Your Easy Guide to Clinical Studies

The exemption from a written Participant Information Sheet (PIS) and Informed Consent Form (ICF) can be granted under special circumstances, such as:

• Physical or cognitive reasons making a participant unable to read or write
• Participant language skills, and where disproportionate efforts would be needed to obtain a written form

 

In the event of a non-written consent, the SP-INV or Site-INV is responsible to provide proof of participant information and consent by including:

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

 

Non-written consent procedures must be described and submitted to the Ethics Committee (EC) for approval.

As a SP-INV:

• Describe reasons why an exemption from the written consent form is necessary
• Describe methods and procedures that guarantee that participants are adequately informed about the study
• Describe methods and procedures that enable participants to freely provide consent to study participation
• Describe how these procedures are documented (e.g. inclusion of applicable witnesses, qualified translator)
• Submit an application to EC for approval
• Train study staff on the implementation of non-written consent procedures, and ensure they are correctly followed and documented

External Links

Swissethics – in particular see

• Information of participants in foreign languages
• Study information for relatives / parents / legal representative

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 (access liable to costs) - see in particular sections

• 5.8 Informed consent

Swiss Law

HRA – see in particular chapter

• 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