ETHICAL AND LEGAL REQUIRMRNTS FOR TRANSNATIONAL GENETIC RESEARCHPDF|Epub|txt|kindle电子书版本网盘下载

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1. Introduction1

1.1. From clinical to clinico-genomic research: New ethical and legal challenges1

1.2. The ACGT project: Developing an ICT infrastructure3

1.3. Aim and structure of the book4

2. Ethical requirements7

2.1. Introduction7

2.2. Informed consent8

2.2.1. Ethical foundations of the doctrine of informed consent8

2.2.1.1. Historical background9

2.2.1.2. General aspects10

2.2.1.3. Informed consent in tissue-based research10

2.2.2. The scope of consent12

2.2.2.1. Models of consent12

2.2.2.1.1. Specified consent13

2.2.2.1.2. Broad or blanket consent for future research14

2.2.2.1.3. Tiered consent models17

2.2.2.1.4. Patients' and donors' perspectives18

2.2.2.1.5. Particularities of consent to research involving children21

2.2.2.2. Informed consent and communication25

2.2.2.2.1. Consent as a process25

2.2.2.2.2. The character of information27

2.2.2.3. Issues to be consented to29

2.2.2.3.1. General requirements30

2.2.2.3.2. Sharing data and information30

2.2.2.3.3. Re-contact31

2.2.2.3.4. Commercial interests31

2.2.2.3.5. The timeframe of consent32

2.2.2.4. The right to withdraw consent32

2.3. The right to know, the duty to inform, and the quality of feedback33

2.3.1. Access to personal information: a donor driven inquiry process34

2.3.2. Feedback of research results: an investigator driven disclosure process35

2.3.2.1. Informing about general research results36

2.3.2.1.1. Ethical foundations36

2.3.2.1.2. Practical challenges of feedback processes regarding general research results37

2.3.2.2. Information about individually relevant research results38

2.3.2.2.1. Ethical foundations39

2.3.2.2.2. What to feed back?40

2.3.2.2.3. Characteristics of genetic research results in the context of cancer trials44

2.3.2.2.4. To whom to feed back?47

2.3.2.2.5. Practical challenges of feedback processes regarding individual research results50

2.4. Summary of consolidated ethical requirements55

2.4.1. Ethical requirements56

2.4.1.1. Summary: The informed consent process56

2.4.1.2. Conclusions: How to design the informed consent process58

2.4.1.3. Summary: Donor driven inquiry processes and investigator driven individual feedback processes60

2.4.1.4. Conclusion: How to organize donor driven inquiry processes and investigator driven individual feedback processes63

2.5. Outlook: Ethical challenges in the European context64

2.5.1.1. Revision of data protection and information flows64

2.5.1.2. Community interests65

3. Legal requirements67

3.1. Introduction67

3.2. Theoretical analysis67

3.2.1. European Data Protection Directive 95/46/EC67

3.2.1.1. Genesis67

3.2.1.2. Scope of the Directive68

3.2.1.2.1. Personal data68

3.2.1.2.1.1. Anonymous data69

3.2.1.2.1.2. Pseudonymous data70

3.2.1.2.2. Territorial application70

3.2.1.3. Fair and lawful data processing70

3.2.1.3.1. General70

3.2.1.3.1.1. Requirement of a legal basis70

3.2.1.3.1.2. Technical and organisational measures71

3.2.1.3.2. Sensitive data72

3.2.1.3.2.1. Definition72

3.2.1.3.2.2. Prohibition of data processing73

3.2.1.3.2.3. Exceptions73

3.2.1.4. Duties of the data controller74

3.2.1.5. Rights of the data subject75

3.2.1.5.1. Information duties regarding data collection from the data subject75

3.2.1.5.2. Information duties regarding data which has not been obtained from the data subject76

3.2.1.5.3 Right of access77

3.2.1.5.4. Right to rectification, erasure or blocking78

3.2.1.5.5. Exemptions and restrictions79

3.2.1.5.6. Right to object79

3.2.1.6. Transfer of personal data to third countries80

3.3 Data protection within a trans-european research project - using the example of ACGT82

3.3.1. Data flows82

3.3.2. Legitimate processing of genetic data (Directive 95/46 EC)84

3.3.2.1. Genetic data84

3.3.2.1.1. Special characteristics of genetic data with regard to data protection85

3.3.2.1.2. Anonymisation of genetic data90

3.3.2.2. Relevance of the character of data processing for the distinction between personal data and anonymous data95

3.4. Data protection framework within genetic research networks101

3.4.1. Anonymisation of genetic data within research networks102

3.4.2. Necessary legal agreements, contracts and informed consents103

3.4.2.1. Contract between the Data Protection Authority and the data exporter (e.g. a hospital)105

3.4.2.1.1. Guarantee of a "state-of- the-art" pseudonymisation105

3.4.2.1.2. Technically and organisationally separated project database105

3.4.2.2. Contract between Data Protection Authority and end users106

3.4.2.2.1. Data controllers within genetic research networks106

3.4.2.2.2. Data Protection Authority as central Data Protection Authority within the research network108

3.4.2.2.3. Ensuring the context of anonymity110

3.4.2.2.4. Separated database111

3.4.2.2.5. No matching111

3.4.2.3. Second pillar and first fallback scenario: Informed Consent112

3.4.2.3.1. Regulatory framework113

3.4.2.3.1.1. Definition113

3.4.2.3.1.2. Declaration of intention113

3.4.2.3.1.3. Freely given113

3.4.2.3.1.4. For a specific case113

3.4.2.3.1.5. Informed indication114

3.4.2.3.2. Scope of the consent114

3.4.2.3.2.1. Object of the consent/purpose specification/future research114

3.4.2.3.2.2. Expected period of usage/temporal scope of the consent115

3.4.2.3.2.3. Death of the patient116

3.4.2.3.2.4. Data transfer to third parties/third countries117

3.4.2.3.3. Consent of relatives needed?117

3.4.2.3.3.1. Additional information of relatives is collected117

3.4.2.3.3.2. No additional information of relatives is collected118

3.4.2.3.4. Consent of the minor data subject or person with intellectual disabilities needed?118

3.4.2.3.5. The right to withdraw and right to erasure119

3.4.2.4. The right to know and the duty of notification120

3.4.2.5. Third Pillar and second fallback scenario: Exceptions for genetic research in national legislations122

4. Legal conclusion125

5. References127

6. Appendix 1- legal terminology137

7. Appendix 2 - relevant regulation141