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Biobank Regulation Template

The Biobank Regulationdefines 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. We thank the biobanks and Institutions which contributed to the development of this document.

Download the Biobank regulation files:

A Word format that can be adapted to your practices is available upon request: bbregulation@swissbiobanking.ch.

To date, a wide variety of biobanks exists. They can 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 uses and are established to respond to diagnostic or therapeutic needs, whereas others are established for research purposes.

A large number of samples and data should be made accessible to researchers to foster biomedical research progress in the health-care domain. This Swiss Biobanking Platform (SBP) template applies primarily to research biobanks embedded into SBP network as well as to other non-research biobanks, whose secondary purpose will be a requalification as a research biobank.

As per 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 also 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 organisation.

In Switzerland, this requirement derives from the need of protecting 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.

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