Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Gene Therapy, GMO, Pathogenic
Was betrifft es? Warum ist das wichtig?
The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies of gene therapy of genetically modified organisms, 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 studies with Medcinal Product (MP) containing genetically modified organisms (i.e. as defined in the Release Ordinance (RO) on the handling of genetically modified and pathogenetic organisms in the environment). This includes in particular replication-competent viruses.
- Pathogenic organisms: are MP studies using pathogenic organisms as defined in the RO
The same provisions and risk-categories as defined for studies with Medicinal Product apply (see Medicinal Product studies). Consequently, studies with transplant products are divided into three risk categories (e.g. risk-categories A, B, or C apply, with A having the lowest and C the highest risk).
Was muss ich befolgen?
As a SP-INV planning studies with gene therapy, genetically modified or pathogenic organisms, you are required to know and comply with the requirements defined in the ClinO ordinance:
Based on the risk-category of your study, submit your application dossier to:
- The Ethics Committee (EC) who grants authorisation of risk-category A, B, and C studies. EC provides, after the acknowledgement of receipt of the formally correct application documents (application dossier) , a reply within:
- 30 days, for monocentric studies
- 45 days, for multi-centre studies
- The Swissmedic who grants authorisation of risk-category B and C studies. Swissmedic provides, after the acknowledgement of receipt of the formally correct application documents (application dossier) , a reply within:
- Within 60 days
- After having received the opinions from SECB, FOPH, and FOEN
- Risk-category A studies are exempt from Swissmedic authorisation
Submission to Swissmedic (submission) and EC (submission) may be done in parallel. Submission to the second authority must be done within two years after approval of the first authority.
Mehr
Swissmedic grants study authorisation if the:
- Swiss Expert Committee for Biosafety (SECB) confirms the quality and safety of the planned product (e.g. participant safety, human health, and environment)
- Federal Office of Public Health (FOPH) and Federal Office for the Environment (FOEN) raise no objections based on the assessment of environmental data
Swissmedic, FOPH and FOEN jointly assess and issue guidelines regarding
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
HumRes: Coordination portal for human research in Switzerland
RO - see in particular
- Art. 3 Definitions
FOEN – Federal Office for the Environment
SECB – Swiss Expert Committee for Biosafety
Swiss Law
ClinO – see in particular articles and annexes
- 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
- Annex 3 Application documents to EC
- Annex 4 Application documents to Swissmedic / FOPH