What is it? Why is it important?

Switzerland has seven Ethics Committees (EC), each one responsible for their respectively assigned cantons, with swissethics being the umbrella organisation

ECs are independent bodies made up of a group of selected individuals (e.g. clinicians (physicians, nurses), scientists, lawyers, chaplains/ethicists, patient representatives).


The aim of the EC is to:


According to swissethics, studies are only ethically justified when:

  • The dignity of study participants is respected
  • The study is of high scientific quality and integrity
  • All legal frameworks and guidelines are respected,
  • The risk-benefit ratio is and remains favourable during study conduct


Prior to implementation, all studies and research projects must be submitted to EC for approval


In the event of a multi-centre study, swissethics defines a:

  • *A Lead-EC:* assigned based on the canton from where a study application is submitted
  • *Local-EC:* are EC(s) from participating study site(s) located in cantons outside the jurisdiction of the Lead-EC


The lead EC is responsible:

  • For the review and approval of the study application dossier (e.g. includes also research project applications)
  • For the review and approval of any amendment(s) during study conduct (e.g. including research project changes)
  • To ensure that the rights, safety, and well-being of study participants are protected at all times


The Local-EC is responsible:

  • To evaluate the qualification and suitability of the study- or research site (e.g. local staff, infrastructure, participant information)

What do I need to do?

As a SP-INV, submit an application dossier for approval to the lead-EC over BASEC (i.e. the EC application portal). In the event of a multi-centre study, study relevant local ECs are also involved


Exempt form an EC submission are:

  • Quality assurance aspects
  • Literature reviews
  • Case reports (e.g. documentation of an unusual clinical phenomenon in a single patient)
  • Research using health-related data that is
    • Anonymized (e.g. processes used to ensure data is anonymized must be approved by EC). Data mining/searches that are not done on anonymous data fall under the HRA
    • Collected anonymously
  • Research conducted on anonymous human biological material
  • Opinion polls


As a SP-INV or Site-INV, ensure that the protection and safety of study participants (e.g. risk-benefit) always takes priority over any scientific or financial interest (e.g. conflict of interest)

Where can I get help?

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

External Links

swissethics - see in particular

  • BASEC: the EC submision portal
  • Mission statement of swissethics
  • List of Swiss ethics committees
  • Position papers and guidelines from swissethics

Declaration of Helsinki -  see in particular

  • Research Ethics Committees


ICH GCP E6(R2) see in particular articles

  • Art. 1.27 EC definition
  • Art. 1.31 IRB definition
  • Art. 3. IRB / EC

ISO 14155:2020 Medical devices (access liable to coast – see in particular annex

  • Annex G EC responsibilities

KOFAM (SNCTP) - see in particular

  • The categorisation of human research projects

Swiss Law

OrgO-HRA – see in particular chapter

  • Ch. 1 Research and EC

HRA – see in particular article

  • Art. 2 Scope of the law
  • Chapter 8 Authorisation, notifications and procedure
  • Chapter 9 Research ethics committees

ClinO – see in particular articles and annex

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

HRO – see in particular articles and annex

  • Art. 14-19 Ethic Committee submission, timelines and approval process including multi-centre studies and studies with radiation source
  • Annex 2 EC submission documents
  • BASEC – Business Administration System for Ethics Committees
  • CTU – Clinical Trial Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IRB – Institutional Review Board
  • ISO – International Organization for Standardization
  • KOFAM – Coordination Office for Human Research
  • OrgO-HRA – Ordinance on Organisational Aspects of the Human Research Act
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Approval ↦ Ethics Committee

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Approval ↦ Ethics Committee

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