ENGLISH

G3P - Good Privacy Protection Practice in Clinical Research: Principles of Pseudonymization and Anonymization

By Karl-Heinz Schriever; Markus Schröder

Book information

Publisher
de Gruyter
Year
2014
ISBN
9783110283280, 9783110367645, 9783110554366
DOI
10.1515/9783110283280
Language
english
Format
EPUB
Filesize
2 MB (1941402 bytes)
Pages
210\0
Library
degruyter.com
Time added
2023-07-26 01:02:22

Description

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. Practical guide, providing the required high degree of data protection Systematic approach to data protection in clinical research. Technical requirements of data protection (pseudonymization and anonymization)

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