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  • Research on humans
    • Protecting humans
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    • 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
  • SNCTP Portal
    • Searching for a clinical trial
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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
  • SNCTP Portal
    • Searching for a clinical trial

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Expertises and reports
Zusammenfassung der Jahresberichte der Ethikkommissionen 2018 PDF 2 MB download
Statistical Report 2018 PDF 2 MB download
kofam Jahresbericht 2018 PDF 99 KB download
Zusammenfassung der Jahresberichte der Ethikkommissionen 2017 PDF 770 KB download
kofam Jahresbericht 2017 PDF 73 KB download
Zusammenfassung der Jahresberichte der Ethikkommissionen 2016 PDF 721 KB download
kofam Jahresbericht 2016 PDF 87 KB download
Zusammenfassung der Jahresberichte der Ethikkommissionen 2015 PDF 2 MB download
Zusammenfassung Tätigkeitsberichte der Ethikkommissionen 2014 PDF 614 KB download
Faktenblatt zum HFG und den Ethikkommissionen PDF 845 KB download
Überblick über die Humanforschung in der Schweiz PDF 2 MB download
Vergleich zwischen dem eidgenössischen Humanforschungsgesetz einschliesslich des Verordnungsrechts sowie der neuen EU-Verordnung vom 16.04.2014 über klinische Prüfungen mit Humanarzneimitteln an Menschen und zur Aufhebung der Richtlinie 2001/20/EG PDF 824 KB download
Tabellarische Übersicht des Vergleichs der KlinV vs. VO 356/2014 PDF 636 KB download
Auswirkungen der VO 356/2014 über klinische Prüfungen mit Humanarzneimitteln PDF 2 MB download
Legislation governing research involving humans
Verfassungsartikel 118b über die Forschung am Menschen PDF 466 KB download
Humanforschungsgesetz, HFG URL Visit Link
Humanforschungsverordnung, HFV URL Visit Link
Verordnung über klinische Versuche; KlinV URL Visit Link
Organisationsverordnung, OV-HFG URL Visit Link
Botschaft zum Bundesgesetz über die Forschung am Menschen URL Visit Link
Erläuternder Bericht über die Verordnungen zum Humanforschungsgesetz (21. August 2013) PDF 513 KB download
Further legal foundations
Heilmittelgesetz, HMG URL Visit Link
Medizinprodukteverordnung, MepV URL Visit Link
Transplantationsgesetz URL Visit Link
Bundesgesetz über den Datenschutz, DSG URL Visit Link
Fortpflanzungsmedizingesetz, FMedG URL Visit Link
Stammzellenforschungsgesetz, StFG URL Visit Link
Strahlenschutzgesetz, StSG URL Visit Link
Strahlenschutzverordnung, StSV URL Visit Link
Freisetzungsverordnung, FrSV URL Visit Link
Bundesgesetz über genetische Untersuchungen beim Menschen, GUMG URL Visit Link
Leitlinie der Guten Klinischen Praxis der Internationalen Harmonisierungskonferenz in der Fassung vom 9. November 2016 (ICH-Leitlinie) URL Visit Link
Guideline on Medical Devices (MEDDEV 2.7/3 vom Mai 2015) PDF 353 KB download
Guidelines and recommendations
SAMW Richtlinien URL Visit Link
Helsinki-Deklaration URL Visit Link
Deklaration von Taipei URL Visit Link
CIOMS-Guidelines URL Visit Link
Good Clinical Practice (GCP) Richtlinie der Europäischen Union URL Visit Link
Good Manufacturing Practice (GMP) Richtlinie der Europäischen Union URL Visit Link
Empfehlungen des Europarats zur Forschung mit biologischem Material URL Visit Link
Richtlinien zur Erstellung der Jahresberichte der Ethikkommissionen PDF 121 KB download
Verfahren hinsichtlich der Berichterstattung des BAG zuhanden der Öffentlichkeit über die Tätigkeiten der Ethikkommissionen PDF 46 KB download
Demonstration materials
Film «Humanforschung in der Schweiz – Das Wichtigste kurz erklärt» ZIP 174 MB download
Film «Humanforschungsprojekte in der Schweiz – Bewilligungspflicht, Klassifizierung und Gesuchseinreichung» ZIP 222 MB download
Infografiken «Forschung am Menschen»: Einzelfiles ZIP 793 KB download
Infografiken «Forschung am Menschen»: PDF Dossier PDF 4 MB download
Infografiken «Gesuche & Verfahren»: Einzelfiles ZIP 884 KB download
Infografiken «Gesuche & Verfahren»: PDF Dossier PDF 6 MB download
Expertises and reports
Rapport de synthèse concernant l'année 2018 PDF 2 MB download
Statistical Report 2018 PDF 2 MB download
kofam rapport annuel 2018 PDF 102 KB download
Rapport de synthèse concernant l'année 2017 PDF 766 KB download
kofam rapport annuel 2017 PDF 68 KB download
Rapport de synthèse concernant l'année 2016 PDF 712 KB download
kofam rapport annuel 2016 PDF 82 KB download
Rapport de synthèse concernant l'année 2015 PDF 2 MB download
Activités des commissions d’éthique pour la recherche: rapport de synthèse 2014 PDF 607 KB download
