Notice2024-29929
The National Institutes of Health Public Access Policy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 18, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The 2024 National Institutes of Health (NIH) Public Access Policy implements additional steps to accelerate free public access to scholarly publications resulting from the research that NIH supports, building upon NIH's long history of providing public access to research results.
Full Text
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<title>Federal Register, Volume 89 Issue 243 (Wednesday, December 18, 2024)</title>
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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102919-102927]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29929]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
The National Institutes of Health Public Access Policy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The 2024 National Institutes of Health (NIH) Public Access
Policy implements additional steps to accelerate free public access to
scholarly publications resulting from the research that NIH supports,
building upon NIH's long history of providing public access to research
results.
FOR FURTHER INFORMATION CONTACT: Hilary Leeds, J.D., Senior Policy
Analyst for Public Access, Office of Science Policy, at (301) 496-9838
or <a href="/cdn-cgi/l/email-protection#b9eadad0dcd7dadce9d6d5d0dac0f9d6dd97d7d0d197ded6cf"><span class="__cf_email__" data-cfemail="6734040e0209040237080b0e041e27080349090e0f49000811">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Increasing access to publications resulting from the National
Institutes of Health (NIH) funding offers many benefits to the
scientific community and the public who funded the underlying research.
When patients, families, and healthcare providers can access published
findings resulting from NIH funding, they are able to better understand
and address the most critical health concerns facing their communities.
It also allows researchers, students, and members of the public in all
communities to have equitable access to such content. This access can
accelerate future research, lead to collaboration, and allow interested
readers and patients to follow the latest advances more closely.
Importantly, these goals reflect NIH's commitment to the responsible
stewardship of the Nation's investment in biomedical research by
improving transparency and accessibility of taxpayer-funded research,
an essential component of fostering trust in research. NIH is issuing
this updated Public Access Policy to further advance these goals by
accelerating free public access to research results.
NIH has a long history of providing access to research products
resulting from its funded research. The NIH Public Access Policy
<a href="https://sharing.nih.gov/public-access-policy/public-access-policy-overview">https://sharing.nih.gov/public-access-policy/public-access-policy-overview</a> in effect since 2008, requires that NIH-supported researchers
submit their final peer-reviewed manuscripts to the National Library of
Medicine's PubMed Central[supreg] digital archive of full-text
biomedical and life sciences journal literature upon acceptance for
publication, to be made freely available to the public after an
allowable embargo period of not more than 12 months after the official
date of publication. The 2008 Policy implements Public Law 110-161
<a href="https://www.congress.gov/110/statute/STATUTE-121/STATUTE-121-Pg1844.pdf">https://www.congress.gov/110/statute/STATUTE-121/STATUTE-121-Pg1844.pdf</a>, which was made a legislative mandate for FY 2009 and beyond
by Public Law 111-8 <a href="https://www.govinfo.gov/content/pkg/PLAW-111publ8/pdf/PLAW-111publ8.pdf">https://www.govinfo.gov/content/pkg/PLAW-111publ8/pdf/PLAW-111publ8.pdf</a>. The Policy has, to date, resulted in more than
1.5 million articles reporting on NIH-supported research being freely
available to the public in PubMed Central.
On August 25, 2022, the White House Office of Science and
Technology Policy (OSTP) released updated policy guidance (2022 OSTP
Memorandum <a href="https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf">https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</a>) to all federal agencies with research
and development expenditures to further promote equity, advance trust
in science, and continue to advance American scientific leadership.
Following the 2022 OSTP Memorandum, NIH released its Plan to Enhance
Public Access to the Results of NIH-Supported Research <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-091.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-091.html</a> in February
2023 (hereafter, the NIH Public Access Plan) and its Draft Public
Access Policy <a href="https://www.federalregister.gov/documents/2024/06/18/2024-13373/request-for-information-on-the-national-institutes-of-health-draft-public-access-policy">https://www.federalregister.gov/documents/2024/06/18/2024-13373/request-for-information-on-the-national-institutes-of-health-draft-public-access-policy</a> in June 2024 (NIH Draft Public Access
Policy). The NIH Public Access Plan and Draft Public Access Policy
provided a roadmap for how NIH proposed to accelerate access to
scholarly publications, consistent with the government-wide expectation
to remove the 12-month embargo period before public availability. This
2024 NIH Public Access Policy is consistent with the expectations of
the 2022 OSTP Memorandum regarding scholarly publications and is
informed by all public feedback, including comments submitted in
response to the NIH Draft Public Access Policy.
Overview of Public Comments
A total of 144 written public comments <a href="https://osp.od.nih.gov/wp-content/uploads/2024/10/Compiled-Public-Comments-on-RFI-on-the-NIH-Draft-Public-Access-Policy-508C.pdf">https://osp.od.nih.gov/wp-content/uploads/2024/10/Compiled-Public-Comments-on-RFI-on-the-NIH-Draft-Public-Access-Policy-508C.pdf</a> were received in response to the
NIH Draft Public Access Policy. Written comments were received from a
variety
[[Page 102920]]
of constituencies, including those from universities, professional
associations, nonprofit organizations, and publishers. In addition, NIH
hosted a public listening session <a href="https://osp.od.nih.gov/events/virtual-listening-session-on-the-nih-public-access-plan/">https://osp.od.nih.gov/events/virtual-listening-session-on-the-nih-public-access-plan/</a> on the NIH
Public Access Plan in April 2023, and in November 2023, NIH sponsored a
workshop <a href="https://www.nationalacademies.org/our-work/enhancing-public-access-to-the-results-of-research-supported-by-the-department-of-health-and-human-services-a-workshop">https://www.nationalacademies.org/our-work/enhancing-public-access-to-the-results-of-research-supported-by-the-department-of-health-and-human-services-a-workshop</a> held by the National Academies of
Sciences, Engineering and Medicine (NASEM) on Enhancing Public Access
to the Results of Research Supported by the U.S. Department of Health
and Human Services (HHS). Commenters and attendees included academic
institutional officials, researchers at various career stages, patient
advocates, publishers, and officials from professional associations,
many of whom also publish academic journals.
