What is it? Why is it important?

The main responsibility of the Ethics Committee (EC) is to protect the rights, safety and well-being of study participants. Several ECs exist in Switzerland. Swissethics is the umbrella organisation.

All human studies need EC approval prior to implementation.

Exceptions are projects using anonymised biological material, or anonymously collected or anonymised health related data.

Still:

  • Anonymization procedures must be defined and approved by EC
  • Even though no EC approval is required, a declaration of no objection from EC can be helpful for publication

More

Studies must be categorised (A, B, C) prior to EC submission.

  • The category will decide which documents to submit to the EC for evaluation and approval.
  • The SP-INV makes an initial categorisation.
  • The EC has the final decision on how the study should be categorised.
  • Instructions on how to classify a study can be found on the KOFAM Website.

What do I need to do?

Submit to the EC as soon as study required documents are finalised.

Documents to be submitted depend on the study:

  • Ordinance: Clinical Trial (ClinO) or Research Project (HRO)
  • Type: medicinal or transplant products, medical device, other interventions, studies including radiation, etc.
  • Category: A, B, C
  • Involved sites: mono-or multicentre

Applicable websites:

  • KOFAM: tool to categorize your study
  • BASEC: EC submission portal

For more information refer to Ethics and Laws in this Study Guide.

More

List of required documents to be submitted to the EC can be found in the Annex of the respective law applicable to your study (ClinO, HRO). Always use currently released templates from swissethics.

For submission on the BASEC portal, you need to:

  • Create a personal login
  • Upload all documents needed for the EC to evaluate your application.

In the event of a multicentre study:

  • The EC to whom SP-INV site is affiliated becomes the lead EC.
  • The SP-INV submits through BASEC study documents for all study sites
  • Competent ECs from participating sites can access study documents through BASEC.

EC evaluates the study and can:

  • Approve the study as submitted without further adaptations
  • Only approve the study based on required adaptations, (e.g. additional information, changes to documents
  • Not approve the study

Where can I get help?

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

External Links

  • Instruction for EC submission are to be found on the swissethics homepage: www.swissethics.ch
  • KOFAM: FOPH portal for human research – in particular see the KOFAM categorizer – assists in the categorisation of human research projects
  • BASEC: submission portal to the EC.
  • Application documents to be submitted to the EC for study approval are listed in the law:
  • HRO Annex 2
  • ClinO Annex 3

Swiss Law

OrgO-HRA – see in particular article

  • Ch. 1. Research and EC

HRA – see in particular article

  • Art. 2. Scope of the law

ClinO – see in particular articles

  • Art. 24-29 Ethic Committee submission, timelines and approval process including multicentre studies and studies with tadiation source
  • Annex 3 Submission documents

HRO – see in particular articles

  • Art. 14-19 Ethic Committee submission, timelines and approval process including multicentre studies and studies with tadiation source
  • Annex 2 Submission documents
Abbreviations
  • BASEC - Business Administration System for Ethics CommitteesClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • KOFAM – Koordinationsstelle
  • Forschung am Menschen
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Approval ↦ Ethics Committee
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): Development ↦ Management ↦ Study Approval ↦ Ethics Committee

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