Regulations for health-related personal data registries

17.12.2024

swissethics publishes a new template for regulations for health-related personal data registries. This template defines the ethical and regulatory requirements necessary for the conduct of further use research projects with the data from registries.

UPDATE: Revision of the HRA Ordinances

17.10.2024

Publication of the 'Swiss specific addendum' for clinical trials according to ClinO

Swissmedic and swissethics have communicated that applications under the ClinO that are submitted before November 1, 2024, under the old law can only be approved under the new law after November 1, 2024.

UPDATE: Revision of the HRA Ordinances

16.09.2024

Publication of the updated templates

Instructions on the procedure for submitting applications before 1 November 2024

The revision of the ordinances of the Human Research Act (HRA), which will come into force on November 1, 2024, requires numerous adjustments for investigators and authorities. The most important aspects of the revision concern the «protection of participants» and the improvement of the «framework conditions for research».

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).

UPDATE: 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. 

Involvement 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.

New 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.

swissethics 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.

Latest 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.

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.