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Submitting Genomic and Phenotypic Data

Guide for NHGRI Extramural Investigators

All data produced with NHGRI support should be shared with the community rapidly, completely, and in NIH-designated data repositories (e.g., AnVIL, dbGaP, GEO). Investigators should follow the steps below to prepare for submission of genomic data.

 

1. Include plans for sharing genomic data in your grant application

Address how you will share any genomic data and associated phenotype and meta data generated in your grant project in the “Resource Sharing Plan” section of the grant application or as per instructions in a Funding Opportunity Announcement (FOA) or Request for Proposals (RFP) for a contract.

2. Scientific review of grant or contract application

Data sharing plans and the proposed budget for data sharing needs will be reviewed by peer reviewers.

3. Prepare and submit Just-In-Time information

Submit Key Documents to the NHGRI GPA and work with your Program Director to finalize:

  1. NHGRI Extramural Genomic Data Sharing Plan (GDSP) Template
     
  2. If your study generates human genomic data, prepare an Institutional Certification (IC) signed by the Authorized Institutional Signing Official* from your institution and Study investigator.

* An Institutional Signing Official is generally a senior official at an institution who is credentialed through 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.

4. The NHGRI GPA registers applicable studies in the dbGaP submission system

If you are generating large-scale human genomic data*, the NHGRI GPA will register your study in dbGaP after your grant or contract has been awarded. Within 48 hours of the registration process, the PI and assistant/submitter will be sent an automatic invitation from dbGaP which includes instructions on the data submission and cleaning process. The invitation expires in 7 days and should be accepted even if nothing more is done until later in the project period.

*If you’re unsure whether you are generating data that meets the definition of large-scale, contact the NHGRI GPA.

5. Proceed with your study to generate genomic data

Include any updates on progress made toward the generation of your genomic data in your Research Performance Progress Report (RPPR).

6. Upload data

Upload data to the repository indicated in your GDS plan:

Privileged Access Period: Once you initiate data submission, you will enter a period of privileged data access, which NHGRI defines as 6 months or the period specified within the RFA or Notice of Grant Award. During this period, your data will not be available to other investigators through the repository while you perform data analysis and prepare for any publication of data.

Learn more about NHGRI’s data submission and release timelines.

7. Study Release

The expectation is that data will be released six months after initiation of data submission OR at the time of first publication (whichever occurs first).

Seeking an Exception to the Expectation for Data Deposition?

If you are requesting an exception to the requirement to deposit genomic data from research participants for your study, include a justification in your Resource Sharing Plan for why data sharing through dbGaP or AnVIL would be inappropriate. Investigators should also provide an alternative mechanism for data sharing. Investigators will also need to document the Alternative Data Sharing Plan in their GDSP Template. Learn more about Alternative Data Sharing Plans.

Note: All GDSPs containing a request for an Alternative Data Sharing Plan will be sent by the GPA to the NHGRI Director, who must review and approve the exception.

Key Elements of Genomic Data Sharing Plans

The following chart outlines the key elements to include when describing plans for genomic data sharing and where NHGRI expects these plans to be documented:

 

Element

Resource Sharing Plan of the application

Pre-award (GDSP Template)

Pre-award (Institutional Certification)

The type of data that will be shared (i.e., the type of genomic data, phenotypic variables, relevant associated data, and information necessary to interpret the data).

 

The data repository to which the data will be submitted.

 

The data standards that will be used.

 

 

An estimated timeline with data sharing milestones (data can be shared incrementally if there are several components in the discovery process).

 

 

Human Only

An indication as to whether an Institutional Review Board (IRB) or analogous review body has reviewed the data sharing aspects of the project, or that a timeline has been provided for such review.

 

 

A description of the appropriate uses of the data (“Data Use Limitations”).

 

 

A request for an exception to use samples without explicit consent for broad data sharing.

 

A request for an Alternative Data Sharing Plan, if data cannot be shared in a public repository because the criteria of the Institutional Certification cannot be met.

 

Last updated: August 4, 2021