What is it? Why is it important?

The Ordinance on Organisational Aspects of the Human Research Act (OrgO-HRA) defines any required organisational procedures regarding:

  • The Ethics Committee (EC)
  • The Federal Office of Public Health (FOPH)

It provides information on:

  • Institutional composition (e.g. member requirements)
  • The organization of each entity (e.g. scientific secretariat, withdrawal from consent)
  • Respective tasks and duties (e.g. stakeholder coordination, decision making procedures)

In addition, the OrgO-HRA regulates data protection such as:

  • Disclosure of personal data to authorities
  • The exchange of data with foreign authorities and institutions

What do I need to do?

This ordinance mainly provides required structural information to the EC and the FOPH.

Consequently, for the planning and implementation of human studies, you do not often refer to this ordinance.

Where can I get help?

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

Swiss Law

FEDLEX – law is available online under numbers

  • 810.308 OrgO-HRA
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • OrgO-HRA – Ordinance on Organisational Aspects of the Human Research Act
Basic ↦ Ethics and Laws ↦ Organisation Ordinance ↦ Aim

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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

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 ↦ Organisation Ordinance ↦ Aim

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