Your Easy Guide to Clinical Studies

Recruiting study participants, requires that they be adequately informed and officially consent to study participation.

 

A participant informed consent process should be in place, 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 the Ethics Committee(EC). As with the study protocol, EC approval is granted on the basis of a particular PIS/ICF version (e.g. document identification). Changes or amendments, require that identifiers are adapted accordingly (e.g. version numbers, release dates), and that the documents are reapproved by EC.

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). The template ensures compliance with the formal document structure, and provides comprehensive guidance on required content
• Establish an informed consent process according to your target population. Describe the informed consent process in your study protocol
• 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 PIS/ICF-site documents under their jurisdiction)
• Define processes to ensure only EC approved PIS/ICF remain in circulation during study conduct

 

Based on:

• 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

External Links

Swissethics – see in particular

• Broad selection of patient information and ICF templates

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: Definition informed consent
• 2.8 Informed consent of trial participants
• II GCP Principles Nr. 2 Informed consent is an integral part of the ethical conduct of a trial

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 Free and informed Consent

Swiss Law

HRA – see in particular articles

• Art. 7 Consent
• Art. 8 Right to receive information
• Chapter 2, section 2 Information and Consent

ClinO – see in particular articles

• Art. 7 Information given to participants
• Art. 8 Exemption to the written form

ClinO-MD - see in particular

• Art. 3b Applicable provisions (refer to ClinO)

HRO – see in particular articles

• Art. 8 Information given to participants
• Art. 9 Exemption to written form