Your Easy Guide to Clinical Studies

The Participant Information Sheet (PIS) is an Ethics Committee (EC) required document provided to study participants with the aim to:

• Explain the study (e.g. study research question / design, type of intervention, safety issues, participant contribution)
• Explain participant applicable rights
• Request an agreement regarding the further-use of collected biological material and health related data. As an alternative, a hospital internal general consent document can be used

 

A PIS:

• Is site specific (i.e. the site includes its contact details for participants to reach site specific researchers, such as the Site-INV)
• Is integrated in an informed consent process that must be described in the study protocol
• Must be submitted and approved by EC

 

Swissethics (EC) provide PIS based on:

• Study type (ClinO, ClinO-MD, HRO)
• Swiss language region (German, French, Italian)
• Type of participant (e.g. adults, children, adolescents, pregnant women, individuals without capacity to give consent)

As a SP-INV:

• Select  from swissethics  (EC) the PIS template applicable to your study
• Include all relevant information enabling  participants or legal representatives to decide on study participation
• Ensure text is written in a comprehensible / lay language, easily understood by target participants
• Submit the PIS to EC for approval. If an approved PIS is amended prior to study start, ensure the amended version is approved by EC (e.g. ensure correct document identification)

 

If a PIS must be provided in a language other than an official Swiss language, submit the translation to the EC. The EC only acknowledges the translated document. The SP-INV is responsible for the correct translation.

 

In the event of languages for which a written translation is not feasible, a qualified translator is used to inform participants. The translator confirms his/her correct translation with his/her signature.

External Links

Swissethics – see in particular

• Broad selection of Patient Information (PIS) and Informed Consent Form (ICF) templates

References

ICH GCP E6(R3) – see in particular guideline

• 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 (access liable to cost) - see in particular sections

• 5.8 Informed consent

Declaration of Helsinki – see in particular principles

• 25 – 32 Free Informed Consent

Swiss Law

HRA – see in particular chapters

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

ClinO – see in particular articles

• Art. 4a Inclusion of relevant groups of persons
• Art. 7 Information given to participants
• Art. 8 Exemption to written form

ClinO-MD – see in particular

• Art. 3a Inclusion of relevant groups of persons
• Art. 3b Applicable provisions (refer to ClinO)

HRO – see in particular articles

• Art. 2c Inclusion of relevant groups of persons
• Art. 8 Information given to participants
• Art. 9 Exemption to the written form