NIH Public Access and Data Management Policies

NIH Public Access and Data Management Policies

The 2024 NIH Public Access Policy is effective July 1, 2025. It requires Author Accepted Manuscripts accepted for publication in a journal on or after July 1, 2025, to be submitted to PubMed Central upon acceptance for publication, for public availability without embargo upon the Official Date of Publication. On the effective date, this policy replaces the previous 2008 Public Access Policy, which provided for an embargo of up to twelve months on the PubMed Central copy of the article. 

The  2023 NIH Data Management and Sharing (DMS) Policy is effective as of January 25, 2023. The DMS policy requires ALL grant applications or renewals that generate Scientific Data (see definition below) to include a data management and sharing plan (DMSP) and budget requests for data management activities when applicable. Additionally, the policy sets an expectation for researchers to share data to the maximum extent possible given certain factors (i.e., legal, ethical, or technical, etc.) which may preclude sharing. This policy differs from the previous 2003 policy which only required grants of $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared.  

2024 Public Access Policy

Does the 2024 Public Access Policy apply to my research?

The 2024 NIH Public Access Policy applies to any Author Accepted Manuscript accepted for publication in a journal, on or after July 1, 2025, that is the result of funding by NIH in whole or in part through:

  • A grant or cooperative agreement, including training grants,
  • A contract,
  • An Other Transaction,
  • NIH intramural research, or
  • The official work of an NIH employee.

The NIH Public Access Policy applies regardless of whether the NIH-funded principal investigator or project director is an author and regardless of whether non-NIH funds contributed to developing or writing the Author Accepted Manuscript. Upon the Effective Date, this Policy replaces the 2008 NIH Public Access Policy.

What do I need to do to comply with the 2024 NIH Public Access Policy?

Beginning July 1, 2025, submit any Accepted Manuscripts to the NIH Manuscript Submission System upon acceptance by the journal. If prompted, specify that there be no embargo period. Some journals will submit articles to PubMed Central on behalf of authors, in which case it is not necessary for the author to submit. Compliance with the policy remains the responsibility of the NIH awardee, not the journal. If your journal is going to submit for you, you should still retain a copy of your accepted manuscript so that you are also in a position to comply. For more information, please consult:

Consider including the following recommended text from NIH in new manuscript submissions to journals: “This manuscript is the result of funding in whole or in part by the National Institutes of Health (NIH). It is subject to the NIH Public Access Policy. Through acceptance of this federal funding, NIH has been given a right to make this manuscript publicly available in PubMed Central upon the Official Date of Publication, as defined by NIH.” This text may accompany the required funding acknowledgement.

Do I need to pay a fee to the publisher, such as an Article Processing Charge (APC), to comply with the NIH Public Access Policy?

No. Authors can deposit their Accepted Manuscripts in PubMed Central without paying a fee to the publisher.

Upon accepting NIH funding, recipients grant to NIH the right to make Author Accepted Manuscripts resulting from the funding publicly available in PubMed Central upon the Official Date of Publication. This is the Government Use License, also known as the Federal Purpose License. For more information about the Federal Purpose License, please see this factsheet from the Higher Educational Leadership Initiative for Open Scholarship.

Authors also agree to a license mirroring that license during the PubMed Central submission process.

NIH encourages, but does not require, authors to indicate in their Submitted Manuscript that, if it is accepted, NIH has a license to make the Accepted Manuscript publicly available upon the Official Date of Publication. In its guidance on the government use license, NIH provides the following sample language for this purpose:

This manuscript is the result of funding in whole or in part by the National Institutes of Health (NIH). It is subject to the NIH Public Access Policy. Through acceptance of this federal funding, NIH has been given a right to make this manuscript publicly available in PubMed Central upon the Official Date of Publication, as defined by NIH.

What tools and resources are available to me regarding the 2024 NIH Public Access Policy?

During the transition from the 2008 Public Access Policy to the 2024 Public Access Policy, Public Access to NIH-Supported Research, from the NIH Office of Science Policy is a good overview of NIH resources.

Need support with copyright, licenses, publishing contracts, or APC discounts for Penn State authors? The Office of Scholarly Communications and Copyright in the University Libraries provides information on these topics and is available to answer questions and consult on specific situations.

NIH Resources on the 2024 Public Access Policy

Frequently Asked Questions: Public Access Policy

Complying with the NIH Public Access Policy does not require paying a fee to the publisher. However, some journals require payment of an Article Processing Charge (APC), page charges, or other fees to publish in the journal. Some of these costs are allowable under NIH policies.

Penn State corresponding authors facing APCs may be able to take advantage of a partial or complete APC discount negotiated by the Libraries.

Unallowable costs:

  • Journal or publisher fees that arise during the course of the publication process for the sole purpose of submitting the Author Accepted Manuscript to PubMed Central ​
  • Costs for services (e.g., peer review) for which there is no resulting, publicly available product
  • Costs for services incurred after closeout of the award, even for an Author Accepted Manuscript subject to the NIH Public Access Policy
  • Costs for publishing services that are charged differentially because an Author Accepted Manuscript is subject to the NIH Public Access Policy or the work is the result of NIH funding (this likely includes the American Chemical Society’s Article Development Charge)

For further guidance, please consult NIH’s Supplemental Guidance on Publication Costs.

