News
Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
16.03.2021
On May 26, 2021, the Medical Device Regulation (MDR at EU level) and in Switzerland the Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on clinical investigations with medical devices, including investigations on proof of efficacy and safety of medical devices. Hence, many additional documents must be submitted to the ethics committees.
Read morePublication in Jusletter: Human research, further use and informed consent
02.02.2021
swissethics was mandated by the FOPH, Human Research Section, in 2020 to prepare a structured analysis on the further use of health-related personal data and biological material and the application of Article 34 HRA (link to the report in German).
Read moreswissethics 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.
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.
Read moreInformation 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.