What is it? Why is it important?

Recruiting study participants, requires that they be adequately informed and officially consent to its participation. A participant informed consent process should be defined, which includes the following documents:

  • The Participant Information Sheet (PIS): provides participants with the required information needed to understand the study, and enable them to make a sound decision regarding study participation
  • The Informed Consent Form (ICF): is handed out together with the PIS. It is the official document where participants confirm their agreement to participate in a study in writing, by dating and signing the document

Prior to study implementation, both the PIS and ICF are reviewed and approved by EC. As with the protocol, approval is granted on the basis of a particular PIS/ICF version.

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PIS/ICF documents must have clearly marked identifiers (e.g. version numbers, release dates). In the event of document changes or amendments, requires that identifiers are adapted accordingly.

What do I need to do?

As a SP-INV:

  • Select and download the official PIS/ICF templates applicable to your study from the swissethics webpage (e.g. children, persons without capacity, emergency patients)
  • Based on the study protocol, fill in all required study information (e.g. study aim, design, risks and safety measures)
  • In the event of a multicentre study, adapt documents according to site specific layouts, and add site specific contact details (e.g. local ECs approve site documents under their jurisdiction)
  • Ensure only EC approved PIS/ICF remain in circulation during study conduct

Based on:

  • Target group, additional legal requirements may apply to the informed consent process (e.g. children studies, where the legal guardian also approves study participation)
  • Participant language background, literacy skills, or cognitive reasons, the EC might approve an exemption to the written PIS/ICF form

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Establish the informed consent process according to your target population and the applicable laws. Describe the implemented informed consent process in your study protocol.

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

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 section (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

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 8 Exemption to written form

HRO – see in particular articles

  • Art. 8 Information given to participants
  • Art. 9 Exemption to written form
Abbreviations
  • CTU – Clinical Trials Unit
  • DMS – Document Management System
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • PIS – Participant Information Sheet
Development ↦ Documents ↦ Required Documents ↦ Participant Information
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 ↦ Documents ↦ Required Documents ↦ Participant Information

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