News
swissethics publishes the updated templates of the protocols for research projects of further use
27.08.2021
The further use of data and samples for research purposes accounts for an increasingly growing proportion of all research projects conducted in Switzerland. Questions on Big Data and data sharing, e.g. also in the context of large national projects such as SPHN, are often in the foreground.
Read moreFederal Council breaks off negotiations on the institutional agreement with the EU: Consequences for the clinical research of medical devices in Switzerland
31.05.2021
On May 26, the Medical Device Regulation (MDR) at EU level and in Switzerland the ordinance for clinical trials of medical devices (ClinO-MD) came into force. At the same time, Switzerland broke off the negotiations on the framework agreement with the EU.
Read moreIn 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").
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