Revision of the Human Research Act and the Stem Cell Research Act

The FOPH has started work on the revision of these two Acts. With this revision, the legal requirements are to be adapted to technological and social developments.

On 7 June 2024, the Federal Council requested the Federal Department of Home Affairs (FDHA) to undertake a revision of the Human Research Act (HRA) and to submit a draft for consultation by the end of 2026. Concurrently, the Stem Cell Research Act (StRA) is also to be revised. With the revision of this legislation, the legal requirements are to be adapted to technological and social developments. The FOPH is currently preparing a preliminary draft for the revision of the HRA and of the StRA.

This work is focusing, in particular, on the following amendments:

  • The HRA and the StRA are closely interrelated: they both regulate research involving human beings, and the arrangements for enforcement are comparable. Integration of the requirements for stem cell research into the HRA is therefore being considered. At the same time, the requirements of the StRA are to be adapted to the latest developments in research.
  • Enforcement of the HRA is to be further harmonised, and the feasibility of a standardised national submission portal for the approval of applications is being examined.
  • Various provisions are being considered to enhance the efficiency of access to and further use of data and biological material for research purposes. At the same time, protection of the dignity and privacy of research participants, data protection and data security are also to be assured.

Revision of Ordinances completed

Prior to the revision of the HRA and the StRA, the associated Ordinances were revised. In this connection, the Federal Council conducted a consultation procedure in 2023. The comments submitted by the cantons, political parties and other stakeholders, as well as the report on the results of the consultation, can be found on the Completed consultation procedures website of the Federal Chancellery (available in French, German and Italian).

On 7 June 2024, the Federal Council approved the partial revision of the implementing provisions and adopted the amended Ordinances. The amended Ordinances came into force on 1 November 2024, with the exception of the provisions on transparency, which came into force on 1 March 2025.

With the revision of the Ordinances associated with the HRA, the conditions for and transparency of human research have been improved, digitalisation developments in the research sector have been taken into account, and the division of responsibilities between federal and cantonal authorities has been brought into line with practice. The amendments concern all the Ordinances associated with the HRA and the Ordinance associated with the StRA.

Further information on the current HRA and the associated Ordinances can be found on the website Regulation of human research in Switzerland.

Further information

Further topics

Federal Office of Public Health FOPH

Biomedicine Division
Human Research Section
Schwarzenburgstrasse 157
Switzerland - 3003 Bern