Fiche d'information générale concernant la LRH et les commissions d'éthique PDF 840 KB download
La recherche sur l'être humain en Suisse : vue d'ensemble PDF 2 MB download
Comparaison entre la législation fédérale relative à la recherche sur l'être humain et le nouveau Règlement de l'UE relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE (disponible seulement en allemand) PDF 824 KB download
Tabellarische Übersicht des Vergleichs KlinV vs. VO 356/2014 (disponible seulement en allemand) PDF 636 KB download
Auswirkungen der VO 356/2014 über klinische Prüfungen mit Humanarzneimitteln (seulement en allemand) PDF 2 MB download
Legislation governing research involving humans
Article constitutionnel 118b concernant la recherche sur l’être humain PDF 459 KB download
Loi relative à la recherche sur l'être humain, LRH URL Visit Link
Ordonnance relative à la recherche sur l'être humain, ORH URL Visit Link
Ordonnance sur les essais cliniques, OClin URL Visit Link
Ordonnance concernant l'organisation découlant de la LRH, Org LRH URL Visit Link
Message sur la loi fédérale relative à la recherche sur l’être humain URL Visit Link
Rapport explicatif sur les ordonnances découlant de la loi relative à la recherche sur l’être humain PDF 512 KB download
Further legal foundations
Loi sur les produits thérapeutiques, LPTh URL Visit Link
Ordonnance sur les dispositifs médicaux, ODim URL Visit Link
Loi sur la transplantation URL Visit Link
Loi fédérale sur la protection des données, LPD URL Visit Link
Loi fédérale sur la procréation médicalement assistée, LPMA URL Visit Link
Loi relative à la recherche sur les cellules souches, LRCS URL Visit Link
Loi sur la radioprotection, LRaP URL Visit Link
Ordonnance sur la radioprotection, ORaP URL Visit Link
Ordonnance sur la dissémination dans l'environnement, ODE URL Visit Link
Loi fédérale sur l'analyse génétique humaine, LAGH URL Visit Link
Directive des bonnes pratiques cliniques de la Conférence internationale sur l’harmonisation dans sa version du 9 novembre 2016 (directive ICH) URL Visit Link
Guidelines on Medical Devices (MEDDEV 2.7/3, mai 2015) PDF 353 KB download
Guidelines and recommendations
Directives de l'ASSM URL Visit Link
Déclaration d'Helsinki URL Visit Link
Déclaration de Taipei URL Visit Link
Directives CIOMS URL Visit Link
Bonnes pratiques cliniques (BPC) Directive de l'Union européenne URL Visit Link
Good Manufacturing Practice (GMP) Directive de l'Union européenne URL Visit Link
Recommandations du Conseil de l'Europe concernant la recherche sur du matériel biologique URL Visit Link
Directives sur la rédaction du rapport annuel des commissions d’éthiques PDF 115 KB download
Procédure concernant les rapports de la OFSP à l'intention de public sur les activités des commissions d'éthique pour la recherche PDF 46 KB download
Demonstration materials
Film «Recherche sur être humain en suisse - L'essentiel en bref» ZIP 172 MB download
Film «Projects de recherche sur l'être humain en Suisse – autorisation, classification et soumission des demandes» ZIP 219 MB download
Infographiques «Recherche sur l'être humain» : documents individuels ZIP 797 KB download
Infographiques «Recherche sur l'être humain» : dossier pdf PDF 4 MB download
Infographiques «Demandes et procédures» : documents individuels ZIP 891 KB download
Infographiques «Demandes et procédures» : dossier pdf PDF 6 MB download
Expertises and reports
Riassunto dei singoli rapporti annuali delle commissioni d’etica 2018 PDF 2 MB download
Statistical Report 2018 PDF 2 MB download
kofam rapporto annuale 2018 PDF 100 KB download
Riassunto dei singoli rapporti annuali delle commissioni d’etica 2017 PDF 748 KB download
kofam rapporto annuale 2017 PDF 66 KB download
Riassunto dei singoli rapporti annuali delle commissioni d’etica 2016 PDF 2 MB download
kofam rapporto annuale 2016 PDF 78 KB download
Riassunto dei singoli rapporti annuali delle commissioni d’etica 2015 PDF 2 MB download
Attività delle commissioni d’etica - rapporto riassuntivo 2014 PDF 604 KB download
Foglio informativo con informazioni generali concernenti la LRUm e le commissioni d’etica PDF 833 KB download
Panoramica sulla ricerca sull'essere umano in Svizzera PDF 2 MB download
Comparazione tra la legislazione federale sulla ricerca sull'essere umano e il nuovo regolamento del'UE del 16 aprile 2014 sulla sperimentazione clinica di medicinali per uso umano e che abroga la direttiva 2001/20/CE (disponibile solo in tedesco) PDF 824 KB download
Tabellarische Übersicht des Vergleichs KlinV vs. VO 356/2014 (disponibile solo in tedesco) PDF 636 KB download