NIH reviewed and considered all feedback to inform and develop the
2024 NIH Public Access Policy. Upon the listed effective date, the new
Policy replaces the 2008 NIH Public Access Policy.
Discussion of Public Comments
A discussion of the public comments on the NIH Draft Public Access
Policy, organized by general topic or theme, is provided below. Each
section outlines the 2008 NIH Public Access Policy's approach on each
issue, proposals in the NIH Draft Public Access Policy, public comments
on the NIH Draft Public Access Policy, and the approach in the 2024 NIH
Public Access Policy (also referred to as the Policy).
Definitions of Article, Manuscript, and Final Published Article
2008 NIH Public Access Policy: The 2008 NIH Public Access Policy
did not have a general term or definition to describe the versions
produced in the various stages of writing and publishing. Frequently
Asked Questions (FAQs) associated with the 2008 NIH Public Access
Policy expanded on some useful terms, such as Final Peer-Reviewed
Manuscript and Final Published Article.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
included a definition of Article to describe, in general, the versions
from the creation of the draft through the Final Published Article. It
also included definitions of Manuscript, Final Published Article,
Journal, and Official Date of Publication (described further in its own
section).
Public Comments: Although some comments supported the Draft Public
Access Policy definitions of Article and Manuscript, other comments
suggested that these terms were used inconsistently. There were many
suggestions to define terms more clearly. Some suggestions included
using other sources for definitions, such as the NISO Journal Article
Version recommendations and the National Science Foundation's Public
Access Plan's terms. Some comments suggested other replacement
definitions. Some comments suggested that articles should not be
considered Final Published Articles until the compilation of a volume
or issue.
2024 NIH Public Access Policy: To communicate clearly and
transparently, the Policy includes the definitions of two precise
terms: Author Accepted Manuscript and Final Published Article. Each
term is uniquely and consistently used throughout the Policy. In the
Policy, the term Final Published Article represents the journal's
authoritative copy, even prior to the compilation of a volume or issue
or the assignment of associated metadata.
Because PubMed Central accepts submissions of the article from both
the author (Author Accepted Manuscript) and journal (Final Published
Article), the term ``article'' is still generally used here in this
preamble to the Policy to refer to both Author Accepted Manuscripts and
the Final Published Articles that are submitted to PubMed Central.
However, it has been removed from the Policy itself. In addition, the
Guidance on Government Use License and Rights includes the term
Submitted Manuscript, as this Guidance discusses the process of
submitting articles to be considered for publication in journals.
Definition of Official Date of Publication
2008 NIH Public Access Policy: When determining the timing of
public release of a manuscript, NIH based the official date of
publication on the later of the electronic or print publication date.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
defined Official Date of Publication as ``the date on which the article
is first made available in final, edited form, whether in print or
electronic (i.e., online) format.''
Public Comments: It was unclear to some if the NIH Draft Public
Access Policy applied to an article upon its acceptance in a journal or
upon its publication. Some comments suggested that the Official Date of
Publication should refer to the point when an article has been issued
pagination or an online article number if that journal does not issue
pagination.
2024 NIH Public Access Policy: The 2024 NIH Public Access Policy
applies to Author Accepted Manuscripts. 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.'' This
clarifies how NIH determines when an Author Accepted Manuscript should
be made publicly available, which is not dependent on the compilation
of a volume or issue or the assignment of associated metadata, as
reflected in the revised definition of Final Published Article.
In addition, the definition of the Official Date of Publication is
consistent with expectations under the NIH Policy for Data Management
and Sharing (DMS Policy <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html</a>). Aligning definitions across the NIH DMS
Policy and the updated NIH Public Access Policy provides consistency
and clarity to those researchers who are subject to both policies.
These modifications and clarifications are aligned with current
practice in scholarly communications.
Scope of the Public Access Policy
2008 NIH Public Access Policy: The 2008 NIH Public Access Policy's
scope included the concept of ``direct'' funding by NIH. The scope of
the 2008 NIH Public Access Policy was not limited to articles reporting
research findings. Rather, the 2008 Policy's requirements applied to
any peer-reviewed article that arose from direct NIH funding and was
accepted for publication in a journal on or after April 7, 2008. For
example, a peer-reviewed article that arose from NIH funding that
described an infrastructure project may have been subject to the 2008
Policy, even if not reporting research findings.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
adopted the 2008 NIH Public Access Policy's scope. Accordingly, the NIH
Draft Public Access Policy applied to any Manuscript accepted for
publication in a journal that results from funding by NIH in whole or
in part. The applicability of the NIH Draft Public Access Policy
depended upon whether the Manuscript was the result of NIH funding in
whole or in part and was not dependent on whether non-NIH funds
contributed to developing or writing the Manuscript itself. In
addition, the NIH
[[Page 102921]]
Draft Public Access Policy's applicability was based on the
Manuscript's acceptance date, regardless of when the award from which
the article resulted was funded.
Finally, the NIH Draft Public Access Policy, like the 2008 NIH
Public Access Policy, did not limit its scope to Manuscripts reporting
only on research (it included, for example, a peer-reviewed article
that resulted from NIH funding and described an infrastructure
project).
Public Comments: Some comments requested clarification of the scope
or suggested that the scope of the Policy be limited to original
research articles. In addition, some comments suggested that the Policy
should apply to the Version of Record rather than the Manuscript.
Comments suggested that the Version of Record is more reliable as it
contains post-publication corrections, for example. Some also suggested
that the Policy should only apply to grants with a minimal funding
threshold. Others suggested that NIH create a fund to help pay for
publication costs for articles related to ongoing and closed awards.
