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General Policy Questions

What does the new NIH Data Management and Sharing Policy mean for me, the investigator?

Previously, NIH grant proposals seeking $500,000 or more in direct costs have been required to include a data sharing plan. However, effective January 23, 2023, all funding requests for research (including extramural grants and contracts, intramural research projects, and other funding agreements), regardless of funding level, that produces scientific data outputs will be required to include a data management and sharing plan. The new Data Management and Sharing Policy applies to Research Projects, some Career Development Awards (Ks), Small Business (SBIR/STTR), and Research Centers.

The new NIH DMS policy means that you, as an investigator applying for a new grant or a competitive renewal that falls into any of these categories, will need to develop and implement a data management and sharing plan as part of your funded research project activities. You will also need to determine the cost of data management and sharing to be included in your proposal budget request. NIH program staff will review the DMS plan for acceptability and require that the plan be executed as a term and condition of award.

Does the new NIH Data Management & Sharing Policy apply to all funding proposals and applications?

No. The policy applies only to research that results in the generation of scientific data including Research projects, some career development awards, small business innovation research (SBIR) and technology transfer (SBTT) awards, and awards for research centers.

The policy does not apply to research and other activities that do not generate scientific data including Training (T), Fellowships (F), Construction (C06), Conference Grants (R13), Resource (Gs) and Research-related Infrastructure Programs (e.g., S06).

To be certain that the policy is applicable to your application, review the list of NIH codes subject to the DMS Policy and the Funding Opportunity Announcement.

What constitutes “scientific data” for the purpose of NIH policy requirements for a DMS plan?

NIH defines scientific data as: “data 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.”

For NIH purposes, scientific data includes “any data needed to validate and replicate research findings,” but 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.”

Will the DMS plan be part of scored peer review criteria?

No. Unless specifically noted in the Funding Opportunity Announcement, peer review will not see or review DMS plans. However, peer review will consider budget items related to data management and planning activities and comment on the reasonableness of the budget.

Note that NIH program staff will be reviewing DMS plans for acceptability and may request modifications prior to award. As a term and condition of award, DMS plans must be approved by NIH and executed as outlined in the approved plan.

Why all the fuss about data management and sharing?

The goal of data management is to ensure that your data are discoverable, interpretable, and usable by you and future researchers. In addition, data management and sharing practices help sustain the value of your data and allow you and others to verify and build upon your published results.

Data management activities include, but are not limited to:

  • Planning for data management and sharing
  • Documenting, formatting, and storing data
  • Curating, archiving, and sharing data
  • Implementing reproducible research best practices

Data management activities should be consistent with the FAIR data principles for findable, accessible, interoperable, and reusable data, while also reflecting the research standards and best practices of specific scientific communities.

Policy Implementation Questions

When does NIH expect researchers to share their data?

Data must be shared no later than the time of an associated publication or at the end of the performance period, whichever comes first.

Keeping up with good data management practices from the beginning of the funded project, however, will aid investigators and research teams in meeting the sharing requirements at the end of the funded period.

How will policy noncompliance be handled by NIH?

NIH will monitor compliance over the course of the funding period during and regular reporting intervals. Noncompliance may result in additional terms and conditions for the award, terminating the award, or the denial of future funding requests.

What if my data contain personally identifiable information (PII) or protected health information (PHI)?

NIH requires award recipients to comply with any applicable laws, regulations, statutes, guidance, or institutional policies that govern the privacy of human participants. Accordingly, NIH acknowledges that certain factors, including protection of participants’ privacy, may limit data sharing. If data cannot be shared for this reason, or other ethical, legal, or technical reasons, the DMS plan should include a compelling rationale for limiting data sharing.

Are there special provisions in the DMS policy for American Indian/Alaksa Native participant data?

Yes. When developing the DMS Policy, NIH sought input from Tribal Nations, with recommendations released in the Tribal Consultation for Data Management and Sharing Report. In accordance with these recommendations, NIH issued Supplemental Information to the NIH Policy for Data Management and Sharing:Responsible Management and Sharing of American Indian/Alaska Native Participant Data that reflects respect for “Tribal sovereignty, with an acute recognition that our failures to honor sovereignty have causes stigmatization and other harms to AI/AN Tribes and communities.”

Will we still be required to prepare an additional genomic data sharing plan for genomics research?

