Guidelines on Data Protection in Medical Research Projects

The trust of patients and test subjects is an essential prerequisite for the success of medical research projects, which can only be carried out with the collection, long-term storage, and analysis of clinical data and specimens. Medical research today is predominantly networked in increasingly large research networks. Accordingly, the importance of data protection and data security continues to grow. The TMF first developed generic data protection concepts for medical research networks in 2003, coordinated them with the federal and state data protection officers, and made them available to the research community. This enabled numerous research projects to develop and coordinate their data protection concepts more quickly - also with the advice of the TMF's Data Protection Workgroup. The insights gained in the process have been incorporated into the current fundamental revision of the generic concepts. The new concept takes into account the complexity of medical research processes through a modular establishment and has also been embedded in a comprehensive guideline. The new concept was also discussed in detail with data protection experts and is recommended by the Conference of Federal and State Data Protection Commissioners as a basis for concretely developing data protection concepts for medical research projects and consortia.

K. Pommerening | J. Drepper | K. Helbing | T. Ganslandt
Leitfaden zum Datenschutz in medizinischen Forschungsprojekten
Generische Lösungen der TMF 2.0

1st edition, 240 pages, September 2014
€ 64.95 [D], ISBN: 978-3-95466-123-7

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