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

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOEN – Federal Office for the Environment
  • FOPH – Federal Office of Public Health
  • GMO – Genetically Modified Organisms
  • HRA – Human Research Act
  • KOFAM – Coordination portal for human research
  • MP – Medicinal Products
  • RO – Release Ordinance Handling of organisms in the environment
  • SECB – Swiss Expert Committee for Biosafety
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Gene Therapy, GMO, Pathogenic
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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