News
Election of the presidency and vice-presidency of swissethics and information concerning the validity period of approvals issued by the ethics committees
14.03.2023
At the general assembly of swissethics, Ms. Dr. Susanne Driessen was confirmed and re-elected as President and Dr. iur. Jürg Müller as Vice President. Ms. Prof. Dr. Caroline Samer, currently Vice President of the Ethics Committee Geneva, was newly elected as Vice President.
The swissethics executive board of directors has decided, on the proposal of the lawyers of the Ethics Committees, that as of March 1, 2023, approvals for clinical trials and research projects will be limited to a period of five years. After five years, the ethics committee will decide whether the project can continue with the documents approved at that time or whether adjustments are necessary. Further details on this process will be communicated at a later date.
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.
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