NIH Data Management and Sharing Policy

A Data Management and Sharing Plan (DMSP) is a brief but essential component of a project and many grant applications. The purpose of a DMSP is to provide details on the management and sharing of research data.

For proposals submitted on or after January 25, 2023, the NIH data management and sharing policy requires that investigators submit a data management and sharing plan with their proposal for all projects that will produce scientific data. NIH program staff will assess the plan to ensure the recommended elements have been well addressed and may require revisions.

NIH has developed an optional DMSP template that aligns with the recommended elements of an NIH DMS plan. In the sections below, we've outlined the considerations for each recommended part addressed in the NIH DMSP and provided links to related resources. OHSU Investigators and their staff can use the DMPTool to create an NIH data management plan and request feedback from an OHSU Librarian. Be sure to use your OHSU email to sign in to access these features. 

Element 1 of the NIH DMSP asks you to describe what data will be generated throughout a project, what data will or will not be shared and why, and how the data will be documented to facilitate interpretation by others. To prepare this part of your plan, consider the following:

• The types and the quantity of scientific data that will be produced or utilized in the study. 
• Any ethical, legal, or technical considerations that will influence which scientific data to keep and share.
• The amount of processing the data will undergo. For example, it may not be possible to share raw data, but you may be able to share de-identified, aggregate, or summary data from a project.
• The metadata and any supporting documentation you will create and make available to help others understand your data.

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Consider any specialized tools required to access or manipulate shared scientific data for reuse or replication. If applicable, specify how needed tools can be accessed. 

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Standards guide how data and related materials should be stored, organized, and described to facilitate access, understanding, and reuse. For example, the Minimum Information About a Microarray Experiment (MIAME) standard is intended to specify all the information necessary for an unambiguous interpretation of a microarray experiment.

When addressing this element of your plan, note the applicable data formats, metadata standards, and documentation approaches, such as data dictionaries and README files, you will use and share. If you are working with one of the OHSU Research Cores, you may want to contact them to see what standards they may use to collect and process research data.

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There are various ways in which to preserve and make scientific data discoverable. In this section, you should describe where and when the scientific data associated with your research will be available. To prepare this part of your plan, consider the following and consult the Preserving and Sharing Scientific Data section of this guide for more in-depth guidance.

• NIH encourages sharing scientific data as early as possible but no later than the time of a related publication or the conclusion of the performance cycle.

• NIH encourages scientists to keep their findings publicly accessible for as long as they believe it would be beneficial to the broader scientific community.

• NIH encourages investigators to use an established repository. Established repositories include NIH-managed repositories and biomedical and generalist repositories supported by other organizations, both public and private.

• Some data require extra preparation or safeguards before they can be shared or can only be shared via controlled access.

Consider using the OHSU Research Data Catalog to create a metadata-only record of your data if an established repository is not acceptable or readily available for sharing your data.

What is the OHSU Research Data Catalog?

The OHSU Research Data Catalog provides metadata-only descriptions of the research data resources, such as datasets and registries that OHSU investigators and research communities generate or steward.

Because it does not store or provide access to data, it can be used to promote the discovery of data resources for which access must be controlled, such as through IRB approval and data use agreements.

The OHSU Research Data Catalog is designed to:

•     Increase the visibility of sensitive research data generated by OHSU researchers.
•     Describe the controlled access requirements associated with sensitive data sets.
•     Support compliance with the NIH Data Management and Sharing policy and other funders' requirements.
•     Facilitate collaboration across departments and institutes.

The OHSU Research Data Catalog is not an appropriate tool for promoting the discovery of research data that can be shared without restrictions or via an external restricted-use repository, such as dbGaP.

Additionally, if your data resource is related to 1.) an industry sponsored research project/trial, and/or 2.) a commercializable material, technology or invention, you should consult with OHSU Technology Transfer before describing it in the Data Catalog.

Complete the OHSU Research Data Catalog Submission Form in order to describe your data resource and its access requirements in the OHSU Research Data Catalog. If you have questions or need support with your submission, contact the OHSU Library.

Some data require extra preparation or safeguards before they can be shared or can only be shared via controlled access. In Element 5, describe any legal, ethical, or technical issues that may influence future access to, distribution, or reuse of the data generated. This section of the DMSP is especially important for managing and sharing data from human participants. To prepare this part of your plan, consider the following:

• Limitations prescribed by federal, tribal, state, or local laws, rules, policies, or current or future agreements.
• Provisions for privacy and confidentiality in accordance with relevant federal, tribal, state, and municipal laws, rules, and guidelines.
• Factors pertaining to informed consent.
• Any potential limitations on future data use that should be communicated to the people or entities responsible for maintaining and disseminating the scientific data (I.e., data repository managers). 

If an established repository is not appropriate or available for sharing your data, you can consider using the OHSU Research Data Catalog to create a metadata-only record of your data. For more information about the OHSU Research Data Catalog, please get in touch with the OHSU Library.

If you plan to utilize the OHSU Research Data Catalog in your NIH DMSP, you can use the following language:

Access to this data will be controlled in accordance with legal, regulatory, and informed consent agreements. A metadata-only description of the data, including the controlled access requirements, will be publicly available in the OHSU Research Data Catalog. Rather than functioning as a data repository, the OHSU Research Data Catalog is a digital wayfinder for researchers looking for datasets relevant to their work.

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In Element 6, you will describe how compliance with this plan will be monitored and managed, the frequency of oversight, and by whom at your institution (e.g., titles, roles). In addition to briefly describing how you and your research team will manage day-to-day and broader compliance activities, you can include the following language about OHSU OPAM's processes:

"The Office of Proposal and Award Management (OPAM) at Oregon Health & Science University, which will be administering this award, has created a data management and sharing plan compliance system as part of their process for submitting the annual NIH progress report. OPAM will secure certification from the PI that the DSMP is compliant as approved. If the PI cannot certify compliance, OPAM will work with the team to ensure non-compliance is adequately addressed."