What is it? Why is it important?

The Human Research Act (HRA) regulates through its Human Research Ordinance (HRO) research projects with Biological Material (BM) and Health related Personal Data (HRpD).

 

According to the type of research, the HRO ordinance is divided into separate chapters, which include:

  • Chapter 2: 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
  • Chapter 3: Research that makes further-use of already sampled BM and already collected HRpD
  • Chapter 4: Reseatch that involves deceased persons
  • Chapter 5: Research that involves embryos and foetuses from abortions

 

Each chapter has its own added requirements

What do I need to do?

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

  • Organise the research project (e.g. financing, study initiation, management)
  • Protect research participants
  • Comply with data protection laws. The project leader must have knowledge or access to required expertise regarding data protection and data safety laws
  • Have the professional qualification, training, and experience required to conduct a research project.
  • Implement appropriate measures so as to ensure correct handling, storage, and maintenance of BM and HRpD (e.g. infrastructure, biobank set-up, access rights, documentation)
  • Comply with the submission, approval, and notification requirements (e.g. Ethics Committee (ECsubmission / approval, FOPH submission / approval)

 

In case of accompanying examinations involving ionising radiation, additional documents must be submitted to EC. If products are not used according to instruction, not authorized, or have no conformity marking, additional documents must be submitted to the FOPH.

Where can I get help?

Your local Research Support Centre can assist you with experienced staff regarding this topic

  • Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

  • Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

  • Bern, Department of Clinical Research (DCR), dcr.unibe.ch

  • Geneva, Clinical Research Center (CRC), crc.hug.ch

  • Lausanne, Clinical Research Center (CRC), chuv.ch

  • St. Gallen, Clinical Trials Unit (CTU), h-och.ch

  • Zürich, Clinical Trials Center (CTC), usz.ch

References

HumRes: Coordination portal for human research in Switzerland

Swiss Law

HRO – see in particular articles, chapters, and annex

  • Art. 3 Responsibilities fo the project leader
  • 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
  • Annex 2: Application documents to EC / FOPH
Abbreviations
  • 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
  • HumRes – Human Research in Switzerland
  • ICF – Informed Consent Form
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Aim

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