What is it? Why is it important?

A donor is a person who donates Biological Material (BM) (e.g. blood, organ tissue, or other seminal fluids) for research. A donor must initially consent to their BM being used for research.


Donor consent can be obtained either through:

  • The participation in a clinical study (consent in a clinical study) or research project (consent in a research project). The donor or study participant agrees that:
    • Collected BM can be used for the clinical study / research project
    • Leftover BM not needed for the clinical study / research project can be used for further-use research
  • A general consent where patients admitted to a local hospital for treatment, agree that leftover BM not needed for diagnostic purposes can be used for further-use research.

What do I need to do?

Based on the use / furhter-use of BM in a research project or clinical study, familiarise yourself with the requirements regarding donor/study participant consent (e.g. further-use and informed consent, informed consent process).


In the event a donor or study participant withdraws consent:

  • No more BM or HrPD can be collected from participants. Upon final data analysis, both the BM and the HrPD must be anonymized
  • Leftover BM destined for further-use research, requires that the BM and HrPD is either destroyed or anonymized


The process used to anonymize BM must be submitted and approved by the Ethics Committee (EC)

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

SOPs, Forms and Templates – see in particular

  • Obtaining consent SOP
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HrPD – Health related Personal Data
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ Donor ↦ In Research

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): Basic ↦ Biobanking ↦ Donor ↦ In Research

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