Some comments asked for additional clarification on what is
encompassed in the term ``Supplemental Material'' and if non-peer-
reviewed written products, such as reviews, perspectives, commentaries,
and editorials, were within scope of the Policy.
2024 NIH Public Access Policy: The Policy maintains the scope of
the NIH Draft Public Access Policy. Specifically, the Policy applies to
final, peer-reviewed articles (i.e., Author Accepted Manuscripts)
accepted for publication in a journal on or after the Effective Date
(December 31, 2025) that result from NIH funding in whole or in part.
Supplemental Material are widely understood to be material included
with the publication that support the publication (e.g., detailed
methods, additional figures).
Importantly, NIH has a long history of ensuring the accuracy and
integrity of the scholarly communication record maintained in its
biomedical literature services over time by including post-publication
updates made through correction, retraction, and/or an expression of
concern. NIH creates links in PubMed Central between citations for
original articles and citations for post-publication updates based on
information published by the journal. All updated or retracted articles
in PubMed Central are clearly identified as such by a prominent banner
and watermark. PubMed Central also links to the Final Published Article
on the journal website whenever possible.
Duration of Public Access Policy Applicability
2008 NIH Public Access Policy: Neither the 2008 NIH Public Access
Policy nor the law that made the 2008 Policy a requirement for FY 2009
and beyond <a href="https://www.govinfo.gov/content/pkg/PLAW-111publ8/pdf/PLAW-111publ8.pdf">https://www.govinfo.gov/content/pkg/PLAW-111publ8/pdf/PLAW-111publ8.pdf</a> specifies an end date to the 2008 Policy's applicability.
This approach is consistent with publishing timelines, in which
publication often happens after the end of an award.
NIH Draft Public Access Policy: NIH did not propose an end date for
applicability to Manuscripts resulting from awards.
Public Comments: Some comments asked for clarification and guidance
on how publication costs may be supported after closeout of an award.
Some suggested that NIH find a way to allow awardees to use NIH funds
to pay publication costs for articles subject to the Policy after
closeout.
2024 NIH Public Access Policy: The law that made the 2008 Policy a
requirement for FY 2009 and beyond does not have an end date for the
Policy's applicability. The 2024 NIH Public Access Policy, when
effective, replaces the 2008 NIH Public Access Policy, which already
applies to final, peer-reviewed accepted articles resulting from NIH
funding for ongoing and closed awards. Therefore, the requirement of
continued applicability is not new, and, consistent with the law and
the 2008 NIH Public Access Policy, the 2024 NIH Public Access Policy
does not include an end date for applicability of the Policy to Author
Accepted Manuscripts within scope. Costs are discussed below in a
separate section.
Policy Effective Date
2008 NIH Public Access Policy: The 2008 NIH Public Access Policy
became effective for manuscripts accepted for publication on or after
April 7, 2008, and which arose from direct funding from an award active
in FY 2008 or beyond, a contract signed on or after April 7, 2008, or
from intramural research or an NIH employee.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
was proposed to become effective for Manuscripts accepted for
publication on or after October 1, 2025.
Public Comments: Several comments expressed preference for an
Effective Date on the latest date such policies should be effective as
outlined in the 2022 OSTP Memorandum, December 31, 2025. These comments
suggested that the additional time would allow for better planning,
communication, and additional opportunities for training for Policy
compliance. It was suggested that this would also allow more time to
renegotiate submission agreements between journal publishers and the
National Library of Medicine. Other comments supported an Effective
Date of October 1, 2025.
Some comments suggested that the Policy should apply only to
articles resulting from awards made after the Effective Date.
Comments requested clear communications around how the Policy would
be initially implemented. Specific comments sought clarification on
whether the Policy would apply retroactively and whether it would apply
to draft or peer-reviewed articles that were not yet published as of
the Policy's Effective Date. Additionally, some comments asked NIH to
publish a clear implementation plan and provide opportunity for public
comment on the implementation plan.
2024 NIH Public Access Policy: The Policy adopts an Effective Date
of December 31, 2025. This approach is responsive to public comments
and allows for additional time for affected groups and institutions to
plan and prepare for the implementation of the Policy, while still
being consistent with the 2022 OSTP Memorandum.
The Policy applies to Author Accepted Manuscripts accepted on or
after December 31, 2025, regardless of when the award was made that
resulted in the Author Accepted Manuscript. This approach avoids a
situation where the 2008 NIH Public Access Policy is in effect at the
same time as the 2024 Policy. Such a situation could have led to
administrative burden in tracking which policies apply to publications
produced under different awards and confusion for readers, with some
articles being made public without an embargo while other newly
published articles would have an embargo applied.
NIH recognizes that some implementation questions might arise
around the Effective Date. NIH anticipates that such issues are time-
limited, and NIH is committed to working with the research community to
prepare for implementation of the updated Policy.
Rights in Author Accepted Manuscripts, Including Creating Derivative
Works
2008 NIH Public Access Policy: The FAQs for the 2008 NIH Public
Access Policy described how and when rights in articles accrue and what
rights may be transferred. NIH provided sample language an author or
institution may have added to a copyright agreement
[[Page 102922]]
with a journal. In addition, authors depositing Manuscripts in PubMed
Central must agree to the NIH Manuscript Submission (NIHMS) Statement
that, in part, allows the Manuscript to be appropriately tagged and
made available on PubMed Central. This ensures that all PubMed Central
articles are available in machine-readable formats that support
accessibility <a href="https://www.ncbi.nlm.nih.gov/pmc/about/accessibility/">https://www.ncbi.nlm.nih.gov/pmc/about/accessibility/</a> and
facilitate text mining <a href="https://pmc.ncbi.nlm.nih.gov/tools/amdataset/#use">https://pmc.ncbi.nlm.nih.gov/tools/amdataset/#use</a>.
