Participant-Centered Consent Toolkit Overview
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1. origins of participant- centered consent at Sage Bionetworks
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Overview of the Sage Bionetworks Participant-Centered Consent Toolkit. Supported by the EDM Forum.
Transcript of Participant-Centered Consent Toolkit Overview
1.
origins of participant-centered consent at Sage
Bionetworks
first attempt at interaction design for
consent
interaction design prioritizes the user and
the experience
courtesy of: David Fore
written by a doctor reviewed by a lawyer
edited by a committee
written by a doctor reviewed by a lawyer
edited by a committee
written by a doctor reviewed by a lawyer
edited by a committee
using ongoing Sage Bionetworks studies,
develop a participant-centric process…and then make it a general toolkit.
2.
the PCC “toolkit” (release date next mid-December)
- create a “user interface” for informed consent documents that assists informedness
what can i do with the patient-centered consent toolkit?
- assist informedness for complex documents - deploy consent as a process via mobile, web
why should i create a user interface for consent?
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
- icons for key concepts in clinical study - all open source or public domain
“nouns and verbs”
from Sage Bionetworks IRB approved studies
from the digital commons
“nouns and verbs”
- icons for key concepts in clinical study - all open source or public domain
“separating your identity from your data”
“sentences” via animation
“recombining and reusing your data”
“sentences” via animation
Parkinsons Disease Mobile Study implementation
3.
supporting methods and materials
clinical reference documents “as filed” and as templates
“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)
as filed: informed consent
template: informed consent
frequently asked questions
storyboard layouts
document-to-interface mapping examples
software workflows
web assets
coming in 2015
more nouns, verbs, sentences, stories
- genomics - medical records - clinical labs
cloud technical architecture for 3rd party app-based studies
