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
  • Collected health-related personal data (HRpD) collected as per routine procedures

According to the law, Informed Consent (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 participant / project HRpD
  • Is coded: participants are allotted individualised project IDs. IDs together with participant identifiers are kept separate from participant/project HRpD data (e.g. a Participant Identification Log)
  • Is anonymised: means required for participant identification has been deleted (e.g. participant identifiers, project ID, Participant Identification Log)

More

Different IC regulations apply based on:

  • Whether the project includes the further use of genetic or non-genetic data
  • How BM / HRpD database is stored in the database (e.g. un-coded, coded, anonymised)

IC regulations for further use of genetic BM / HRpD:

  • Un-coded: project information to participants must be provided in writing and orally and consent is given in writing
  • Coded: project information to participants must be provided in writing or orally and consent is given in writing
  • Anonymisation: project information to participants must be provided in writing or orally and the participant does not dissent to anonymization

IC regulations for further use of non-genetic HRpD:

  • Un-coded: project information to participants must be given in writing or orally and consent is given in writing
  • Coded: project information to participants must be given in writing or orally and participant gives no dissent to data collection

What do I need to do?

As a researcher apply IC procedures based on:

  • Planned further use of HRpD (genetic / non-genetic) and BM (genetic)
  • How participant information is stored in the project database (e.g. un-coded, coded, anonymised)

Adaptations include how:

  • Participants are informed about the project, which is either:
    • In writing and orally
    • In writing or orally
  • IC is collected from participants, which is either:
    • In writing
    • Participant does not dissent to its BM / HRpD being used for research

As a researcher responsible for a particular research site:

  • Define local IC procedures
  • Define how the Participant ID Log can be protected from unauthorised access and accidental disclosure (e.g. access is only permissible by authorized staff)

More

Participants must provide consent and the EC must approve the project prior to using data for research purposes.

In exceptional cases where participant IC is missing, the EC will evaluate and decide whether data from participants with missing consent can be used in the project. Aspects to clarify for EC include:

  • Is it impossible or disproportionately difficult to obtain consent or to provide information on the right to dissent, or would this impose an undue burden on the person concerned?
  • Are there any documented refusals?
  • Do research interests outweigh the interests of the person concerned in deciding on the further use of his or her biological material and data?

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

Swiss Law

FEDLEX – law are available online under number

  • 810.30 HRA
  • 810.301 HRO

HRA – see in particular article

  • Art. 34 Absence of informed consent

HRO – see in particular chapter / section

  • Chapter 3, section 2. Informed Consent and Information
Abbreviations
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DOB – Date of Birth
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HRpD – Health-Related Personal Data
  • IC – Informed Consent
  • ID – Identification
Basic ↦ Ethics and Laws ↦ Human Research Ordinance ↦ Further use and Informed Consent
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 and Informed Consent

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