NIH Draft Public Access Policy: NIH focused on achieving the NIH
Draft Public Access Policy's goals regarding rights for Manuscripts
through minimally burdensome pathways. First, the NIH Draft Public
Access Policy clarified that, upon the acceptance of funding,
government use rights are granted to NIH. NIH proposed incorporating a
statement granting NIH the right to make Manuscripts publicly available
in PubMed Central upon the Official Date of Publication into Notices of
Award and applicable contracts. This would help clarify that NIH's
rights would be automatically established at the acceptance of funding,
without requiring funded recipients to take additional steps.
Secondly, the NIH Draft Public Access Policy proposed that authors
depositing Manuscripts in PubMed Central would provide a license to NIH
that mirrored the Government Use License as part of a revised
Manuscript Submission Statement, granting NIH the rights to 1) make
Manuscripts publicly available in PubMed Central upon the Official Date
of Publication and 2) create derivative works in order to make
Manuscripts available in machine-readable formats to support
accessibility and facilitate text mining, consistent with current
practice.
Beyond these measures, NIH did not propose requiring authors to
apply a particular license to their Manuscripts.
In the Draft Guidance on Government Use License and Rights, NIH
encouraged authors to clearly communicate NIH's rights through a
statement in the Manuscript itself. In this Guidance, NIH proposed
sample language for authors to place in their Manuscripts if desired.
Public Comments: NIH received many comments on rights. Many
comments were broadly supportive of the draft language of the license
that would be provided to NIH upon acceptance of award, while many
others were broadly opposed. Some comments supported including NIH's
rights in award conditions as being fully consistent with the
government use rights. Others questioned the legal bases for NIH's
proposal and suggested it could restrict an author's ability to
determine how their works will be reused. Others requested
clarification around the scope of NIH's rights, such as whether the
license could prevent authors from depositing their articles in
institutional repositories.
Regarding the proposed language for the standard license when
depositing Manuscripts in PubMed Central, comments were similarly split
between support and opposition. Some suggested that the standard
language added consistency and minimized confusion for those who are
depositing, while others suggested that the language did not help
authors understand their rights. Some were also confused as to how this
language differed from the suggested language that was provided for
authors to include in the article.
Comments were divided on the inclusion of the proposed license to
allow for creating derivative works. Many supported the proposed
language and indicated that it helped ensure accessibility, make
critical information more widely available, and allow for machine
readability. Many further suggested edits to the license and use
statements that would grant rights to the full public reuse of the
Manuscripts, with appropriate attribution. Those in opposition asserted
that the proposal was not in alignment with the Government Use License
and could undermine existing copyright agreements and the safeguards
that publishers provide. Some also stated that the ability to create
derivative works could undermine the integrity of the scientific
record. Others suggested that if NIH were to include the ability to
create derivative works in the license, there should be additional
clarifications around specific use cases and limitations, providing
adequate attribution to authors, and a way to enforce only appropriate
uses.
2024 NIH Public Access Policy: The Policy includes relevant
language about NIH's rights to make Author Accepted Manuscripts
available in PubMed Central without embargo upon the Official Date of
Publication. NIH reiterates that this does not mean that NIH has rights
to the Final Published Article, as defined in the Policy, but only to
the Author Accepted Manuscript, as defined in the Policy.
The Policy also requires that those depositing Author Accepted
Manuscripts in PubMed Central agree to a revised Manuscript Submission
Statement reiterating NIH's right to post such Author Accepted
Manuscripts without embargo upon the Official Date of Publication. The
language for this statement, as included in the Guidance on Government
Use License and Rights, has been modified from the Draft Public Access
Policy to remove the phrase ``create derivative works.'' Because NIH
had not intended the language to convey what comments suggested
regarding the potential to compromise scientific integrity, NIH has
removed the phrase. NIH will, however, continue using features,
existing or to-be-developed, that ensure accessibility and usability.
NIH also reserves the right to, in the future, reasonably interpret
statutory and/or regulatory language to permit uses of content that are
consistent with copyright law, that provide value to users, and that
are considered to be in line with practices of the time.
Regarding comments that proposed NIH should provide the public with
full reuse rights through explicit language about reuse of the work for
any purpose with attribution, NIH notes that such language is akin to
authors providing NIH with a particular license. As stated in the NIH
Draft Public Access Policy, NIH does not believe that a particular
license is needed to achieve the Policy's goals.
Finally, NIH clarifies that the Policy does not prevent authors
from depositing their Author Accepted Manuscripts into institutional
repositories, as long as Author Accepted Manuscripts are also deposited
in PubMed Central per the Policy.
Publication Costs
2008 NIH Public Access Policy: According to the 2008 NIH Public
Access Policy FAQs, ``Publication costs, including author fees, may be
charged to NIH grants and contracts on three conditions: (1) such costs
incurred are actual, allowable, and reasonable to advance the
objectives of the award; (2) costs are charged consistently regardless
of the source of support; (3) all other applicable rules on
allowability of costs are met.'' Importantly, even if such costs were
not incurred during a specific period of performance of an award, an
award may still be charged for publication costs before its closeout.
NIH Draft Public Access Policy: In the NIH Draft Public Access
Policy, NIH clarified that compliance with the Draft Policy is free.
NIH proposed maintaining a free pathway for compliance through
depositing the Manuscript in PubMed Central.
The NIH Draft Public Access Policy noted that if authors were asked
to pay a third-party fee for the submission of Manuscripts to PubMed
Central, the NIH Draft Public Access Policy would not permit this fee
to be paid from NIH
[[Page 102923]]
funds because it is not a legitimate publication expense. The NIH Draft
Public Access Policy indicated reasonable costs associated with
publication that were allowable may be requested in the budget for the
project as direct or indirect costs.
