NIH applications submitted on or after January 25, 2023 will will require use of the new Forms-H and will need to abide by NIH’s new Data Management and Sharing Policy (DMSP). This change marks a significant departure in how researchers are expected to share study data. Although you may hear more about this in the coming months, below is a summary to keep you in-the-know.
The intention of the NIH DMSP is to make NIH-funded study scientific data available more quickly, thus potentially leading to the acceleration of biomedical discovery. Making data available more quickly can enable validation of research results, provide data sets, and encourage data reuse for future research studies.
Who needs to include a Data Management and Sharing Plan?
Applications submitted on or after January 25, 2023 must include a Data Management and Sharing (DMS) plan for review. The policy applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.
Scientific Data are “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 include any data needed to validate and replicate research findings. Scientific data do 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.” 1
Research Projects, some Career Development Awards (Ks), Small Business SBIR/STTR, and Research Center grants generate scientific data and therefore will need to include a DMS plan. The DMSP does not apply to Training (T), Fellowship (Fs), Construction (C06), Conference (R13), or Resource (Gs) grants, or to Research-Related Infrastructure Programs.
Will the new DMS plan replace the Data and Safety Monitoring Plan?
Based on the information currently available, for grants the DMS plan will be attached in the Research Plan under a newly-added field, Other Plan(s). The Data and Safety Monitoring Plan will continue to be attached in Section 3.3 of the Human Subjects and Clinical Trials Information.
For contracts, the DMS information will be included as part of the technical evaluation.
What should the DMS plan contain?
The six elements that need to be included in the DMS plan are: (1) Data Type; (2) Related Tools, Software, and/or Code; (3) Standards; (4) Data Preservation, Access, and Associated Timelines; (5) Access, Distribution, or Reuse Considerations; and (6) Oversight of Data Management and Sharing. For brevity here, we won’t discuss what should be in each section, but you can find guidance here. As long as the elements are addressed in the DMS plan, NIH does not have a required format, but has provided a suggested format and soon will have a PDF fillable format version of the same document.
Any limitations regarding data that can or cannot be shared can be documented in the DMS plan for NIH to consider.
Will my reviewers see my DMS plan and will it be part of my impact score?
No, reviewers will not see an applicant’s DMS plan and it will not be part of the impact score. Program staff will review the DMS plan and determine its appropriateness. Any concerns must be resolved prior to making an award.
Can the DMS plan be revised?
Yes. If, due to certain circumstances (e.g. IRB review feedback), the DMS plan needs to be revised, it can be done. The revised DMS plan must be signed by an institutional official.
What kind of data am I required to share?
Final research data, commonly accepted in the scientific community as necessary to validate research findings, should be shared. Data from human subjects studies can be shared if it is de-identified, thereby protecting the identity and privacy of research participants.
By when do I need to share the data?
Data should be made accessible as soon as possible, no later than the end of the project performance period, or the time of an associated publication, whichever is sooner. If a publication has an ePub date and a print date, the data must be shared based on whichever publication date is earlier.
Where can I house/store my data?
Researchers can share data in a repository most appropriate for their data type and discipline. NIH has provided links to generalist repositories, the Registry of Research Data Repositories, and a list of NIH-supported data repositories. Investigators should evaluate their needs at submission preparation time and determine whether data storage fees should be included as part of their budget (see the next question for guidance regarding including data management and sharing costs as direct costs.
Can I include data management and sharing costs in my budget?
Yes. Allowable costs for data management and sharing that can be included in the proposal budget are
- Curating data
- Developing supporting documentation
- Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
- De-identifying data
- Preparing metadata to foster discoverability, interpretation, and reuse
- Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository)
- Preserving and sharing data through established repositories, such as data deposit fees
Unallowable costs include:
- Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs)
- Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data
- Costs that are double charged or inconsistently charged as both direct and indirect costs
While we’ve attempted to cover the topics that we think our readers would ask, this is by no means exhaustive. NIH’s Scientific Data Sharing web site has resources and information regarding the DMSP, including a FAQ.