a new model for informed consent - participant centered consent - broad institute
DESCRIPTION
Lecture to the Program in Medical and Population Genetics, Broad Institute.TRANSCRIPT
1. !
hypothesis: data at scale demands new methodology.
not just solo labs, but communities.
TCGA Pan-Cancer Consortium
TCGA Pan-Cancer Consortium
TCGA Pan-Cancer Consortium
the problem: the tacit knowledge used to analyze data is not
captured.
it’s a science practice problem. it is not a
technology problem.
doi:10.7303/syn1710680.4
TCGA Pan-Cancer Consortium
combining new practice with version
control and provenance…
18NPG papers
68core projects248
researchers
28institutions
1070datasets1723
results
TCGA Pan-Cancer Consortium
gained users from across TCGA
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groups datasets subtypes
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G ...
http://synapse.org
https://github.com/Sage-Bionetworks/Synapse-Repository-
Services
not just solo labs, but challenges.
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76% accurate.
generated an entire suite of available math models attacking the
problem.
2. !
hypothesis: we are capable of engaging the general public.
IRB approved for 100,000 participants
just submitted: post-chemo cognitive impact
patricia ganz, ucla ann partridge, dana farber
kathryn schmitz, u penn
3. !
hypothesis: we must design better informed consent
experiences
the problem: we use to consent to offload
liability, not to engage in a new kind of science.
written by a doctor edited by a lawyer re-edited by a committee
presented to a participant for zero-sum game
written by a doctor edited by a lawyer re-edited by a committee
presented to a participant for zero-sum game
comprehension language time format
regulatory issues liability fears
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key insights: !
make the interface visual !
bring the experience into the consent process itself
1. initial metaphor
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2. initial design
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3. second revision
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4. !
the participant-centered consent toolkit
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PCC Visual Language PCC consent workflows Sample clinical documents Implementation support !
Attribution-only licensing
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everything needed to create visual consent interfaces…
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currently support: surveys / PRO tools mobile / sensors basic study concepts !
looking for driving projects to extend support…
if anyone wants to stand up an app-based study…
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filed umbrella protocol for 3rd party support…
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(the price is data becomes open over time)
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
we want to work with you.
