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Sinopsis
Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection.The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented.Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.
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K.-H. Schriever, University of Applied Sciences at Biberach, Germany; M. Schröder, Tembit Software GmbH, Berlin, Germany
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G3P: Good Privacy Protection Practice in Clinical Research: Principles of Pseudonymization and Anonymization
Publicado por
De Gruyter, 2014
ISBN 10: 3110367645
ISBN 13: 9783110367645
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Hardcover. Condición: Near Fine. 1st Edition. Hardcover, xii + 198 pages, NOT ex-library. A clean and bright copy with unmarked text and firm binding, free of inscriptions and stamps. Boards show mild handling wear. Issued without a dust jacket. -- Contents: 1 Introduction 2 Study Modes [Screening Mode: Pharmacogenetic Information for Screening;Pre- Unspecified Mode: Pharmacogenetic as Part of a Study; Possible Approaches, Summary: Clinical Trial with Genetic Part; Biobanks: What do we Mean by That?] 3 Protection Masks & Procedures [Identified Samples/Data; De-identified Samples/Data; Anonymized Samples/Data; Re-identification] 4 Coding Methods for De-identified Samples/Data [Single & Double & Triple-coded Samples/Data] 5 Relationships Among the Protection Masks 6 Data Types 7 Anonymization [Basic Terms & Ideas; Masking; Discarding the Key; Maintaining the Reliability of Stored Data; Security Measures] 8 Validation: A Brief Introduction [Preliminaries; Basic Definitions & Terms; General Principles of Computer System Validation; Primary Validation: Specification Phase & Preparing Operational Use & Testing Phase] 9 Request Management [Genetic Review Board (GRB); Request Specification; Subrequest Specification; Involvement of External Service Providers] 10 Legal Requirements & Regulations [Basic Ideas; Data Protection in the European Union (EU); Transfer of Personal Data to Third Countries; Binding Corporate Rules; Data Protection in the United States (U.S.): A Brief History] 11 Informed Consent [Sections Mandatory for a Genetic Informed Consent] 12 Selected Data Protection & Medical Sites [Germany; Europe; US; Global Initiatives] 13 Impact of External Services on Data Protection [Introduction; Scenario 1: Using GDI Throughout; Scenario 2: Replacing GDI by nGDI Upon Sample Registration, Performed by regCRO; Scenario 3: Replacing GDI by nGDI Upon Sample Registration, Performed by Sponsor; Scenario 4: Sample Registration by CRO, Proprietary Labeling with CROSID; Scenario 5: Barcoded Label bSID at Study Site; Overall Summary; External Statistical Evaluation; External Biobanking] 14 Practical Approach to Clinical Trials with Supplementary Genetic Parts [Introduction; Overall Project Topology; Checklist: Trial Set-up & System Topology & Sample Management & ICs, Ethics Committees Restrictions & Anonymization & Statistical Evaluation] 15 Appendix 1: Data Protection in the European Union [Council of Europe (COE); EU Privacy Directive: Definitions; Tasks of the Article 29 Data Protection Working Party] 16 Appendix 2: Data types [EU Privacy Directive (October 24,1995); Council of Europe (COE) Definition of Data Types; Federal Data Protection Act (GER) as of 1. Jan. 2003] 17 Appendix 3: Protection Masks [EMA definition of anonymous sample/data; Germany; Spain; US] 18 Appendix4: Informed Consent (IC) [Nuremberg Code; EU Privacy Directive (October 24,1995); COE: Rec No. R (97) 5, Explanatory Memorandum to Rec (97) 5; Oviedo Convention; UNESCO Universal Declaration on Bioethics & Human Rights; Key Issues in Informed Consent for Pharmacogenomics Research; International Declaration On Human Genetic Data; CIOMS: Ethical Guidelines for Biomedical Research; Human Genetic Examination Act (Genetic Diagnosis Act Gen DG)] 19 Appendix 5: Security [EU Privacy Directive (October 24,1995); Federal Data Protection Act (Germany); Council of Europe Recommendation No. R (97) 5; US: Privacy Act of 1974 (Comments from William W. Lowrance, cf. (42)); Safe Harbor Privacy Principles 2000; UN: ICCPR International Covenant on Civil & Political Rights] 20 Abbreviations 21 References; Index -- The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Nº de ref. del artículo: 005161
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G3P - Good Privacy Protection Practice in Clinical Research
Publicado por
De Gruyter, DE, 2014
ISBN 10: 3110367645
ISBN 13: 9783110367645
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Hardback. Condición: New. 1st. Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection.The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented.Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations. Nº de ref. del artículo: LU-9783110367645
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