What is it? Why is it important?

Chapter 2 of the HRO ordinance regulates human research projects that prospectively sample or collect Biological Material (BM) and collect Health-Related personal Data (HRpD) from participants. Project aims are to:

  • Answer a scientific question
  • Make the data/samples available for reuse at some later date in order to answer research questions


In addition to general provisions, the HRO includes:

What do I need to do?

In addition to general HRA responsibilities, the project leader of a chapter 2 HRO project must:

  • Categorise the project based on expected risks and burdens (R&B), with category:
    • A – having only minimal R&B
    • B – having more than minimal R&B
  • Provide insurance coverage for category B projects
  • Set-up a database which guarantees data quality (e.g. traceability) and data confidentiality (e.g. data protection act)
  • Take measures to protect data (e.g. coding of research data, access control, secure storage, secure data exchange)
  • Define IC procedures (e.g. participant information (e.g. PIS) and recruitment)
  • Ensure participants are adequately informed about the planned research project regarding:
    • Expected obligations, potential safety issues, damage coverage, project results, financing
    • Their right to withhold and revoke consent (regarding study participation) at any time
  • Report the completion or discontinuation of a research project to EC within 90 days


Ensure to adhere to notification procedures, such as:


Multi-centre projects:

  • Ensure appropriate agreements are in place between project leader and participating site(s), such as data / sample sharing agreements – DTA / MTA).

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Research projects with persons


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

HRO – see in particular articles and chapters / sections

  • Art. 6 Research project purpose
  • Art. 7 Categorisation and definition of minimal risks and burdens
  • Chapter 2, section 2. Authorisation procedures
  • Chapter 2, section 3. Notification and reporting
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DTA – Data Transfer Agreement
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
  • MTA – Material Transfer Agreements
  • PIS – Participant Information Sheet
  • R&B – Risks & Burdens
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Projects with Data and Biological Material

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 ↦ Human Research Ordinance ↦ Projects with Data and Biological Material

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