Auswirkungen der VO 356/2014 über klinische Prüfungen mit Humanarzneimitteln (solo in tedesco) PDF 2 MB download
Legislation governing research involving humans
Articolo costituzionale 118b concernente la ricerca sull’essere umano PDF 458 KB download
Legge sulla ricerca umana, LRUm URL Visit Link
Ordinanza sulla ricerca umana, ORUm URL Visit Link
Ordinanza sulle sperimentazioni cliniche, OSRUm URL Visit Link
Ordinanza sull'organizzazione relativa alla LRUm, Org-LRUm URL Visit Link
Messaggio relativo alla legge federale concernente la ricerca sull’essere umano URL Visit Link
Rapporto esplicativo concernente le ordinanze relative alla legge sulla ricerca umana PDF 473 KB download
Further legal foundations
Legge sugli agenti terapeutici, LATer URL Visit Link
Ordinanza relativa ai dispositivi medici, ODmed URL Visit Link
Legge sui trapianti URL Visit Link
Legge federale sulla protezione dei dati, LPD URL Visit Link
Legge sulla medicina della procreazione, LPAM URL Visit Link
Legge sulle cellule staminali, LCel URL Visit Link
Legge sulla radioprotezione, LRaP URL Visit Link
Ordinanza sulla radioprotezione, ORaP URL Visit Link
Ordinanza sull'emissione deliberata nell'ambiente, OEDA URL Visit Link
Legge federale sugli esami genetici sull'essere umano, LEGU URL Visit Link
La direttiva sulla Buona prassi clinica della Conferenza internazionale di armonizzazione nella versione del 9 novembre 2016 (linea guida ICH) URL Visit Link
Guideline on Medical Devices (MEDDEV 2.7/3 del maggio 2015) PDF 353 KB download
Guidelines and recommendations
Direttive della ASSM URL Visit Link
Dichiarazione di Helsinki URL Visit Link
Dichiarazione di Taipei URL Visit Link
CIOMS-Guidelines URL Visit Link
Good Clinical Practice (GCP) Direttiva dell'Unione europea URL Visit Link
Good Manufacturing Practice (GMP) Direttiva dell' Unione europea URL Visit Link
Raccomandazioni del Consiglio d'Europa per la ricerca condotta su materiale biologico URL Visit Link
Le direttive per l’allestimento dei rapporti annuali delle commissioni d’etica PDF 120 KB download
Direttiva sulla procedura concernente la rendicontazione dell'UFSP a destinazione del pubblica sull'attività delle commissioni d'etica per la ricerca PDF 55 KB download
Demonstration materials
Filmato «Ricerca sull'essere humano in svizzera - L'essenziale in breve» ZIP 172 MB download
Film «Progetti di ricerca sull'essere umana in Svizzera – autorizzazione, classificazione e presentazione della domanda» ZIP 221 MB download
Infografiche «Ricerca sull'essere umano»: documenti singuli ZIP 795 KB download
Infografiche «Ricerca sull'essere umano»: dossier pdf PDF 4 MB download
Infografiche «Domanda e procedura»: documenti singuli ZIP 884 KB download
Infografiche «Domanda e procedura»: dossier pdf PDF 6 MB download
Expertises and reports
Summary report of the activity reports of the Ethics Committees 2018 PDF 2 MB download
Statistical Report 2018 PDF 2 MB download
kofam annual report 2018 PDF 98 KB download
Summary report of the activity reports of the Ethics Committees 2017 PDF 750 KB download
kofam annual report 2017 PDF 73 KB download
Summary report of the activity reports of the Ethics Committees 2016 PDF 210 KB download
kofam annual report 2016 PDF 88 KB download
Summary report of the activity reports of the Ethics Committees 2015 PDF 2 MB download
Activities of the ethics committees for research – Summary report 2014 PDF 600 KB download
Factsheet containing general information on the HRA and the ethics committees PDF 828 KB download
Overview on research on humans in Switzerland PDF 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 PDF 824 KB download
Table comparing Clinical Trials Ordinance (ClinO) and CTR (only in German) PDF 636 KB download
Auswirkungen der VO 356/2014 über klinische Prüfungen mit Humanarzneimitteln (only in german) PDF 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
HRA Organisation Ordinance, OrgO-HRA URL Visit Link
Further legal foundations
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) PDF 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) PDF 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) PDF 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 PDF 4 MB download
Infographics «Applications & procedure»: individual documents ZIP 873 KB download
Infographics «Applications & procedure»: pdf dossier PDF 6 MB download
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Survey on the Swiss National Clinical Trials Portal (SNCTP)

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