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.

A General Consent:

  • Offers a harmonized and standardized solution, with the prospect of sharing data and BM aimed at research
  • Can be used in retrospective research, where the BM and/or HrPD has already been collected. All research project must be approved by the Ethics Committee (EC) in order to use BM or HrPD covered by the GC
  • Does not cover prospective research, where BM and/or HrPD are collected according to a study protocol. The consent for further-use of leftover BM and/or HrPD collected in a clinical study must be obtained through a study-specific ICF

What do I need to do?

If you plan a research project with already collected BM and/or HrPD:

  • Contact the hospital representative responsible for the management of the GC. Request an assessment regarding the availability of BM and/or HrPD
  • Submit the project to the EC for approval. Only upon EC approval will access to BM and/or HrPD be granted

 

Inform yourself on 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 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

References

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
Abbreviations
  • 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
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): Development ↦ Management ↦ Study Documents ↦ General Consent

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