What is it? Why is it important?

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

  • Biological Material (BM)
  • Health-related Personal Data (HrPD)

 

According to the law, Informed Consent (IC) IC-procedures must be adapted based on whether project data:

  • Contains genetic information from participants
  • Is un-coded: participant identifiers (e.g. name, address, DOB) are documented together with project HrPD data
  • Is coded: participants are allotted individualised project IDs. IDs together with participant identifiers are kept separate from project HrPD data (e.g. participant identification-log)
  • Is anonymised: means required for donor identification has been deleted (e.g. participant identifiers, project ID, identification-log)

What do I need to do?

Based on collected data (genetic / non-genetic) and handling of participant identifiers (coded, un-coded, anonymised) adapt IC-procedures accordingly.

 

Adaptations include how:

  • Participants are informed about the project, which is either:
    • In writing and orally
    • In writing or orally
  • IC is collected, which is either:
    • In writing
    • Or the participant does not dissent to its BM/HrPD data being used for research (e.g. in the IC the participant must be informed about his/her requirement to actively dissent to the BM/HrPD being used for research)

 

In the event IC is missing from already collected BM/HrPD, an application is submitted to the EC and approval must be received prior using the data for the project.

More

For BM and genetic HrPD the following regulations apply:

  • Un-coded data: Information must be provided in writing and orally and consent is given in writing
  • Coded data: Information must be provided in writing or orally and consent is given in writing
  • Anonymised: Information must be provided in writing or orally and participant gives no dissent

For non-genetic HrPD the following regulations apply:

  • Un-coded data: Information must be given in writing or orally and consent is given in writing
  • Coded data: Information must be given in writing or orally and participant gives no dissent

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic.

SBP Documents

General

  • Biobank Regulation

Ethical / Legal

  • Ethical, legal and professional compliance list for human research biobanks applicable in Switzerland

Swiss Law

HRO – see in particular chapter, articles and sections

  • Chapter 3 Further Use of Biological Material and Health-related Personal Data for Research
  • Art. 28 IC for genetic data in un-coded form
  • Art. 29 IC for genetic data in coded form
  • Art. 30 Participant information and anonymisation
  • Art. 31 IC for non-genetic data in un-coded form
  • Art. 32 IC for non-genetic data in coded form
  • Section 3 Authorisation and notification requirements
  • Section 4 Authorisation and notification requirements in the absence of IC
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DOB – Date of Birth
  • EC – Ethics Committee
  • HrPD – Health-Related Personal Data
  • HRO - Human Research Ordinance
  • IC – Informed Consent Form
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ The Swiss Law ↦ Further Use and Informed Consent
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
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 Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Basic ↦ Biobanking ↦ The Swiss Law ↦ Further Use and Informed Consent

Please note: the Easy-GCS tool is currently under construction.