The Human Research Act (HRA) is turning 10 years old! Join us on our social media channels and discover interesting insights and highlights from the anniversary and the birthday symposium on November 22, 2024:
More about the symposium: 10 years HRA | Kofam
The four amended ordinances to the Human Research Act came into force on 1 November 2024.
This does not include the new provisions on transparency (e.g., the obligation to publish a summary of clinical trial results), which will not come into force until 1 March 2025. The provisions in question are the amended Section 5 of the ClinO (Art. 64–67) and the amended Section 5 of the ClinO-MD (Art. 41 and 42). This will allow electronic systems to be adapted to the new requirements.
Further information is available at: Amendement of the HRO ordinances
All revised ordinances are now also available in English at the following links:
As of November 1, 2024, the feature of the Categorizer and Casestudies are no longer be available on the kofam website.
For any questions regarding the correct classification or categorization of your research project, please contact your responsible ethics committee.
The enforcement authorities published information for applicants on September 16, 2024, regarding the practical procedure during the transition to the revised ordinances.
Updated instructions and templates are available on the websites of swissethics and Swissmedic.
Further information can be found on the kofam website.
The statistical report "Human Research in Switzerland 2023" and the summary report "Activities of the Research Ethics Committees 2023" are now available in the "Downloads" section of our website.
These reports describe biomedical research in Switzerland governed by the Human Research Act for the year 2023. The information comes from BASEC, which is managed by the umbrella organization of research ethics committees (swissethics), and from the individual activity reports of the cantonal research ethics committees (EKOS, EKNZ, KEK-BE, KEK-ZH, CCER, CER-VD and CE-TI).
Since 1 July 2024, Sponsors of clinical trials with medicinal products, medical devices and novel therapies that are not financed by commercial third-party funding may apply for a fee reduction. Further information can be found on the Swissmedic website:
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.
Further information can be found on the kofam website.
On 7 June 2024, the Federal Council instructed the Federal Department of Home Affairs (FDHA) to revise the Human Research Act (HRA) and submit a draft act to it by the end of 2026. Further information can be found on the page «The regulation of human research in Switzerland».
