What is it? Why is it important?

Switzerland has seven Ethics Committees (EC), each one responsible for their respectively assigned cantons.

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

The Swiss Association of Research Ethics Committees (named swissethics) makes up the umbrella organisation.

The aim of the EC is to:

  • Protect the interest of individuals
  • Oversee compliance with applicable ethical standards, regulatory requirements, and guidelines (e.g. ICH GCP, Swiss law)

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 are respected,
  • The risk/benefit ratio is and remains favourable during study conduct

More

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?

Prior to implementation, all human studies and research projects, must initially be approved by the Ethics Committee (e.g. in a multi-centre study several local ECs are usually involved).

Exceptions are:

  • Quality studies or research
  • Literature reviews
  • Case reports (e.g. documentation of an unusual clinical phenomenon in a single patient)
  • Research using health-related data that is
    • Anonymized
    • Collected anonymously
  • Research conducted on anonymous human samples
  • Opinion polls

As a SP-INV or Site-INV, ensure that the protection of study participants always takes priority over any scientific or financial 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: EC submission portal
  • Mission statement of swissethics
  • List of Swiss ethics committees

References

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.308 OrgO-HRA

HRA – see in particular chapters

  • Chapter 8 Authorisation, notifications and procedure
  • Chapter 9 Research ethics committees

OrgO-HRA – see in particular chapter

  • Chapter 1 Research ethics committee
Abbreviations
  • BASEC – Business Administration System for Ethics Committees
  • CTU – Clinical Trial Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IRB – Institutional Review Board
  • ISO – International Organization for Standardization
  • OrgO-HRA – Ordinance on Organisational Aspects of the Human Research Act
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Basic ↦ Ethics and Laws ↦ Authorities ↦ 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): Basic ↦ Ethics and Laws ↦ Authorities ↦ Ethics Committee

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