What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) transplantation studies of human organs, tissues, and cells.


Study set-up and type will decide the risk-category of the study (e.g. risk-categories A, B, or C apply, with A having the lowest and C the highest risk).


Risk-Category A includes transplatation studies:

  • That are recognised as standard guidelines, prepared in accordance with internationally accepted quality criteria


Risk-Category C includes transplatation studies:

  • That are not recognised as standard, as specified under risk-category A
  • With embryonic and foetal tissues and cells

What do I need to do?

As a Sp-INV planning transplantation studies with human organs, tissues, and cells, you are required to know and comply with requirements defined in the ClinO ordinance:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study


Based on risk-category, submit your application dossier to:

  • The Ethics Committee (EC, application dossier) who grants authorisation of risk-category A, B, and C studies, and provides a reply within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies
  • The Federal Office of Public Health (FOPH, approval) who grants authorisation of risk-category B and C studies, and provides a reply:
    • Within 30 days
    • Risk-category A studies are exempt from FOPH authorisation


As the EC and FOPH coordinate their assessments, the EC submission and FOPH submission must be done in parallel.

Where can I get help?

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


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

  • Art. 33 Procedures and deadlines FOPH
  • Art. 49 Categorisation of studies of transplantation
  • Art. 51 Procedures and deadlines EC
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • KOFAM – Coordination portal for human research
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation

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 ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation

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