News
Comprehensibility as an ethical dimension
14.12.2022
The new template for the patient information for clinical trials is based on linguistic criteria for comprehensibility and at the same time meets the regulatory and legal requirements. It was developed and elaborated by swissethics (working group with consultation of all ethics committees) in collaboration with Prof. Dr. Felix Steiner and his team (previously at the ‘Zurich University of Applied Sciences’, ZHAW). Prof. Steiner was mandated by the FOPH to carry out a systematic analysis of information documents to assess their comprehensibility. As of now, the use of the new template is obligatory for clinical trials submitted to the ethics committees. In a transitional period until 31.03.2023, the old template is also still accepted.
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.
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