The Draft Guidance on Publication Costs contained examples of
unallowable costs, based on cost principles and the NIH Grants Policy
Statement (GPS). Regarding the ability to pay publication costs after
an award has ended, the Draft Guidance stated that NIH cannot pay
publication costs after closeout of an award (as affirmed in revisions
to 2 CFR 200.461 <a href="https://www.federalregister.gov/documents/2024/04/22/2024-07496/guidance-for-federal-financial-assistance#sectno-reference-200.461">https://www.federalregister.gov/documents/2024/04/22/2024-07496/guidance-for-federal-financial-assistance#sectno-reference-200.461</a>). Points to Consider for Authors and Institutions in Assessing
Reasonable Costs were included in the Draft Guidance on Publication
Costs.
Public Comments: NIH received many comments on costs. There were
comments that supported the free pathway to compliance, while other
comments suggested that framing it as such undermines the efforts of
publishers and could disrupt revenue streams. Some of these comments
suggested that the Policy could impact publication quality, cause
shifts in journal models (e.g., subscription- or article processing
charge (APC)-based), or broadly increase APCs. Some suggested that
smaller publishers, such as those supported by professional societies,
will be particularly impacted by the Policy. Comments also expressed
uncertainty about whether compliance with the Policy would require
authors to pay journals to make their articles available immediately
upon publication.
Comments both supported and opposed the information in the Draft
Guidance on Publication Costs. Those supporting NIH's approach
suggested that the Guidance would allow for the best use of funds and
increase access to scientific research overall. Others proposed that
NIH also cover fees related to other aspects of publishing, such as the
peer review process and copyediting, as well as fees associated with
novel ways of making the results of NIH funding publicly available.
Many requested clarification on allowable costs and provided some
specific suggestions and comments about circumstances that could
warrant the use of NIH funds. Some suggested that NIH should add
factors about why authors might choose to pay a fee to the Points to
Consider for Authors and Institutions in Assessing Reasonable Costs (in
the Draft Guidance on Publication Costs).
Other comments proposed that NIH pay for publication costs after
closeout of the award and that this approach should be consistent
across federal agencies. Comments also suggested that NIH should
provide additional resources and guidance to underserved populations,
such as researchers from historically excluded backgrounds, early-stage
investigators, and researchers from lower-resourced institutions.
2024 NIH Public Access Policy: First, NIH reiterates that
compliance with the Policy does not require the payment of an open
access fee to a journal.
NIH also reiterates that the free pathway to compliance can be
achieved by depositing the Author Accepted Manuscript into PubMed
Central for public availability upon the Official Date of Publication
without embargo.
NIH recognizes and understands that publishing itself is not free.
NIH has developed Guidance on Publication Costs to guide institutions
and authors when budgeting for and paying allowable and reasonable
publication costs. The available compliance pathways of both the free
deposition of the Author Accepted Manuscript to PubMed Central and also
the journal deposition of the Final Published Article to PubMed Central
support equity in publishing opportunity and, in particular, author
choice. Importantly, through this Policy, NIH does not prevent authors
from publishing findings resulting from NIH funding in journals that do
not make their content immediately, publicly available, as long as the
Author Accepted Manuscript is deposited in PubMed Central for public
availability upon the Official Date of Publication. In this way, NIH
promotes author choice in journal selection.
Regarding APCs and potential impacts, NIH recognizes that it is
unclear how and to what extent publishing costs will be affected by
NIH's and the government-wide policies that ensure taxpayer access to
the results of the research they funded without embargo. NIH will
continue to consider appropriate methods to monitor costs for potential
impacts on relevant communities once the Policy has been implemented
and any downstream effects are more readily apparent.
The Guidance on Publication Costs outlines key factors for
allowability and Points to Consider for Authors and Institutions in
Assessing Reasonable Costs. NIH has clarified some areas of the Draft
Guidance on Publication Costs in response to comments received.
The GPS does not limit allowable costs only to articles that are
subject to the Policy. NIH acknowledges that the public dissemination
of results from NIH funding does not occur only through peer-reviewed
publications. Models for sharing research findings are evolving and
allowable costs may be requested for publicly disseminating works
reporting on the results of NIH funding that are not subject to the NIH
Public Access Policy. NIH notes, however, that the unallowable costs
listed in the Guidance on Publication Costs continue to apply, and
works must be made publicly available to qualify for costs.
NIH also makes clear that institutions, through their policies, may
choose how to allot benefits under agreements with publishers and use
NIH funds for publishing in ways that are otherwise allowable and
ensure direct and indirect costs are charged consistently, regardless
of the source of funds.
NIH notes that the use of institutional resources, such as library
services, to aid in Policy compliance is not only permitted but
encouraged.
NIH cannot allow costs to be paid from an award after its closeout
or from a contract after it is expired. However, costs for publication
may be charged after the period of performance and prior to closeout
(i.e., during the 120-day liquidation period). These costs must only be
for the originally approved activities and must not be associated with
any new work performed outside of the period of performance.
Finally, NIH has added some additional considerations to the Points
to Consider for Authors and Institutions in Assessing Reasonable Costs
that address concerns that the points were only outlining reasons not
to pay a fee. NIH promotes consideration of all relevant factors when
authors and institutions are deciding whether costs are reasonable in
particular circumstances.
Compliance and Enforcement
2008 NIH Public Access Policy: The 2008 NIH Public Access Policy
noted that the awardee institution is responsible for complying with
the terms and conditions of the award. Compliance could be achieved
through submission of the article by the author or journal to PubMed
Central. NIH could take one or more enforcement actions depending on
the severity and duration of the noncompliance, in accordance with
applicable statutes, regulations, and policies.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
adopted the same pathways to compliance as the
[[Page 102924]]
2008 NIH Public Access Policy. It also reinforced the requirement to
properly communicate and acknowledge federal funding in articles.
