What is it? Why is it important?

The Informed Consent Form (ICF) is a document handed out together with the PIS, where participants voluntarily confirm their willingness to participate in a study.

  • Consent is documented in writing. Both participant and resepctive investigator (SP-INV or Site-INV) date and sign the ICF
  • Only after the participant has signed the ICF and thus formally agreed to participate in the study, can study assessments and procedures start (e.g. participant questionnaire, analytical screening tests)

In order for participants to decide on study participation information is provided:

  • Verbally through personal discussion with health care providers
  • Through answering any questions participants might have about the study
  • In writing by handing out a copy of the PIS to participants

More

In order to decide whether to participate in a study, participants should be:

  • Unmistakably informed and understand their contribution to the study (e.g. time investment, provision of biological material and health related data, administration of IMP/MD and the appearance of potential side effects)
  • Given ample opportunity to ask questions in order to make a sound decision regarding participation
  • Given adequate time to decide
  • Informed regarding their right to with-hold or revoke their consent at any time, without stating reasons why participation is no longer desired
  • Informed that revoking consent carries no disadvantages on ongoing or future medical treatments or care given to participants

Neither Site-INV, nor the study staff, should coerce or unduly influence participants to participate or continue to participate in a study.

What do I need to do?

Implement informed consent procedures where

Each participant is provided with his/her personal ICF, and:

  • Enters his/her name, gender, and date of birth
  • Personally enters place, dates and signs the ICF

Site-INV/SP-INV or delegated person:

  • Enters name (legibly) and personally dates and signs the ICF immediately after the participant
  • Provides the participant with a signed copy of the ICF
  • Makes a note in the medical history and study database confirming study inclusion
  • Files ICF in ISF

More

  • The study delegation log must clearly list designated study staff responsible for informing participants about the study including dating and signing the ICF. In most cases this would be the SP-INV or a Site-INV.
  • Document time when ICF was obtained. This is especially important if study relevant procedures are planned the same day.
  • Ensure that all hand-written text is clearly legible, with personal signatures being excluded.
  • Document the whole ICF process in the source data of the patient (e.g. medical records). In the event of any deviations to the process, provide explanations enabling reconstruction of procedures.

Regarding the ICF process do NOT:

  • Leave date and place empty
  • Pre-enter date & place on behalf of the participant
  • Forget to make participant sign the document
  • Personally forget to sign the document
  • Have the document signed by a non-authorised staff member
  • In a multicentre study forward signed and dated ICF documents of a participating study site to the SP-INV of the study

Signed ICFs of a participating study site are filed in the site specific ISF and not in the TMF of the study. The ICF remains at the study site where participants were recruited for the study.

Where can I get help?

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

External Links

Swissethics – in particular see

  • 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

References

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 - see in particular sections (access liable to cost)

  • 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

  • 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
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Management ↦ Study Documents ↦ Informed Consent Form

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