What is it? Why is it important?

The Human Research Act (HRA) regulates through its Human Research Ordinance (HRO):

  • The implementation of research projects that collect Biological Material (BM) and Health-related Personal Data (HrPD) from donors to (HRO, Chapter 2):
    • Answer a scientific question
    • Make further-use for research purposes
  • The handling of already collected BM and HRpD for further-use in research (HRO, Chapter 3)


General provisions are included to ensure the:

  • Scientific quality and integrity of the project, which provides confidence in research results
  • Qualification and training of researchers
  • Adherence to EC/FOPH authorisation and notification procedures
  • Implementation of data protection laws

What do I need to do?

As a project leader you are responsible for:

  • Conducting a research project in Switzerland
  • Protecting participants at the research site
  • Organising the research project (e.g. initiation, management, EC approval, financing). An alternative SP-INV can take on this responsibility
  • The ongoing professional qualification and training of all research staff involved
  • The correct handling and storage of BM and HrPD (e.g. infrastructure, access, documentation)


Whether you plan a research project with BM/HRpD or you want to make further-use of already collected BM/HrPD, make yourself familiar with the respective requirements provided by the law.

Where can I get help?

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

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

Ethical / Legal

  • Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland

Swiss Law

HRO – see in particular articles and chapters

  • Art. 1 Purpose
  • Art. 2 Applicable provisions
  • Art. 3 Project leader responsibilities
  • Art. 4 Professional qualifications
  • Art. 5 Storage of health-related personal data and biological material
  • Chapter 2 Research Involving Measures for Sampling of Biological Material or Collection of Health-Related Personal Data from Persons
  • Chapter 3 Further Use of Biological Material and Health-related Personal Data for Research
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO - Human Research Ordinance
  • HrPD – Health-Related Personal Data
  • SBP – Swiss Biobanking Platform
  • SP-INV – Sponsor-Investigator
Basic ↦ Biobanking ↦ The Swiss Law ↦ Human Research Ordinance

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 ↦ Biobanking ↦ The Swiss Law ↦ Human Research Ordinance

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