What is it? Why is it important?

Chapter 2 of the HRO regulates human research projects that sample Biological Material (BM) and collect health-related personal data (HRpD) from participants.


Project aims are to:

  • Answer a scientific question
  • Make further use for research purposes


In addition to HRO general provisions, requirements include:

  • The categorisation of the research project based on expected risks (e.g. A, B, C, with C representing the highest risk))
  • Applicable informed consent (IC) IC-procedures
  • Insurance coverage
  • EC/FOPH application and approval
  • Notification requirements (e.g. safety reporting)

What do I need to do?

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

  • Categorise the project based on expected risks and burdens (R&B), with category:
    • A having only minimal Rand B
    • B having more than minimal R and B
  • Define project IC-procedures
  • Ensure donors are adequately informed about:
    • Expected project obligations, potential safety issues, damage coverage, project results, financing
    • Their right to withhold and revoke consent at any time
  • Follow EC/FOPH authorisation procedures
  • Adhere to notification procedures regarding:

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

SOPs, Forms and Templates – see in particular

  • Biological material management SOP

Ethical / Legal

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

Swiss Law

HRO– see in particular chapter, articles, section

  • Chapter 2 Research Involving Measures for Sampling of Biological Material or Collection of Health-Related Personal Data from Persons
  • Art. 6 Research project purpose
  • Art. 7 Categorisation
  • Art. 8 Information and rights
  • Art. 10 Consequences of revocation of consent
  • Art. 13 Coverage
  • Section 2 Authorisation procedures
  • Section 3 Notification and reporting
  • BB – Biobank
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRO - Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • R&B – Risks & Burdens
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
Basic ↦ Biobanking ↦ The Swiss Law ↦ Research with 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 ↦ Research with Biological Material

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