What is it? Why is it important?

Communication requirements with donors, providing Biological Material (BM), include:


  • Biobank responsibilities: Biobanks must adopt adequate measures with the aim to inform the public about their activities (e.g. website, newsletter, scientific publications, conferences). Usually, Biobanks do not directly communicate with donors, but allow access to information through their public communication strategy


  • Researcher responsibilities: Researchers inform their donors about their rights to:
    • Receive information in the event of questions
    • Be informed of results concerning their health
    • Abstain from such information or designate a person who takes the decision for them


Donor communication and feedback can highlight biobanking processes in need of improvement. As a consequence, donor communication can feed into biobank improvement strategies.

What do I need to do?

As a biobank operator define the communication strategy. Ensure information remains current and applicable to donors.


As a researcher, define donor communication strategies that covers:

  • Donor questions or requests, such as issues upon BM collection, concerns related to personal data, withdrawal of consent
  • Incidental-findings / results. These are results obtained from the analysis of BM, and which could potentially be of health interest to donors


Regarding incidental-findings, set-up procedures that describe:

  • What results do require donor contact and information?
  • How can donor wishes be guaranteed? Donors can abstain from being informed about incidental-findings (e.g. if applicable, check information on the consent form (ICF))
  • Who contacts the donor and is responsible for any potential follow-up (e.g. treating physician, genetic counsellor, study SP-INV/Site-INV)?
  • How are donors contacted (e.g. by post, e-mail, phone call, private consultations)?

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

  • Safety and complaint SOP


Declaration of Taipei – see in particular principles

  • 14 Ethical Principles
  • 21 Governance

Swiss Law

HRA – see in particular articles

  • Art. 8 Right to receive information
  • Art. 19 Liability

HRO – see in particular article

  • Art. 8 Information
  • BM: Biological Material
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • HrPD – Health-related Personal Data
  • ICF – Informed Consent Form
  • SBP: Swiss Biobanking Platform
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
Development ↦ Biobanking ↦ Donor Consent ↦ Communication

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

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 ↦ Biobanking ↦ Donor Consent ↦ Communication

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