Schriever / Schröder G3P - Good Privacy Protection Practice in Clinical Research

Principles of Pseudonymization and Anonymization
1. Auflage 2014
ISBN: 978-3-11-038159-7
Verlag: De Gruyter
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 210 Seiten

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.

Zielgruppe

All stakeholders in clincal trials and research, Data-protection

Autoren/Hrsg.

Schriever, Karl-Heinz

Schröder, Markus

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Diagnosis Related Groups (DRG), Medizinische Klassifikation, Medizinische Gutachten
• Sozialwissenschaften Politikwissenschaft Regierungspolitik Umwelt- und Gesundheitspolitik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Public Health, Gesundheitsmanagement, Gesundheitsökonomie, Gesundheitspolitik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien

Über Autor(innen)

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