Human research legislation

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

Swiss Federal Human Research Act (HRA, RS 810.30)

The HRA lays down key guidelines that have to be followed in research projects involving humans.
The main goal of the legislation is to safeguard the dignity, privacy and health of people involved in research. A secondary goal is to create a favourable framework for research and enhance its quality and transparency.

Ordinance on Clinical Trials with the exception of Clinical Trials of Medical Devices (ClinO; RS 810.305)

The ClinO regulates clinical trials involving humans with the exception of clinical trials of medical devices. A clinical trial is defined as a research project involving humans assigned to a specific health-related intervention, for example the use of a particular drug. The aim of a clinical trial is to investigate the effects of the intervention on health or the structure and function of the human body.

Ordinance on Clinical Trials with Medical Devices (ClinO-MD; RS 810.306)

European law has tightened the control mechanisms for medical devices following a number of incidents. Switzerland also decided to revise its medical devices legislation and bring it into line with the EU provisions. A new ordinance, ClinO-MD, has been drawn up on the basis of this revision. Since 26 May 2021, ClinO-MD has governed clinical trials with medical devices that were previously governed by ClinO. Under the terms of ClinO-MD, a clinical trial is the systematic investigation of a device involving one or more persons for the purpose of assessing the safety or performance of the device. As of 26 May 2022, in vitro diagnostic medical devices are similarly governed by ClinO-MD.

Human Research Ordinance (HRO; RS 810.301)

The HRO regulates all research projects involving humans that do not qualify as clinical trials. This includes, for example, the collection of health-related data or the further use for research of pre-existing biological material.  

HRA Organisation Ordinance (OrgO-HRA; RS 810.308)

The OrgO-HRA defines how the ethics committees and the Coordination Office for Human Research (kofam) are organised.

Further legally binding rules and classifications

According to Annex 1 of the ClinO, the following rules and classifications are applicable:

 

According to Art. 10 para. 4 OrgO-HRA the following rules and classifications are in force:

According to ClinO-MD, the following rules are applicable:

Further information

The evolution of human research legislation

The federal legislation on human research replaces a confusing and incomplete array of different laws, implementing an article of the Federal Constitution that allows the Confederation to enact rules governing research.

Last modification 19.04.2022

Top of page

Contact

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

Coordination Office for Human Research (kofam)

www.kofam.ch

E-mail

Print contact

https://www.bag.admin.ch/content/bag/en/home/gesetze-und-bewilligungen/gesetzgebung/gesetzgebung-mensch-gesundheit/gesetzgebung-forschung-am-menschen.html