What is it? Why is it important?

The General Consent (GC) allows hospital patients to consent to their health related data and/or biological material being used for further research. Thus, the source of any collected data is based on treatment due to some given illness.

  • The GC does not cover the consent of any data and/or biological material collected according to a study protocol (prospective research).
  • Data collected with the GC can be used at some later date (retrospective research).
  • Before data collected through GC can be used in a defined research project, requires that the project and any intended data is initially submitted to the EC for approval.

More

  • The implementation of a GC has been approved by all Swiss university and some cantonal hospitals.
  • For researchers the GC offers a harmonized and standardized solution, with the prospect of sharing information in the event of planning joint studies or research projects.

What do I need to do?

Evaluate whether you want to collect participant data and/or biological material for further use that currently has not been assigned to a specific study or research project.

If so, inform yourself regarding any GC implemented at your local hospital or use an officially approved GC template.

Planned studies or research projects planning to use data collected with GC also need initial EC approval.

More

Use of GC might require some structural organisation. Inform yourself on how GC processes are managed at your hospital, such as:

  • How can I access the official GC template?
  • How and when do participants receive the GC?
  • How are GC hard copies archived (signed and dated)?
  • How is the consent recorded in the electronic system of the hospital?
  • How are consent withdrawals managed and documented?
  • How can I access data from consenting participants?

EC approval for projects using data collected with GC only becomes necessary once you plan a specific study or research project. 

Where can I get help?

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

External Links

Swissethics – in particular see

  • Templates for general consent in German, French, or Italian
  • Guidelines on the retention period of biological material and personal data of further use projects without consent

Universitäre Medizin Schweiz / Médecine Universitaire Suisse

  • Deutsch: unimedsuisse.ch/de/projekte/generalkonsent
  • Français: unimedsuisse.ch/fr/projets/consentment-general

Swiss Law

HRO – see in particular chapter

  • Chapter 3, section 2. Informed consent and information in the further use of biological material and health-related data for research
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GC – General Consent
Development ↦ Management ↦ Study Documents ↦ General 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): Development ↦ Management ↦ Study Documents ↦ General Consent

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