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 (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)

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

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 lasted until 16 August 2023.

The comments received from the cantons, political parties and other interested parties as part of the consultation process are available on the Federal Chancellery's "Completed consultation procedures" website.

The FOPH is currently evaluating the comments.

The ordinances submitted for consultation are currently being revised. It is planned that the Federal Council will bring the revised ordinances into force in the 4th quarter of 2024.

Documents

---

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

Links

Laufende Vernehmlassungen EDI

Legislation

Press releases

Java script is required to display press releases. If you are unable or unwilling to activate Java script you may use the link below to access the Federal Administration News Portal, where you can read the announcements.

To the Federal Administration News Portal

Last modification 02.02.2024