Legal & Ethical Issues Nancy Baker Chief Operating Officer GSI (UK)
Establishing a Framework Athens,  20 May 2010
Application of Research Athens,  20 May 2010 Legal & Ethical Research applied across two dimensions Pilot Deployment Opera...
Application of Research Athens,  20 May 2010 Legal & Ethical Research applied across two dimensions <ul><li>Ethical conduc...
Impact of Research <ul><li>Effect on Technical Design of Product </li></ul><ul><ul><li>Differentiation of level of persona...
Impact of Research <ul><li>Effect on Pilot Implementation Design </li></ul><ul><ul><li>Established standards for encryptio...
Impact of Research <ul><li>Effect on Pilot Programme Design </li></ul><ul><ul><li>Pilots are NOT subject to clinical trial...
Key Documents Produced <ul><li>D6.1 “Report on National & European Legislation” </li></ul><ul><ul><li>Available for public...
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Legal and ethical issues (the LLM project)

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Legal and ethical issues (the LLM project)

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