Current legislative project: Revision of Ordinances

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

On 6 December 2019, the Federal Council requested the FOPH to undertake a revision of the Ordinances associated with the Federal Act on Research involving Human Beings (Human Research Act, HRA). Work on the revision was initiated at the beginning of 2020 but had to be suspended during the Covid-19 pandemic, until July 2022.

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
• the Ordinance on Clinical Trials with Medical Devices; ClinO-MD
• the Human Research Ordinance; HRO
• the HRA Organisation Ordinance; OrgO-HRA  

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

• the Stem Cell Research Ordinance; SCRO

The consultation procedure on the partial revision of the implementing provisions for the HRA was opened by the Federal Council on 26 April 2023 and ran until 16 August 2023.

Regularly updated information on the status of the legislative project is published on this page.

The corresponding documentation is available in German, French and Italian in the documents tab on the following websites :

Website in German

Website in French

Website in Italian

Documents

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

Links

Laufende Vernehmlassungen EDI

Legislation

Press releases

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To the Federal Administration News Portal

Last modification 27.09.2023