Patient information and Declaration of consent / biobank regulations / 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

Template for drafting information for participants in studies involving humans

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)

Deutsch
5.4
updated: 17.10.2019
Français
5.4
updated: 17.10.2019
Italiano
5.4
updated: 17.10.2019
Study information for relatives/parents/legal representatives (ClinO)

Template for writing the study information for relatives/parents/legal representatives according to ClinO

Deutsch
1.2
updated: 28.11.2017
Français
1.3
updated: 28.11.2017
Italiano
1.3
updated: 28.11.2017
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

HRO with persons (HRO chap. 2)

Template of swissethics 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
2.4
updated: 17.10.2019
Français
2.5
updated: 17.10.2019
Italiano
2.4
updated: 17.10.2019
Study information for relatives/parents/legal representatives (HRO)

Template for writing the study information for relatives/parents//Eltern/legal representatives according to HRO

Deutsch
1.3
updated: 30.11.2017
Français
1.4
updated: 30.11.2017
Italiano
1.4
updated: 30.11.2017

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.

Deutsch
2019/2_D
Français
2019/2_F
Italiano
2019/2_I
Template for a patient information/informed consent for the collection of biological material according to HRA/HRO art. 8

Please use this template:

  1. for an additional (prospective) collection of biological material as part of a regular planned collection during a routine examination,
  2. for a (prospective) collection in connection with a research project that has already been approved by the Ethics Committee,
  3. for a (prospective) collection of biological material without the patient being under any treatment.
Deutsch
1.0
updated: 01.10.2019
Français
1.0
updated: 01.10.2019
Italiano
1.0
updated: 01.10.2019
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


GDPR

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