Importantly, the NIH Draft Public Access Policy stated that
noncompliance with the requirement to properly communicate and
acknowledge federal funding is itself a violation of the terms and
conditions of award and also could result in noncompliance with the NIH
Public Access Policy. It noted that non-competing continuation grant
awards are subject to a delay in award processing and that
noncompliance may affect future funding for the institution.
Public Comments: Some comments asked whether submission to PubMed
Central would be the responsibility of the journal or the author and
how compliance with the Policy would be monitored. Others asked for
clarification around the flexibility of depositing Manuscripts
immediately upon acceptance in PubMed Central, given processing times
and other unforeseeable delays.
2024 NIH Public Access Policy: Compliance with the Policy is the
responsibility of the institution, but, as noted in the Policy,
compliance may be achieved through the pathway of the journal's
submission of the Final Published Article to PubMed Central. NIH
intends to continue monitoring compliance through existing processes.
The 2024 NIH Public Access Policy outlines additional information on
compliance and enforcement for awards, contracts, Other Transaction
agreements, and NIH employees.
Regarding processing times, as noted in the NIH Draft Public Access
Policy, implementation accounts for processing time that may be needed
before public availability in PubMed Central. When Author Accepted
Manuscripts are deposited into PubMed Central, an NIH Manuscript
Submission Identifier (NIHMSID) may be used temporarily until the
submission process is complete and a PubMed Central Identifier (PMCID)
is assigned.
Accessibility and Understandability
2008 NIH Public Access Policy: NIH currently makes content in
PubMed Central available in accessible and machine-readable formats. In
addition, NIH has multiple ways to make research results available to
the public, including through press releases and the Public Health
Relevance Statement and the Outcomes section in RePORTER.
NIH Draft Public Access Policy: The Draft Policy noted that, as
supporting technologies continue to develop, NIH would consider
additional approaches to increase understanding of NIH-funded
scientific research.
Public Comments: Some comments suggested that the Draft Public
Access Policy would increase accessibility of NIH research. Others
noted that plain language summaries could enhance understandability.
2024 NIH Public Access Policy: Accessibility of PubMed Central
content is paramount, and NIH will continue to make content accessible
for those using assistive technologies. PubMed Central continues to
improve the user experience and make its content more perceivable,
operable, understandable, and robust, guided in part by feedback from
those who use assistive technologies. NIH appreciates comments noting
that, to make discoveries truly accessible to the public, information
should be disseminated in ways that are meaningful and digestible. NIH
is regularly looking for ways to promote the sharing of the results of
its funded research, whether through press releases, websites, summary
information on awards in RePORTER, or other means.
NIH Public Access Policy
Purpose
Increasing access to publications resulting from National
Institutes of Health (NIH) funding offers many benefits to the
scientific community and the public who funded the underlying research.
When patients, families, and healthcare providers can access published
findings resulting from NIH funding, they are able to better understand
and address the most critical health concerns facing their communities.
It also allows researchers, students, and members of the public in all
communities to have equitable access to such content. This access can
accelerate future research, lead to collaboration, and allow interested
readers and patients to follow the latest advances more closely.
Importantly, these goals also reflect NIH's commitment to the
responsible stewardship of the Nation's investment in biomedical
research by improving transparency and accessibility of taxpayer-funded
research, an essential component of fostering trust in research.
To achieve these goals, the NIH Public Access Policy requires
Author Accepted Manuscripts accepted for publication in a journal, on
or after December 31, 2025, to be submitted to PubMed Central upon
acceptance for publication, for public availability without embargo
upon the Official Date of Publication.
Definitions
Author Accepted Manuscript: The author's final version that has
been accepted for journal publication and includes all revisions
resulting from the peer review process, including all associated
tables, graphics, and supplemental material.
Final Published Article: The journal's authoritative copy,
including journal or publisher copyediting and stylistic edits, and
formatting changes, even prior to the compilation of a volume or issue
or the assignment of associated metadata.
Journal: A periodical publication that is either (1) included in
the ``journal'' section of the National Library of Medicine (NLM)
Catalog <a href="https://www.ncbi.nlm.nih.gov/nlmcatalog/journals">https://www.ncbi.nlm.nih.gov/nlmcatalog/journals</a> or (2) meets
all of the following criteria:
<bullet> Requirements for ISSN assignment;
<bullet> Content is issued over time under a common title;
<bullet> Is a collection of articles by different authors; and
<bullet> Is intended to be published indefinitely.
Official Date of Publication: 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.
Scope and Effective Date
The NIH Public Access Policy applies to any Author Accepted
Manuscript accepted for publication in a journal, on or after December
31, 2025, that is the result of funding by NIH in whole or in part
through:
<bullet> A grant or cooperative agreement, including training
grants,
<bullet> A contract,
<bullet> An Other Transaction,
<bullet> NIH intramural research, or
<bullet> 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.
Requirements
The NIH Public Access Policy requires:
<bullet> Submission of an electronic version of the Author Accepted
Manuscript to PubMed Central upon its acceptance for publication for
public availability without embargo upon the Official Date of
Publication;
[[Page 102925]]
<bullet> An acknowledgment in the Author Accepted Manuscript and
Final Published Article that satisfies the requirements in the NIH
Grants Policy Statement (GPS) regarding communicating and acknowledging
federal funding (GPS 4.2.1 <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_4/4.2.1_acknowledgement_of_federal_funding.htm</a> and GPS
8.2.1 <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.1_rights_in_data__publication_and_copyrighting_.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.1_rights_in_data__publication_and_copyrighting_.htm</a>), as well as
analogous requirements for acknowledging federal funding as
incorporated into the terms of Other Transaction agreements and
applicable contracts; and
<bullet> When an Author Accepted Manuscript is submitted to NIH,\1\
agreeing to a standard license that mirrors that of the Government Use
License at 2 CFR 200.315 <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR8feb98c2e3e5ad2/section-200.315">https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR8feb98c2e3e5ad2/section-200.315</a>, or its successor regulation, explicitly granting NIH
the right to make the Author Accepted Manuscript publicly available
through PubMed Central without embargo upon the Official Date of
Publication.
