consent to research

designed by: john wilbanks

sponsored by:Sage Bionetworks

Kauffman FoundationLybba

pro bono counsel provided by:dan vorhaus (

traditionalstudy

institution

“normal” home of research study- university- medical center

traditionalstudy

institution

novelinstitutions

emerging home of research study- may invest at university- may invest in novel studies (including mobile, company, ???)

“normal” home of research study- university- medical center

traditionalstudy

institution

- forming nodes, but not networks.- unlikely to achieve integration.

novelinstitutions

traditionalstudy

institution

traditionalstudy

institution

traditionalstudy

institution

traditionalstudy

institution

traditionalstudy

institution

traditionalstudy

institution

traditionalstudy

institution

novelinstitutions

novelinstitutions

novelinstitutions

novelinstitutions

novelinstitutions

privacy aggregator

privacymarketplace

- privacy intermediaries to facilitate private access- empower granular access to private information- focused on HIPAA sensitive data

what‘s missing?

public access to information needed to build models of disease.

the role of research in the system - of individuals who want their data used to generate new knowledge

what do we propose to build?

standards that allow for open and extensible communication across all four classes of entities.

1. the creation of “public genomic records” that are individual, but not identified.

2. consent systems and user interfaces that allow those public genomic records to move from place to place

what do we propose to build?

standards that allow for open and extensible communication across all four classes of entities.

1. the creation of “public genomic records” that are individual, but not identified.

2. consent systems and user interfaces that allow those public genomic records to move from place to place

Sage Bionetworks

what do we propose to build?

standards that allow for open and extensible communication across all four classes of entities.

1. the creation of “public genomic records” that are individual, but not identified.

2. consent systems and user interfaces that allow those public genomic records to move from place to place

Consent to Research

“approve once, research many times”

sage bionetworks “public genomic records”

“static” genomic

data

full genome sequencegenome variation (i.e. 23andme)

sage bionetworks “public genomic records”

“dynamic” genomic

data

DNA expressionRNA expressionmethylation“the new new machine”

sage bionetworks “public genomic records”

“observational”data

phenotypic disease response“ambient” data (smartphones etc)

sage bionetworks “public genomic records”

“static” genomic

data

“dynamic” genomic

data

“observational”data

sage bionetworks “public genomic records”

“static” genomic

data

“dynamic” genomic

data

“observational”data

requires “informed consent” to share.

old school consent

new school consent

new school consent

(has a real legal tool underneath)

coming in 2012.

want to learn more?

follow @wilbanksfollow @sagebio

http://del-fi.org/consenthttp://sagebase.org/commons