Research Data Services: HHS/NIH Requirements

New NIH Data Management and Sharing Policy

The NIH has released new policy for Data Management and Sharing (effective January 25, 2023) that applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. The Syracuse University Libraries and Office of Research Development have developed the following guidance to aid researchers on adhering to the new policies.

Under the DMS policy, NIH expects that investigators and institutions:

• Plan and budget for the managing and sharing of data
• Submit a DMS plan for review when applying for funding
• Comply with the approved DMS plan

Researchers applying for NIH funding must create and submit to the NIH a Data Management and Sharing Plan (a “Plan”) outlining how scientific data and any accompanying metadata used in research will be managed and shared, considering any potential restrictions or limitations. A Plan should include a brief summary of:

• The type of data managed, preserved, and shared;
• Related tools, software, and/or code used;
• Standards applied to the data;
• Methods of data preservation, access, and associated timelines;
• Approach for access, distribution, and reuse considerations; and
• Oversight of data management and sharing.

Researchers should consider how to maximize appropriate sharing of data, while acknowledging existing legal, ethical, or technical factors that may call for justified limitations or exceptions.

In particular, NIH highlights the importance of informed consent and emphasizes that researchers should clearly communicate with prospective subjects how their scientific data are expected to be used and shared.

The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.  To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

NIH Resources

• Scientific Data Sharing - NIH website providing information and assistance on the new policy
• Final NIH Policy for Data Management and Sharing - full text of the new policy
• Data Management and Sharing Policy Overview - brief summary on requirements of DMS Plans
• NIH Data Management and Sharing Requirements Series - webinars on the new NIH Data Management and Sharing policy
• Data Management and Sharing Policy slide deck – Informative overview provided by NIH detailing activities subject to DMS policy, DMS Plan format, assessment during peer review, budgeting, and repository selection
• NIH Repositories for Sharing Scientific Data
• NIH Policy on Rigor and Reproducibility
• Sample DMS Plans
• FAQs - Data Management & Sharing Policy - Find answers from NIH to frequently asked questions. Includes answers regarding the scope of the policy, managing and sharing scientific data, compliance, and more.

Syracuse University Resources

Research Data Services can assist you in creating a data sharing plan by determining what data can or will be shared as well as in what formats and where the data will be stored. Contact Research Data Services to schedule an appointment.

• Data Management Planning – Research Data Services can assist you in writing a Data Management Plan (DMP). It is very important that you begin writing your DMP as early as possible since you will need to specify where you will deposit your data and how much it will cost.
  • DMPTool -   The DMPTool provides a step-by-step interface for creating a DMP for NSF, NIH and many other funding agencies. You can create your DMP, save it, export it and even re-use it in future proposals. You also have the ability to allow your collaborators view or edit your DMP as well as request help from Research Data Services directly. Syracuse University is a subscriber, so be sure to use your syr.edu email address when registering and signing in.
  • DMPTool NIH Template – Template with the specific NIH requirements
• Data Curation resources – Finding an appropriate repository for your data can be a challenging task. In many cases, the NIH will specify a repository in the RFP. When a specific repository is not required, this guide can help you choose one appropriate for your needs.
• QDR: The Qualitative Data Repository at Syracuse University - The Qualitative Data Repository is hosted by the Center for Qualitative and Multi-Method Inquiry, a unit of the Maxwell School of Citizenship and Public Affairs. QDR is a dedicated archive for storing and sharing digital data (and accompanying documentation) generated or collected through qualitative and multi-method research in the social sciences and related disciplines. QDR has published data for a number of NIH-funded studies in the past. Its curators are happy to advise you on data management planning for qualitative and multi-method proposals. Contact them at qdr@syr.edu

Budgeting for DMS Activities

The new DMS Policy allows researchers to budget for data management and sharing activities. Reasonable costs may be included in NIH budget requests for:

• 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

Costs must be incurred during the performance period.

• NIH Application Instruction Updates – Data Management and Sharing (DMS) Costs - Updated instructions for submitting data sharing costs (as of Aug 5, 2023)

• Budgeting for Data Management & Sharing - NIH provides information about budgeting for DMS activities and allowable costs.
• Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing - The National Institutes of Health (NIH) recognizes that making data accessible and reusable for other users may incur costs. To assist individuals and entities subject to the final NIH Policy for Data Management and Sharing, this supplemental information outlines categories of allowable NIH costs associated with data management and sharing.

