Legislazione e linee guida sulla ricerca sull'essere umano

Svizzera

• Diritto svizzero

Internazionale

• WMA: Dichiarzione di 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)

Istituzioni - Associazioni

Svizzera

• Ufficio federale della sanità pubblica (UFSP)

  • UFSP Sezione ricerca sull'essere umano

  • Koordinationsstelle Forschung am Menschen (kofam)

• Istituto svizzero per gli agenti terapeutici (Swissmedic)

• Accademia Svizzera delle Scienze Mediche (SAMW)

  • Swiss Personalized Health Network (SPHN)

  • Zentrale Ethikkommission (ZEK)

• Commissione nazionale d'etica per la medicina umana (NEC-CNE)

• Società Svizzera di Etica Biomedicale (SGBE-SSEB)

• Swiss Clinical Trial Organisation (SCTO)

• Swiss Biobanking Platform (SBP)

• Fondo Nazionale Svizzero (FNS)

• Dachverband Schweizerischer Patientenstellen (in tedesco)

• Organizzazione Svizzera dei pazienti (SPO)

• Accademia Europea dei pazienti Sezione Svizzera (EUPATI-CH)

Internazionale

• 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)

Registri e altro

Registri di studi

• kofam: Portale di ricerca per sperimentazioni cliniche in Svizzera (SNCTP)

• swissethics: Registry of All Reseach Projects (RAPS)

• European Clinical Trials Database (EudraCT)

• EU Clinical Trials Register (EU Clinical Trials Register)

• US National Institutes of Health NIH: (ClinicalTrials.gov)

• WHO: International Clinical Trials Registry Platform (ICTRP)

Biobanche

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

Altro

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