| Expertises and reports | |||
|---|---|---|---|
| Statistical Report 2019 | 2 MB | download | |
| Summary of the 2019 annual reports of the ethics committees 2019 | 335 KB | download | |
| kofam annual report 2019 | 115 KB | download | |
| 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 | |
| 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 536/2014 über klinische Prüfungen mit Humanarzneimitteln (only in german) | 2 MB | download | |
| Legislation governing research involving humans | |||
|---|---|---|---|
| Human Research Act, HRA | URL | Visit Link | |
| Human Research Ordinance, HRO | URL | Visit Link | |
| Clinical Trials Ordinance, ClinO | URL | Visit Link | |
| Ordinance on clinical trials with medical devices, ClinO-MD, only in German/French/Italian | URL | Visit Link | |
| Explanatory report on the total revision of the Medical Devices Ordinance and Ordinance on Clinical Trials with Medical Devices (new medical devices regulation) (May 2019), only in German/French/Italian | URL | Visit Link | |
| HRA Organisation Ordinance, OrgO-HRA | URL | Visit Link | |
| Further legal foundations | |||
|---|---|---|---|
| Therapeutic Products Act, TPA | URL | Visit Link | |
| Medical Device Ordinance, MedDO | 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 | |||
|---|---|---|---|
| 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 | |||
|---|---|---|---|
| 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 | 1 MB | download |
| Infographics «Applications & procedure»: pdf dossier | 6 MB | download | |
| Infographics «Categorization of clinical trials with medical devices» | 58 KB | download | |