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Research on humans
Amendment of the HRA ordinances
Symposium
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
SNCTP Portal
Searching for a clinical trial
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Expertises and reports
Statistical Report 2022
4.28 MB
Annual summary report of the ethics commissions 2023
1.76 MB
Annual summary report of the ethics commissions 2022
1.64 MB
Statistical Report 2022
5 MB
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
Further legal foundations
Therapeutic Products Act (TPA)
(Link)
Radiological Protection Ordinance (RPO)
(Link)
Therapeutic Products Act (TPA)
(Link)
Therapeutic Products Act (TPA)
(Link)
Therapeutic Products Act (TPA)
(Link)
Radiological Protection Act (RPA)
(Link)
Medical Devices Ordinance (MedDO)
(Link)
Therapeutic Products Act (TPA)
(Link)
Transplantation Act
(Link)
Data Protection Act (FADP)
(Link)
Reproductive Medicine Act (RMA)
(Link)
Stem Cell Research Act (StRA)
(Link)
Release Ordinance (RO)
(Link)
Federal Act on Human Genetic Testing (HGTA) (only available in German, French and Italian)
(Link)
Guideline on Good Clinical Practice of the International Conference on Harmonisation in the version of 9 November 2016 (ICH Guideline)
(Link)
Guidelines and recommendations
SAMS Guidelines
(Link)
Declaration of Helsinki
(Link)
Declaration of Taipei
(Link)
CIOMS Guidelines
(Link)
Good Clinical Practice (GCP) Directive of the European Union
(Link)
Good Manufacturing Practice (GMP) Directive of the European Union
(Link)
Recommendations of the Council of Europe on research with biological 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
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)
Ordinance on Clinical Trials with Medical Devices (ClinO-MD)
(Link)
Explanatory report on the complete revision of the Ordinance on Medical Devices and the Ordinance on Clinical Trials with Medical Devices (new medical devices regulations) (Mai 2019)
(Link)
Ordinance for Clinical Trials with Medical Devices (ClinO-MD)
(Link)
Dispatch on the Federal Act on Research involving Human Beings (only available in German, French and Italian)
(Link)
(Only in German/French/Italian) Explanatory Report on the Ordinances on the Human Research Act (August 21, 2013)
513 KB
(Only in German/French/Italian) Explanatory report on the revision of the ordinances on the Human Research Act (June 7, 2024)
510 KB
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)
BASEC
pre-BASEC form
25 KB
BASEC
(Link)
Demonstration materials
Partial revision of the HRA and StRA ordinances 2024 - Slideset for enforcement authorities and researchers
622 KB
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»: pdf dossier
3.59 MB
Infographics «Applications & procedure»: pdf dossier
5.82 MB
Infographics «Categorization of clinical trials with medical devices»
58 KB
