Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Gene Therapy, GMO, Pathogenic
What is it? Why is it important?
The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies of gene therapy, and genetically modified organisms (GMO), or pathogenic organisms.
Studies using:
- Gene therapy: are studies in which genetic information is introduced into somatic cells (somatic gene therapy)
- Genetically modified organisms: are MP studies using genetically modified organisms (e.g. as defined in the Release Ordinance (RO) on the handling of organisms in the environment)
- Pathogenic organisms: are MP studies using pathogenic organisms as defined in the RO
- Based on the study intervention, risk categories A, B, ore C apply, with A having the lowest and C the highest risk. As applicable, the same provisions and risk categorisations as defined for MP studies apply
What do I need to do?
For studies with genetically modified or pathogenic organisms, you are required to know and comply with the 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 the 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
- Swissmedic who grants authorisation of category B and C studies and provides a reply:
- Within 60 days
- After having received the opinions from SECB, FOPH, and FOEN
- For the duration of the study, but no longer than 5 years upon approval
- Category A studies are exempt from Swissmedic authorisation
More
Swissmedic grants study authorisation if the:
- SECB confirms the quality and safety of the planned product (e.g. participant safety, human health, and environment)
- FOPH and FOEN raise no objections based on the assessment of environmental data
Swissmedic, FOPH and FOEN jointly assess and issue guidelines regarding
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
References
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
Swiss Law
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 814.911 RO
ClinO – see in particular articles
- Art. 22 Definitions and categorisation of studies of gene therapy and genetically modified pathogenic organisms
- Art. 26 Procedures and deadlines EC
- Art. 27 Procedures and deadlines EC in multi-centre clinical trials
- Art. 33 Procedures and deadlines Swissmedic
- Art. 35 Special provisions