Legislation and guidelines for research involving humans

Switzerland

International

Institutions - organisations

Switzerland

  • Bundesamt für Gesundheit (BAG)
    • Koordinationsstelle Forschung am Menschen (kofam)
  • Schweizerische Zulassungs- und Aufsichtsbehörde für Heilmittel (Swissmedic)
  • Schweizerische Akademie der Medizinischen Wissenschaften (SAMW)
    • Swiss Personalized Health Network (SPHN)
    • Zentrale Ethikkommission (ZEK)
  • Nationale Ethikkommission im Bereich Humanmedizin (NEC-CNE)
  • Schweizerische Gesellschaft für Biomedizinische Ethik (SGBE-SSEB)
  • Swiss Clinical Trial Organisation (SCTO)
  • Swiss Biobanking Platform (SBP)
  • Schweizerischer Nationalfund (SNF)
  • Dachverband Schweizerischer Patientenstellen
  • Schweizerische Stiftung Patientenschutz (SPO)
  • Europäische Patientenakademie Landesplatform Schweiz (EUPATI-CH)

International

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • Council for International Organizations of Medical Sciences (CIOMS)
  • Council of Europe, The Committee on Bioethics
  • FDA: Clinical Trials and Human Subject Protection
  • Europäische Patientenakademie (EUPATI)
  • European Network of Research Ethics Comittees (EUREC)
  • European Forum for Good Clinical Practice (EFGCP)
  • Stakeholders Acting Together On the ­ethical impact assessment of ­Research and Innovation (SATORI)

Registries and more

Study registries

  • kofam: Portal für klinische Versuche in der Schweiz (SNCTP)
  • swissethics: Registry of All Reseach Projects (RAPS)
  • European Clinical Trials Database (EudraCT)
  • Europäische Studienregister (EU Clinical Trials Register)
  • US National Institutes of Health NIH: (ClinicalTrials.gov)
  • WHO: International Clinical Trials Registry Platform (ICTRP)

Biobanks

  • Recommendations of the Committee of Ministers to Member States on research on biological materials of human origin, Council of Europe (CM/Rec//2016)6)

Other

  • Data Management Systeme: swissethics encourages the use of professional data management systems like OpenClinica, RedCap, secuTrial. etc. (in alphabetical order)