News
swissethics publishes four updated templates of the patient information and consent forms for research participants in the context of research with persons
20.09.2020
swissethics publishes four updated templates of the patient information and consent forms for research participants in the context of research with persons: The patient information and consent forms for clinical trials and non-clinical trials are made available to the participants themselves or - if they are lacking capacity - to their legal representatives (or relatives).
Read moreGuidance document for the researchers for the conduct of basic research projects
16.07.2020
It is often unclear whether a basic research project falls within the scope of the Human Research Act (HRA) or not. This depends on whether it is research according to the definition of the HRA (generation of generalisable knowledge), whether it is a research into the function and structure of the human body and whether biological, human material and the data are used in uncoded, coded or anonymised form.
Read moreUpdated submission Form “RESEARCH PROJECT APPLICATION FORM”: New question on the declaration of interests of the principal investigator(s)/institution(s).
13.07.2020
A question on ‘declaration of interests’ of the principal investigator(s)/institution(s) has been added to the form for the submission of clinical trials and research projects. The question is mandatory for all new submissions and for already approved/ongoing clinical trials and research projects. If the question is not answered, the form will display an error on screen 14 preventing the submission of the amendment/changes.
Read moreCovid-19: Changes for the Ethics Committees March to June 2020: Challenges and effects on the number of applications and on the timelines
01.07.2020
The Covid-19 pandemic has posed new and very serious challenges to ethics committees and all other institutions involved in human research. In an overview document swissethics has compiled the most important aspects of the Covid-19 pandemic of the past months for the ethics committees. It shows how the researchers were supported by extremely short processing times despite a considerably larger number of research applications. In addition, ethical standards are discussed, particularly with regard to informed consent. The document is published in German and in French.
Implementation: guiding principles for registers in human research
02.06.2020
Advisory opinion of the ethics committees on registers, biobanks and research projects in accordance with Art. 51 HFG
The pure creation of data registries or biobanks is not formally subject to authorisation under the HRA. However, projects that re-use these data and biological samples must generally be approved by an ethics committee. The ethics committees now offer a preliminary examination of the data registries and biobanks.
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