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