NIH Data Management and Sharing Policy Guidance and Resources

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The National Institutes of Health (NIH) has made several key changes to grant processes related to Data Management and Sharing (DMS) and the harmonized Genomic Data Sharing (GDS) policies as of January 25, 2023 (documented in NOT-OD-21-013). The NIH has a user-friendly website on NIH Scientific Data Sharing to guide researchers on these substantive changes.

 

Please be aware of the NIH policy, FAQ, Houston Methodist and other resources as you write your 2023 NIH grant and contract applications.

 

Key Points:

  • The DMS policy is effective for applications received on/after January 25, 2023.
  • The DMS policy requires a data management plan for all competing applications that generate scientific data, even if the budget is under $500,000 per year.
  • Data sharing is expected, when possible, within ethical, legal and technical constraints.
  • NIH can block funding for grants with unacceptable data sharing plans.
  • More information on PI obligations and institutional compliance with this policy will be sent in forthcoming updates. Meanwhile, see the NIH website to review this important change.

Related Guidance:

Does the DMS policy apply to my grant application?

Previously, only research grants with direct costs of $500,000 or more per year required a data sharing plan.

The new DMS policy applies to all research, funded or conducted in whole or in part by the NIH, that results in the generation of scientific data.

This includes all NIH-supported research regardless of funding level, including extramural grants, extramural contracts and other funding agreements.

Scientific data is defined 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.

  • Scientific data includes any data needed to validate and replicate research findings.
  • 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.”

The DMS policy applies to all research that generates scientific data, including:

  • Research Projects
  • Some Career Development Awards (Ks)
  • Small Business SBIR/STTR
  • Research Centers

The DMS policy does not apply to research and other activities that do not generate scientific data, including:

  • Training (T)
  • Fellowships (Fs)
  • Construction (C06)
  • Conference Grants (R13)
  • Resource (Gs)
  • Research-Related Infrastructure Programs (e.g., S06)

Note especially that mechanisms that did not generally need a data sharing plan on the pre-2023 policy (such as K awards) will require a plan by the new definition if scientific data is generated or if specific funding opportunity announcements (FOA) still require a plan by exception. You can find a list of applicable activity codes here.

This policy applies at the time of initial grant submission and for competing renewals. Updates to the DMS Plan are to be incorporated into regular reporting, including annual Research Performance Progress Reports (RPPRs).

Social/behavioral data, qualitative data and new datasets derived from secondary use of existing data can also meet the definition of scientific data for purposes of this policy. The NIH FAQ page has additional information on the timetable of data sharing and acceptable “ethical, legal, or technical” reasons to limit data sharing (as well as unacceptable rationales).

How will the NIH assess the DMS Plan? Is it a scored item?

Reviewers will not generally be asked to comment on the DMS Plan or factor the plan into the impact score unless the project or FOA specifically calls for such review. However, NIH program staff do review the DMS Plan to ensure all essential elements have been addressed reasonably. “Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

How do I prepare my grant application to be compliant with the new policy?

Resources on writing a data management plan, including the required elements and a template, are on the NIH website. The new grant submission forms (Forms-H) have been modified to allow the upload of the new 2-page format plan and associated budgetary line items associated with DMS implementation.

You will need to budget time in your grant writing to consider how the DMS policy impacts your specific project. There is no “boilerplate” verbiage to cover the substantive issues of management and sharing which may apply to the data your specific project generates, though the NIH has links available to relevant best practices (see Additional Resources below).

Also, consider reviewing the institute-specific DMS expectations for the institutes and centers whose funding priorities best match your research proposal.

For research involving human subjects, refer to NOT-OD-22-213 for “Operational Principles for Protecting Participant Privacy When Sharing Scientific Data,” and consult with the Institutional Review Board. An additional supplemental policy, NOT-OD-22-214, covers “Responsible Management and Sharing of American Indian/Alaska Native Participant Data,” to ensure best practices for data management and sharing with respect to Tribal sovereignty, research laws and norms. Additional guidance on this topic is forthcoming.

Are workshops and webinars available?

Additional Houston Methodist workshops on DMS topics are forthcoming. NIH has also posted a two-part webinar and slides:

What are the relevant Houston Methodist policies and infrastructure related to the oversight of DMS/GDS implementation?

Updates will provide additional guidance on how Houston Methodist will support principal investigators in writing, implementing and overseeing the DMS Plan and GDS components where relevant.

Whom can I contact for further assistance?

  • For data management and biorepository support, contact the Center for Health Data Science and Analytics at chdsa@houstonmethodist.org.
  • For budget-related questions, contact the Office of Grants and Contracts at OGC@houstonmethodist.org.
  • For grant proposal development or assistance with planning timelines and tasks related to proposal submissions, contact the Office of Faculty and Research Development at academicaffairs@houstonmethodist.org.

Additional Resources