What is it? Why is it important?

Chapter 2 of the HRO regulates human research projects that prospectively sample 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:

  • The categorisation of the research project based on expected risks (e.g. with A having a low and B a higher risk)
  • The definition of Informed consent (IC) procedures
  • Required insurance coverage
  • EC / FOPH submission and approval
  • Required safety procedures during study conduct (e.g. safety and protective measures, notification of serious events)
  • Notification requirements (e.g. changes, project completion or discontinuation)

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
  • Provide a database which guarantees data integrity, traceability and data protection
  • 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 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 at any time
  • Report the completion or discontinuation of a research project to EC within 90 days

More

Ensure to adhere to notification procedures, such as:

  • Serious events including safety and protective measures
  • Project completion or discontinuation

Multi-centre projects:

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

References

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.301 HRO

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
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DTUA – Data Transfer User Agreement
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
  • MTA – Material Transfer Agreements
  • 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 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 ↦ Projects with Data and Biological Material

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