What is it? Why is it important?

In these research projects, the Human Research Ordinance (HRO) regulates the prospective collection of Biological Material (BM) and Health-Related personal Data (HRpD) from participants in order to:

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

 

The regulatory requirements of these projects are defined under chapter 2 of the HRO.

Research projects are categorised based on risk-category into:

  • Category A, which:
    • Entails only minimal risks and burdens; or
    • Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria
  • Category B, which:
    • Entails more than minimal risks and burdens; and
    • Is not recognised as standard as specified under category A

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In particular, minimal risks and burdens may be associated with:

  • Surveys and observations
  • Peripheral venous or capillary blood sampling and skin punch biopsies of limited extent
  • Non-invasive interventions removing or collecting bodily substances, in particular, saliva, urine and stool samples
  • Taking swabs
  • Magnetic resonance imaging scans without a contrast medium
  • Ultra-sound examinations or electrograms
  • Accompanying examinations involving ionising radiation, provided the effective dose is below 5 mSv per research project and person concerned, without using a contrast medium and:
    • The radiopharmaceutical is used in accordance with authorisation or are exempt from authorisation, or
    • Using an authorised MP in accordance with instructions for use

What do I need to do?

As a project leader:

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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 transfer agreements – DTA / MTA).

 

In case of research projects 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

External Links

Swissethics – see in particular

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

References

HumRes: Coordination portal for human research in Switzerland

Swiss Law

HRO – see in particular articles and chapters / sections

  • Art. 5 Storage of HrPD and BM
  • Art. 6 Research project purpose
  • Art. 8 Participant right to information
  • Art. 7 Categorisation and definition of minimal risks and burdens
  • Chapter 2, section 2. Authorisation procedures
  • Chapter 2, section 3. Notification and reporting
Abbreviations
  • 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
  • HumRes – Human Research in Switzerland
  • 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
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 ↦ Projects with Data and Biological Material

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