Key Documents for Genomic Data Sharing

To share genomic data with NIH and NCI repositories, investigators will need to complete the following documentation.

Extramural Program Data Sharing Plan (DSPs)

Extramural investigators submit a  Data Sharing Plan (DSP) as part of their funding application. The DSP should be consistent with NIH Data Sharing Policies and discussed with the investigator’s Program Officer early in the research planning process. The formal approved DSP and Institutional Certifications must be submitted and approved as part of Just-in-Time (JIT) materials. Program Officers must approve the DSP prior to funding. NCI expects that DSPs will be collected and reviewed at the research planning process. NCI staff will assess whether the project falls within the scope of the GDS policy, and if so, whether the DSP is adequate based on NIH Guidance for Investigators in Developing Data Sharing Plans.

Institutional Certifications

The Institutional Certification assures that institutions planning to submit genomic data to NIH will meet the expectations of the GDS policy. The certification, provided by the submitting Investigator and certified by the institutional Signing Official (SO), clearly delineates any data use limitations (DULs) on the research use of the data, as agreed to in the informed consent documents signed by study participants.

For a multi-site project (with samples collected at several institutions), institutions should either:

  • Submit a single-site institutional certification from each site contributing samples, or
  • Submit a multi-site certification. NIH understands that the submitting institution may not be the local institution or Institutional Review Board of record for all sites. If the submitting institution chooses to submit a multi-site Institutional Certification, the submitting institution will assure NIH that, based on either its own review or assurance from other institutions, that the expectations and conditions of the Institutional Certifications(s) are met for the entire data set.

An Institutional Certification should be submitted at the earliest possible point in time. The certification should be provided to NCI prior to award, along with any other Just-in-Time (JIT) information.

Basic Study Information

The Basic Study Information for extramural and non-NIH funded investigators should be submitted once the data generation and cleaning is completed. 
           
Extramural Grantees:  Basic Study Information Form
Non-NIH Funded Investigators:  Basic Study Information for Non-NIH-Funded Studies Form
 
For additional questions about data sharing, please contact the NCI Office of Data Sharing.

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