swissethics and SwissPedNet publish a guidance document on: inclusion of adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication

30.09.2020

When including adolescents/adolescents in a clinical trial, there are many ethical questions and complex implications such as the possibility of pregnancy in minors and the contraceptive measures to be used depending on their physical and psychological development.

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).

Guidance 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.

Covid-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.