What is it? Why is it important?

The Informed Consent Form (ICF) is an Ethics Committee (EC) required document handed out to participants either separately or as a joint document with the Patient Information Sheet PIS. On the ICF participants voluntarily confirm their willingness to participate in a study or project by dating and signing the document together with the researcher.



  • Is a short summary of information provided in the PIS
  • Is site specific (i.e. sites include their contact details for participants to reach site specific researchers, such as the Site-INV)
  • Has a section for participants and researchers to date an sign the document
  • Is integrated in an informed consent process that must be described in the study protocol
  • Must be submitted and approved by EC
  • Is only valid once a participant has dated and signed the document


Researchers should not coerce or unduly influence participants to participate or continue to participate in a study.

What do I need to do?

As a SP-INV:

  • Select  from swissethics (EC) the ICF template applicable to your study
  • Summarise main information needed for study participants to sign and date the document


In order for participants to decide on study participation, they must:

  • Be informed about the study:
    • Through personal contact and discussions with health care provider
    • In writing by receiving a copy of the ICF and PIS
  • Understand and able to comply with expected study tasks (e.g. time investment, provision of biological material and health related data, administration of IMP/IMD, report on potential adverse events)
  • Know their right to revoke consent at any time
  • Be given adequate time to decide


ICF management includes to:

  • Train study staff on the informed consent process
  • Establish a site-delegation-log listing staff responsible to recruit and inform participants
  • Ensure the signed ICF documents remain at the study site and protected from unauthorised access


ICF quality checks include:

  • All information except signatures are legible
  • For identification purposes:
    • The name of staff signing the ICF is entered
    • A participant sticker for later identification is attached, or participant name and date of birth is included
  • Participants have personally dated and signed the document
  • The time when the document was signed is entered. This is especially important if study relevant procedures are planned the same day
  • Participants and study staff sign the ICF together on the same date
  • A signed copy is handed out to participants


Mistakes to avoid in the ICF process

  • To leave date and place empty
  • Pre-enter date & place on behalf of the participant
  • Forget to make participant sign the ICF
  • Personally forget to sign the document
  • Have the document signed by non-authorised staff not listed on the site-delegation-log
  • To use an outdated or amended non EC approved ICF in the study
  • In a multi-centre study: forward signed and dated ICFs from a participating study site to the SP-INV of the study


Signed ICFs of a participating study site are filed in the ISF and not in the TMF of the study. 

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 patient information and ICF templates
  • Conception and application of an electronic informed consent
  • Time for consideration
  • Monetary contributions to patients participating in research projects


ICH GCP E6(R2) – see in particular guidelines

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


ISO 14155:2020 Medical device (access liable to costs) - see in particular section

  • 5.8 Informed consent


Declaration of Helsinki – see in particular principles

  • 25 – 32 Informed Consent

Swiss Law

HRA – see in particular articles

  • Art. 7. Consent
  • Chapter 2, section 2. Information and consent
  • Chapter 3 all sections. Requirements vulnerable persons

HRO – see in particular articles and chapter

  • Art. 8 Information given to participants
  • Art. 10 Consequences of revocation of consent
  • Art. 11 Research projects in emergency situations
  • 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. 9 Consequences of revocation of consent
  • Art. 15 Post hoc consent in emergency situations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • PIS – Participant Information Sheet
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Development ↦ Management ↦ Study Documents ↦ Informed Consent Form

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 ↦ Informed Consent Form

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