Legal and ethical issues (the LLM project)
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  • 1. Legal & Ethical Issues Nancy Baker Chief Operating Officer GSI (UK)
  • 2. Establishing a Framework Athens, 20 May 2010
  • 3. Application of Research Athens, 20 May 2010 Legal & Ethical Research applied across two dimensions Pilot Deployment OperationalDeployment
  • 4. Application of Research Athens, 20 May 2010 Legal & Ethical Research applied across two dimensions
    • Ethical conduct of research
    • - Anonymity/Privacy
    • - Autonomy
    • Dignity
    Ethical design of system/service Regulatory Framework to enable commercial market of service Pilot Deployment OperationalDeployment
  • 5. Impact of Research
    • Effect on Technical Design of Product
      • Differentiation of level of personally identifiable data in the LLM data base
      • No names and addresses in pilot deployment, but possible in operational deployment
    • Effect on Pilot Implementation Design
      • Established standards for encryption to protect anonymised user data
      • Developed flexible models for server and database deployment to enable multi-country aggregation in pilot deployment
    Athens, 20 May 2010
  • 6. Impact of Research
    • Effect on Pilot Implementation Design
      • Established standards for encryption to protect anonymised user data
      • Developed flexible models for server and database deployment to enable multi-country aggregation in pilot deployment
    Athens, 20 May 2010
  • 7. Impact of Research
    • Effect on Pilot Programme Design
      • Pilots are NOT subject to clinical trials reviews BUT are being conducted, internally, based upon ICH GCP standards wherever applicable
      • Key focus is upon ensuring user privacy and anonymity of personally identifiable data
      • Consistently applied informed consent procedures
      • Internal audits to assure compliance
    Athens, 20 May 2010
  • 8. Key Documents Produced
    • D6.1 “Report on National & European Legislation”
      • Available for public level dissemination
    • D6.2 “ Technical Specifications for User Privacy Reassurance”
      • Confidential within project consortium
    • D 6.3 “National and European security and certification requirements including issues of liability”
      • In progress – will be made available for public level dissemination
    • D 6.4 “Ethical Guidelines Report”
      • In progress – will be made available for public level dissemination
    Athens , 20 May 2010