The Resource Ethical and legal requirements of transnational genetic research, by Nikolaus Forgó ... [et al.]

Ethical and legal requirements of transnational genetic research, by Nikolaus Forgó ... [et al.]

Label
Ethical and legal requirements of transnational genetic research
Title
Ethical and legal requirements of transnational genetic research
Statement of responsibility
by Nikolaus Forgó ... [et al.]
Contributor
Subject
Language
eng
Cataloging source
BTCTA
Index
no index present
LC call number
K3611.I5
LC item number
E84 2010
Literary form
non fiction
Nature of contents
  • bibliography
  • legislation
http://library.link/vocab/relatedWorkOrContributorName
Forgó, Nikolaus
http://library.link/vocab/subjectName
  • Informed consent (Medical law)
  • Human experimentation in medicine
  • Genomics
Label
Ethical and legal requirements of transnational genetic research, by Nikolaus Forgó ... [et al.]
Instantiates
Publication
Bibliography note
Includes bibliographical references
Contents
  • Aim and structure of the book
  • Community interests
  • 3.
  • Legal requirements
  • 3.1.
  • Introduction
  • 3.2.
  • Theoretical analysis
  • 3.2.1.
  • European Data Protection Directive 95/46/EC
  • 3.2.1.1.
  • 2.
  • Genesis
  • 3.2.1.2.
  • Scope of the Directive
  • 3.2.1.2.1.
  • Personal data
  • 3.2.1.2.1.1.
  • Anonymous data
  • 3.2.1.2.1.2.
  • Pseudonymous data
  • 3.2.1.2.2.
  • Ethical requirements
  • Territorial application
  • 3.2.1.3.
  • Fair and lawful data processing
  • 3.2.1.3.1.
  • General
  • 3.2.1.3.1.1.
  • Requirement of a legal basis
  • 3.2.1.3.1.2.
  • Technical and organisational measures
  • 3.2.1.3.2.
  • 2.1.
  • Sensitive data
  • 3.2.1.3.2.1.
  • Definition
  • 3.2.1.3.2.2.
  • Prohibition of data processing
  • 3.2.1.3.2.3.
  • Exceptions
  • 3.2.1.4.
  • Duties of the data controller
  • 3.2.1.5.
  • Introduction
  • Rights of the data subject
  • 3.2.1.5.1.
  • Information duties regarding data collection from the data subject
  • 3.2.1.5.2.
  • Information duties regarding data which has not been obtained from the data subject
  • 3.2.1.5.3.
  • Right of access
  • 3.2.1.5.4.
  • Right to rectification, erasure or blocking
  • 3.2.1.5.5.
  • 2.2.
  • Exemptions and restrictions
  • 3.2.1.5.6.
  • Right to object
  • 3.2.1.6.
  • Transfer of personal data to third countries
  • 3.3.
  • Data protection within a trans-european research project - using the example of ACGT
  • 3.3.1.
  • Data flows
  • 3.3.2.
  • Informed consent
  • Legitimate processing of genetic data (Directive 95/46 EC)
  • 3.3.2.1.
  • Genetic data
  • 3.3.2.1.1.
  • Special characteristics of genetic data with regard to data protection
  • 3.3.2.1.2.
  • Anonymisation of genetic data
  • 3.3.2.2.
  • Relevance of the character of data processing for the distinction between personal data and anonymous data
  • 3.4.
  • 2.2.1.
  • Data protection framework within genetic research networks
  • 3.4.1.
  • Anonymisation of genetic data within research networks
  • 3.4.2.
  • Necessary legal agreements, contracts and informed consents
  • 3.4.2.1.
  • Contract between the Data Protection Authority and the data exporter (e.g. a hospital)
  • 3.4.2.1.1.
  • Guarantee of a "state-of- the-art" pseudonymisation
  • 3.4.2.1.2.
  • Ethical foundations of the doctrine of informed consent
  • Technically and organisationally separated project database
  • 3.4.2.2.
  • Contract between Data Protection Authority and end users
  • 3.4.2.2.1.
  • Data controllers within genetic research networks
  • 3.4.2.2.2.
  • Data Protection Authority as central Data Protection Authority within the research network
  • 3.4.2.2.3.
  • Ensuring the context of anonymity
  • 3.4.2.2.4.
  • 2.2.1.1.
