News
In vitro diagnostic (IVD) medical devices - Clinical performance studies: Expected changes in the legal requirements and BASEC
16.05.2022
On May 26, 2022, the In Vitro Diagnostic Medical Device Regulation (IVDR at EU level) and in Switzerland the revised Ordinance on clinical trials with medical devices (ClinO-MD) will come into force. Accordingly, new requirements will be placed on IVD performance studies.
Read moreNO to the ban on animal and human experimentation: swissethics rejects the federal popular initiative «Yes to the ban on animal and human experiments» of February 13, 2022
13.01.2022
The Federal Act on Research involving Human Beings (HRA) thoroughly regulates clinical trials and research projects in Switzerland. swissethics is committed to clinical research that meets the highest ethical and scientific standards.
Acceptance of the initiative would create ethically questionable situations. All clinical trials would then be banned in Switzerland, medical care in Switzerland would be put at risk and patients would no longer benefit from new medicines and medical innovations. This is ethically unacceptable.
swissethics supports the positions of unimedsuisse, SAMW and SCTO. These provide further information and arguments on the compelling need to reject this initiative (in German link, in French link).
Comprehensibility as an ethical dimension
29.11.2021
The comprehensibility of the patient information and consent forms is a prerequisite for good, fair and correct information concerning participation in clinical trials and research projects. Unfortunately, not all such documents submitted to ethics committees fulfil this requirement to the desired and necessary extent.
Read morePosition paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products
09.09.2021
The development of novel technologies and digitalization in the field of therapeutic products offers new opportunities. Through the use of these technologies in clinical trials, it is possible that study visits do not always have to be carried out in the hospital, but can also take place at home.
Read moreswissethics 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").
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.
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