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:

  • Donor participation in a clinical study or 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.


A donor can withdraw consent.

  • For study participants no more BM or HrPD can be collected. 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.

What do I need to do?

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


Leftover BM from biopsies no longer needed by the pathologist, can either be collected:

  • Anonymously: at collection, BM carries no donor identification markers thus preventing donor identification. The donor can still oppose to anonymization of his/her BM, as it is possible that information of significant health interest could become avaialble. Explain the consequences of anonymisation in the ICF.
  • In a coded form: based on the retention of a donor-identification-log, donors can be re-identified at a later time point. The log is kept separate from the BM or BIMS (biobanking database). 


In both instances, the donor / study participant agrees for his/her BM being used in further research.


In the event of anonymously collected BM, the process used to ensure anonymisation must be submitted and approved by the Ethics Committee.

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.

  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • SBP – Swiss Biobanking Platform
Basic ↦ Biobanking ↦ Donor ↦ In Research

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
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 Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
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.