From U Mannheim: The necessity of broad consent and complementary regulations for the protection of personal data in biobanks

http://www.ncbi.nlm.nih.gov/pubmed/22722690

Public Health Genomics. 2012;15(5):263-71. Epub 2012 Jun 20.

The necessity of broad consent and complementary regulations for the protection of personal data in biobanks: what can we learn from the german case?

Taupitz J, Weigel J.

Source

University of Mannheim, Faculty of Law, Mannheim, Germany.

Abstract

In order to follow population-based approaches for certain causes and risks of illnesses, more and more biobanks have been set up during the last years. Here, samples and personal data of the donors are collected and saved, whereby concrete research aims, at the time of storage of the bio-probes and the related data, are mostly undetermined. Biobanks, therefore, have the character of a collection of material and data that can be used for initially undetermined research projects. Under legal aspects the question arises whether the data subjects can consent only to an already determined use of their samples and data or can consent to a general use for research. In this article, we discuss the validity of broad consent and in how far the arising deficits in data protection need to be and can be compensated. Broad consent is, in our opinion, generally legally valid. It leads, however, to an encroachment of the ruling basic principles of data protection law. The 5-pillar concept of the German Ethics Council therefore suggests additional regulations to compensate the lacks of broad consent. While other recommendations and opinions - as far as can be seen - do only describe in vague terms the conditions for statutory regulations, the opinion of the German Ethics Council comprises very concrete statements. It, therefore, might serve as a model in the international debate on privacy and biobanks. As a result of the current debate, we identify this as a paradigm shift in data protection in biobanks.