  • Separated database
  • 3.4.2.2.5.
  • No matching
  • 3.4.2.3.
  • Second pillar and first fallback scenario: Informed Consent
  • 3.4.2.3.1.
  • Regulatory framework
  • 3.4.2.3.1.1.
  • Definition
  • 3.4.2.3.1.2.
  • Machine generated contents note:
  • Historical background
  • Declaration of intention
  • 3.4.2.3.1.3.
  • Freely given
  • 3.4.2.3.1.4.
  • For a specific case
  • 3.4.2.3.1.5.
  • Informed indication
  • 3.4.2.3.2.
  • Scope of the consent
  • 3.4.2.3.2.1.
  • 2.2.1.2.
  • Object of the consent/purpose specification/future research
  • 3.4.2.3.2.2.
  • Expected period of usage/temporal scope of the consent
  • 3.4.2.3.2.3.
  • Death of the patient
  • 3.4.2.3.2.4.
  • Data transfer to third parties/third countries
  • 3.4.2.3.3.
  • Consent of relatives needed?
  • 3.4.2.3.3.1.
  • General aspects
  • Additional information of relatives is collected
  • 3.4.2.3.3.2.
  • No additional information of relatives is collected
  • 3.4.2.3.4.
  • Consent of the minor data subject or person with intellectual disabilities needed?
  • 3.4.2.3.5.
  • right to withdraw and right to erasure
  • 3.4.2.4.
  • right to know and the duty of notification
  • 3.4.2.5.
  • 2.2.1.3.
  • Third Pillar and second fallback scenario: Exceptions for genetic research in national legislations
  • 4.
  • Legal conclusion
  • 5.
  • References
  • 6.
  • Appendix 1- legal terminology
  • Informed consent in tissue-based research
  • 2.2.2.
  • scope of consent
  • 2.2.2.1.
  • Models of consent
  • 2.2.2.1.1.
  • 1.
  • Specified consent
  • 2.2.2.1.2.
  • Broad or blanket consent for future research
  • 2.2.2.1.3.
  • Tiered consent models
  • 2.2.2.1.4.
  • Patients' and donors' perspectives
  • 2.2.2.1.5.
  • Particularities of consent to research involving children
  • 2.2.2.2.
  • Introduction
  • Informed consent and communication
  • 2.2.2.2.1.
  • Consent as a process
  • 2.2.2.2.2.
  • character of information
  • 2.2.2.3.
  • Issues to be consented to
  • 2.2.2.3.1.
  • General requirements
  • 2.2.2.3.2.
  • 1.1.
  • Sharing data and information
  • 2.2.2.3.3.
  • Re-contact
  • 2.2.2.3.4.
  • Commerical interests
  • 2.2.2.3.5.
  • timeframe of consent
  • 2.2.2.4.
  • right to withdraw consent
  • 2.3.
  • From clinical to clinico-genomic research: New ethical and legal challenges
  • right to know, the duty to inform, and the quality of feedback
  • 2.3.1.
  • Access to personal information: a donor driven inquiry process
  • 2.3.2.
  • Feedback of research results: an investigator driven disclosure process
  • 2.3.2.1.
  • Informing about general research results
  • 2.3.2.1.1.
  • Ethical foundations
  • 2.3.2.1.2.
  • 1.2.
  • Practical challenges of feedback processes regarding general research results
  • 2.3.2.2.
  • Information about individually relevant research results
  • 2.3.2.2.1.
  • Ethical foundations
  • 2.3.2.2.2.
  • What to feed back?
  • 2.3.2.2.3.
  • Characteristics of genetic research results in the context of cancer trials
  • 2.3.2.2.4.
  • ACGT project: Developing an ICT infrastructure
  • To whom to feed back?
  • 2.3.2.2.5.
  • Practical challenges of feedback processes regarding individual research results
  • 2.4.
  • Summary of consolidated ethical requirements
  • 2.4.1.
  • Ethical requirements
  • 2.4.1.1.
  • Summary: The informed consent process
  • 2.4.1.2.
  • 1.3.
  • Conclusions: How to design the informed consent process
  • 2.4.1.3.
  • Summary: Donor driven inquiry processes and investigator driven individual feedback processes
  • 2.4.1.4.
  • Conclusion: How to organize donor driven inquiry processes and investigator driven individual feedback processes
  • 2.5.
