How to Submit A Non-NIH funded Study to dbGaP

Pre-Submission: Identify the NIH Institute, Center, or Office that is most closely aligned with the purpose of the research to be submitted

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)

Step 2: Collect required documents and information and submit to GPA

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.
  • 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.

Step 3: The NIH GPA reviews the submission

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.

Step 4: If accepted, begin registration process

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.