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.
The comprehensibility of the patient information and consent forms is a prerequisite for good, fair and correct information concerning participation in clinical trials and research projects. The example-based guideline succinctly lists the essential aspects needed for a comprehensible information document: the information must be provided in a step-by-step, coherent and descriptive manner using simple words and layman-comprehensible sentences, as well as appropriate visualizations.
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)
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)
Template for writing the study information for relatives/parents/legal representatives according to ClinO, ClinO-MD
Guideline of swissethics for drafting and using a concise study information in case of amendments to the study protocol
Template of swissethics for writing the concise study information - short form - in case of amendments to the study protocol
Template for drafting information for pregnant study participants or pregnant partners of study participants
Guideline of swissethics on the conception and application of an electronic informed consent (eIC) in clinical trials, according to ClinO
Research projects with persons (HRO chap. 2)
Template of swissethics for HRO with persons, according to HRA/HRO chapter 2 (neither ClinO nor HRO chapter 3 "further use")
Template for writing the study information for relatives/parents//Eltern/legal representatives according to HRO
Further use of biological material and personal data (HRO chap. 3) / Biobanks
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. As per the swissethics statement of 22 February 2019 on the generla consent (link): “Every institution that uses the general consent is obliged to respect national and international norms and standards for the data banks (registries) and biobanks. In this way, the rights of donors who voluntarily participate in the research can be guaranteed.
The general consent can be used in principle for people who are capable of discernment. If a legal representative has to sign in the event of incapacity in the consent procedure, the patient himself has to agree again when he regains his capacity. More detailed information will be provided at a later stage on the specific requirements for the incapacity in the consent procedure and for children and adolescents.” (See in particular the recommendations of unimedsuisse of 12 January 2020 (link)).
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.
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.
Template of swissethics for the further use of biological material and genetic personal data in uncoded form for a research project (art. 28 HRO)
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
Recommendations
Consensus paper of swissethics / SCTO (Swiss Clinical Trial Organisation)