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

1. 1.
origins of participant-centered
consent at Sage
Bionetworks

2. first attempt at
interaction
design for
consent

4. interaction design
prioritizes the user and
the experience

5. courtesy of: David Fore

6. written by a doctor
reviewed by a lawyer
edited by a committee

7. written by a doctor
reviewed by a lawyer
edited by a committee

8. written by a doctor
reviewed by a lawyer
edited by a committee

9. using ongoing Sage
Bionetworks studies,
develop a participant-centric
process…and then
make it a general toolkit.

10. 2.
the PCC “toolkit” (release
date next mid-December)

11. what can i do with the
patient-centered consent
toolkit?
- create a “user interface” for
informed consent documents
that assists informedness

12. why should i create a user
interface for consent?
- assist informedness for
complex documents
- deploy consent as a
process via mobile, web

13. 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

14. “nouns and verbs”
- icons for key
concepts in clinical
study
- all open source or
public domain
from Sage Bionetworks
IRB approved studies

15. “nouns and verbs”
from the digital
commons
- icons for key
concepts in clinical
study
- all open source or
public domain

17. “sentences” via animation
“separating your
identity from your data”

18. “sentences” via animation
“recombining and
reusing your data”

21. Parkinsons Disease Mobile
Study implementation

44. 3.
supporting methods and
materials

45. clinical
reference
documents “as
filed” and as
templates

46. “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)

47. as filed:
informed consent

48. template:
informed consent

49. frequently asked
questions

50. storyboard layouts

51. document-to-interface
mapping examples

52. software workflows

53. web assets

54. coming in 2015

55. more nouns, verbs,
sentences, stories
- genomics
- medical records
- clinical labs

56. cloud technical architecture for 3rd
party app-based studies