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ICH adopts E6(R3) guideline on good clinical practices

Publications swissethics

Annual reports and other publications of swissethics

Updated documents

List of documents recently updated by swissethics

News

swissethics is mandated by the Conference of the Cantonal Ministers of Public Health (GDK/CDS)

04.07.2023

At the plenary meeting of the GDK in 2023, the association of research ethics committees swissethics has received a mandate from the Cantons. This mandate includes the recognition of swissethics as the coordinating body of the ethics committees and as a reliable partner and contact point for the general public.

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Consortium for the ecological transformation of the health system

08.06.2023

The Swiss Forum for a Sustainable Health System is taking place today in Bern. Within this framework, the Swiss Consortium for Sustainable Health and Ecological Change in the Health System was founded. swissethics is a member of this consortium, whose aim is to promote synergies between partners, make efforts visible and advance innovative ideas that can reduce the environmental impact of health services.

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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.

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