2 A Conditional Use of Biological Samples|27
3|References|28
2|Chapter 3: Personal Data Protection in Tumor Banks|30
3|3.1 Consent as an Uncertain Requirement for the Collection of Personal Data by Tumor Banks|33
4|3.1.1 Uncertainties Surrounding the Necessity and Modalities of Consent|33
4|3.1.2 Uncertainties Surrounding the Extent and Effects of Consent|35
3|3.2 Confidentiality as an Illusory Requirement for the Transmission of Personal Data by Tumor Banks|36
4|3.2.1 A Relative Requirement for the Transmission of Personal Data|37
4|3.2.2 An Artificial Requirement for the Transmission of Personal Data|38
3|References|39
2|Chapter 4: The Policies of Tumor Biobankers: Main Strategies and an Example of the Policies Adopted by the Nice Hospital Bioba...|41
3|4.1 Introduction: Present and Future Issues|41
3|4.2 What Policy(ies) for a ``Biobanker´´?|42
4|4.2.1 The Collection´s Target Pathology/Pathologies, If Any|43
4|4.2.2 The Type of Bioresource Collected|43
4|4.2.3 The Biobanker´s Field of Expertise|43
4|4.2.4 The Hospital´s or Institution´s Policies and General Organization|44
3|4.3 Choosing a Policy for a Biobank|45
3|4.4 The Policy Drawn Up for the Nice University Hospital Biobank (BB-0033-00025, Nice, France)|45
3|4.5 Conclusion: One or Several Policies for Biobankers?|47
3|References|48
2|Chapter 5: The Concept of Biological Samples Collection|50
3|5.1 Introduction|50
3|5.2 Definition of Biological Sample and Biological Collection|50
4|5.2.1 Biological Sample|50
4|5.2.2 Biological Collection|51
3|5.3 How Are Collections Established and Used in 2017?|51
4|5.3.1 Establishment of a Biological Collection|51
4|5.3.2 Use of a Biological Collection|51
5|5.3.2.1 Collections Regulated by the Jardé Law|51
5|5.3.2.2 Collections Not Regulated by the Jardé Law|52
3|5.4 Clinical Research and Biological Samples Regulation|52
4|5.4.1 Prior to the Jardé Law|52
5|5.4.1.1 Interventional Studies|52
5|5.4.1.2 Non-interventional Studies|54
4|5.4.2 New Regulation: The Jardé Law|54
5|5.4.2.1 Category 1 Studies: Interventional Studies Exceeding the Minimal Risks Standard (Former Biomedical Studies)|55
5|5.4.2.2 Category 2 Studies: Interventional Studies Presenting Minimal Risk and Not Involving Medication|56
5|5.4.2.3 Category 3 Studies: Non-interventional Studies Involving the Human Person and Corresponding to Purely Observational St...|56
3|5.5 Function of a Biological Resource Centre (BRC): Its Collections, Its Missions: Example BRC-Cancer Toulouse University Inst...|56
4|5.5.1 Missions of a Biological Resource Centre|56
4|5.5.2 Example: BRC-Cancer Toulouse University Institute for Cancer (TUIC)|57
4|5.5.3 Modus Operandi|58
3|5.6 Conclusion|58
3|References|59
2|Chapter 6: Does Tumor Bank Regulation Promote the Valorization of Tumor Collections?|60
3|6.1 What Does a Simplification of the Regulation of Biobanks Activity Entail for Their Valorization?|63
4|6.1.1 Simplifying the Management of Biobanks Activity for Specific Research Purposes|64
4|6.1.2 The Simplification of Procedures Regarding the Build-Up of Biological Sample Collections|65
3|6.2 Are We Moving Towards a Simplification of Data Access?|67
4|6.2.1 The Simplification of the Implementation of Data Processing Procedures|68
4|6.2.2 Is It an Effective Simplification?|69
3|References|71
2|Chapter 7: Economic Modeling and Valorization of Biobanks|72
3|7.1 Economic Operation of a Biobank|73
3|7.2 Challenges Affecting Valorization|75
4|7.2.1 Information Asymmetries|75
4|7.2.2 Biobank Decisions|76
5|7.2.2.1 Strategic Positioning|76
5|7.2.2.2 Conditions of Transfer|78
5|7.2.2.3 Networking|79
3|7.3 Conclusion|80
3|References|80
2|Chapter 8: Socializing Tumors: From the Conservation of Tumors in Banks to Their Ontological Variations|82
