What is it? Why is it important?

The Federal Human Research Act (HRA) is the Swiss law aimed at protecting 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, which involves:

  • 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
  • Ensure research transparency

A total of four ordinances are derived from the HRA:

  • ClinO
  • ClinO-MD
  • HRO
  • OrgO-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?

When performing studies involving human beings, you are required to know and comply with the requirements defined in the HRA act.

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 relevant articles that need to be complied with in your study

Where can I get help?

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO
  • 810.308 OrgO-HRA
  • 810.31 StRA

HRA – see in particular articles

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

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