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.