What is it? Why is it important?

Initiating a study or research project that involves:

  • The collection of Biological Material (BM) from donors
  • The further-use of BM and Health-related Personal Data (HrPD) for Research

requires that biobanking procedures are in place in order to comply with requirements from the Ethics Committe (EC), applicable regulatory requirements (HRAHRO), relevant standards (ICH-GCP, ISO norms), and principles (Declaration of Helsinki and Taipei)


Ethics requirements include that:

  • Donors must consent to their BM being used for research purposes. Consent is given within the context of a specific project and/or a broader research framework called "further use"
  • Appropriate organizational measures are in place in order to protect the storage of BM and HrPD, which includes:
    • Access to required resources and technical equipment (e.g. facilities and materials, equipment maintenance)
    • Traceability and documentation of BM and applicable processing operations (e.g. BIMS)
    • The prevention of unauthorized or accidental disclosure, alteration, deletion and copying
    • Protected access to BM/HrPD (e.g. restricted to study / research staff)

What do I need to do?

Before starting your study or research project, make sure the project complies with ethics, regulatory, and applicable norms and principles.


Consider apects such as:


For the delegation of tasks and responsibilities (e.g. documented in a staff delegation-log), ensure only to recruit qualified and trained staff

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

Ethics & Legal

  • Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland

External Links

Swissethics – see in particular

  • Templates and Checklists / patient information and declaration of consent
  • Further-use of BM and HrPD / Biobanks
  • Topics / Biobanks and data registries


Declaration of Taipei – see in particular principles

  • 8 – 19 Ethical principles

Declaration of Helsinki – see in particular principles

  • 3 - 15 General principles

Swiss Law

HRA – see in particular article

  • Art. 16 Informed consent

HRO – see in particular article and chapters

  • Art. 5 Storage of health-related personal data and biological material
  • Chapter 2 Research involving measures for sampling of BM or collection of HrPD from persons
  • Chapter 3 Further use of BM and HrPD for research
  • Chapter 3, section 2. Informed consent and information
  • BM – Biological Material
  • BIMS – Biobank Information Management System or LIMS Laboratory Information Management System
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HrPD – Health-related Personal Data
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • SBP – Swiss Biobanking Platform
Set-Up ↦ Biobanking ↦ Regulatory Affairs ↦ Requirement

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
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 Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Set-Up ↦ Biobanking ↦ Regulatory Affairs ↦ Requirement

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