Legislation and guidelines for research involving humans
Switzerland
International
- WMA: Deklaration von Helsinki
- ICG-GCP: Guidelines
- CIOMS: International ethical guidelines for health-related research involving humans
- ECRIN Campus: Ethical and regulatory requirements in Europe
- EQUATOR Network: Reporting quidelines
- Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
- Medical Devices Guidance document (MEDDEV 2.7 : Clinical investigation, clinical evaluation)
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)
- FDA: Clinical Trials and Human Subject Protection
- Europäische Patientenakademie (EUPATI)
- European Network of Research Ethics Comittees (EUREC)
- European Forum for Good Clinical Practice (EFGCP)
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)