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Biobank Regulation Template

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 responsible for the management and the custodianship 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.

Beyond the legal requirements and ethical/professional standards, the Regulation promotes transparency concerning its organisation and its activities thereby enhancing public trust.

Download the Biobank regulation consultation files:

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