Data Management

NIH Data Management and Sharing

Overview

NIH has revised its Data Management and Sharing Policy (“DMS Policy”) effective with proposals submitted on or after January 25, 2023. NIH now requires the submission of a data management and sharing plan at the time of proposal submission. See NIH Institute specific data sharing policies for additional guidance. Download a simplified version of the DMS Policy.

Scope

The NIH DMS Policy applies to all research, conducted in whole or in part by NIH, that will result in the generation of scientific data. Scientific data is defined as “the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.” Scientific data does not include “laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens. Data Sharing is defined as “the act of making scientific data available for use by others (e.g., the larger research community, institutions, the broader public), for example, via an established repository.”

The Policy applies to following types of projects

• Research projects
• Certain Career Development Awards (K-series)
• Small Business SBIR/STTR
• Research Center grants 

The Policy does not apply to the following types of projects

• Training (T-series)
• Fellowships (F-series)
• Certain non-research Career Awards
• Conference Grants (R13)
• Resources (G-series)
• Research Related Infrastructure Programs

View a list of NIH activity codes that are subject to this DMS Policy. If you are unsure which data management policies apply to your project, please visit the NIH’s determination tool.

Requirements of the Policy

The NIH DMS Policy requires the following activities:

• Submission of a DMS Plan at time the proposal is submitted
• Compliance with the approved Plan;
• Reporting on the progress of the Plan in the annual RPPR
• Review and approval by the NIH Program Officer of changes to the Plan during the project period
• Sharing and accessibility of scientific data as soon as possible but no later than the time of publication of findings in a peer-reviewed journal or at the end of the award, whichever comes first.

The FORMS-H grant application form now includes a Section 17. Other Plan(s) attachment in the Other Research Training Plan Section.

Costs of complying with the Policy may be incorporated in Section F, Other Direct Costs, of the R&R Budget Form. Allowable costs include those associated with curating data and developing supporting documentation, local data management, and preserving and sharing data through established repositories.

Creating a DMS Plan using the DMPTool or Fillable NIH Form

To create a DMS Plan, researchers can use the fillable NIH form.

Georgetown strongly encourages the use of the DMPTool, a free web-based tool developed and maintained by the California Digital Library. This tool provides templates with Georgetown and general boilerplate text and guidance based on a variety of sponsor requirements. The tool gives researchers the option of registering their Plan and obtaining a DMP ID, a persistent unique identifier for inclusion in your grant application.

Georgetown is affiliated with the tool. When you sign in, enter your Georgetown email address and you will see the option to “Sign up with Institution (SSO)” and you can use your Georgetown Net ID and password.

For Medical Center proposals, Research Development Services (RDS) will prepopulate the first page of the DMPTool with the relevant information and send it to the researcher for completion. Researchers should contact RDS for assistance. For assistance with the elements of the plan, Medical Center researchers may contact Jonathan Hartmann at the Dahlgren Memorial Library at jth52@georgetown.edu. Main Campus researchers should contact the Office of Research Services with questions regarding use of the DMPTool. For assistance with the elements of the plan, please contact the Lauinger Library Digital Scholarship Services staff at digitalscholarship@georgetown.edu.

Elements of a DMS Plan

Data type

• Description of the types of scientific data to be generated, used, managed, preserved and shared
  • Size, amount, modality, level of aggregation, degree of data processing that has occurred, metadata, other relevant data, and associated documentation

Related Tools, Software and/or Code

• Whether specialized tools, software, and/or code are needed to access or manipulate data, the names of the tools or software, and how they can be accessed

Standards

• Data formats, dictionaries, identifiers, definitions or state that no common standards exist

Data preservation, access, and associated timelines

• Repository name
• How the data is findable and identifiable, e.g., Persistent Unique Identifier
• When and for how long the data will be made available

Access, Distribution, or Reuse Considerations

• Describe applicable factors affecting subsequent access, distribution or reuse related to
  • Informed consent
  • Privacy and confidentiality protections (Certificates of Confidentiality, etc.)
• Specify whether access to human subjects data be controlled
  • Other restrictions by law, e.g., HIPAA or contract, e.g., data use agreement

Oversight of data management and sharing

• How will compliance be managed, frequency of oversight and by whom (roles and titles)

Selecting a Repository

NIH encourages the use of existing repositories; view guidance on how to select them.

