NIH Public Access Policy

A new NIH Public Access Policy was announced December 2024. Beginning in 2025, the new policy will be in place. This new policy requires NIH-funded authors to ensure immediate full text access (in PubMed Central) to manuscripts supported by NIH awards. This replaces the allowable 12 month embargo period on full text access in PubMed Central in the current policy.

Timeline

• August 2022 - the White House Office of Science and Technology Policy released policy guidance (2022 OSTP Memorandum, or "the Nelson memo") to accelerate public access to federally funded journal publications. This guidance removes any embargo periods for federally funded manuscripts and requires them to be immediately accessible in agency-designated repositories.
• February 2023 - the NIH released its NIH Plan to Enhance Public Access to the Results of NIH-Supported Research (NIH Public Access Plan), which outlined updated requirements for authors to make NIH-funded manuscripts available in PubMed Central (PMC) immediately upon publication (first date of publication, whether it is "online ahead of print" or print publication date). This removes the 12 month embargo period which is allowed by the current NIH Public Access Policy. Comments were accepted from the public on this Plan until April 25, 2023.
• June 2024 - considering the public comments from the NIH  Public Access Plan, the NIH released the NIH Draft Public Access Policy.
• December 17, 2024: The NIH announced the new NIH Public Access Policy in NOT-OD-25-047. This notice explains the changes from the 2008 policy to the 2024 policy and provides links to the notice on the Government Use License (with sample language for inclusion in manuscripts) as well as a notice on publication costs. 
• The new policy will take effect December 31, 2025. All NIH-funded manuscripts published on or after that date must be available in PMC immediately upon publication. Besides immediate full text access, there are other significant requirements and recommendations in the new policy.

Requirements and recommendations from the NIH - and potential pain points for authors

Requirements

1. Authors must ensure "submission of an electronic version of the final peer-reviewed Manuscript to PubMed Central upon its acceptance for publication, for public availability without embargo upon the Official Date of Publication." In the new policy notice, the NIH names this version the "Author Accepted Manuscript", differentiating it from the "Final Published Article" from the publisher/journal. 

• Also from NOT-OD-25-047: "When determining the release of an Author Accepted Manuscript for public availability, the definition of Official Date of Publication is applicable. NIH has revised the definition of Official Date of Publication to be “the date on which the Final Published Article is first made available in final, edited form, whether in print or electronic (i.e., online) format.”When determining the release of an Author Accepted Manuscript for public availability, the definition of Official Date of Publication is applicable. NIH has revised the definition of Official Date of Publication to be “the date on which the Final Published Article is first made available in final, edited form, whether in print or electronic (i.e., online) format.”"
• Pain point for authors: uploading the manuscript to PubMed Central via NIHMS immediately upon acceptance means that there may not yet be an official PubMed entry and PMID to link to the NIHMS record during upload. If authors do not associate an electronic identifier (such as a DOI) with the record during upload, the record will have no links to the official PubMed entry for the manuscript (when it is created), and no link to the official published version. Many authors or their delegates create NIHMS records that have only a title and journal title. As s result, the NIHMS record is incomplete and cannot be merged with the official record, and is usually non-compliant on subsequent progress reports. This will cause delay in funding.
  • Authors or those uploading manuscripts at NIHMS should take extra care to create the most complete record possible: include all available information, especially any available electronic identifiers. Authors should ask their publisher or journal's editorial staff when the first online published version will be available, and if they can have the DOI for the manuscript.
  • Some journals automatically upload full text to PubMed Central -- these journals are called PMC Journals. More journals may begin the practice of uploading NIH-funded manuscripts immediately and directly to PMC, or immediately to NIHMS, so the author or PI can approve them for final deposit to PMC.
  • Under no circumstances are authors required to pay journals an extra fee beyond standard article costs to submit manuscripts to PMC. Some authors may choose to pay journals for this convenience, but the free avenue of author or delegate upload via NIHMS is always an option, and the NIH will not pay for these journal fees. An updated notice on allowable and unallowable publication costs is available from the NIH in NOT-OD-25-048.

2. "An acknowledgment in the Manuscript and Final Published Article that satisfies the requirements in the NIH Grants Policy Statement regarding communicating and acknowledging federal funding..." The Draft NIH Public Access Policy goes on to state that "non-compliance with the requirement to properly communicate and acknowledge federal funding is itself a violation of the terms and conditions of award and also may result in non-compliance with the NIH Public Access Policy."

• Sample language for the in-manuscript acknowledgement is available from the NIH's Grants Policy Statement page:
  • "Research reported in this [publication, release] was supported by [name of the Institute, Center, or other funding component] of the National Institutes of Health under grant number [specific NIH grant number in this format: R01GM012345]."
• In addition to the Grants Policy Statement, the NIH provides language on a statement on rights (also addressed below under the Government Use License section):
  • “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.”
• Also recommended is this disclaimer:
  • "The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."
• Pain points for authors:
  • The acknowledgement of specific grant numbers according to the NIH Grants Policy Statement has not changed from the 2008 Public Access Policy. What has changed is that failure to include this in-text acknowledgement can be regarded as non-compliance. This is difficult when there are multiple coauthors on a manuscript, and the first author may not be aware of NIH funding for their coauthor(s), and thus may omit the acknowledging statement.
  • The inclusion of the Government Use License statement in the manuscript is a newer recommendation, based upon the requirement to make full text available immediately in PubMed Central, and adds another statement that authors should include in the manuscript. 

3. When a manuscript is submitted to PubMed Central (via NIHMS) authors must give the NIH "a standard license that mirrors that of the Government Use License at 45 CFR 75.322(b), or its successor regulation, explicitly granting NIH the right to make the Manuscript publicly available through PubMed Central without embargo upon the Official Date of Publication."
   • The language in this license reads: "I hereby grant to NIH, a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use this work for Federal purposes and to authorize others to do so. This grant of rights includes the right to make the final, peer-reviewed manuscript publicly available in PubMed Central upon the Official Date of Publication.” 
   • This license will be automatically included on the NIHMS Reviewer's approval form for the deposit of the manuscript to PubMed Central via NIHMS. 

Recommendations on the Government Use License

The Government Use License (45 CFR 75.322(b)) states:

"The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so."

• The NIH recommends that authors include "a statement in the Manuscript that indicates it is subject to the NIH Public Access Policy and that this means that NIH, as the funding agency, has the right to make the Manuscript publicly available in PubMed Central upon the Official Date of Publication." 
  • Including this statement in the manuscript makes it clear to the journal and publisher that the NIH is legally allowed the right to make the manuscript available in PMC immediately.
  • The NIH has published sample language for such a statement in NOT-OD-25-049:
    • “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.”
  • Pain points for authors:
    • Adding another statement to the Acknowledgements or Funding section of a manuscript may be difficult for authors to remember, or - similar to inclusion of NIH funding and award numbers on the author agreement and in-text - may be omitted by coauthors who are unaware of their colleagues' funding when completing the manuscript.
    • Some journals may object to giving the NIH the copyright for reproduction/hosting in PMC. This is a federal law which should supersede any claims by the publisher or journal, but it's possible that some journals may choose to reject a manuscript if this right is claimed.

There are many other details in the Draft NIH Public Access Policy. We encourage our users to read the draft, along with NOT-OD-25-047. We will keep you updated with information in this guide and in our library news.