The new policy affects researchers seeking funding for any NIH grant proposal that will generate scientific data. This guide, written by members of Harvard Library Research Data Services, provides library staff with resources and information to share with their users. 

This month, the National Institutes of Health (NIH) will implement a new Data Management and Sharing Policy for all funding proposals submitted on or after January 25, 2023. This new policy requires sharing underlying data and research methods behind scholarly publications to align with global trends in research data management best practices and open access principles. By requiring researchers to formally plan for the management and sharing of research data, the NIH has made significant steps to support research rigor and reproducibility through a “cultural shift that makes data sharing the norm,” while maximizing research outcomes and use of taxpayer dollars.

Julie Goldman, Countway Library’s Research Data Services Librarian, said, “The new NIH policy gives researchers a chance to embrace open science practices and acknowledge the benefits that broadly sharing our scholarship has for all.”

She added, “I envision more positive shifts in the world of data sharing, tenure and promotion, open-access publishing, and trust in science.”

Overview

Beginning with the first funding deadlines in January, all NIH grant proposals will be required to include a formal, two-page Data Management and Sharing Plan (DMSP), which must include the following elements:

• Data Type: Describe the scientific data to be managed, preserved, and shared
• Related Tools, Software, and/or Code: Indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse
• Standards: Indicate what standards will be applied to the data and associated metadata
• Data Preservation, Access, and Associated Timelines: Plans and timelines for data preservation and access, including the name of the repository/ies where scientific data will be deposited
• Access, Distribution, or Reuse Considerations: Describe any applicable factors
• Oversight of Data Management and Sharing: Indicate how compliance with the Plan will be monitored and managed, the frequency of oversight, and by whom
   

Crucially, in addition to adding a required DMSP, the data management strategies stated in the plan will be audited and monitored externally, and compliance with stated plans may affect the funding status of grants.

Fortunately, here at Harvard affiliates have access to a variety of computing infrastructure and systems to effectively manage and steward a wide range of research outputs associated with modern, data-driven, computational research.

Harvard’s libraries, Harvard University Information Technology (HUIT), Research Computing, and Sponsored Programs offices have all been adding services and building capacity to support researchers complying with this new policy next year.

In the resources section below, we’ve included links to an executive summary of the policy and a collection of FAQs that we created specifically for Harvard users. We’ve also included resources from the NIH designed to support researchers writing and implementing a DMSP for the 2023 funding cycles.

Along with the requirement to make research data publicly available, in its new policy the NIH strongly encourages the use of established data repositories. When selecting an appropriate repository, researchers should plan to utilize subject- or domain-specific repositories for their data types if possible. When a disciplinary repository does not exist, researchers should use generalist repositories that accept all data types. We’ve included information on Harvard Dataverse and other generalist repositories in the resources section below.

History and Context

This new policy is a continuation of NIH leadership in promoting open research, which began in 2003 when the first NIH Policy on Data Sharing was implemented. It required recipients of grants larger than $500K in direct costs to submit formal plans for the “timely release and sharing” of data.

The NIH strengthened its commitment to open access in 2008 when it added the Public Access Policy, which requires all NIH-funded researchers to submit or have submitted an electronic version of their final, peer-reviewed manuscript to the National Library of Medicine's PubMed Central.

Other funders and federal agencies have adopted similar policies as a result of NIH activities, including the National Science Foundation, US Department of Defense, and the White House Office of Science and Technology Policy, which in 2022 has recently formalized support for open access and data sharing across all funding agencies.

In the years since the first Policy on Data Sharing was implemented, we have witnessed significant progress in open science practices from public and private funders, publishers and journals, and labs and institutions. Universities and research support organizations are building services and infrastructure to make it easier and faster for researchers to practice open scholarship and meet funder and journal requirements.

Resources Roundup

Harvard University-Tailored Materials

• Office of the Vice Provost for Research Research Data Management
• Harvard University NIH Policy Briefing Sheet — collects the important information from the NIH policy documents and guidance into an executive summary. This is a great place to start if you’re unfamiliar with the policy.
• Harvard University NIH Policy FAQ — compiles Harvard-focused answers for data management and sharing questions based on current NIH guidance. This FAQ is being updated as guidance from the NIH becomes clearer. Researchers and staff can submit questions by using the “Submit your question” button on the bottom of the page.
   

NIH Data Management and Sharing Policy

• NIH Scientific Data Sharing Website — collects information about how to comply with their policies and provides specific domain guidance and resources.
• NIH Data Management and Sharing Policy Resources
• FAQs for the NIH Policy for Data Management and Sharing — helps guide researchers in navigating the new requirements.
• Upcoming RDM Seminars — attend virtual and in-person trainings or watch on demand webinar recordings.
   

Data Repository Guidance

• Generalist Repository Comparison Chart
• Generalist Repository Ecosystem Initiative (GREI) — brings together seven established generalist repositories that will work together to enhance data sharing of NIH-funded research. Harvard Dataverse is an active member of the project, and also serves as an institutional repository for all Harvard researchers.
• GREI Collaborative Webinar Series
• Repositories for Sharing Scientific Data — NIH-supported domain or program-specific repositories
• Nature’s Scientific Data Repository Guidance — another great resource for finding a repository
   

By Ceilyn Boyd, Julie Goldman, and Katie Mika, Harvard Library Research Data Services