Regulation of human research in Switzerland

Research involving human beings in Switzerland is regulated by the Human Research Act and the four associated Ordinances.

The Human Research Act (HRA)

The Federal Act on Research involving Human Beings (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).

The HRA and the associated Ordinances can be found under “Legislation” below.

Documents

Note: Explanatory reports on the ClinO-MD, its adaptation in the context of the non-updating of the MRA, as well as its adaptation due to the enactment of the IvDO can be found on FOPH's internet site Revision of Swiss medical devices legislation under "Documents".

• Verfassungsartikel über die Forschung am Menschen (in German) (PDF, 465 kB, 30.04.2010)
• Botschaft zum Verfassungsartikel über die Forschung am Menschen (PDF, 618 kB, 12.09.2007)
• Botschaft zum Entwurf eines Bundesgesetzes über die Forschung am Menschen (in German) (PDF, 828 kB, 07.12.2009)
• Erläuternder Bericht (in German) (PDF, 513 kB, 19.09.2013)Erläuternder Bericht über die Verordnungen zum Humanforschungsgesetz

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• Regulierungsfolgenabschätzung (in German) (PDF, 2 MB, 19.09.2013)Regulierungsfolgenabschätzung zum Entwurf des Ausführungsrechts des Humanforschungsgesetzes (HFG)

Human Research in Switzerland in 2021 (PDF, 2 MB, 25.04.2023)FOPH-Swissethics Statistical Report on the type and number of human research projects

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

Last modification 02.05.2023