Study Registration and Data Submission to an NIH-Designated Controlled-Access Data Repository
When planning to register a study in the NIH database of Genotypes and Phenotypes (dbGaP) and submit human genomic and associated phenotypic data to an NIH-designated controlled-access data repository, please consider the following steps:
Please note that the plan for data submission and sharing should be according to that delineated in the genomic data sharing plan in the funding application and the Institutional Certification, which are submitted prior to award. NIH intramural investigators should follow the genomic data sharing plan approved by their IC. NIH Guidance for Investigators in Developing Genomic Data Sharing Plans for NIH-Funded Studies describes the type of information that should be included in a genomic data sharing plan and includes examples of plans.
- Contact the appropriate NIH Institute or Center (IC) Genomic Program Administrator (GPA). This step is very important and should be first in the study registration and data submission process. It should occur as early in the process as possible, even during planning, as it helps the NIH IC to prepare for upcoming data submissions, facilitates communications with data repository staff, and identifies special situations that may need to be considered, such as studies with a complicated design or organizational structure.
- Complete the registration and data submission process electronically in the dbGaP authorized access portal which involves:
- Providing basic study information (e.g., data types, number of participants).
- Uploading the Institutional Certification, an assurance that plans for the submission of large-scale human genomic data to the NIH meet the expectations of the NIH GDS Policy.
- Uploading the data to the dbGaP submission portal, once the registration is approved and complete.
- Processing of the data by dbGaP staff.
Related Resources for dbGaP Study Registration and Data Submission
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 should review the supplemental instructions for more information and helpful tips on how to prepare a successful 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 genome sequence data should review the Special Instructions.
- Upon submitting a DAR, certify, along with the institution, adherence to:
- 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