How to Register and Submit a Study in dbGaP

Each funding institute or center (IC) has designated staff, referred to as GPAs, to assist investigators with registering and submitting genomic data. Note that an investigator cannot register a study in dbGaP by themselves.

• For Extramural (Grants & Contracts) and NIH Intramural investigators:
  • Consult with your Program Officer to identify the appropriate GPA
  • See our List of GPAs by IC
• For Non-NIH funded investigators:
  • See How to Submit A Non-NIH funded Study to dbGaP for step-by-step instructions.

dbGaP Submission process

Use this document to follow along with the dbGaP data submission process.

Download PDF (471 KB)

Prepare and obtain an institutional review board (IRB) review for a signed Institutional Certification, which will be required at Just in Time for NIH funded researchers, before submitting data.

Gather basic study information, which must be later entered in dbGaP during registration. Below is a list of standard information collected at this stage.

Some funding institutes or centers (ICs) may require additional information, and/or require that the investigator submit this information to the IC before the registration process. Investigators should discuss with their GPA (see Step 1 below) as early as possible to find out whether this is the case.

• Target dates for data submission and data release
• Number of participants
• Data type
• Secondary contact information
• Consent groups
• Acknowledgement statement

The GPA will initiate registration in the dbGaP system using the Principal Investigator (PI) name, study name, and grant number (extramural) or protocol number (intramural) when the basic study information has been received and the Institutional Certifications have been approved.

Once the GPA has initiated the registration in dbGaP, the PI may receive an email with instructions for completing the study registration process.

The PI (or designee) enters basic study information in dbGaP (see Step 2 above), and can update as needed

• The GPA (optionally with the PI) uploads the signed Institutional Certification and creates a Data Use Certification in dbGaP.
  • A Data Use Certification describes the terms and conditions of using the data from the uploaded study.
• The Institutional Certification assures NIH that the study submission complies with the GDS Policy and sets limits, if any, on how other researchers may use the dataset.
  • For Extramural (Grants & Contracts) and NIH Intramural investigators:
    • should have completed a signed institutional certification submitted as part of JIT and prior to award
  • For Non-NIH funded investigators:
    • will need to complete a signed institutional certification to accompany their study submission. Learn more about registering a study in dbGaP for non-NIH funded investigators.

• Once the GPA verifies the study registration in dbGaP, the PI or designee will receive an email invitation to the dbGaP submission portal.
• The registration system changes the study to “Complete” and locks the study from any further changes until it is released.

Under the NIH GDS Policy, large-scale human genomic studies must be registered in dbGaP, but the data may be submitted to dbGaP and/or another repository, per the approved GDS plan.

Step 7a: If submitting data to dbGaP

• For those investigators submitting data to dbGaP, a detailed study submission guide is available.
  • After submission of the metadata to dbGaP, the PI receives a study accession number and a password-protected preview site to review and approve.
  • The dbGaP team will process and prepare the data.
  • When the data will be submitted to a repository other than dbGaP, the study will have a public page on dbGaP with the metadata and provide access control when necessary.
  • After the PI approves the preview site, dbGaP publishes a public display of summary-level data and controlled-access release of individual-level data.
• Studies that have been granted an alternate data sharing plan may not have to submit data to dbGaP, but must still register the study in dbGaP.

Step 7b: If submitting data to a repository other than dbGaP

• Investigators not submitting data to dbGaP must:
  • Register the study in dbGaP
  • Submit study metadata to dbGaP

The decision to accept non-NIH-funded study data is made by the NIH Institute, Center, or Office. Investigators should send the information described below to a Genomic Program Administrator (GPA) at the most relevant NIH Institute, Center, or Office (full list of ICOs)

The investigator should provide the following information to the GPA:

• Basic information about the study as listed below, which may be submitted in any format. NIH provides a template (PDF, 281 KB).
  • Target dates for data submission and data release
  • Number of participants
  • Data type
  • Secondary contact information
  • Consent groups
  • Acknowledgement statement
• An indication of whether the study has been published or accepted for publication. If published, please provide appropriate documentation (i.e., the publication citation or a copy of any correspondence indicating that an article about the study has been accepted for publication).
• A completed Institutional Certification signed by the investigator and the authorized Institutional Signing Official (SO). Learn about Institutional Certifications and see step by step instructions for filling out an Institutional Certification.
  • While the review of this request can be initiated without the certification, the review process will be expedited if the certification is received at the time of submission.

The SO is generally a senior official at the investigator’s institution who is credentialed through the NIH eRA Commons system and is authorized to enter the institution into a legally binding contract and sign on behalf of an investigator who has submitted data or a data access request to NIH. The institutional official is typically an academic administrator at the level of Vice President or above or a Dean.

Acceptance of the submission is based upon a consideration of the value of the data to the scientific community and the availability of NIH resources necessary to share the data.

Scientific value can be assessed through considerations of IC priority, publication plans, and the quality and quantity of the data.

• NIH resource considerations include the number of data submissions, data complexity, and any use limitations on the data.
  • For those wishing to deposit the data into the Sequence Read Archive (SRA), note that non-NIH funded submissions to the SRA that have more than 1 terabyte of data must arrange for support to cover submission costs to SRA. If NIH determines that the non-NIH-funded submission is acceptable, support for the submission costs of data to SRA larger than 1 terabyte could come from the IC or from the submitter as a conditional gift to the National Library of Medicine.

After review, the GPA will contact the investigator with any questions and/or to notify them of the IC’s decision, and also whether the option of donating funds as a conditional gift to support the deposition and storage of non-NIH-funded genomic research data in dbGaP is appropriate.

If accepted, please follow the instructions starting at Step 3: GPA registers the study in dbGaP in How to Register and Submit a Study in dbGaP.