data2health/governance-pathways

CTSA Data Sharing Governance Pathways Project

governance-pathways

CTSA Data Sharing Governance Pathways Project

Problem statement

Clear governance pathways within and between CTSAs are needed to expediently allow safe sharing of electronic health data for research. This project provides governance "Pathways" documentation to promote collaborative and flexible data sharing for CTSA hubs.

Project description

Clear governance pathways within and between CTSAs are needed to expediently allow safe sharing of electronic health data for research. Some CTSAs have multiple collaborating institutions within their institute, who own data (e.g., EHR derived health system data), but struggle to create governance agreements to share the data for research. CTSAs also take on laborious honest brokerage processes and others are struggling to tighten their governance to be in full compliance. CTSAs need clear guidelines and governance vehicles to execute safe and compliant data sharing with individual researchers and across institutions. This project aims to create a library of DUAs and best practice information, a Master Data Use agreement that can be flexibly populated as a template, and "Pathways" documentation for CTSA hubs to aid decisionmaking and authoritative data sharing. The ultimate goal is to promote collaborative and flexible data sharing across the whole of the CTSA Program.

Alignment to program objectives

TODO see here

Contact person

Point person (github handle)	Site	Program Director
Liz Zampino (ezampino	UW	Adam Wilcox

Leads

Lead(s) (github handle)	Site
Adam Wilcox (@abwilcox)	UW
Christine Suver (@cfsuver)	Sage Bionetworks

Team members

Team Members (github handle)	Site
Adam Wilcox (@abwilcox)	UW
Liz Zampino (@ezampino)	UW
Rania Mussa (@ramussa)	UW
Ann Novakowski (@ankimno)	Sage Bionetworks
Christine Suver (@cfsuver)	Sage Bionetworks

Repositories

https://github.com/EBISPOT/DUO

Deliverables

Get involved

Working documents

The project folder of Google Documents is available to all onboarded participants.

Slack channel

The project slack channel (#governance) is accessible to onboarded participants. You will not automatically be added to Slack; however, we encourage you to please join via the link you are emailed when you onboard (bit.ly/cd2h-onboarding-form).

governance-pathways's Issues

Library of DUAs

This will be the library for general consumption; we should enable search, it is a “library”.

Draft email to CTSA hubs

Email requesting DUA that can be mapped to the matrix

add computabe elements to DUA library for search

It would be terrific if the library had search capabilities. To do so would likely require creating a simple model of tags or attributes for each. Also it would be good if you could retrieve the most recent version of the document with the search term/classification highlighted.

Schedule Weekly Project Meetings

Attendees:
Melissa Haendel @mellybelly
John Wilbanks @wilbanksjohn
Liz Zampino @ezampino
Kair Stephen @kstephen0909
Sean Mooney @sdmooney

Melissa added: Justin Guinney @jguinney
Christine (?) from Sage.

repo tags - review custom tags

@mellybelly @jmcmurry I created tags based on this sheet in this repo .

Pls review and confirm this is correct and final; I will then copy over to all repos.

Recruit CTSA hubs to evaluate Builder Tool

"test drive" at hubs.

Support data sharing “levels”

e.g. set-level, line-level, etc.

Ask CTSA Steering Committee to step forward with interest

Melissa to ask at SC F2F.

Develop sustainability plan

How will guidance chart sustain process?

Draft DUA templating system to hubs

Present draft DUA templating system to hubs.

Enable co-implementation alongside SMART IRB

It would be terrific to allow CTSAs to address DUAs and central IRBs simultaneously.

Paper content source-Grid and Mapping

Draft of paper is based upon this source document

Collect requirements from experts

This group may be external to CTSA hubs.

