swissethics publishes recommendations on research adapted to gender

16.12.2020

Gender equity in research is an important issue: there are significant differences between men and women in many clinical drug trials, as well as in non-clinical trials with persons or in research projects of further use of health-related personal data and biological material.

The published recommendations address essential steps towards equitable research between the sexes, with ethics commissions playing an important role in the evaluation of the applications.

The recommendations are published in German and French.

Guidance document on the use of food stuffs and food supplements in research

07.12.2020

swissethics has published a short guidance document regarding the use of food stuffs and food supplements in research. These products could be classified as investigational medicinal products (IMP) according to ClinO, in which case they would have to be made according to GMP and be submitted to the ethics committee and Swissmedic.

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

Due to the current situation, changes were introduced in the document “Joint guidance of swissethics - Swissmedic on the conduct of clinical trials during COVID-19 pandemic”. Details related to the changes are outlined in the guidance paper.

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).