Regulation of human research in Switzerland

Research involving human beings in Switzerland is regulated by the Federal Act on Research involving Human Beings (Human Research Act, HRA) and the four associated Ordinances.

Purpose and scope of the Human Research Act (HRA)

The Human Research Act (HRA), together with the associated Ordinances, has been in force since 1 January 2014.

The purpose of the HRA is to protect the dignity, privacy and health of persons involved in research. In addition, the Act is designed to create favourable conditions for human research, as well as helping to ensure quality and transparency.

Falling within the scope of the HRA is not only research involving human beings but also research involving biological material of human origin, health-related personal data, deceased persons, and human embryos and foetuses.

The HRA does not apply to research involving human embryonic stem cells, which is regulated by the Stem Cell Research Act (StRA).

Ordinances (implementing provisions)

The Ordinances associated with the HRA specify in more detail the ethical, scientific and legal requirements to be observed in human research.
The implementing provisions comprise four Ordinances:

• the Ordinance on Clinical Trials with the Exception of Clinical Trials of Medical Devices (ClinO);
• the Ordinance on Clinical Trials with Medical Devices (ClinO-MD);
• the Ordinance on Human Research with the Exception of Clinical Trials (HRO) and
  
• the Ordinance on Organisational Aspects of the Human Research Act (OrgO-HRA).

Evaluation of the HRA

The HRA was evaluated from 2017 to 2019. The evaluation (in French and German) showed that the regulations are purposeful on the whole, although there is room for improvement. The evaluation assessed whether the purpose of the HRA – the protection of dignity, privacy and health of human beings involved in research, the creation of favourable conditions for research and ensuring quality and transparency – were achieved and the requirements are appropriate. The results, supplemented by departmental research projects conducted by the FOPH, led to 13 optimisation recommendations.

Revision of the Ordinances and the law

The results of the HRA evaluation were duly noted by the Federal Council on 6 December 2019. Based on these results, the Federal Council commissioned the FOPH to conduct a partial revision of the HRA’s implementing ordinances. 

On 7 June 2024, the Federal Council adopted amendments to the implementing ordinances. They came into force on 1 November 2024 with the exception of the transparency provisions, which came into force on 1 March 2025. Further information can be found on the website "Concluded legislative project: revision of associated Ordinances".

The evaluation also showed that the provisions of the HRA on the further use of personal data and biological material for research purposes, among other things, are no longer up to date. Therefore, on June 7, 2024, the Federal Council commissioned the Federal Department of Home Affairs (FDHA) to revise the Human Research Act and to submit a draft law to it by the end of 2026.

Documents

Note: the legislative documents concerning the HRA and its ordinances are available only in German, French and Italian language. 

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Links

• 03.3007 - Motion on research on humans, constitutional basis
• 07.072 – Federal Council business, constitutional provision
• 98.3543 - Motion to create a federal law on medical research involving humans
• 09.079 - Federal Council business: research involving humans, federal act
• Bericht über die Ergebnisse des Vernehmlassungsverfahrens zum Vorentwurf einer Verfassungsbestimmung und eines Bundesgesetzes über die Forschung am Menschen (only in German, French and Italian)

Legislation

Press releases

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To the Federal Administration News Portal

Further information

Last modification 01.03.2025