Concluded 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. The revised ordinances came into force on 1 November 2024.

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

The Federal Council conducted a consultation procedure on the partial revision of the implementing provisions of the HRA from 26 April 2023 to 16 August. 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 came into force on 1 November 2024, with the exception of the provisions on transparency, which came into force on 1 March 2025.

The ordinances can be found on the publication platform for federal legislation (Fedlex):

• Ordinance on Clinical Trials; ClinO
• Human Research Ordinance; HRO
• Organisational Ordinance HRA; OrgO-HRA
• Ordinance on Clinical Trials with Medical Devices; ClinO-MD
• Stem Cell Research Ordinance; SCRO

The explanatory report of 21 August 2013 on the original ordinances and the explanatory report on the amendments of 7 June 2024 can be found under ‘Documents’ on either the German, French or Italian language site. 

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)

Partial revision of the HRA and StRA ordinances (PDF, 571 kB, 14.03.2025)Information for enforcement authorities and researchers, as at 1 March 2025

Links

Procédures de consultation terminées - 2023

Legislation

Press releases

Press releases are available in German, French and Italian.

Last modification 14.03.2025