Current legislative project: Revision of Ordinances

The implementing provisions for the Human Research Act have been revised by the FOPH. It has adapted the HRA Ordinances in line with national and international developments in human research.

On 6 December 2019, the Federal Council requested the Federal Department of Home Affairs (FDHA) to undertake a revision of the Ordinances associated with the Federal Act on Research involving Human Beings (Human Research Act, HRA). 

With the revision of the HRA Ordinances,

• the conditions for and transparency of human research are to be improved,
• digitalisation developments in the research sector are to be taken into account, and
• the division of responsibilities between federal and cantonal authorities is to be aligned with practice.

The amendments concern all the Ordinances associated with the HRA:

• the Clinical Trials Ordinance; ClinO (SR 810.305)
• the Ordinance on Clinical Trials with Medical Devices; ClinO-MD (SR 810.306)
• the Human Research Ordinance; HRO (SR 810.301)
• the HRA Organisation Ordinance; OrgO-HRA  (SR 810.308)

Also affected by the amendments is the Ordinance associated with the Stem Cell Research Act:

• the Stem Cell Research Ordinance; SCRO (SR 810.311)

On 26 April 2023, the Federal Council opened the consultation procedure on the partial revision of the implementing legislation for the HRA. The consultation procedure ran until 16 August 2023.

The opinions submitted as part of the consultation procedure by the cantons, the parties and other interested circles, as well as the report on the results of the consultation, can be found on the Federal Chancellery’s website “Concluded consultation procedures" (report available in French, German and Italian).

On 7 June 2024 the Federal Council approved the partial revision of the implementing ordinances and adopted the amended ordinances. 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 on the implementation of the amendments to the ordinances can be found on the Website of the Coordination Office for Human Research (Kofam).

At the same time as adopting the partial revision of the HRA ordinances, the Federal Council instructed the FDHA to revise the HRA and submit a draft bill to it by the end of 2026.

Documents

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See website in German, French and Italian (no documents in English available)

Links

Procédures de consultation terminées - 2023

Website of the Coordination Office for Human Research - Kofam

Legislation

Press releases

Press releases are available in German, French and Italian.

Last modification 10.07.2024