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, the accompanying ordinances and further legislation

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 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. Since 26 May 2022, in vitro diagnostic medical devices have also been 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 are organised.

Further legally binding rules and classifications

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

Principles and Procedures for Integrity in Scientific Research of the Swiss academies of arts and sciences, dated May 2021 - only available in German, French and Italian.
Guideline for Good Clinical Practice issued by the International Conference on Harmonisation, in the version dated 9 November 2016 (ICH Guideline)
Annexes VIII and X to Directive 93/42/EEC3 and Annexes 6 and 7 to Directive 90/385/EEC4 and the requirements specified in EN ISO 14155:2011 for clinical trials of products as defined in Art. 2a, para. 2, TPA (the definition of serious adverse events in accordance with Article 42 is based on the Guidelines on Medical Devices (MEDDEV 2.7/3) of December 2010)
The new version (standard EN ISO 14155), updated in 2020, has come into force. Annex 1 will thereforeus be amended in the near future.

International Classification of Diseases issued by the World Health Organization (WHO) (ICD-10), 2010 version. The relevant disease groups are those identified by three-character codes.
A new version (ICD-11) came into force on 1 January 2022; the Annex will therefore be amended in the near future.

According to Art. 10 para. 1 let. c OrgO-HRA the following rules and classifications are in force:

Guidelines on preparation of ethics committee reports (PDF, 121 kB, 02.03.2017)(only available in German, French and Italian)

Procedures concerning the reporting by the FOPH to the public on the activities of the ethics committees (PDF, 46 kB, 29.03.2017)(only available in German, French and Italian)

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

Further information

Regulation of human research in Switzerland

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