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.

Based on the study intervention, risk categories A or C apply, with A having the lowest and C the highest risk.

Category A studies are transplantations:

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

Category C studies are transplantations:

  • 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?

For 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:

  • EC who grants authorisation of category A, B, and C studies and provides a reply within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies
  • The FOPH who grants authorisation of category B and C studies and provides a reply:
    • Within 30 days
    • Category A studies are exempt from FOPH authorisation

EC and FOPH submission can be done in parallel as they coordinate their assessments.

Where can I get help?

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

References

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art. 33 Procedures and deadlines FOPH
  • Art. 49 Categorisation of studies of transplantation
  • Art. 51 Procedures and deadlines EC
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • KOFAM – Coordination portal for human research
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Transplantation

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