G3P - Good Privacy Protection Practice in Clinical Research

Markus Schröder

ISBN 10: 3110367645 / ISBN 13: 9783110367645

Verlag: De Gruyter, Mercury Learning And Information Sep 2014, 2014

Beschreibung

This item is printed on demand - it takes 3-4 days longer - Neuware -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. 210 pp. Englisch.

Bestandsnummer des Verkäufers 9783110367645

Bibliografische Details

• Titel: G3P - Good Privacy Protection Practice in Clinical Research
• Verlag: De Gruyter, Mercury Learning And Information Sep 2014
• Erscheinungsjahr: 2014
• Sprache: Englisch
• ISBN-10: 3110367645
• ISBN-13: 9783110367645
• Einband: Buch
• Zustand: Neu
• Abmessungen: 246B x 175 H x 18 T Millimeter Breite: 246 mm, Höhe: 175 mm, Tiefe: 18 mm
• Gewicht: 544 Gramm

Über diesen Titel

Inhaltsangabe

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.

Über die Autorin bzw. den Autor

K.-H. Schriever, University of Applied Sciences at Biberach, Germany; M. Schröder, Tembit Software GmbH, Berlin, Germany