Electronic Data Use Agreement Tool
(e-DUA)Development
December 9, 2010
Rebecca Hulea
Alex Kanous
Background:DSIC Issues
• Proprietary, contractual, human research, and privacy considerations, such as:• Common Rule• FDA Regulations• HIPAA• IRB Considerations• Institutional Research Policies• Funding Agreements• Contract Restrictions• Investigator/Institutional Interest• Publication Status• Patent Status
Background:Data Sharing & Security Framework
Background:Using the DSSF
• Sensitivity Analysis Process • Assess data sensitivity by reference to the Framework’s four
principal elements• Assign a low, medium or high sensitivity rating to the data
• Colors should be thought of as a spectrum, not perfectly defined categories
• Determine which data can be shared• Determine the type of agreements and security/data access
controls necessary to share
• Framework functions only as a guide and sensitivity determination is ultimately to be determined by the institution
The Electronic Data Use Agreement(E-DUA) Tool
Building upon the DSSF’s data characterization to fulfill the practical need of generating a data use agreement to govern the
transfer of data.
Project Timeline
Project Activities to Date:• Identify Representative DUAs: completed• Catalog Range of Variations in Clause
Language: completed
Current and Future Activities• Draft Standardized Clause Language: Current• Clause Mapping/Structuring: 12-22-2010• DSIC Community Feedback: Early Jan. ‘11
Overview of Representative DUA Selection Process
Representative DUAs
TYPE OF DATA DATA SET PROVIDER
Format/Organization
Synthesizing Representative DUA Language
• Review of existing DUA language identified:• Organization of agreement• Language drafting styles• Generally, the range of issue areas to be addressed by the model DUA:
Data Privacy/Security Concerns
• Re-identification• Permitted
Use/Disclosure• Reporting
Misuse/Unauthorized Disclosures
• Data Security• DHHS Reporting• Authorization to
Release data
IRB/Consent Concerns
• Restrictions to Data Sharing (ex: IRB policies, consent documentation)
Proprietary, Publishing Concerns
• Publishing Restrictions
• Intellectual Property Rights
Institutional Concerns
• Funding/Sponsor Restrictions
Overview of Modular DUA and Clause Construction Process
• Modular DUA and Clause Construction Process:• Identified issues areas were compared to the four domain considerations
of the DSSF and to the different levels of data sensitivity possible within each domain to assist in developing DUA content.
• Model language is being crafted to address each level of data sensitivity within each of the domains.
Privacy/Confidentiality Considerations
• Re-identification• Permitted
Use/Disclosure• Reporting
Misuse/Unauthorized Disclosures
• Data Security• DHHS Reporting• Authority to Release
Human Research Considerations
• IRB Oversight• Consent
Documentation
Proprietary Considerations
• Publishing Restrictions
• Intellectual Property Rights
Contractual Considerations
• Funding/Sponsor Restrictions
Moving Forward
Complete
Standardize Clause
Language
Develop Clause
Relationship Mapping
Solicit Community
Input