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)

The Swiss Federal Human Research Act (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.

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.

Clinical Trials Ordinance (ClinO)

The Ordinance on Clinical Trials in Human Research (ClinO) regulates clinical trials involving humans. 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 on health or the structure and function of the human body.

Human Research Ordinance (HRO)

The Ordinance on Human Research with the Exception of Clinical Trials (HRO) regulates all research projects involving humans that do not quality 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)

The Ordinance on Organisational Aspects of the Human Research Act (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 Clinical Trials Ordinance (ClinO), the following rules and classifications are applicable:

Last modification 17.08.2018

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Human Research Section
Schwarzenburgstrasse 157
3003 Berne
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