CD2H Phase 2 Proposal
Project Title: CTSA Data Sharing Governance Pathways Project
Point Person: Kari Stephens, UW, firstname.lastname@example.org
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. Specifically. examples and templates of standardized Data Use Agreements (DUAs) that promote collaborative and flexible data sharing are needed.
- Built regional centralized data network with demonstrated success (K. Stephens, Data QUEST, UW CTSA)
- Developed model at UW for data sharing of clinical data under consent waiver
- Identified business risks, compliance and federal law impacts of data sharing
- Assessed best practices at several sites
- White paper in development
- Operationalized study specific and institution wide data use and BAA agreements for trusted partner data sharing
- In Phase 1, we developed a DUA and IRB for UW and Wash U to support a specific data use case with broad data applicability that are currently under review at both institutions
GitHub repo: N/A
With the implementation of the new common rule, it is expected that observational research under a waiver of consent using electronic health record data will continue to expand. Yet CTSAs do not have clear pathways on how to expediently allow safe sharing of electronic health data for research. Some CTSAs have 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. Finally, they need examples and templates to make creation of standardized DUAs and related governance easy to execute, and in a manner that is maximally collaborative and flexible in terms of downstream research.
A pilot test of a harmonized governance solution to support multiple use cases of cross site data sharing without the need for individual DUAs per project. If successful, will result in a governance approach ready for broader application.
CTSAs will be able to use these governance solutions “out of the box” rather than creating these solutions from scratch. CTSAs will be able to execute data sharing governance faster and easier both through existing pathways identified by this project, and via examples of successful execution of these pathways by institutions large and small affiliated with CD2H. Institutional leadership may feel more confident in pathways endorsed by an entity like CD2H, streamlining use and adoption of these strategies.
Expected outputs (6 months):
- Governance landscape and model of best practices
- DUA template reviewed and signed by a couple CTSA institutions to allow NCATS to store data in their cloud environment
- DUA and IRB examples/templates with written descriptions to be a governance “toolkit” for CTSAs to use for cross institutional data sharing
- Exploration of the feasibility of development of a master consortium agreement to aid in cross CTSA data sharing to advance ACT functionality