3|8.1 The Socialization of Living Organisms as a Focus of Research?|83
3|8.2 A Sociological Fieldwork on Tumor Biological Resources|83
3|8.3 The Sociotechnical Chain of Biobanking|85
4|8.3.1 Scene 1: Collection|85
5|8.3.1.1 Selecting Tumors|85
5|8.3.1.2 Collecting|86
5|8.3.1.3 Conditioning|87
5|8.3.1.4 Delivering|87
4|8.3.2 Scene 2: The Exploitation in the Hospital Laboratory|88
4|8.3.3 Scene 3: Managing Tumor Entities|89
3|8.4 Making Biological Resources: An Ontological Plurality|90
3|References|92
1|Part II: The Issues Related to Tumor Collections Valorization|94
2|Chapter 9: The Valorization of Tumor Collections: Reconciling the Interests of the Different Actors|95
3|9.1 Patients´ Rights: A Central Concern When Valorizing Collections|96
4|9.1.1 Respecting Patient Autonomy in the Medical Relationship|96
4|9.1.2 Biological Resource Centers: In Charge of the Quality and Safety of Samples and Associated Data|98
5|9.1.2.1 The Need for BRCs to Meet Biobanking Standards|99
5|9.1.2.2 Providing Biological Resources|99
3|9.2 Reconciling Individuals´ Rights with Scientific and Economic Imperatives|100
4|9.2.1 Developing a ``Market´´ in Human Biological Material and Associated Data|100
4|9.2.2 The Effectiveness of Laws Governing the Non-Commercialization of the Human Body and the Lack of Property Rights on Biolo...|103
3|References|104
2|Chapter 10: The Development of Tumor Collections: The Interest of the European Union|106
3|10.1 The Union´s Policy: A Policy That Encourages Research|108
4|10.1.1 The Competence of the Union in the Field of Research: A Specific Shared Competence|108
4|10.1.2 European Infrastructures for Research Excellence: From ERIC to BBMRI-ERIC|109
3|10.2 The Union´s Regulation with Regards to Access to Biological Samples and Data for Research Purposes|110
4|10.2.1 The Inherent Limitations in the European Research Infrastructure|111
4|10.2.2 Better European Governance as an Asset for the Development of Collections|112
3|References|116
3|Reports|117
1|Part III: The Means for Tumor Collections Valorization|118
2|Chapter 11: Academic Valorization of Biobanks|119
3|11.1 The Intrinsic Value of Collections|119
4|11.1.1 The Historical Value of Collections Held by Public Establishments|119
5|11.1.1.1 Census of Biological Collections|120
5|11.1.1.2 The Legal Framework for Existing Collections|121
4|11.1.2 The Scientific Value Added by Research|122
5|11.1.2.1 Academic Research|123
6|Cohorts and Registers|123
5|11.1.2.2 Commercial Research|124
3|11.2 Valorization of Collections|125
4|11.2.1 Academic Valorization Through Practice|125
5|11.2.1.1 Measure 1 of the ``Cancer Plan´´: Strengthen Multidisciplinary Research|125
5|11.2.1.2 The IBiSA Scientific Interest Group|126
5|11.2.1.3 Biobanking and Biomolecular Resources Research Infrastructure|126
5|11.2.1.4 Public Population Project in Genomics and Society (P3G)|127
3|11.3 Scientific Valorization Through Publications|127
4|11.3.1 Academic Credit for Bioresources|128
4|11.3.2 Citing Bioresources: The CoBRA Guidelines|129
4|11.3.3 Publishing a Bioresource: A New Type of Journal|130
3|References|130
2|Chapter 12: Commercialization Through the Use of Private Law Contracts|132
3|12.1 Introduction|132
3|12.2 The Marketability of the Object|135
4|12.2.1 A Complex Object, the Asset Nature of Which Is Discussed|135
4|12.2.2 A Complex Object, the Marketability of Which Is Limited|137
3|12.3 The Efficiency of the Chosen Legal Tool|139
4|12.3.1 The Capacities of the Parties|139
4|12.3.2 The Terms of the Contract|142
3|References|145
2|Chapter 13: The Governance Framework of North American Biobanks: A Rapidly Evolving Policy Patchwork|146
