What is it? Why is it important?

An exemption from the written 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, where disproportionate efforts would be needed to create a written form

SP-INV or Site-INV is responsible to provide proof of participant information and consent by including:

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

More

Special measures and processes needed to provide information and document consent must be described and approved by EC prior to implementation.

What do I need to do?

  • Describe reasons why an exemption from the written consent form is necessary
  • Describe methods and processes put in place that guarantee that participants are adequately informed about the study and are able to freely give their consent 
  • Describe how these processes are documented (e.g. inclusion of applicable witnesses, qualified translator)
  • Submit all information to the EC for approval prior to implementation

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
  • Guidelines on the retention period of biological material and personal data of further use projects without consent

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

Swiss Law

HRA – see in particular

  • 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
Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Documents ↦ Exemption from written Consent
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 ↦ Exemption from written Consent

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