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 sample Biological Material (BM) and collect Health-Related personal Data (HRpD) from participants in order to:
    • Answer a scientific question
    • Make further use of BM and HRpD for research purposes
  • The handling of BM and HRpD that is collected as per routine procedures for further use in research

General provisions include to ensure the:

  • Scientific quality and integrity of the project
  • Qualification and training of researchers
  • Adherence to EC / FOPH authorisation and notification procedures
  • Compliance with data protection law (e.g. collection, storage, sharing of biological material and HRpD)

The obligation of an additional approval by the FOPH is only applicable to projects that include the use of a radiation source(s).

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Human research projects may be based on the collection or reuse of BM or HRpD from patients, healthy volunteers, deceased persons, embryos and foetuses, and spontaneous or induced abortions including stillbirths.

What do I need to do?

As a project leader conducting a research project in Switzerland, responsibilities include to:

  • Manage overall project coordination (e.g. finances, study initiation, management)
  • Protect research participants
  • Comply with data protection laws
  • Have the professional qualification, training, and experience required to conduct the research project
  • Implement appropriate measures so as to ensure correct handling, storage, and maintenance of BM and HRpD (e.g. infrastructure, access, documentation)
  • Submit a project application to EC / FOPH for approval

The HRO ordinance differentiates between:

  • Prospective research projects involving the collection of (non-routine) BM / HRpD
  • The handling of BM and HRpD that is collected as per routine procedures for further use in research

Based on project type, different requirements apply (e.g. ICF procedures, EC approvals, data collection or retrieval procedures, clinical project report).

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Multi-centre studies:

  • Apart from EC submission, project financing and the overall coordination of the research project, the Site-INV carries the same responsibilities as the project leader - only at the local site level.

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 number

  • 810.301 HRO

HRO – see in particular articles and chapters

  • Art. 1 Purpose
  • 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 researc
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • ICF – Informed Consent Form
  • KOFAM – Coordination portal for human research
  • Site-INV – Site Investigator
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Aim
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 ↦ Human Research Ordinance ↦ Aim

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