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.
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
- 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
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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
Swissethics – see in particular
- Broad selection of patient information and ICF templates
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
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