The 2024 Public Access Policy defines the Official Date of Publication as the earlier of the electronic and print publication dates. The 2008 Public Access Policy defined it as the later of the two.

2023 Data Management and Sharing Policy

Data Management and Sharing Plan Requirements

The data management and sharing plan (DMSP) should outline in 2-pages how data will be managed and shared by addressing the following elements: 

  1. data type,
  2. related tools, software, and/or code,
  3. standards, data preservation, access,
  4. associated timelines, access, distribution, or reuse considerations, and
  5. oversite of data management and sharing.

The DMSP will be submitted with your grant application and assessed by NIH Program Staff (peer reviewers can also comment on the proposed data management budget). The Institute, Center, or Office (ICO)-approved plan will become a Term and Condition of the Notice of Award. As research progresses, the DMSP can be updated and re-approved as it is intended to be a living document.

Does the 2023 Data Management & Sharing Policy Apply to My Research?

The NIH Data Management & Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.

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.

Scope of Policy

This policy covers all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements. Therefore, the DMS policy applies to: Research Projects, Some Career Development Awards (Ks), Small Business SBIR/STTR, and Research Centers and does not apply to: Training (T), Fellowships (Fs), Construction (C06), Conference Grants (R13), Resource (Gs), and Research-Related Infrastructure Programs (e.g., S06).

For more details on research covered by this policy, see the NIH Research Covered by the 2023 Data Management & Sharing Policy page.

NIH Resources on the 2023 Data Management and Sharing Policy

What Can Be Included in the Budget for Data Management and Sharing?

The Supplemental Policy Information: Allowable Costs for Data Management and Sharing, outlines that funds may be requested for data management and sharing activities in the budget and budget justification sections of an application. Note that all allowable costs will need to be incurred during the performance period. 

For more details on allowable and unallowable costs, see the NIH Budgeting for Data Management and Sharing resource.

Additionally, a helpful resource, created by the National Academies of Science, Engineering, and Medicine, may be useful when developing a budget for data management and sharing costs: Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data.

As of October 5, 2023, NIH no longer requires the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories.

What Tools & Resources Are Available to Me Regarding the Data Management and Sharing Policy?

The NIH has provided many FAQs and Supplements to the new policy as well as resources on planning and Budgeting for Data Management and Sharing, Data Management, and Sharing Scientific Data.  

Need support with data management plans, data documentation, and data sharing and preservation? The Data Learning Center Data Management Support Team within the Penn State University Libraries also offers resources and tools for creating data management plans as well as sharing data.

Need support with determining the appropriate data storage option for during your research project?

Additionally, when determining where to store data during a project, Penn State offers tools for determining information classification levels and storage options available:

Need support with high-performance computing?

Presentations

In addition to the resources provided above, the following presentations give an overview of the policy, available support, and how to create a data management plan. 

Frequently Asked Questions: Data Management and Sharing Policy

NIH provides Guidance about allowable costs. There are currently no budget caps on cost. Costs are requested as seperate line item with accompanying justification. 

As of October 5, 2023, NIH no longer requires the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories.

Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first. See NIH’s 2023 Data Sharing FAQs for more information.

NIH acknowledges that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described when drafting DMS plans. A compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH. See NIH’s 2023 Date Sharing FAQ page for justifiable reasons to limit sharing.

See exceptions above.

The DMS Plan will likely be submitted prior to IRB during the proposal submission process. IRB is aware of the NIH DMS Policy. Data management activities outlined in the IRB Study Protocol should align with what is written in the DMS Plan that is submitted to NIH.

This is a known service gap at PSU. Researchers can budget for this as an allowable cost if their lab/group are not able to perform deidentification.

No. Only applies to new proposals going forward.

Element 6, “oversight,” of the DMS Plan should describe how the Principal Investigator (PI) and/or CO-Is will monitor and manage the DMS Plan. This section should not list the Office of Sponsored Programs or Office of Research Affairs. PIs are the stewards of the scientific data that is generated as a part of their sponsored research. This means that the PI is responsible for the oversight of the data management and sharing plan, and the implementation of said plans, for their research projects.

Oversight of DMS Plans includes:
  • Awareness of the elements listed in the DMS Plan
  • Sharing the DMS Plan with study team members
  • Ensuring that data management and sharing activities follow what is listed in the DMS Plan
  • Modification of DMS Plans if data management and sharing activities change throughout the duration of the project (e.g., a different data repository will be used than what is listed, there are new limitations on what data can be shared, etc.).
  • Working with authorized institutional officials (e.g., your grants and contracts office) to submit DMS Plan modifications to have them reapproved by NIH Program Officers.

The current policy is from 2003. See more information here. Toggle between applications before/after Jan 25th 2023 to compare.

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