What is it? Why is it important?

A General Consent (GC) is a consent form used by hospitals with the aim to ask patients if they would agree to donate their leftover biological material (BM) and/or collected health related personal data (HrPD) for further research.


The source of BM and HrPD is therefore based on the hospital treatment of some given illness.



  • Can be used in retrospective research, where the required BM and/or HrPD has already been collected. Still, prior to be given access, a defined research project must be submitted and approved by the Ethics Committee (EC)
  • Does not cover prospective research, where BM and/or HrPD are collected according to a study protocol. Consent regarding any further-use of leftover BM and/or HrPD in studies is collected with a study respective consent form


All Swiss universities and some cantonal hospitals have approved the implementation of a GC. 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?

As a researcher, planning a research project with already collected BM and/or HrPD:

  • Define a research project that includes the use of retrospective data and material
  • Contact the hospital representative responsible for the management of the GC. Request an assessment regarding the availability of project required BM and/or HrPD. Access will only granted from patients that approved sharing and signed the GC
  • Submit the project to the EC for approval. Only upon EC approval will access to BM and/or HrPD be granted


Inform yourself how the GC is managed at your hospital. Questions to ask might be:

  • How and when do patients receive the GC?
  • Can I use the GC template of the hospital?
  • How are GCs archived?
  • How are patient approved GC recorded in the electronic system of the hospital?
  • How are consent withdrawals managed and documented?
  • How is the access to BM and/or HrPD from patients that signed the GC managed?

Where can I get help?

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

External Links

Swissethics – see in particular

  • 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


unimedsuisse - see in particular

  • General Consent

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
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GC – General Consent
  • HRO – Human Research Ordinance
  • HrPD – Health related Personal Data
Development ↦ Management ↦ Study Documents ↦ General Consent

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Documents ↦ General Consent

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