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.