What is it? Why is it important?

The Participant Information Sheet (PIS) is an Ethics Committee (EC) required document provided to study participants with the aim to:

  • Explain the study (e.g. study background and aim, type of intervention, safety issues, participant contribution)
  • Request an agreement regarding the further-use of collected biological material and health related data. As an alternative, a hospital internal general consent document can be used



  • Is site specific (i.e. the site includes its contact details for participants to reach site specific researchers, such as the Site-INV)
  • Is integrated in an informed consent process that must be described in the study protocol
  • Must be submitted and approved by EC


Swissethics (EC) provide PIS based on:

  • Study type (ClinO, ClinO-MD, HRO)
  • Swiss language region (German, French, Italian)
  • Type of participant (e.g. adults, children, adolescents, pregnant women, individuals without capacity to give consent)

What do I need to do?

As a SP-INV:

  • Select  from swissethics  (EC) the PIS template applicable to your study
  • Include all relevant information enabling  participants or legal representatives to decide on study participation
  • Ensure text is written in a comprehensible / lay language, easily understood by target participants
  • Submit the PIS to EC for approval. If an approved PIS is amended prior to study start, ensure the amended version is approved by EC (e.g. ensure correct document identification)


If a PIS must be provided in a language other than an official Swiss language, submit the translation to the EC. The EC only acknowledges the translated document. The SP-INV is responsible for the correct translation.


In the event of languages for which a written translation is not feasible, a qualified translator is used to inform participants. The translator confirms his/her correct translation with his/her signature.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Broad selection of PIS templates
  • Further use of biological material and personal data
  • Study information for relatives / parents / legal representative
  • Conception and application of an electronic informed consent
  • Information of participants in foreign languages


ICH GCP E6(R2) – see in particular guideline

  • 4.8. Informed consent of trial participants


ISO 14155:2020 Medical devices (access liable to cost) - 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 chapter

  • Chapter 2, section 2. Information and consent

HRO – see in particular articles

  • Art. 8 Information given to participants
  • Art. 9 Exemption to written form
  • Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 8.Exemption to written form
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GDPR - General Data Protection Regulation
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • HRO – Human Research Ordinance
  • ISO – International Organization for Standardization
  • HRO – Human Research Ordinance
  • PIS – Participant Information Sheet
  • Site-INV – Site-Investigator
Development ↦ Management ↦ Study Documents ↦ Participant Information Sheet

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 ↦ Participant Information Sheet

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