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
- Oviedo Convention: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
- Additional Protocol to the Oviedo Convention concerning biomedical research
- WMA: Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks, October 2016
- ECRIN Campus: Ethical and regulatory requirements in Europe
- EQUATOR Network: Reporting quidelines
- Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
- Regulation (EU) No 536/2014 of the European Parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use (CTR)
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR)
- Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG)
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)