What is it? Why is it important?

Chapter 3 of the HRO regulates research related to the further use of:

  • Sampled Biological Material (BM) collected as per routine procedures
  • Health-related personal data (HRpD) collected as per routine procedures

Regulations apply to:

  • The set-up of a project database
  • BM / HRpD handling, such as:
    • Procuring, merging or collecting
    • Storage of BM or HRpD (in biobank (BB) or database, respectively)
    • Accessibility and sharing of BM or HRpD
    • Data protection (e.g. protection of participant identity)
  • BM / HRpD anonymization and coding procedures including conditions for breaking the code
  • Informed Consent (IC) procedures:
    • Genetic versus non-genetic data
    • Research in the absence of IC
  • EC submission and approval requirements
  • Notification requirements (e.g. changes, project completion or discontinuation)

More

Based on the law, research participants must be adequately informed about their rights, including how their data is being used for research. Information is provided to participants either through a general consent form or based on a specific research project.

Information to include are:

  • The general aim for collecting BM / HRpD
  • The anonymization of BM / HRpD and its potential consequences
  • The participant right to:
    • Dissent to the anonymization of their BM / HRpD
    • Withhold or revoke consent at any time
    • Receive information including relevant results concerning their health (e.g. not possible once samples are anonymised)
  • Measures taken to protect BM / HRpD
  • The possibility of BM / HRpD being passed on to 3rd parties for research purposes (including international transfers)

What do I need to do?

In addition to general HRA responsibilities, a project leader of a chapter 3 HRO project must:

  • Provide for an HRO compliant database:
    • Define how data is recorded in the database (e.g. individual participant Identification (ID)-codes)
    • How data is re-identified (e.g. participant identification log)
    • How to protect and track data entry (e.g. access control, audit-trail)
  • Define and adapt IC procedures based on:
    • How data is recorded in the database (e.g. un-coded, coded, anonymised)
    • The inclusion of genetic information. Genetic HRpD follow the same IC procedures / data protection rules as those applicable for BM
    • The inclusion of BM / HRpD covered by the General Consent (e.g. procedures might differ depending on participating site(s))
  • Report the completion or discontinuation of a research project to EC within 90 days

More

As a researcher responsible for a particular research site:

  • Define local IC procedures
  • Define how data can be protected from unauthorised access and accidental disclosure (e.g. access should only be possible by authorized project staff)

In the event, registries contain un-coded data (e.g. participant identifiers such as name, DOB), requires that the data is initially coded prior to being exported for analytical purposes. This protects participant identity and ensures adherence to data protection laws.

Sharing of HRpD and BM:

  • Before any transfer ensure appropriate agreements are in place between project leader and participating site(s), or project leader and research collaborators (e.g. laboratory) (e.g. 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 / Further use with consent

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. 5 Storage of health-related personal data and biological material
  • Art. 24 Definition of further use
  • Art. 25-27 Anonymization, coding, breaking the code
  • Art. 30 Information on the proposed anonymization
  • Chapter 3, section 2. Informed Consent and Information
  • Chapter 3, section 3. Authorisation and notification requirements
  • Chapter 3, section 4. Authorisation and notification requirements when IC missing
Abbreviations
  • BB – Biobank
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DOB – Date of Birth
  • DTUA – Data Transfer User Agreement
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRpD – Health-Related Personal Data
  • HRO - Human Research Ordinance
  • IC – Informed Consent
  • ID- Identification
  • MTA – Material Transfer Agreements
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Further use of 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 ↦ Further use of Data and Biological Material

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