Other Resources

• Research Data Access and Preservation Association  help guides 
• COGR NIH Data Management and Sharing (DMS) Policy Resource Page
• Informed Consent for Secondary Research with Data and Biospecimens
• National Academies Guide - Forecasting Costs of Biomedical Data Preservation
• QDR’s templates for informed consent for data sharing
• Deposit NIH Data at ICPSR

 FAQs

• Which data do I have to share?
  • NIH expects investigators to maximize the appropriate sharing of “scientific data”, which is defined as data commonly accepted in the scientific community as being of sufficient quality to validate and replicate the research findings. However, they note that other data may also be of benefit to the scientific community, giving the example of data underlying null and negative findings. The data that underlies research publications are the most obvious to be shared, at a minimum.
• When should data be shared?
  • NIH expects investigators to share data at the time of publication for an associated research article or at the end of the performance period, whichever is sooner.  Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants have different stipulations as outlined in their directive.
• Where should I share my data?
  1. 1. Top priority goes to any repository named in the FOA or required by the Institute or Center 
     2. In the absence of requirements, prioritize a domain-specific repository if one is suited to your Institute, discipline, or data type
     3. If no domain repositories fit, consider an approved generalist repository. See our Data Curation research guide for more options.
• What if we work with human subjects data? Is it still affected?
  • Yes, a DMS Plan will be required for studies producing scientific data even if the data is from human subjects
  • If the consent forbids sharing, that should be addressed in the Plan. In the future, consider updating your consent forms with this NIH resource on informed consent for Future Use and/or Sharing. Always prioritize restricting your sharing to the terms of your consent forms.
  • For clinical trials, consider naming clinicaltrials.gov as your repository and describing the sharing you do there as your DMS Plan sharing approach.
  •  For human subjects data under a Data Use Agreement, always prioritize following the DUA over any sharing. Describe the terms of the DUA, and what (if anything) remains to be shared. For example, summary or aggregate findings might still be appropriate, depending on the terms of your DUA.
• How do I address the section on Oversight of Data Management and Sharing?

  • The Proposal PI is required to monitor and manage the DMS plan, with at least yearly examination and oversight of data sharing and storage at the time of the RPPR, to ensure compliance with NIH DMS guidelines. The Office of Sponsored Programs verifies the inclusion of the DMS plans with new proposals. Any changes to the DMS plan will be communicated to NIH by the PI through the Office of Sponsored Program as required.

  • Sample language: PI _[name]_, will be responsible for the day-to-day oversight of lab/team data management activities and data sharing. Broader issues of DMS Plan compliance oversight and reporting will be handled by the PI and Co-I team as part of Syracuse University’s general stewardship, reporting, and compliance

• How will the new DMS Plan be reviewed?

  • Peer Review will not see or review DMS Plans, but will consider any related budget items. NIH program staff will review the DMS Plan for acceptability and may request modifications prior to award as appropriate.

• How is this different than a Data Sharing Plan from before 2023?

  • See the policy comparison chart for some key differences

• Where can I get more training or discussions?
  • Official webinars and slides are available at https://sharing.nih.gov/about/learning 

Information for this guide provided by the following resources:

NIH Scientific Data Sharing. https://sharing.nih.gov/

University of Michigan National Institutes of Health - Data Management & Sharing Plan Research Guide. https://guides.lib.umich.edu/c.php?g=682739&p=6631766

Brown University NIH Policy for Data Management and Sharing. https://www.brown.edu/research/conducting-research-brown/nih-policy-data-management-and-sharing

Virginia Commonwealth University NIH Data Sharing Research Guide. https://guides.library.vcu.edu/nihdmsp

University of Illinois Library Research Data Service NIH Data Management and Sharing Policy. https://researchdataservice.illinois.edu/nih-data-management-and-sharing-policy-goes-into-effect-soon/

Two divisions of the Health and Human Services Administration, the Centers for Disease Control (CDC) and the Agency for Healthcare Research and Quality (AHRQ) will be implementing new policies regarding public access to publications and data generated from grants awarded by the two agencies. These policies were mandated for all federal agencies awarding grants by the White House Office of Science and Technology Policy in 2013 for the purpose of making research funded, ultimately, by the public available to the public.

Beginning in October 2015, both the CDC and the AHRQ will require all publications resulting from research funded by either agency to be deposited in PubMed Central (PMC). PMC is a repository of scholarly articles published in the biomedical and life sciences fields. Both agencies will require the articles to be submitted within one year of publication.

Additionally, both agencies will require that any data generated by the research will also need to be made public. Researchers must include a Data Management Plan (DMP) in their grant proposal which outlines how the data will be collected, processed, safeguarded and, ultimately, made publicly accessible. The CDC indicates that it will work to identify repositories for data with the possibility of using their existing archives administered by the National Center for Health Statistics. The AHRQ says that it will partner with a commercial archive to provide a place for data.

These requirements for making publications and data publicly available are not all that new. What is new, however, is the increased emphasis on compliance. Both agencies make it clear that the Data Management Plan will be reviewed with the rest of the proposal and could negatively impact the score assigned to the proposal. Until now, the DMP was reviewed separately from the rest of the proposal and was commented on, but did not affect the final funding decision. Additionally, new awards will not be made if the terms of previous awards, such as publishing the data or following the DMP as stated, had not been fulfilled.

The CDC’s plan is CDC Plan for Increasing Access to Scientific Publications and Digital Scientific Data Generated with CDC Funding, and the AHRQ plan is AHRQ Public Access to Federally Funded Research.