What is it? Why is it important?

Prior to implementation and according to the HRA law, human studies and research projects require initial approval from the Ethics Committee (EC).

The implementation of clinical studies are defined in the:

  • ClinO ordinance for Medicinal Product (Drug) studies
  • ClinO-MD ordinance for Medical Device studies

The implementation of research projects is defined in the HRO ordinance. Research projects involve:

  • The sampling of biological material (BM) or collection of health-related personal data (HRpD)
  • The further use of BM and HRpD

What do I need to do?

Familiarise yourself with:

  • Regulatory requirements that must be met in order to receive EC approval
  • How to create an EC submission dossier of your study

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – see in particular

  • Home / Mission statement
  • Topics

References

SAMS Manual on Research with human subjects – see in particular chapter

  • Chapter 7 Independent review by EC

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.301 HRO
  • 810.305 ClinO
  • 810.306 ClinO-MD

HRA – see in particular articles

  • Art. 47 Responsible EC
  • Art. 48 Official measures

ClinO – see in particular articles

  • Art. 24 Application
  • Art. 25 Review areas

ClinO-MD – see in particular articles

  • Art. 10 Application
  • Art. 11 Review areas

HRO – see in particular articles

  • Art. 14 Application
  • Art. 15 Review areas
  • Art. 34 Review areas for project involving further use of data or biological material
  • Art. 37 Review areas for project involving further use of data or biological material in the absence of IC
  • Art. 41 Review areas for project involving deceased persons
  • Art. 45 Review areas for project involving embryos and foetuses
Abbreviations
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research with the Exception of Clinical Trial
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
Concept ↦ Ethics and Laws ↦ Study Planning ↦ Ethics Requirements
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): Concept ↦ Ethics and Laws ↦ Study Planning ↦ Ethics Requirements

Please note: the Easy-GCS tool is currently under construction.