Requesting Access to Controlled-Access Data Maintained in NIH-Designated Data Repositories (e.g., dbGaP)

Responsible stewardship of controlled-access data subject to the NIH GDS Policy is shared among the NIH, the investigators approved to access the data, and the investigators’ institutions. Investigators who are interested in obtaining controlled-access data from NIH-designated data repositories for secondary research use must:

• Submit a Data Access Request (DAR) through the dbGaP authorized-access portal, describing the proposed research use of the data.
  • Investigators are encouraged to review the Tips for Preparing a Successful Data Access Request for more information on what elements to include in a DAR.
  • The investigator must be a tenure-track professor, senior scientist, or equivalent, to be able to submit a DAR.
  • For collaborations between multiple institutions, the investigator(s) at each institution must submit a separate DAR and receive approval before data may be accessed. Each institution is ultimately responsible for the oversight of its investigator’s management and use of the data.
  • Investigators wishing to access HeLa cell whole genome sequence data should review the Special Instructions.
  • Upon submitting a DAR, certify, along with the institution, adherence to:
    • The terms of access described in the Data Use Certification (DUC) Agreement and the Genomic Data User Code of Conduct.
    • The NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy.
  • Allow for Data Access Committees (DACs) review of the DAR. DACs, comprised of federal employees with the appropriate expertise, are established by NIH Institutes or Centers to review DARs based on whether the request conforms to the specifications within the NIH GDS Policy and program specific requirements or procedures (if any), and for consistency with any data use limitations. Based on their review, DACs approve or disapprove DARs, or return DARs for revision.

Once approved, investigators may download and access the data for one year. Prior to the expiration of the one-year access period, investigators must also submit a project renewal or close-out report, describing the progress made on the approved research project.

Related Resources for Requesting Access to dbGaP Data

• dbGaP How-to Tutorials (YouTube). Instruction videos that guide dbGaP users through the following processes:
  • Data Access Requests
  • Project Renewals
  • Project Close-Outs
• NIH Extramural Investigator Data Access Request Flowchart 
  • NIH Staff Data Access Request Flowchart
  • NIH Staff Request Form for Permission to Access Controlled-Access Data  
  • NCI Staff Request Form for Permission to Access Controlled-Access Data
• Tips for Preparing a Successful Data Access Request
• Model Data Use Certification (DUC) Agreement
  • Genomic Data User Code of Conduct