Data Sharing and Access to Identifiable Data

Data Sharing and Access to Identifiable Data

Data Sharing and Publication

Data Sharing: REGARDS can share a fully de-identified dataset with investigators as soon as the Ancillary Study Proposal or Manuscript Proposal is approved and the investigator provides REGARDS study staff with IRB approval for secondary data analysis.  A fully de-identified dataset does not contain dates, names, addresses, or geographic identifiers smaller than a state. If an investigator needs access to geographic data or other PHI, a data use agreement with UAB is needed. After the data use agreement is executed, the investigator will be provided with login credentials to access data through a VPN but geographic data cannot leave UAB servers.  

Publication and Presentation of Data (abstracts, presentations, posters and manuscripts): All investigators must adhere to the REGARDS Publications and Presentations Policies and Procedures. Prior to working on analyses investigators need to have an approved Manuscript Proposal. This is needed even if the investigator has an approved Ancillary Study Proposal.

Access to Identifiable data

To access identifiable data researchers must follow a structured process designed to protect participant data. First, the researcher must obtain Institutional Review Board (IRB) approval from their home institution, confirming that the proposed research is approved to use identifiable data. Next, a Data Use Agreement (DUA) for limited data and/or a Business Authorization Agreement (BAA) for direct identifiers must be established between the researcher’s institution and the REGARDS coordinating center, outlining the terms of data access and use. Once these steps are completed and verified, the researcher is granted remote login access to a secure computing environment where the identifiable data can be analyzed, ensuring data confidentiality and integrity throughout the research process.  No individual data may leave the remote data session. Aggregate data will be checked by REGARDS statisticians to verify that it does not contain identifiers.

Types of identifiable data:

• Name
• Address (all geographic subdivisions smaller than state, including street address, city, county, zip code and FIPS codes longer than 2 digits)
• Month and day (except years) of dates related to an individual (including birthdate, REGARDS enrollment date, date of death, and exact age if over 89)
• Telephone numbers
• Fax number
• Email address
• Social Security Number
• Medical record number
• Health plan beneficiary number
• Account number
• Certificate or license number
• Vehicle identifiers and serial numbers, including license plate numbers
• Device identifiers and serial numbers
• Web URL
• Internet Protocol (IP) Address
• Finger or voice print
• Photographic image - Photographic images are not limited to images of the face.