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NIH Public Access Policy

Describes the NIH Public Access Policy and compliance, including the process for obtaining PMCIDs

The NIH Public Access Policy - The Law

The NIH Public Access Policy implements Division F Section 217 of PL 111-8 (Omnibus Appropriations Act, 2009).  The law states:

The Director of the National Institutes of Health ("NIH") shall require in the current fiscal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, that the NIH shall implement the public access policy in a manner consistent with copyright law.

You are not required to submit manuscripts for work that was funded by grants or awards given prior to NIH Fiscal Year (FY) 2008--which began October 2007--although you may do so if you choose and if you own rights to the material. Compliance is connected to current NIH funding as of FY2008, and the date of acceptance of the publication.

The Policy applies to any manuscript that:

  • Is peer-reviewed;
  • And is accepted for publication in a journal on or after April 7, 2008;
  • And arises from: 
    • Any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond, or;
    • Any direct funding from an NIH contract signed on or after April 7, 2008, or;
    • Any direct funding from the NIH Intramural Program, or;
    • An NIH employee

If you are publishing a manuscript based on NIH-grant-funded data collected during the mandated period you must comply, even if the publication is made long after the grant has expired.

 

Enforcement on NIH Progress Reports

In February of 2013, the NIH announced that it will begin enforcing the Public Access Policy for all noncompeting grant renewals beginning in July 2013. What does this mean?

For non-competing continuation grant awards with a start date of July 1, 2013 or beyond:

  1. NIH will delay processing of an award if publications arising from it are not in compliance with the NIH Public Access Policy.
  2. Investigators will need to use My NCBI  to enter papers onto progress reports.  Papers can be associated electronically using the RPPR, or included in the PHS 2590 using the My NCBI generated PDF report .

Please see NOT-OD-12-160  for more details.

An updated NIH Public Access Policy is coming in 2024-2025

Beginning in 2025, a new NIH Public Access Policy will be in place. This new policy requires NIH-funded authors to ensure immediate full text access to manuscripts supported by NIH awards.

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.
  • The new policy will take effect October 1, 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"
    • Pain point for authors: uploading the manuscript to PubMed Central via NIHMS immediately upon acceptance means that there will 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 can ask their publisher or journal's editorial staff if they 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.
  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]."
    • 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 point for authors: The NIH acknowledgement has not changed from the current 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.
  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."
    • Pain point for authors: It is not yet known if this license will be automatically included on the NIHMS Reviewer's approval form or if the author must upload it with the manuscript. We will update this section when that information is available.

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." Sample language will be provided by the NIH to be included in manuscripts.
    • 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.
    • 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 - 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. We will keep you updated with information in this guide and in our library news.