patient-centered consent
DESCRIPTION
Briefing on the Patient-Centered Consent (a Sage Bionetworks project in conjunction with the Electronic Data Methods Forum).TRANSCRIPT
1. !
the odds of successful conversion to wisdom go up as more people can see the
data.
accuracy of model jumped three orders of magnitude in nine days.
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76% accurate.
2. !
the “portable legal consent” experiment
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but…most don’t have data, and most who have data,
don’t have computationally useful data.
and “standards” are hard to come by in consent.
3. !
the patient-centered consent toolkit
provide open source methods and tools for
consent that outperform local methods and tools
1. series of interviews and requirements gathering
2. interaction design process and prototyping
3. software development
1. initial metaphor
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2. initial design
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3. post-workshop revision
implementation in 2 Sage Bionetworks clinical studies (parkinsons,
post-chemo cognition)
user interface to consent
informed consent document
IRB
map between form and interface
reviews for ethical and scientific propriety
reviews for effectiveness in informing
mobile clinical study protocoluse standard, vetted interface
and open source software code for consent
write locally appropriate consent forms
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4. PD mobile study (IRB approved)
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Sage Bionetworks Patient Centered Consent toolkit Beta release 10/2014 with EDM Forum
• design files • individual elements • screen compositions
• sample workflows • derived from PD and BCS apps
• boilerplate consent forms • legal text • mapped and annotated to design files
• software • code for “loop” for PD app as approved • implementation guidance
• FAQ • protocol design tips
Release Strategy !
• article in E-GEMS methods journal
• website with open source tools (attribution licenses)
• pre-committed beta testers (U. Washington, Cincinnati Childrens Hospital)
• public presentations through autumn (Stanford Ethics of Data, NIMH, CHoP, Broad Institute, Defrag, OpenCon, Partnering for Cures)
• social media promotion !
• liase with PRIM&R and others to smooth review of protocols using toolkit