Lurie childrens wilbanks 2017

Promote OPEN SYSTEMS, INCENTIVES, and NORMS to redefine how complex biological data is GATHERED,

SHARED, AND USED.

1.

weird times for privacy and research.

“my car knows i listen to my wife’s playlist”

what’s benefit? what’s harm?

how do we know?

what’s benefit? what’s harm?

how do we know?

what happens if we import toxic ethics from tech to health?

what happens if we import “the commons”from tech to health?

2.

cloud and “network science” are tidal forces.

we see three pillars to modern scientific methods

Open Science

Team Science

Participant centered Science

pilot approaches to create open systems, incentives, and norms

Open Science

Team Science

Participant centered Science

Pilot Systems and Approaches

build infrastructure to provide robust, reusable solutions

Open Science

Team Science

Participant centered Science

Pilot Systems and Approaches

Infrastructure

Open Science

Team Science

Participant centered Science

Pilot Systems and Approaches

Infrastructure

support research communitiesthat operate under these principles

3.

the technology wave is building.

“Investigators will meet annually in-person with each participant to assess and record

progression … every six months, the team will conduct phone and mail surveys regarding

diagnosis, medications, and other impacts of the disease…”

high-dimensional data

62yoldMan 67yoldWoman

same medicine, different impacts

tapping number shows effects of medication and daily variation

50

75

100

125

150

date

y

−1.0

−0.5

0.0

0.5

1.0sign(delta)

sharing personal

thoughts on day-to-day

changes

4.

issues and opportunities in e-consent

social pressures that increase rates of “yes” disappear…

comprehensionlanguagetimeformat

regulatoryliability

1. “technical debt” means traditional (non-mobile) consent has known problems, but hard to change.

2. signs of support for new methods of using technology as pedagogy in consent This project was supported by grant number U18HS022789 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency of Healthcare Research and Quality. Additional funding came from the Robert Wood Johnson Foundation and the Helmsley Charitable Trust, and essential support from the Electronic Data Methods Forum at Academy Health.

1. tiered information access by participants

2. “pictorial” dominant on first information tier

3. text dominant on second information tier

4. require perfect score on short assessment

your clinical protocol is going to be clearly

exposed.

initial metaphor

38

screen structure

navigation to/from reinforces concept

study “narrative”

summative / formative assessments of comprehension and informedness

changeable by participant

identity test

data use statement

I WILL CREDIT PARTICIPANTS

To complete this form: 1.  Enter your name (see *) 2.  Mark your initials on the line in the upper right corner of each box (9 times, total) 3.  Sign and date

I, _____________________*, reaffirm my commitment to the Synapse Awareness and Ethics Pledge. I will adhere to the

following principles for responsible research:

__________________________ * Printed name __________________________ Signature __________________________ Date

I WILL NOT RE-IDENTIFY

___

I WILL NOT SHARE

___

I WILL NOT USE FOR ADVERTISING

___

I WILL KEEP SECURE

___ ___

I WILL PUBLISH OPEN ACCESS

___

___

I WILL PROTECT PRIVACY

I WILL REPORT ANY BREACHES

___ ___

I WILL FOLLOW THE LAW

participants and public get to see the users / uses.

iconographic representations of key concepts in informed consent

open source methods

design layouts

workflows

web templates and assets

100,000+ enrolled in Sage-supported studies since March 2015

26 known studies using methods

integrated into Apple ResearchKit

5.

where is this all going?

http://ascopubs.org/doi/abs/10.1200/JCO.2012.45.4553

RK approach + video

chat and video

• reformat visual content into a chat UI and let participants interact via Q&A

• possible to implement via SMS as well

• reformat visual content into longer form video

DNA sequencing and results return are different from sensors and surveys - have

to teach and assess higher risk, uncertainty, unknowables…

Identifiability Knowable harms Unknown unknowns

wacky ideas

interaction required

the sorting hat• Automatic sorting, no work required

• Consent process that could “bin” participants into likely risk and consent them in specific tracks

• Suggested for projects that involve consent of known sequences for which risk could be computed (i.e. at Broad etc) but interesting conceptually - what are the bins that could be used for sorting?

ballot box• Manual selection and movement of choices

• Consent process where participant is faced with multiple statements and has to “vote” with them, with an interpretation of sorts provided at the end

• I.e. place seven statements on the screen about the study, let participant sort them into “things that make me more / less likely to want to enroll”

• I.e. ask seven binary questions about the study, display results with commentary “i think i am unlikely to be a victim of genetic discrimination”

• Suggested for projects where there isn’t a lot of real estate (mobile) but also for where there isn’t a lot of risk (perhaps not sharing broadly)

colossal cave adventure

• Interactive, quiz-based game where wrong answers receive immediate correction, has an endpoint / finish line

• Consent process where participant must “find their way” through a moderately easy puzzle

• I.e. contextualize a risk such as long-term care insurance - before “share genome” should correctly choose “i thought about long term care insurance”

• Suggested for projects where there isn’t a lot of real estate (mobile) but where there is medium risk (perhaps sharing broadly inside Sage style approaches)

kobayashi maru• From Star Trek: “The objective of the test

is not for the cadet to outfight or outplan the opponent but rather to force the cadet into a no-win situation and observe how he/she reacts.’

• Consent process where participant must engage with ambiguity of DNA risk and benefit through scripted situation(s)

• Put a set of unanswerable questions about the risks and benefits of genome research use, donation and sharing together - but make sure there are no “right” answers.

please @ me

john.wilbanks@sagebase.orghttp://sagebase.org/platforms/governance

@wilbanks