What is it? Why is it important?

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).

What do I need to do?

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.

More

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

Where can I get help?

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HumanRes – Human Research Switzerland
  • MP – Medicinal Products
  • RO – Release Ordinance Handling of organisms in the environment
  • SECB – Swiss Expert Committee for Biosafety
  • SP-INV – Sponsor Investigator
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Gene Therapy, GMO, Pathogenic
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Gene Therapy, GMO, Pathogenic

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