Gesetzgebung und Richtlinien Forschung am Menschen

Schweiz

• Bundesrecht Schweiz

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)

Institutionen - Verbände

Schweiz

• Bundesamt für Gesundheit (BAG)

  • BAG Sektion Forschung am Menschen

  • 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)

Register und sonstiges

Studienregister

• 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)

Biobanken

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

Sonstige

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