Information on the coronavirus: new and updated document “Joint guidance document on the management of clinical trials with medicinal drug products in Switzerland during the COVID-19 pandemic”

05.11.2020

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.

Updated 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.