  • Outlook: Ethical challenges in the European context
  • 2.5.1.1.
  • Revision of data protection and information flows
  • 2.5.1.2.
Dimensions
25 cm.
Extent
ix, 141 p.
Isbn
9781849461283
System control number
  • (CaMWU)u2153206-01umb_inst
  • 2272141
  • (Sirsi) i9781849461283
  • (OCoLC)668189940
Label
Ethical and legal requirements of transnational genetic research, by Nikolaus Forgó ... [et al.]
Publication
Bibliography note
Includes bibliographical references
Contents
  • Aim and structure of the book
  • Community interests
  • 3.
  • Legal requirements
  • 3.1.
  • Introduction
  • 3.2.
  • Theoretical analysis
  • 3.2.1.
  • European Data Protection Directive 95/46/EC
  • 3.2.1.1.
  • 2.
  • Genesis
  • 3.2.1.2.
  • Scope of the Directive
  • 3.2.1.2.1.
  • Personal data
  • 3.2.1.2.1.1.
  • Anonymous data
  • 3.2.1.2.1.2.
  • Pseudonymous data
  • 3.2.1.2.2.
  • Ethical requirements
  • Territorial application
  • 3.2.1.3.
  • Fair and lawful data processing
  • 3.2.1.3.1.
  • General
  • 3.2.1.3.1.1.
  • Requirement of a legal basis
  • 3.2.1.3.1.2.
  • Technical and organisational measures
  • 3.2.1.3.2.
  • 2.1.
  • Sensitive data
  • 3.2.1.3.2.1.
  • Definition
  • 3.2.1.3.2.2.
  • Prohibition of data processing
  • 3.2.1.3.2.3.
  • Exceptions
  • 3.2.1.4.
  • Duties of the data controller
  • 3.2.1.5.
  • Introduction
  • Rights of the data subject
  • 3.2.1.5.1.
  • Information duties regarding data collection from the data subject
  • 3.2.1.5.2.
  • Information duties regarding data which has not been obtained from the data subject
  • 3.2.1.5.3.
  • Right of access
  • 3.2.1.5.4.
  • Right to rectification, erasure or blocking
  • 3.2.1.5.5.
  • 2.2.
  • Exemptions and restrictions
  • 3.2.1.5.6.
  • Right to object
  • 3.2.1.6.
  • Transfer of personal data to third countries
  • 3.3.
  • Data protection within a trans-european research project - using the example of ACGT
  • 3.3.1.
  • Data flows
  • 3.3.2.
  • Informed consent
  • Legitimate processing of genetic data (Directive 95/46 EC)
  • 3.3.2.1.
  • Genetic data
  • 3.3.2.1.1.
  • Special characteristics of genetic data with regard to data protection
  • 3.3.2.1.2.
  • Anonymisation of genetic data
  • 3.3.2.2.
  • Relevance of the character of data processing for the distinction between personal data and anonymous data
  • 3.4.
  • 2.2.1.
  • Data protection framework within genetic research networks
  • 3.4.1.
  • Anonymisation of genetic data within research networks
  • 3.4.2.
  • Necessary legal agreements, contracts and informed consents
  • 3.4.2.1.
  • Contract between the Data Protection Authority and the data exporter (e.g. a hospital)
  • 3.4.2.1.1.
  • Guarantee of a "state-of- the-art" pseudonymisation
  • 3.4.2.1.2.
  • Ethical foundations of the doctrine of informed consent
  • Technically and organisationally separated project database
  • 3.4.2.2.
  • Contract between Data Protection Authority and end users
  • 3.4.2.2.1.
  • Data controllers within genetic research networks
  • 3.4.2.2.2.
  • Data Protection Authority as central Data Protection Authority within the research network
  • 3.4.2.2.3.
  • Ensuring the context of anonymity
  • 3.4.2.2.4.
  • 2.2.1.1.
  • Separated database
  • 3.4.2.2.5.
  • No matching
  • 3.4.2.3.
  • Second pillar and first fallback scenario: Informed Consent
  • 3.4.2.3.1.
  • Regulatory framework
  • 3.4.2.3.1.1.
  • Definition
  • 3.4.2.3.1.2.
  • Machine generated contents note:
  • Historical background
  • Declaration of intention
  • 3.4.2.3.1.3.
