UNC Institutional Certification (dbGaP) Request Form

UNC Institutional Certification (dbGaP) Request Form

Purpose

The UNC Institutional Certification (dbGaP) Request Form form is used when UNC‑Chapel Hill serves as the institutional official certifying data submission to dbGaP or another NIH‑designated controlled‑access repository. Submission of this form is required prior to IRB issuance of an Institutional Certification.

Download the Form

When to Use This Form

Submit this form when:

  • You plan to share individual‑level human genomic or phenotypic data to an NIH repository, and
  • UNC will serve as the institutional certifying entity
  • If you are under a Just‑In‑Time (JIT) deadline and required documents are not yet available, contact OHRE regarding a Provisional Institutional Certification before completing a full request. A more detailed Genomic Data Sharing Plan must be provided to the funding IC prior to award.

How to Complete the Form

Principal Investigator Information: Provide accurate PI and study details. List all IRB studies associated with the samples being shared.

Sample Source: Indicate where the samples originated. Check all that apply and include IRB numbers or repository names as requested. Samples may originate from a different protocol than the one currently under review.

Sample Collection Date: NIH data sharing requirements differ depending on whether samples were collected before or after January 25, 2015. Your selections must align with the NIH Institutional Certification form(s) you submit.

Risk Considerations: This section addresses whether data sharing presents:

  • Foreseeable risks to individual participants or families
  • Risks to groups or populations

If risks exist, briefly explain. These responses should align with your informed consent language and NIH forms.

Data Identifiability: Indicate whether the dataset is:

  • Anonymous
  • Coded (with key retained locally)
  • Other (explain)

Direct identifiers must not be submitted to repositories.

Informed Consent Review: List all versions of consent forms used for participants whose data will be shared. Do not upload signed consent forms, only the IRB approved templates.

Data Access Level & Genomic Summary Results: Select access levels consistent with:

  • What participants were told in consent
  • Any disease‑specific or population‑based limitations

If sensitivities exist, explain clearly.

Required Attachments: Upload the following document with the submission.

Submission & Review: Submit the completed form and attachments per IRB instructions. OHRE/IRB staff will review for consistency with:

Need Help?

For questions about completion, JIT deadlines, or certification requirements, contact OHRE.