Please note that some NIH Institutes or funding announcements may have requirements for specific repositories. Please follow that guidance or check with the relevant NIH Program Officer. 

In addition, Georgetown also has its own repository, DigitalGeorgetown, that is available to all Georgetown researchers free of charge. If faculty have questions or need general advice regarding the identification of repositories, they can contact Jonathan Hartmann at the Dahlgren Memorial Library at jth52@georgetown.edu. Main Campus faculty may contact Lauinger Library Digital Scholarship Services staff at digitalscholarship@georgetown.edu. 

Researchers anticipating the generation of large data sets may contact Alisa Kang in University Information Services at alisa.kang@georgetown.edu. 

Human Subjects Data Considerations

There have been no changes to existing laws and regulations regarding the protection of human subjects. All human subjects research is subject to review and approval by the Institutional Review Board (“IRB”). Review of the NIH approved DMS Plans will be a component of IRB review for all NIH funded research awarded on or after January 25, 2023. The IRB will review the conditions for data sharing, consider whether limitations on future use of study data are appropriate, ensure that the risks of data sharing have been considered, and verify that the informed consent is consistent with the DMS Plan.

NIH has emphasized that researchers engage prospective participants regarding what is expected to happen with the data they contribute through the informed consent process. The informed consent must clearly communicate information about data sharing and use and whether the study is subject to a Certificate of Confidentiality. Researchers must consider whether there are any limitations that could arise due to existing laws and regulations or the applicability of a Certificate of Confidentiality, and whether access to scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. The IRB templates will be updated soon to include language consistent with the NIH Policy.

Unless the consent form specifically states that identifiable data will be shared, all human subjects’ data must be de-identified prior to sharing with other researchers or deposited into a data repository. View information regarding the HIPAA regulations. Georgetown recommends deidentification consistent with the Safe Harbor Rule at §164.514(b)(2).

Institutional Oversight

Oversight of compliance with the NIH DMS Policy will be shared by multiple offices at Georgetown. At time of proposal submission, the Main Campus Office of Research Services (“ORS”) and the Medical Center Office of Research Development Services will ensure that proposals include a data management and sharing plan. For projects involving human subjects research, Plans must be submitted with the protocol for review by the Institutional Review Board at the Just in Time stage prior to grant award. At the time of submission of the progress reports or RPPRs, ORS and the Medical Center’s Office of Sponsored Research will review the RPPR to verify that researchers have documented their compliance with the plan. When the grant expires, the Office of Research Oversight will verify that the researcher has deposited the data in a data repository. The Office of Technology Commercialization will review the data use agreements associated with the data repositories.

Georgetown Data Management Resources

• Lauinger Library
• Dahlgren Memorial Library
• University Information Services (UIS)

NIH Resources

• NIH Policy for Data Management and Sharing (NOT-OD-21-013)
• Protecting Privacy When Sharing Human Research Participant Data (NOT-OD-21-013)
• Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
• Allowable Costs for Data Management and Sharing (NOT-OD-21-015)
• Selecting a Repository for Data Resulting from NIH-Supported Research (NOT-OD-21-016)
• National Human Genome Research Institute’s Expectation for Sharing Quality Metadata and Phenotypic Data (NOT-HG-21-022)
• Implementation Details for the NIH Data Management and Sharing Policy (NOT-OD-22-104)
• New NIH “FORMS-H” Grant Application Forms and Instructions (NOT-OD-22-195)

Please note that other U.S. Government sponsors have data management and sharing requirements as well. View additional information about these requirements.