  • Freely given
  • 3.4.2.3.1.4.
  • For a specific case
  • 3.4.2.3.1.5.
  • Informed indication
  • 3.4.2.3.2.
  • Scope of the consent
  • 3.4.2.3.2.1.
  • 2.2.1.2.
  • Object of the consent/purpose specification/future research
  • 3.4.2.3.2.2.
  • Expected period of usage/temporal scope of the consent
  • 3.4.2.3.2.3.
  • Death of the patient
  • 3.4.2.3.2.4.
  • Data transfer to third parties/third countries
  • 3.4.2.3.3.
  • Consent of relatives needed?
  • 3.4.2.3.3.1.
  • General aspects
  • Additional information of relatives is collected
  • 3.4.2.3.3.2.
  • No additional information of relatives is collected
  • 3.4.2.3.4.
  • Consent of the minor data subject or person with intellectual disabilities needed?
  • 3.4.2.3.5.
  • right to withdraw and right to erasure
  • 3.4.2.4.
  • right to know and the duty of notification
  • 3.4.2.5.
  • 2.2.1.3.
  • Third Pillar and second fallback scenario: Exceptions for genetic research in national legislations
  • 4.
  • Legal conclusion
  • 5.
  • References
  • 6.
  • Appendix 1- legal terminology
  • Informed consent in tissue-based research
  • 2.2.2.
  • scope of consent
  • 2.2.2.1.
  • Models of consent
  • 2.2.2.1.1.
  • 1.
  • Specified consent
  • 2.2.2.1.2.
  • Broad or blanket consent for future research
  • 2.2.2.1.3.
  • Tiered consent models
  • 2.2.2.1.4.
  • Patients' and donors' perspectives
  • 2.2.2.1.5.
  • Particularities of consent to research involving children
  • 2.2.2.2.
  • Introduction
  • Informed consent and communication
  • 2.2.2.2.1.
  • Consent as a process
  • 2.2.2.2.2.
  • character of information
  • 2.2.2.3.
  • Issues to be consented to
  • 2.2.2.3.1.
  • General requirements
  • 2.2.2.3.2.
  • 1.1.
  • Sharing data and information
  • 2.2.2.3.3.
  • Re-contact
  • 2.2.2.3.4.
  • Commerical interests
  • 2.2.2.3.5.
  • timeframe of consent
  • 2.2.2.4.
  • right to withdraw consent
  • 2.3.
  • From clinical to clinico-genomic research: New ethical and legal challenges
  • right to know, the duty to inform, and the quality of feedback
  • 2.3.1.
  • Access to personal information: a donor driven inquiry process
  • 2.3.2.
  • Feedback of research results: an investigator driven disclosure process
  • 2.3.2.1.
  • Informing about general research results
  • 2.3.2.1.1.
  • Ethical foundations
  • 2.3.2.1.2.
  • 1.2.
  • Practical challenges of feedback processes regarding general research results
  • 2.3.2.2.
  • Information about individually relevant research results
  • 2.3.2.2.1.
  • Ethical foundations
  • 2.3.2.2.2.
  • What to feed back?
  • 2.3.2.2.3.
  • Characteristics of genetic research results in the context of cancer trials
  • 2.3.2.2.4.
  • ACGT project: Developing an ICT infrastructure
  • To whom to feed back?
  • 2.3.2.2.5.
  • Practical challenges of feedback processes regarding individual research results
  • 2.4.
  • Summary of consolidated ethical requirements
  • 2.4.1.
  • Ethical requirements
  • 2.4.1.1.
  • Summary: The informed consent process
  • 2.4.1.2.
  • 1.3.
  • Conclusions: How to design the informed consent process
  • 2.4.1.3.
  • Summary: Donor driven inquiry processes and investigator driven individual feedback processes
  • 2.4.1.4.
  • Conclusion: How to organize donor driven inquiry processes and investigator driven individual feedback processes
  • 2.5.
  • Outlook: Ethical challenges in the European context
  • 2.5.1.1.
  • Revision of data protection and information flows
  • 2.5.1.2.
Dimensions
25 cm.
Extent
ix, 141 p.
Isbn
9781849461283
System control number
  • (CaMWU)u2153206-01umb_inst
  • 2272141
  • (Sirsi) i9781849461283
  • (OCoLC)668189940

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