Project document and wireframe for the Consent to Research project at http://del-fi.org/consent

1. consent to research designed by: john wilbanks sponsored by: Sage Bionetworks Kauffman Foundation Lybba pro bono counsel provided by: danvorhaus

2. traditional study institution “normal” home of research study - university - medical center

3. novel institutions emerging home of research study - may invest at university - may invest in novel studies (including mobile, company, ???) traditional study institution “normal” home of research study - university - medical center

5. unlikely to achieve integrationtraditional study institution

6. novel institutions novel institutions traditional study institution novel institutions novel institutions traditional study institution traditional study institution novel institutions traditional study institution traditional study institution traditional study institution traditional study institution

8. empower granular access to private information

9. focused on HIPAA sensitive dataprivacy marketplace

10. 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

11. what do we propose to build? standards that allow for open and extensible communication across all four classes of entities. the creation of “public genomic records” that are individual, but not identified consent systems and user interfaces that allow those public genomic records to move from place to place

12. what do we propose to build? standards that allow for open and extensible communication across all four classes of entities. the creation of “public genomic records” that are individual, but not identified consent systems and user interfaces that allow those public genomic records to move from place to place Sage Bionetworks

13. what do we propose to build? standards that allow for open and extensible communication across all four classes of entities. the creation of “public genomic records” that are individual, but not identified. consent systems and user interfaces that allow those public genomic records to move from place to place Consent to Research

14. “approve once, research many times”

16. sage bionetworks “public genomic records” “static” genomic data full genome sequence genome variation (i.e. 23andme)

17. sage bionetworks “public genomic records” “dynamic” genomic data DNA expression RNA expression methylation “the new new machine”

18. sage bionetworks “public genomic records” “observational” data phenotypic disease response “ambient” data (smartphones etc)

19. sage bionetworks “public genomic records” “static” genomic data “dynamic” genomic data “observational” data

20. sage bionetworks “public genomic records” requires “informed consent” to share. “static” genomic data “dynamic” genomic data “observational” data

21. old school consent

25. new school consent

26. new school consent (has a real legal tool underneath)

34. coming in 2012.

35. want to learn more? follow @wilbanks follow @sagebio http://del-fi.org/consent http://sagebase.org/commons