Your Easy Guide to Clinical Studies

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

For studies on transplantation the risk-categories A or C apply, with A having a low and C a high risk

 

Risk-Category A includes studies with transplatation:

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

 

Risk-Category C includes studies with transplatations:

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

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:

 

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

• The Ethics Committee (EC) who provides a reply, after acknowledgement of receipt of the formally correct application documents (application dossier) , within:
  • 30 days, for monocentric studies
  • 45 days, for multi-centre studies

 

• The Federal Office of Public Health (FOPH) who grants authorisation of risk-category C studies. The FOPH provides a reply, after acknowledgement of receipt of the formally correct application documents (approval), 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 may be done in parallel.

For category C studies submission to the second authority must be done within two years after approval of the first authority

References

HumRes: Coordination portal for human research in Switzerland

Swiss Law

ClinO – see in particular articles and annexes

• Art. 33 Procedures and deadlines FOPH
• Art. 49 Categorisation of studies of transplantation
• Art. 51 Procedures and deadlines EC
• Annex 3 Application documents to EC
• Annex 4 Application documents to Swissmedic / FOPH