---------------------------------------------------------------------------
\1\ This happens typically through the NIH Manuscript Submission
(NIHMS) System.
---------------------------------------------------------------------------
Government Use License and Rights
<bullet> By accepting NIH funding, the recipient grants to NIH, as
the funding agency, 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, which includes making Author Accepted
Manuscripts publicly available in PubMed Central upon the Official Date
of Publication. A statement that conveys this point is incorporated
into Notices of Award, the terms of Other Transaction agreements, and
applicable contracts.
<bullet> NIH encourages authors to include a statement that
indicates the Author Accepted Manuscript is subject to the NIH Public
Access Policy and that this means that NIH, as the funding agency, has
the right to make the Author Accepted Manuscript publicly available in
PubMed Central upon the Official Date of Publication. NIH provides
sample language in the Guidance on Government Use License and Rights
that authors may choose to include in Author Accepted Manuscripts. Such
a statement ensures transparency and ensures awareness that NIH has the
right to make the Author Accepted Manuscript available in PubMed
Central without embargo upon the Official Date of Publication.
<bullet> Authors are not expected to provide rights to NIH to the
Final Published Article, and the rights that accrue to NIH upon the
acceptance of funding are to the Author Accepted Manuscript. However,
as noted in the section on Compliance and Enforcement, NIH will accept
submission of the Final Published Article to PubMed Central from
journals or publishers with formal agreements with NLM as compliant
with the Policy when it may be made publicly available without embargo
upon the Official Date of Publication.
NIH Funding of Publication Costs
Reasonable costs associated with publication that are allowable
costs of the project budget may be requested as direct or indirect
costs, as specified in the GPS 7.9 <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.9_allowability_of_costs_activities.htm">https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.9_allowability_of_costs_activities.htm</a>
and as incorporated into the terms of Other Transaction agreements and
applicable contracts (see the Guidance on Publication Costs for more
information). Submission of Author Accepted Manuscripts to PubMed
Central remains free for authors under the NIH Public Access Policy.
If, during the course of the publication process, an author is asked to
pay a fee for submission of the Author Accepted Manuscript to PubMed
Central, such costs are not allowable.
Compliance and Enforcement
Regarding submission to PubMed Central, compliance with the Policy
may be achieved through either:
<bullet> Submission of the electronic version of the Author
Accepted Manuscript to PubMed Central upon its acceptance for
publication, for public availability without embargo upon the Official
Date of Publication, or
<bullet> Submission of the Final Published Article to PubMed
Central from journals or publishers with formal agreements with NLM,
upon the Official Date of Publication, for public availability without
embargo.
Additional details on compliance and enforcement can be found
below:
<bullet> Grants: Noncompliance with the NIH Public Access Policy
may be considered by NIH regarding future funding decisions for the
recipient institution (e.g., as authorized in the NIH GPS 8.5, Specific
Award Conditions and Remedies for Noncompliance (Specific Award
Conditions and Enforcement Actions <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.5_special_award_conditions_and_remedies_for_noncompliance__special_award_conditions_and_enforcement_actions_.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.5_special_award_conditions_and_remedies_for_noncompliance__special_award_conditions_and_enforcement_actions_.htm</a>)). Non-competing
continuation grant awards are subject to a delay in award processing
for noncompliance with the NIH Public Access Policy.
<bullet> Contracts: Compliance with and enforcement of the Policy
will be consistent with the contract and the Federal Acquisition
Regulations, as applicable.
<bullet> Other Transaction Agreements: Compliance with and
enforcement of the Policy will be consistent with applicable NIH
policies and the terms of the agreement.
<bullet> Intramural Research and the Official Work of NIH
Employees: Compliance with and enforcement of the Policy will be
consistent with applicable NIH policies and procedures.
Communicating and acknowledging federal funding enables a clear,
public-facing indication of NIH funding in Author Accepted Manuscripts
and Final Published Articles. Failure to include required
acknowledgments may result in noncompliance with the NIH Public Access
Policy, in addition to resulting in noncompliance with terms and
conditions of funding regarding communicating and acknowledging federal
funding.
Guidance on Government Use License and Rights
Purpose
Federal agencies have, by law, certain rights to products resulting
from federal funding. For works (e.g., Author Accepted Manuscripts)
under the Government Use License (2 CFR 200.315 <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR8feb98c2e3e5ad2/section-200.315">https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR8feb98c2e3e5ad2/section-200.315</a>), or its successor regulation, the
National Institutes of Health (NIH) ``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.''
These rights also apply as incorporated into the terms of Other
Transaction agreements and applicable contracts (e.g., the rights in
data clause within the contract).
This Guidance assists authors in navigating compliance with the NIH
Public Access Policy with minimal burden. NIH also encourages authors
to be clear with journals and publishers to ensure journals and
publishers understand that NIH has a right to make Author Accepted
Manuscripts publicly available upon the Official Date of Publication.
[[Page 102926]]
Public Access Policy Requirements Related to Rights
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, and
this is affirmed via a statement in Notices of Award, in the terms of
Other Transaction agreements, and in applicable contracts.
Authors submitting Author Accepted Manuscripts to PubMed Central
must agree to a submission statement as part of the standard PubMed
Central manuscript submission process. Under the NIH Public Access
Policy, authors submitting an Author Accepted Manuscript to PubMed
Central must provide NIH with a standard license that mirrors the
Government Use License. This language, included as part of this
submission statement to PubMed Central, states:
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.
The language in this statement may evolve, but it includes a grant
of rights to NIH to make the Author Accepted Manuscript publicly
available in PubMed Central without an embargo, upon the Official Date
of Publication.
