What is it? Why is it important?
The Participant Information Sheet (PIS) is any information given to participants describing a study, including the use / further use of collected biological material and health related data.
Selection of PIS is based on the following criteria:
- Type of study according to the law (ClinO, HRO)
- The Swiss language region where participants are recruited (German, French, Italian)
- Type of recruited participants (e.g. adults, children, adolescents, pregnant women, individuals without capacity to give consent)
It might be necessary to provide the PIS in a language other than an official Swiss language:
What do I need to do?
Categorise your study based on the Swiss law. If in doubt, clarify the category of your study upfront with the EC.
- Select the applicable PIS template provided by swissethics based on:
- Type of study: interventional clinical study (ClinO) versus nonclinical research project (HRO) with the exclusive collection of biological material or health related data
- Type of population (e.g. adults, children, pregnant women, other vulnerable groups)
- Include all relevant information enabling participants or legal representatives to decide on study participation
- Ensure text is written in a comprehensible language easy understood by recruited target participants
- Submit the PIS to be approved by EC before being used
For more information refer to Ethics and Laws in this Study Guide.
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 PIS templates
- Further use of biological material and personal data
- Study information for relatives/parents/legal representative
- Conception and application of an electronic informed consent
- Information of participants in foreign languages
- Application of the General Data Protection Regulation (GDPR)
ICH GCP E6(R2) – see in particular guideline
- 4.8. Informed consent of trial participants
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- 5.8 Informed consent
Declaration of Helsinki – see in particular principles
- 25 – 32 Informed Consent
HRA – see in particular
- Chapter 2, section 2. Information and consent
HRO – see in particular articles
- Art. 8 Information given to participants
- Art. 9 Exemption to written form
- Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data
ClinO – see in particular articles
- Art. 7 Information given to participants
- Art. 8.Exemption to written form