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Participant-Centered Consent Toolkit Overview

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Overview of the Sage Bionetworks Participant-Centered Consent Toolkit. Supported by the EDM Forum.

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Participant-Centered Consent Toolkit Overview

  1. 1. 1. origins of participant-centered consent at Sage Bionetworks
  2. 2. first attempt at interaction design for consent
  3. 3. interaction design prioritizes the user and the experience
  4. 4. courtesy of: David Fore
  5. 5. written by a doctor reviewed by a lawyer edited by a committee
  6. 6. written by a doctor reviewed by a lawyer edited by a committee
  7. 7. written by a doctor reviewed by a lawyer edited by a committee
  8. 8. using ongoing Sage Bionetworks studies, develop a participant-centric process…and then make it a general toolkit.
  9. 9. 2. the PCC “toolkit” (release date next mid-December)
  10. 10. what can i do with the patient-centered consent toolkit? - create a “user interface” for informed consent documents that assists informedness
  11. 11. why should i create a user interface for consent? - assist informedness for complex documents - deploy consent as a process via mobile, web
  12. 12. what’s in the toolkit? - visual design tools you can use to represent clinical study actions - reference documents and templates you can use to bootstrap a consent user interface - methods documentation to help you get started
  13. 13. “nouns and verbs” - icons for key concepts in clinical study - all open source or public domain from Sage Bionetworks IRB approved studies
  14. 14. “nouns and verbs” from the digital commons - icons for key concepts in clinical study - all open source or public domain
  15. 15. “sentences” via animation “separating your identity from your data”
  16. 16. “sentences” via animation “recombining and reusing your data”
  17. 17. Parkinsons Disease Mobile Study implementation
  18. 18. 3. supporting methods and materials
  19. 19. clinical reference documents “as filed” and as templates
  20. 20. “as filed” - available for copying and distribution (especially for use as precedent) templates - available as open source documents for reuse and derivatives (for creating new clinical submissions to an IRB)
  21. 21. as filed: informed consent
  22. 22. template: informed consent
  23. 23. frequently asked questions
  24. 24. storyboard layouts
  25. 25. document-to-interface mapping examples
  26. 26. software workflows
  27. 27. web assets
  28. 28. coming in 2015
  29. 29. more nouns, verbs, sentences, stories - genomics - medical records - clinical labs
  30. 30. cloud technical architecture for 3rd party app-based studies

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