Expertises and reports | |||
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Summary report of the activity reports of the Ethics Committees 2018 | 2 MB | download | |
Statistical Report 2018 | 2 MB | download | |
kofam annual report 2018 | 98 KB | download | |
Summary report of the activity reports of the Ethics Committees 2017 | 750 KB | download | |
kofam annual report 2017 | 73 KB | download | |
Summary report of the activity reports of the Ethics Committees 2016 | 210 KB | download | |
kofam annual report 2016 | 88 KB | download | |
Summary report of the activity reports of the Ethics Committees 2015 | 2 MB | download | |
Activities of the ethics committees for research – Summary report 2014 | 600 KB | download | |
Factsheet containing general information on the HRA and the ethics committees | 828 KB | download | |
Overview on research on humans in Switzerland | 2 MB | download | |
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 | download | |
Table comparing Clinical Trials Ordinance (ClinO) and CTR (only in German) | 636 KB | download | |
Auswirkungen der VO 356/2014 über klinische Prüfungen mit Humanarzneimitteln (only in german) | 2 MB | download |
Legislation governing research involving humans | |||
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Human Research Act, HRA | URL | Visit Link | |
Human Research Ordinance, HRO | URL | Visit Link | |
Clinical Trials Ordinance; ClinO | URL | Visit Link | |
HRA Organisation Ordinance, OrgO-HRA | URL | Visit Link |
Further legal foundations | |||
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Therapeutic Products Act, TPA | URL | Visit Link | |
Transplantation Act | URL | Visit Link | |
Federal Act on Data Protection, FADP | URL | Visit Link | |
Reproductive Medicine Act, RMA | URL | Visit Link | |
Stem Cell Research Act, StRA | URL | Visit Link | |
Radiological Protection Act, RPA | URL | Visit Link | |
Radiological Protection Ordinance, RPO | URL | Visit Link | |
Release Ordinance, RO | URL | Visit Link | |
Federal Act on Human Genetic Testing, HGTA | URL | Visit Link | |
Guideline for Good Clinical Practice issued by the International Conference on Harmonisation, in the version dated 9 November 2016 (ICH Guideline) | URL | Visit Link | |
Guidelines on Medical Devices (MEDDEV 2.7/3, May 2015) | 353 KB | download |
Guidelines and recommendations | |||
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Directives of the SAMS | URL | Visit Link | |
Declaration of Helsinki | URL | Visit Link | |
WMA Declaration of Taipei | URL | Visit Link | |
CIOMS-Guidelines | URL | Visit Link | |
Good Clinical Practice (GCP) Guidelines of the European Union | URL | Visit Link | |
Good Manufacturing Practice (GMP) Guidelines of the European Union | URL | Visit Link | |
Recommendations of the European Counsil on research on biological materials | URL | Visit Link | |
Guidelines on preparation of ethic committee reports (only available in German, French and Italian) | 121 KB | download | |
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 | download |
Demonstration materials | |||
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Film «Human research in Switzerland - Main points in brief» | ZIP | 325 MB | download |
Movie «Human research projects in Switzerland – authorisation, classification and submission of applications» | ZIP | 210 MB | download |
Infographics «Research on humans»: individual documents | ZIP | 796 KB | download |
Infographics «Research on humans»: pdf dossier | 4 MB | download | |
Infographics «Applications & procedure»: individual documents | ZIP | 873 KB | download |
Infographics «Applications & procedure»: pdf dossier | 6 MB | download |