plc sage congress 2012

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SYNAPSE CITIZENS CONTROL DATA ACCESS PORTABLE LEGAL CONSENT SYNAPSE GOVERNANCE SHARED COLLABORATION SPACE SHARED COLLABORATION SPACE GOVERNANCE

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Slides for session on Portable Legal Consent at Sage Congress 2012.

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Page 1: PLC Sage Congress 2012

SYNAPSE

CITIZENS CONTROLDATA ACCESS

PORTABLE LEGALCONSENT

SYNAPSEGOVERNANCE

SHAREDCOLLABORATION

SPACE

SHAREDCOLLABORATION

SPACEGOVERNANCE

Page 2: PLC Sage Congress 2012

PROBLEM #1:CLINICAL DATA IS NOT LEGALLY INTEROPERABLE WITHOUT INTERVENTIONTHREE SCENARIOS

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PORTABLE CONSENT TO POPULATE THE INFRASTRUCTURETHREE SCENARIOS

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terms in blue pop up to definitions

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volunteer must click to proceed

all boxes must be checked

Page 12: PLC Sage Congress 2012

volunteer cannot skip video

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thanks for pro bono review:Dan Vorhaus

Bartha KnoppersRusty Bromley

Wilson Sonsini Goodrich & RosatiSage Bionetworks Ethics Advisory Team

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user decides what data to upload

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can researchers contact

(anonymously)?

Page 19: PLC Sage Congress 2012

patient

please email

patient #XYZ12

3

researcher

Page 20: PLC Sage Congress 2012

data types:1. genome2. medical / health records3. lifestyle4. laboratory (connect via GUID)

Page 21: PLC Sage Congress 2012

Individual Level Data

De-identifiedDataset

Sage BionetworksCGRE

Portable Legal Consent

1 2 3 4 5

Participants

Researchers

CGRE Database Synapse Database

Advocacy Foundation

Hospital

Advocacy Foundation

Portable Legal Consent

Public Recruitment

Sage BionetworksSynapse

Page 22: PLC Sage Congress 2012

IRB submission supported by:

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PORTABLE LEGAL CONSENT POPULATES SYNAPSE WITH INTEROPERABLE HEALTH DATATHREE SCENARIOS

Page 25: PLC Sage Congress 2012

timeline:

05/2012 - patient enrollment 08/2012 – “bolt on” tools09/2012 – vendor integration tools12/2012 – 25,000 enrolled02/2013 – 100 organizations onboard05/2013 – 50,000 enrolled

Page 26: PLC Sage Congress 2012

special thanks

Lara MangraviteChristine SuverCarolina Rossini

Page 27: PLC Sage Congress 2012

test drive at https://plc-cgr.weconsent.us

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