No. NIH is harmonizing and integrating the genomic data sharing requirements so that only one DMS plan must be submitted and implemented. The NIH Genomic Data Sharing Policy guidance provides specific information on writing a plan for sharing genomic data as part of the DMS plan.

Data Management and Sharing Plan Questions

Are resources available to help write and execute a data management and sharing plan?

UNC is committed to supporting investigators as we transition into a new era of open science practices and professional expectations related to data management and sharing.

The Office of the Vice Chancellor for Research is working to ensure that investigators have the support and resources needed to plan and implement data management and sharing for all NIH funded research projects conducted at UNC.

UNC is expanding the campus data management infrastructure capacity so that important research at UNC can continue to be funded, while also complying with the new DMS Policy requirements from NIH as well as other current and forthcoming DMS mandates.

Bookmark this site, as it will be updated with new information and resources as we approach the policy change deadline in January.

How do I create a data management and sharing (DMS) plan?

The NIH DMS Policy website includes a Writing a Data Management & Sharing Plan section, which provides comprehensive guidance on writing a DMS plan that describes in detail each of the recommended elements to include in the plan.

To ease the process of drafting a DMS plan, use the DMPTool. The Odum Institute Data Archive sponsors the DMPTool, which is a free online “wizard” for creating DMS plans that align with funding agency policy requirements including those for NIH. The DMPTool provides a customized template that includes suggested language and links to relevant resources to make it easy to generate a robust DMS plan that meets funder requirements.

Data Repository Questions

NIH encourages the use of a data repository for data sharing. What is the purpose of a data repository?

Established data repositories provide standards-based tools and services designed to support FAIR data principles to ensure that data are findable, accessible, interoperable, and reusable. They have policies, infrastructure, and expertise in place to ensure that data can be discovered, interpreted, and used now and into the future.

In developing the Data Management and Sharing Policy, NIH referred to the TRUST Principles for digital repositories and FAIR Guiding principles for scientific data management and stewardship as the basis for setting expectations for data management and sharing as well as for identifying desirable characteristics for data repositories.

How do I choose a data repository that is appropriate for my data?

NIH has created a list of desirable characteristics researchers should look for when selecting a data repository as part of their data management plan. These characteristics ensure the data deposited into a repository are preserved, accessible, and reusable even after the end of the project’s active phase.

  • Unique persistent identifier
  • Long-term sustainability
  • Metadata
  • Curation and quality assurance
  • Free and easy access
  • Broad and measured reuse
  • Clear use guidance
  • Security and integrity
  • Confidentiality
  • Common format
  • Provenance
  • Retention policy

Based on these desirable characteristics for data repositories, NIH has also published a list of NIH-supported repositories. While NIH does not endorse or require sharing data in any particular repository, this non-exhaustive list represents some repositories that possess the desirable characteristics. Investigators should consider the repository that is most appropriate for the specific data generated from the research project.

What if I share my data as supplemental materials with my published research article? Does that meet the NIH requirements?

This does not meet the NIH requirements for data management and sharing. NIH has provided a list of characteristics for repositories that meet the requirements laid out in the new policy.

Data Management and Sharing Budget Questions

How will costs associated with data management and sharing be paid for?

Allowable data management and sharing costs must be included in your proposal as a direct cost in your budget and budget justification to ensure that adequate funding is available to cover implementation of your DMS plan.

How do I estimate costs for data management and sharing activities to be included in the project budget?

NIH recognizes that there are costs associated with data management and sharing. Accordingly, investigators may request funds for data management and sharing in the budget and budget justification. NIH defines allowable costs that may be included in the budget request, which include the following:

  • Curating data
  • Developing supporting documentation
  • Formatting data
  • De-identifying data
  • Preparing metadata
  • Local data management for data that require unique or specialized infrastructure
  • Preserving and sharing data through established repositories

These allowable costs should be considered in your data management and sharing budget. Note that allowable costs included in the submitted budget must be incurred during the performance period, including those for long-term preservation of the data beyond the award period.

NIH also defines the following unallowable costs that should not be considered in the budget estimate:

  • Infrastructure costs that are covered by F&A
  • Costs associated with routine research activities such as data collection or access costs
  • Costs that are double charged or inconsistently charged as both direct and indirect costs

Get Help with the New Data Sharing Requirements

We know this is a big change, and we are here to help. Please click the link below to request assistance with a data management plan.

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