Patient information and Declaration of consent / general consent / GDPR
The competent ethics committee verifies the Patient Informed Consent as part of the authorization procedure, in one of the official languages German, French or Italian. The ethics committee only acknowledges receipt of Patient Informed Consent written in non-official languages. The sponsor or the project lead is responsible for the accurate translation.
Templates and documents that were updated in the last 2 months are marked with green color.
Glossary for medical terms and abbreviations
Please use the glossary for medical terms below to improve readability and comprehensibility of your patient information.
Enter the medical term in the search box to get suggestions for an alternative wording. The glossary is available for German and French.
Deutsch
z.B. « Rekonvaleszenz » = « Genesungszeit »
(Beschreibung erscheint nach Klick auf gefundenen Begriff.)
Français
par ex. « érythème » = « rougeur de la peau (disparaissant à la pression) »
(Texte visible après avoir cliqué sur un résultat.)
Clinical trials (ClinO, ClinO-MD)
Study information for participants in clinical trials according to HRA / ClinO / ClinO-MD
swissethics-template for drafting information for participants in studies involving humans in accordance with the Human Research Act (HRA) and the Ordinance on Clinical Trials (ClinO, ClinO-MD)
Deutsch
6.2
updated: 05.07.2021
Français
6.2
updated: 05.07.2021
Italiano
6.2
updated: 05.07.2021
Study information for relatives/parents/legal representatives (ClinO, ClinO-MD)
Template for writing the study information for relatives/parents/legal representatives according to ClinO, ClinO-MD
Deutsch
2.2
updated: 05.07.2021
Français
2.2
updated: 05.07.2021
Italiano
2.2
updated: 05.07.2021
Study information in case of amendments
Guideline of swissethics for drafting and using a concise study information in case of amendments to the study protocol
Deutsch
1.2
updated: 16.09.2021
Français
1.2
updated: 16.09.2021
Italiano
1.2
updated: 16.09.2021
Template of swissethics for writing the concise study information - short form - in case of amendments to the study protocol
Deutsch
1.1
updated: 05.07.2021
Français
1.1
updated: 05.07.2021
Italiano
1.1
updated: 05.07.2021
Study information for pregnant study participants or pregnant partners of study participants
Template for drafting information for pregnant study participants or pregnant partners of study participants
Deutsch
1.0
updated: 10.08.2018
Français
1.0
updated: 10.08.2018
Italiano
1.0
updated: 10.08.2018
Conception and application of an electronic informed consent (eIC)
Guideline of swissethics on the conception and application of an electronic informed consent (eIC) in clinical trials, according to ClinO
English
1.1
updated: 23.08.2019
Research projects with persons (HRO chap. 2)
Study information for HRO-projects with persons, according to HRA/HRO chapter 2
Template of swissethics for HRO with persons, according to HRA/HRO chapter 2 (neither ClinO nor HRO chapter 3 "further use")
Deutsch
3.2
updated: 25.11.2021
Français
3.2
updated: 25.11.2021
Italiano
3.2
updated: 25.11.2021
Study information for relatives/parents/legal representatives (HRO)
Template for writing the study information for relatives/parents//Eltern/legal representatives according to HRO
Deutsch
2.2
updated: 25.11.2021
Français
2.2
updated: 25.11.2021
Italiano
2.2
updated: 25.11.2021
Further use of biological material and personal data (HRO chap. 3) / Biobanks
General consent
Template general consent: for the general further use of coded personal data and coded material for research purposes.
As a researcher, you must ensure that the General
Consent is implemented in your institution before using it.
The institutions based in the cantons of Ticino, Vaud,
Fribourg, Valais and Neuchâtel must consult with the competent Ethics Committee
on the valid version of the Consent General before using it.
English
2019/4_E
updated: 19.04.2021
Template for a patient information/informed consent for the collection of biological material according to HRA/HRO art. 8
Please use this template:
- for an additional (prospective) collection of biological material as part of a regular planned collection during a routine examination,
- for a (prospective) collection in connection with a research project that has already been approved by the Ethics Committee,
- for a (prospective) collection of biological material without the patient being under any treatment.
Deutsch
1.1
updated: 16.12.2020
Français
1.1
updated: 16.12.2020
Italiano
1.1
updated: 16.12.2020
Template for a patient information/informed consent according to HRA/HRO art. 28
Template of swissethics for the further use of biological material and genetic personal data in uncoded form for a research project (art. 28 HRO)
Deutsch
2.0
updated: 01.02.2020
Français
2.0
updated: 01.02.2020
Italiano
2.0
updated: 01.02.2020
Application of the General Data Protection Regulation (GDPR)
Guideline ‘application of the General Data Protection Regulation (GDPR)’ and swissethics-template for drafting additional information (addendum) for study participants in line with the General Data Protection Regulation
Deutsch
1.0
updated: 26.09.2018
Français
1.0
updated: 26.09.2016
Italiano
1.0
updated: 26.09.2018
Recommendations
Information of participants in foreign languages
Consensus paper of swissethics /
SCTO (Swiss Clinical Trial Organisation)
Deutsch
n/a
updated: 22.10.2012
Français
n/a
updated: 22.10.2012
