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Research on humans
Protecting humans
Legislation
Stakeholders and their rights and obligations
Determinants for human research projects
Applications & procedure
Manual entry of pre-BASEC studies into the SNCTP
Authorisation of research projects
Projects that do not require authorisation
Research projects involving persons that require authorisation
Research projects in the area of further use that require authorisation
Submission of applications
Procedure for research projects involving radiation sources or therapeutic products capable of emitting ionising radiation
Clinical trials with medical devices, including in-vitro diagnostic products: changes in the legal requirements
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Expertises and reports
Annual summary report of the ethics commissions 2021
399 KB
Statistical report 2021
2.59 MB
Summary of the 2020 annual reports of the ethics committees
620 KB
Statistical Report 2020
3.74 MB
kofam annual report 2020
107 KB
kofam annual report 2019
115 KB
Summary of the 2019 annual reports of the ethics committees 2019
335 KB
Statistical Report 2019
2.37 MB
Summary report of the activity reports of the Ethics Committees 2018
2.05 MB
Statistical Report 2018
2.18 MB
kofam annual report 2018
98 KB
Summary report of the activity reports of the Ethics Committees 2017
750 KB
kofam annual report 2017
73 KB
Summary report of the activity reports of the Ethics Committees 2016
210 KB
kofam annual report 2016
88 KB
Summary report of the activity reports of the Ethics Committees 2015
1.6 MB
Activities of the ethics committees for research – Summary report 2014
600 KB
Overview on research on humans in Switzerland
1.61 MB
Comparison between the Federal Act on Research involving Human Beings incl. the Clinical Trials Ordinance as well as the new Regulation (EU) No 536/2014 of 16 April on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
824 KB
Table comparing Clinical Trials Ordinance (ClinO) and CTR (only in German)
636 KB
Auswirkungen der VO 536/2014 über klinische Prüfungen mit Humanarzneimitteln (only in german)
1.63 MB
Authorisation authorities
Ethics Committee of Zurich
(Link)
Ethics Committee of Berne
(Link)
Ethics Committee for North-West and Central Switzerland
(Link)
Ethics Committee of East Switzerland
(Link)
Ethics Committee of Ticino
(Link)
FOPH Transplantation (only in German, French and Italian)
(Link)
Ethics Committe of Geneva
(Link)
swissethics
(Link)
SECB
(Link)
FOEN Biotechnology
(Link)
FOPH Biosafety
(Link)
Ethics Committee of Vaud
(Link)
FOPH Radiation Protection (only in German, French and Italian)
(Link)
Swissmedic
(Link)
Legislation governing research involving humans
Human Research Ordinance (HRO)
(Link)
Art. 118b of the Federal Constitution
(Link)
(Only in German/French/Italian) Constitutional Article 118b on research involving human subjects
466 KB
Clinical Trials Ordinance (ClinO)
(Link)
HRA Organisation Ordinance (OrgO-HRA)
(Link)
Verordnung über klinische Versuche mit Medizinprodukten, KlinV-Mep
(Link)
Erläuternder Bericht zur Totalrevision der Medizinprodukteverordnung und Verordnung über klinische Versuche mit Medizinprodukten (neue Medizinprodukte-Regulierung) (Mai 2019)
(Link)
Ordinance for Clinical Trials with Medical Devices (ClinO-MD)
(Link)
Human Research Act (HRA)
(Link)
(Only in German/French/Italian) Explanatory Report on the Ordinances on the Human Research Act (August 21, 2013)
513 KB
Further legal foundations
Therapeutic Products Act (TPA)
(Link)
Therapeutic Products Act (TPA)
(Link)
Therapeutic Products Act (TPA)
(Link)
Therapeutic Products Act (TPA)
(Link)
Federal Act on Data Protection (FADP)
(Link)
Transplantation Act
(Link)
Medizinprodukteverordnung, MepV
(Link)
Reproductive Medicine Act (RMA)
(Link)
Stem Cell Research Act (StRA)
(Link)
Federal Act on Human Genetic Testing (HGTA)
(Link)
Radiological Protection Act (RPA)
(Link)
Strahlenschutzgesetz, StSG
(Link)
Strahlenschutzverordnung, StSV
(Link)
Freisetzungsverordnung, FrSV
(Link)
Radiological Protection Ordinance (RPO)
(Link)
Leitlinie der Guten Klinischen Praxis der Internationalen Harmonisierungskonferenz in der Fassung vom 9. November 2016 (ICH-Leitlinie)
(Link)
Guidelines on Medical Devices (MEDDEV 2.7/3, May 2015)
353 KB
Guidelines and recommendations
SAMW Richtlinien
(Link)
Helsinki-Deklaration
(Link)
Deklaration von Taipei
(Link)
CIOMS-Guidelines
(Link)
Good Clinical Practice (GCP) Richtlinie der Europäischen Union
(Link)
Good Manufacturing Practice (GMP) Richtlinie der Europäischen Union
(Link)
Empfehlungen des Europarats zur Forschung mit biologischem Material
(Link)
Guidelines on preparation of ethic committee reports (only available in German, French and Italian)
121 KB
Procedures concerning the reporting by the FOPH to the public on the activities of the ethics committees (only available in German, French and Italian)
46 KB
Demonstration materials
Casestudies for performance studies with IVDs
111 KB
Infographic "Categorisation of performance studies with IVDs"
63 KB
Film «Human research in Switzerland - Main points in brief»
324.71 MB
Movie «Human research projects in Switzerland – authorisation, classification and submission of applications»
209.89 MB
Infographics «Research on humans»: individual documents
796 KB
Infographics «Research on humans»: pdf dossier
3.67 MB
Infographics «Applications & procedure»: individual documents
1.36 MB
Infographics «Applications & procedure»: pdf dossier
5.84 MB
Infographics «Categorization of clinical trials with medical devices»
58 KB
BASEC
pre-BASEC form
25 KB
BASEC
(Link)
