What is it? Why is it important?

The Federal Human Research Act (HRA) is a Swiss law with the aim to protect the dignity, privacy, and health of human beings involved in research.


The HRA applies to research concerning human diseases, structure and function of the human body, involving:

  • Persons
  • Deceased persons
  • Embryos and foetuses
  • Biological material
  • Health-related personal data


The act is designed to:

  • Create favourable research conditions
  • Help to ensure research quality (e.g. quality assurance)
  • Ensure research transparency (e.g. publication)


A total of four ordinances are derived from the HRA:


HRA does not apply to research which involves:

  • IVF embryos in accordance with the Stem Cell Research Act (StRA)
  • Anonymised biological material
  • Health-related data collected anonymously (e.g. participant is unknown) or anonymised (e.g. upon collection data is rendered anonymised, participant can no longer be identified)

What do I need to do?

As a SP-INV and Site-INV, performing studies involving human beings, you are required to know and comply with the requirements defined in the HRA.


Read the HRA and the applicable ordinance applicable to your study:

  • Be familiar with the organisation of the various chapters and sections
  • As applicable, tag articles you are required to comply with

Where can I get help?

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

Swiss Law

HRA – see in particular articles

  • Art. 1 Purpose
  • Art. 2 Scope
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • IVF – In Vitro Fertilization
  • OrgO-HRA – Ordinance on Organisational Aspects of the Human Research Act
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • StRA – Stem Cell Research Act
Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Human Research Act

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): Basic ↦ Ethics and Laws ↦ Swiss Law ↦ Human Research Act

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