News
In memoriam Professor Dr. med. Peter Meier-Abt
31.05.2021
Peter Meier Abt passed away on May 27, 2021. He was a lifelong advocate for medicine in Switzerland and far beyond at universities, at the Swiss Academy of Medical Sciences, and other institutions.
Read moreThe Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force
26.05.2021
The Medical Device Regulation (MDR) in the EU and the Ordinance on clinical trials with medical devices (ClinO-MD) in Switzerland came into force today, May 26, 2021.As of today, all new clinical trials with medical devices must be submitted to the Ethics Committee using the new submission form “RESEARCH PROJECT APPLICATION FORM FOR MEDICAL DEVICES”, which meets the requirements of MDR and ClinO-MD.
swissethics publishes a new template of the patient information for the “Re-Consent”
13.04.2021
In clinical trials, sometimes fundamental conditions change in the course of the study, for example when new safety data are available or it is clear that the participants are exposed to a (new) risk. In this case, an amendment is submitted to the ethics committee and the participants must be informed accordingly and give their consent in writing (so-called "re-consent").
Read moreClinical 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 moreClinical 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.
If you are planning to submit a new clinical investigation with a medical device before May 26, 2021, or if you currently have a clinical investigation with a medical device under review by the ethics committee, we strongly advise you to read on the swissethics.ch website how the transition of such investigations is to be regulated.
Weblinks to the instructions in English, German, French and Italian on the swissethics.ch website.
Weblink to the newsletter of April 1st 2021.
Publication 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.
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.
Read more