What is it? Why is it important?

Prior to collecting Biological Material (BM) for a study, requires that donors are adequately informed about:

  • The overall aim of the study
  • The protection of their BM and their associated data (e.g. data confidentiality, storage and protected access)
  • Their right to:
    • Information
    • Withdraw consent without providing reasons
    • Dissent to have their BM anonymised


Study participants are handed out:

  • A Participant Information Sheet (PIS): The document provides information on the planned the study (e.g. the intervention, sampling of BM, medical exams, questionnaires, planned study visits)
  • An Informed Consent Form (ICF): The document is handed out together with the PIS. Participants date and sign the document, thereby confirming their willingness to:
    • Participate in the study
    • Provide BM needed to evaluate the effect of the study intervention

What do I need to do?

Based on your study:

  • Download the respective PIS/ICF from the swissethics homage. Fill in forms by describing the implementation of your study (e.g. both PIS/ICF require EC approval)
  • Describe the informed consent process in a SOP or WI and include:
    • How study information is provided to donors and how consent is obtained (e.g. orally, with translator, translated PIS/ICF)
    • How to document consent and respective consent activities
    • Procedures in the event of consent withdrawal (e.g. destruction or anonymisation of BM and HrPD)
  • Describe how to document donor information and collected BM (e.g. in BIMS or in a separate dataset, only hard copies)


Ensure donors have:

  • The required information needed to decide on study participation
  • Have the opportunity to ask questions
  • Have sufficient time to freely decide


In anticipation that a doror / study participant withdraws from the study, include in the PIS/ICF that already collected BM and HrPD will be retained and used in the study. If this information is missing the BM and its associate data must be destroyed.

An option is to anonymise the data, but the donor / study participant can refuse to have its BM and HrPD anonymised (e.g. important results might become available through its analysis). Thus, the wishes of the donor / study participant must be taken into consideration. In any event, after finalising the data analysis, BM and any associates data from donors / study participants must be anonymised, or destroyed.

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.

External Links

Swissethics – see in particular

  • Templates and Checklists / patient information and declaration of consent
  • Further-use of BM and HrPD / Biobanks


ICH GCP E6(R2) – see in particular guidelines

  • 1.28. Informed consent definition
  • 4.8. Informed consent of trial participants

ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular sections

  • 5.8 Informed consent

Declaration of Helsinki – see in particular principles

  • 25-32 Informed Consent

Swiss Law

HRA – see in particular article and chapter

  • Art. 7 Consent
  • Chapter 2, section 2. Information and consent

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 8 Exemption to the written form
  • Art. 9 Consequences of revocation of consent
  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • ClinO – Clinical Trials Ordinance
  • EC – Ethics committee
  • HRA – Human Research Act
  • HrPD – Health-related Personal Data
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedure
  • WI – Working Instruction
Development ↦ Biobanking ↦ Donor Consent ↦ In Clinical Studies

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): Development ↦ Biobanking ↦ Donor Consent ↦ In Clinical Studies

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