a new model for informed consent - participant centered consent - broad institute

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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http://synapse.org

https://github.com/Sage-Bionetworks/Synapse-Repository-

Services

not just solo labs, but challenges.

code sharing a prerequisite.

http://synapse.org

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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…

https://www.scienceexchange.com/

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.

thank you. !

@wilbanks john.wilbanks@sagebase.org