Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Transplantation
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
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