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).

Developments in the field of digitalisation and the possibilities of data processing mean that the provisions of the Human Research Act, particularly those related to the further use of personal data and biological material for research purposes, are no longer up to date. For this reason, on 7 June 2024 the Federal Council charged the Federal Department of Home Affairs (FDHA) with revising the HRA and submitting a draft act by the end of 2026.

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).

On 7 June 2024 the Federal Council adopted the amendments to the implementing ordinances. They enter into force on a staggered basis from 1 November 2024. You will find more information and the provisional amending enactments on the "Current legislative project: Revision of Ordinances" site.


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 Medical devices legislation under "Documents".


Human research legislation

In Switzerland, research involving humans is governed by the Human Research Act and its implementing ordinances. The legislation is primarily designed to safeguard the dignity, privacy and health of people involved in research.

Press releases

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To the Federal Administration News Portal

Further information

Current 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.

Last modification 11.06.2024

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Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Bern
Tel. +41 58 463 51 54

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