Key Documents for Genomic Data Sharing

To share genomic data with NIH and NCI repositories, investigators will need to complete the following documentation. Some documents, such as the data sharing management plans, must be submitted prior to the award of funding. Investigators should work with their NCI Program Official regarding expectations.

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 formally 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 projects 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), must delineate any "data use limitations (DULs)" on the secondary research use of the data, as agreed to in the informed consent documents signed by study participants.

An Institutional Certification will be required to certify and confirm allowable data use for each sample within the genomic data set to be submitted to NIH repositories. Specifically, for each Institutional Certification, the Institutional Review Board (IRB) or privacy board (of the institution where the samples were collected) should advise both the Principal Investigator (PI) submitting genomic data generated from those samples and their Institution's SO on the broadest allowable data use(s) and expectations as consistent with the informed consent provided by each participant from which samples used to generate the genomic data (as defined in the NIH Genomic Data Sharing Policy). The Institutional Certification(s) will need to be signed by the submitting PI and his/her Institutional SO who, as the institution’s legal authority, attests that the IRB has reviewed and determined that the data uses are consistent with the informed consent and agree with the conditions of the Institutional Certification.

Submit your Institutional Certification with appropriate signatures to the Program Officer or Genomic Program Administrator with Just-in-Time funding material. For a multi-site project (with samples collected at several institutions), either:

  • Submit a single-site Institutional Certification from each site contributing samples, or 
  • Submit a multi-site Institutional 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.

Please note that General Research Use without any further restricting modifiers allows the maximal benefit of research funded with public dollars and is preferred whenever possible and consistent with informed consent. If disease-specific data use or data-use modifiers are required, please contact the NCI Office of Data Sharing for further guidance.

For more information about submitting research data, please visit the Submitting Research Data page.

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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