1. Electronic Data Use Agreement Tool (e-DUA) Development December 9, 2010 Rebecca Hulea Alex Kanous

2. 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

3. Background: Data Sharing & Security Framework

4. 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

5. 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.

6. 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

7. Overview of Representative DUA Selection Process Representative DUAs TYPE OF DATA DATA SET PROVIDER Format/Organizati on

8. 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

9. 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

10. Moving Forward Complete Standardize Clause Language Develop Clause Relationship Mapping Solicit Community Input