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.
