Considerations When Developing a Data Sharing Plan

NIH promotes sharing research data broadly with other researchers through several data-sharing policies and resources.

De-identified data from human research participant studies are most often shared through a controlled-access model where qualified researchers may request data access to address specific research questions. An example of a controlled-access database is NIH’s database of Genotypes and Phenotypes (dbGaP). Some datasets may be truly “public” data sets, where anyone may have access to de-identified data. Available public data sets can be found at

For large budget research grants (those seeking $500,000 or more in subtotal direct costs), and grants that include producing large-scale genomic data, the NIH data-sharing policies expect that NIH-supported researchers will share final datasets (or data used for the main publications) through controlled-access models for de-identified data from human participants (e.g. dbGaP).

Large Budget Grants

To be compliant with NIH data sharing policies for large budget grants, the de-identified data may be made available in various ways, such as depositing the dataset to an NIH controlled-access database, securely transferring a dataset for analysis, or using an enclave model (such as a secure, access-controlled Cloud platform) for data access and analysis.

When considering how to share their data, NIH-supported investigators may choose to:

  • Use an NIH data repository, and NIH will be responsible for sharing the data in accordance with the data sharing policies; or
  • Store their data locally and provide access to the data in accordance with NIH policies.

If investigators choose the second option, they must consider the long-term sustainability of data storage and the resources needed to respond to data access requests. Over time, the resources required to store data and to review and respond to data requests may become more challenging, particularly once the grant supporting the original research project comes to an end.

Important Caveats

If you are considering a grant application that falls within the scientific areas of interest of the Epidemiology and Genomics Research Program (EGRP), scientific program directors in EGRP are available to advise investigators on options available to them as they develop data-sharing plans. EGRP-specific requirements related to data sharing plans for ARAs are available.