What is it? Why is it important?

The exemption from a written Participant Information Sheet (PIS) and Informed Consent Form (ICF) can be granted under special circumstances, such as:

  • Due to physical or cognitive reasons making a participant unable to read or write
  • Based on participant language skills, and where disproportionate efforts would be needed to create a written form


In the event of a non-written forms, the SP-INV or Site-INV is responsible to provide proof of participant information and consent by including:

  • Confirmation from a witness, or
  • The recording of verbal consent, or
  • The confirmation of an independent qualified translator providing oral information and gives written confirmation thereof


Non-written consent procedures must be described and submitted to the Ethics Committee (EC) for approval.

What do I need to do?

As a SP-INV:

  • Describe reasons why an exemption from the written consent form is necessary
  • Describe methods and procedures that guarantee that participants are adequately informed about the study
  • Describe methods and procedures that enable participants to freely provide consent to study participation
  • Describe how these procedures are documented (e.g. inclusion of applicable witnesses, qualified translator)
  • Submit an application to EC for approval
  • Train study staff, and as applicable participating study sites, on the implementation of non-written consent procedures, and ensure they are correctly followed and documented during study conduct

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissethics – in particular see

  • Information of participants in foreign languages
  • Study information for relatives / parents / legal representative


ICH GCP E6(R2) – see in particular guidelines

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

ISO 14155:2020 Medical devices (access liable to costs) - see in particular sections

  • 5.8 Informed consent

Swiss Law

HRA – see in particular chapter

  • Chapter 2, section 2. Information and consent

HRO – see in particular article

  • Art. 9 Exemption to written form

ClinO – see in particular article

  • Art. 8 Exemption to written form
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee HRA – Human Research Act
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Documents ↦ Exemption from written Consent

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): Development ↦ Management ↦ Study Documents ↦ Exemption from written Consent

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