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The Biobank Regulation defines the biobank purpose, activities, organisation and reflects its daily practices. Beyond the compliance with legal requirements and ethical/professional standards, the Regulation promotes transparency, and thus public trust towards research.
This document has been developed by SBP with the expertise of its Governance Advisory Board members and was submitted to public consultation in Spring 2018. Since November 2019, Swissethics has endorsed SBP Regulation Template which is now also available on their website.
Download the editable Biobank Regulation Template (version: November 2019):
To date, a wide variety of biobanks exists. They differ in their purpose, size, funding sources, nature of their activities, as well as by the types of biological samples and data collected. Some biobanks are intended exclusively for clinical use and are established to respond to diagnostic or therapeutic needs, whereas others have been set up for research purposes.
A large number of samples and data should be made accessible to researchers to foster biomedical research progress. This template applies primarily to research biobanks embedded into the SBP network as well as to other non-research biobanks, whose secondary purpose will be a requalification as a research biobank.
As defined by SBP, « a biobank is an organized entity with a governance in place, responsible for the management of biological resources ». Likewise, biological resources include biological material and its associated data. Associated data stands for personal data, including health-related data, and preanalytical data.
In compliance with international standards, any biobank managing human samples must have a Biobank Regulation that defines its purpose, operational processes, and organization.
In Switzerland, this requirement derives from the need to protect the fundamental rights of participants, in particular, their personal freedom (art. 10 Cst) and privacy (art. 13 Cst), as well as their personality rights (art. 28ss CC). Furthermore, provisions related to research involving human beings (refer notably to art. 118b Cst, art. 43 HRA and art. 5 HRO) and to data protection strongly support the elaboration of such a document.