What is it? Why is it important?

Chapter 3 of the HRO regulates research related to the further use of already collected:

  • Biological Material (BM)
  • Health-related Personal Data (HrPD)


Regulations apply to:

  • BM/HRpD handling, such as:
    • Procuring, merging or collecting
    • Registration or cataloguing
    • Biobanking (storage of BM)
    • Documentation (project database)
    • Accessibility and sharing
  • BM/HrPD anonymisation and coding procedures, including conditions for breaking the code
  • Informed Consent (IC) procedures:
    • Genetic versus non-genetic data
    • Research in the absence of IC
  • EC application and approval requirements
  • Notification requirements (e.g. changes, project completion or discontinuation)

What do I need to do?

In addition to the general HRO responsibilities, project leader responsibilities include to:

  • Implement IC procedures based on whether:
    • BM/HrPD data is kept un-coded, coded or anonymised
    • HrPD data contain genetic information
  • Keep participant identification-log or codes access protected (e.g. allows for participant identification)
  • Follow EC approved anonymisation procedures
  • Adequately inform project participant about:
    • The nature, purpose and duration of the project
    • The measures taken to protect BM/HrPD
    • Their right to receive information including results concerning their health
    • Their right to withhold and revoke consent at any time


Ensure correct anonymisation procedures (e.g. deletion of participant name, DOB, address, identifier code). Planned anonymisation procedures must be documented and require EC approval prior to implementation. Donors of BM can opt-out from anonymisation, as essential health information might become known (e.g. incidental findings)

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 Regulation

Ethical / Legal

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

Swiss Law

HRO – see in particular chapter, articles, sections

  • Chapter 3: Further Use of Biological Material and Health-related Personal Data for Research
  • Art. 5 Storage of health-related personal data and biological material
  • Art. 24 Definition of further use
  • Art. 25-27 Anonymisation, coding, breaking the code
  • Section 2 IC procedures
  • Section 3 Authorisation and notification requirements
  • Section 4 Authorisation and notification requirements with absence of IC
  • BB – Biobank
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DOB – Date of Birth
  • EC – Ethics Committee
  • HrPD – Health-Related Personal Data
  • HRO - Human Research Ordinance
  • IC – Informed Consent Form
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ The Swiss Law ↦ Further Use of Biological Material

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): Basic ↦ Biobanking ↦ The Swiss Law ↦ Further Use of Biological Material

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