News
Revision of the HRA Ordinances and e-consent - entry into force on 1.11.2024
08.08.2024
With the entry into force of the revised ordinances to the HRA, it will now also be possible to obtain the electronic consent of study participants in clinical trials and research projects (e-consent, cf. ClinO art. 7c, ClinO-Mep art. 25 lit. dbis, and HRO art. 8 para. 3).
Read moreUPDATE: New implementing regulations apply as of 1 November 2024
15.07.2024
Now with weblinks to the adapted Ordinances:
The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.
Read moreInvolvement of patients and research participants in ethics review processes
09.07.2024
The active involvement of patients in clinical research is essential and its added value is undisputed. The inclusion of the experience of living with illness and active participation in the evaluation of research applications is important and helpful. Since 2022, patient representatives have been legally required within the research ethics commission.
Read moreNew implementing regulations apply as of 1 November 2024
07.06.2024
The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.
Read moreswissethics publishes recommendations on research adapted to "sex and gender"
19.04.2024
"Sex and gender" equity is a very important topic in medical research and clinical practice. In 2020, swissethics published recommendations on the topic of "sex and gender"-equitable research. A working group has now addressed the topic further and developed instructions on how to implement the aspect of "sex and gender" in research in an ethically appropriate manner.
Read moreLatest changes to the ICF template for clinical trials
07.11.2023
Following comments from various stakeholders and after careful evaluation, swissethics is publishing a new and revised version of the ICF template for clinical trials. The focus continues to be on the comprehensibility of the text for laypersons through a clear and simple choice of words, good structuring and visualization of the text.
Read moreswissethics 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.
Read moreConsortium 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.
Read moreElection 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.