3|13.1 Introduction|146
3|13.2 Canada|147
4|13.2.1 Legal Framework|147
5|13.2.1.1 Free and Informed Consent|147
5|13.2.1.2 Free and Informed Consent in Québec Civil Law|148
5|13.2.1.3 Ethics Policies|149
4|13.2.2 Privacy|150
4|13.2.3 Fiduciary Duties|151
5|13.2.3.1 Fiduciary Relationships and the Common Law Trust|151
5|13.2.3.2 The Québec Fiducie|152
5|13.2.3.3 The Duty of Good Faith|153
4|13.2.4 Property Rights in Biospecimen|154
5|13.2.4.1 Property Rights in Biospecimens in Jurisprudence|154
5|13.2.4.2 The CCQ Rejection of Property Rights in the Human Body|155
5|13.2.4.3 Patents|156
3|13.3 The US|157
4|13.3.1 The Common Rule|158
5|13.3.1.1 Biobanking in the US|159
4|13.3.2 Legal Framework|159
5|13.3.2.1 Free and Informed Consent|159
6|Federal Legislative Framework|159
5|13.3.2.2 Jurisprudence|160
4|13.3.3 Privacy|161
5|13.3.3.1 Federal Privacy Laws|161
6|Common Rule/Final Rule|162
6|HIPAA|163
4|13.3.4 Fiduciary Duties|163
4|13.3.5 Property Rights in Biospecimens|164
5|13.3.5.1 Property Rights|164
5|13.3.5.2 Patents|165
5|13.3.5.3 Jurisprudence|166
3|13.4 Conclusion|168
4|13.4.1 Lingering Questions|168
3|References|169
2|Chapter 14: Biobank Expertise and the Research Unit-Biobank Relationship|170
3|14.1 Modeling|171
4|14.1.1 The Research Unit|171
4|14.1.2 The Biobank|172
4|14.1.3 The Project´s Social Value|172
4|14.1.4 Sharing the Project´s Value|173
3|14.2 Results|174
4|14.2.1 The Sample Tariff|174
4|14.2.2 Participation, Contracts, and Expertise|175
4|14.2.3 Effort, Contracts, and Expertise|176
4|14.2.4 What Level of Expertise?|178
3|14.3 Economic Challenges of Networking|178
3|14.4 Public Policy Recommendations|179
3|References|179
2|Chapter 15: Extra-Patrimoniality for the Patient|180
3|15.1 A Tumor Is Part of a Human Body|181
4|15.1.1 An Element of the Human Body Is Not Part of a Person´s Property|182
4|15.1.2 A Bodily Element Is Part of a Person: It Can Only Be Collected from Their Body|183
3|15.2 A Tumor Is Different from Other Elements: It Is Harmful to the Person|184
4|15.2.1 No Circulation Is Possible from Body to Body|184
4|15.2.2 A Necessary Removal|185
3|References|186
2|Chapter 16: The Moment of Patrimonialization|187
3|16.1 Introduction|187
3|16.2 The Sources of Supply|188
4|16.2.1 The Main Supply: Bodies Without Legal Personality|189
5|16.2.1.1 Surgical Residues: A Simple Absence of Opposition|189
5|16.2.1.2 Samples from Deceased Persons|191
5|16.2.1.3 Embryos|192
4|16.2.2 The Subsidiary Resource: Samples on Persons|194
5|16.2.2.1 In the Context of a ``Classical´´ Biomedical Study|194
5|16.2.2.2 In the Context of a Simplified Regime|195
3|16.3 The Rights on Elements Once the Bank Has Been Established|198
4|16.3.1 The Almost Non-existent Rights for Natural Persons|198
4|16.3.2 The Rights of the Bank on the Elements|200
3|References|204
2|Chapter 17: The Patrimonial Specificities of Public Persons|205
3|17.1 Specificities Regarding Public Property|206
4|17.1.1 An Increased Protection: The Exemption from Seizure|206
4|17.1.2 A Limited Flexibility: Non-assignment at a Low Price|207
3|17.2 The Specificities Regarding the Public Service of Biobanks|209
4|17.2.1 The Techniques of De Facto Universality and ``Administrative Fund´´ in the Service of Tumor Banks|209
4|17.2.2 The Challenges of the Biobank Public Service|211
3|References|213
2|Chapter 18: Biological Sample Collection in the Era of Genomic Medicine: A New Example of a Public Commons?|215
3|18.1 The Commons, a Theoretically Relevant Model|216
3|18.2 The Commons, Tested by Practices|220
3|References|224
1|Erratum to: Public Regulation of Tumor Banks|226
2|Erratum to: X. Bioy (ed.), Public Regulation of Tumor Banks, https://doi.org/10.1007/978-3-319-90563-1|226