What is it? Why is it important?

The Biobank Regulation (BR) is a document describing the set-up and governance of the biobank. Its aim is to guarantee:


The biobank regulation address aspects such as:

  • Biobanking processes and inherent responsibilities (e.g. strategic, operational, administrative management, scientific committee)
  • Sustainability (e.g. funding aspects, dispositions in case of biobank dissolution)
  • Donor rights and consent procedures (e.g. further-use of Biological Material (BM), data confidentiality, withdrawal of consent procedures, BM storage guidelines)
  • Access rights (e.g. restricted to biobanking staff)
  • Quality control procedures (e.g. quality assurance, risk control-measures)

What do I need to do?

When setting up your BR document include aspects such as:

  • The purpose and scope of your biobank (e.g. research, diagnostic, therapeutic)
  • The organisation of your biobank such as:
    • The organigram of your biobank
    • Required staff roles and responsibilities
  • The nature of stored BM
  • Access rights to BM and its data
  • Donor consent and withdrawal procedures (e.g. consent regarding the further-use and/or leftover BM no longer needed in studies or for diagnostic purposes)
  • Procedures for handling enquiries and complaints (e.g. how can donors contact the biobank. How can donors be re-contact upon addressing a complaint)
  • Data confidentiality
  • The funding of the biobank


The biobank head approves and releases the BR document. If applicable, make the document available to biobanking staff and customers. Review BR on a regular basis to ensure it remains current.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

Biobank regulations

  • English

External Links

Swissethics – see in particular

  • Topics / Biobanks and data registries


Declaration of Taipei – see in particular principle

  • 21 Governance

Swiss LawDecl. Taipei

HRA – see in particular article

  • Art. 43 Storage

HRO – see in particular

  • Art. 5 Storage of biological material
  • BM – Biological Material
  • BR- Biobank Regulation
  • EC – Ethics Committee
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • SBP – Swiss Biobanking Platform
Concept ↦ Biobanking ↦ Regulatory Requirements ↦ Biobank Regulation

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Biobanking ↦ Regulatory Requirements ↦ Biobank Regulation

Please note: the Easy-GCS tool is currently under construction.