Your Easy Guide to Clinical Studies

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

 

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

• 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

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 (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