Stakeholders

Stakeholders:

• Requirements to be a 'stakeholder'

• Identify stakeholders that align with matrix dimensions

• Conduct outreach to individuals/orgs (identify recruitment process)

• Identify roles: Approvers, creators, & moderators

• Identify matrix reviewers (quality check) Associated with Task

Write the "how we made DUA templates" paper

Invite pilot CTSAs and others to co-author

Best practice guide(s)

Best practice guide(s) for BAA vs. DUA? De-identification (define)? Counts, etc

Educational offerings about what practices exist that are good to share

Provide highlights regarding revealed best practices.

@biodevlab

Survey collaborators

Survey the interested parties.

Please contribute here the questions we should ask these individuals.
1- State the question clearly
2- Nested questions if plausible
3- Brief rationale behind question

Collect DUAs across CTSA consortium

These will be collected via specific interactions or via Maturity Model interviews/contacts. @rchampieux @davedorr9

Complete the position paper for data governance

Complete John’s Port Huron:

Matrix review by experts

Schedule consultation with Beth Britt and Sean Mooney in separate chats to go over matrix: https://docs.google.com/document/d/1g5hbbEPO6bqtbiMppjtYTZ_qb5IDNC-SUmUgtPM50kc/edit

Provide templating system

using DUO, possibly using DUOS.

Solidify use cases to be addressed in master agreement(s)

i.e., cohort discovery, de-id data sharing for obs studies, limited data sets, identified data sharing

Put master DUA template(s) into the CTSA FOA

specifics TBD.

Requirements from stakeholders

We need a defined (but simple) process for obtaining requirements from stakeholders. Related to #6

Paper content source- Data Sharing Principals

Based upon presentation found here

Add maturity model interviewees

Include (in an ongoing fashion) maturity model interviewees. @davedorr9 @rchampieux

Matrix Requirements

For example:

• Enable data query tool independent activities preparatory to research (cohort discovery)
• Share row level de-identified data w/o an IRB and DUA
• Share limited datasets without a DUA
• Share identified datasets in a compliant way to enable the learning health system living laboratory
• Better understanding of when a membership agreement, a study specific DUA, a master DUA w/o a BAA and when a master DUA with a BAA is required

Perform online search for CTSA DUAs

Populating a table here under public tab

Make presentation to Steering Committee

present draft DUA master agreement system to SC.
Requires supermajority to proceed.

submit manuscript describing CD2H gov project outcomes

should include pilot CTSA sites as co-authors

Informative Community Engager - one pager

One page document describing the mission of the project, goals and desirable outcomes.
Address how members can contribute.
Communication Plan for convene meetings.

Update engagement plan

Add meeting minutes to engagement plan, zoom invite and meeting schedule to the engagement.md file here in GitHub

Governance Approaches

Synthesize governance approaches (i.e., CTSA DUAs, ACT agreement, etc). This will require:

• categorizing DUAs
• marking up DUAs with key components in an iterative manner
• creating a master DUA template
• defining the slots where DUO can be integrated
• having compliance and legal experts review

Tool Wireframes

Cultivate core community group

Select PM strategies to communicate: google docs, list-serve, slack, github, calendaring, meetings

NCI Cancer Research Data Commons

What governance structure is NCI currently using? How can we replicate, model, etc. ?

Pilot DUA with Wash U and UW

This will support concrete data sharing for a clinical use case developed in phase 1 work, completing a demonstration project in tangible terms to help illustrate the observational de-identified use case.

Navigating FDP sources

Evaluate thefdp.org and determine the best way to apply their work towards our guidelines

Review other sources for potential requirements

For example: DUOS, Elixr, European agreement, NIH DUA policies, ACT agreement, PCORnet CDRNs, TriNetX, etc.

Pathways documentation

Governance pathway documentation regarding process, versioning, decision tree, signatory authority examples, etc. Ensure doc addresses question of: “how to decide you need a DUA and how to execute one”

CTSAs ratify DUA pathways and master use agreement

Present to PIs at the fall meeting.
Supermajority to proceed.
PIs will take it back to their institutions to implement.

Convene governance interest group

Convene group of iDTF and CTSA PIs who expressed interest - goal: get feedback on governance pain points and our strawman plan.