Development↦Management↦Study Documents↦Exemption from written Consent
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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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