Guidance for Communicating Rights in Author Accepted Manuscripts
NIH highly encourages authors to be transparent during the journal
submission process by indicating to the journal or publisher that the
Author Accepted Manuscript, should the Submitted Manuscript \2\ be
accepted, is subject to the NIH Public Access Policy, and that this
means that NIH, as the funding agency, has the right to make the Author
Accepted Manuscript publicly available in PubMed Central upon the
Official Date of Publication. NIH does not require that authors
demonstrate to NIH what was communicated to publishers.
---------------------------------------------------------------------------
\2\ The author's pre-accepted version of the manuscript that is
submitted to a journal or publisher.
---------------------------------------------------------------------------
NIH suggests that authors include the points above as a statement
in the Submitted Manuscript. Such a statement may accompany the
required funding acknowledgment. NIH provides the following sample
language that may be included in the Submitted Manuscript and then,
should it be accepted, the Author Accepted Manuscript:
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.
Guidance on Publication Costs
Purpose
The National Institutes of Health (NIH) reiterates that compliance
with the Public Access Policy is free. However, NIH recognizes that
some peer-reviewed publishing routes may result in publication costs,
including, but not limited to, article processing charges (APCs).
Publication costs are allowable when they comport with the existing NIH
cost principles (Grants Policy Statement (GPS) 7.2 <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.2_the_cost_principles.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.2_the_cost_principles.htm</a> and GPS 7.9.1 <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.9_allowability_of_costs_activities.htm#Selected">https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.9_allowability_of_costs_activities.htm#Selected</a> (Publication and
Printing Costs). Cost principles clarify when costs should be allocated
as direct versus indirect costs, and they clarify charges and fees that
are allowable under the outlined conditions.
This Guidance clarifies publication costs that are not allowable
based on existing cost principles. It also outlines Points to Consider
for Authors and Institutions in Assessing Reasonable Costs. This
Guidance is intended to help funded authors and institutions understand
what costs are allowable and reasonable under the NIH Public Access
Policy. The NIH GPS also permits allowable and reasonable costs to be
used to make public other works resulting from NIH funding that are not
subject to the NIH Public Access Policy. This Guidance includes a brief
section describing these kinds of works. The factors for what make
costs unallowable are broadly applicable, regardless of whether the
publication or other work is subject to the NIH Public Access Policy.
Public Access Policy Requirements Related to Costs
All costs must comport with 2 CFR 200 subpart E <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-E">https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-E</a>,
or its successor regulation, as implemented in NIH GPS 7.2 and GPS 7.9
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/
7.9_allowability_of_costs_activities.htm. These principles also apply
as analogous requirements in the terms of Other Transaction agreements.
For applicable contracts, all publication costs must comport with 2 CFR
200 subpart E, or its successor regulation, and the terms and
conditions of the contract.
The NIH Public Access Policy clarifies that reasonable costs that
are allowable may be requested in the budget for the project as direct
or indirect costs, as specified in the NIH GPS and as incorporated into
the terms of Other Transaction agreements and applicable contracts.
Importantly, the NIH Public Access Policy also states that submission
of Author Accepted Manuscripts to PubMed Central remains free for
authors. 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 are not allowable costs.
Compliance with the Policy does not require the payment of an open
access fee to a journal.
Other Unallowable Costs
In addition to not allowing the payment of fees to submit Author
Accepted Manuscripts to PubMed Central, examples of other unallowable
costs are listed below in the context of the corresponding rules that
can be found in the NIH GPS. This list may be updated as needed.
<bullet> Costs for services (e.g., peer review) for which there is
no resulting, publicly available product are unallowable because costs
must be chargeable or assignable in accordance with the relative
benefits received (GPS 7.2).
<bullet> Costs for which the institution already pays a fee that
would cover all publication costs (e.g., an agreement the institution
has with a publisher whereby all authors from that institution may
publish for free in exchange for subscription services) are unallowable
because costs may not be double charged or inconsistently charged as
both direct and indirect costs (GPS 7.4 <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.4_reimbursement_of_facilities_and_administrative_costs.htm">https://grants.nih.gov/grants/policy/nihgps/HTML5/section_7/7.4_reimbursement_of_facilities_and_administrative_costs.htm</a>). Note
that institutions have discretion in apportioning publication costs
among agreements and NIH funds, as long as when NIH funds are used,
such costs are otherwise allowable and consistently charged, regardless
of the source of funds, per institutional policy.
<bullet> 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 are
unallowable because charges must be levied impartially on all items
[[Page 102927]]
published by the journal, whether or not under a federal award (GPS
7.9.1).
<bullet> Costs for services incurred after closeout of the award,
even for an Author Accepted Manuscript subject to the NIH Public Access
Policy, are unallowable because the costs of publications must be
incurred before closeout (GPS 7.9.1). Note that this means that costs
for publication may be charged after the period of performance and
prior to closeout (i.e., during the 120-day liquidation period).
However, these costs must only be for the originally approved
activities and must not be associated with any new work performed
outside of the period of performance.
Points To Consider for Authors and Institutions in Assessing Reasonable
Costs
As stated in Section 7.2 of the NIH GPS, a cost may be considered
reasonable if the nature of the goods or services acquired or applied
and the associated dollar amount reflect the action that a prudent
person would have taken under the circumstances prevailing when the
decision to incur the cost was made. NIH promotes reasonable
publication costs to ensure an equitable system for publishing
opportunities. However, establishing a particular threshold for what is
reasonable may lead to inequitable outcomes in specific circumstances,
so NIH is instead providing these Points to Consider in assessing
reasonable costs to guide authors and institutions. While NIH may
modify this approach in the future, NIH encourages researchers and
institutions to consider, when determining whether costs are
reasonable:
<bullet> Amount of publication cost in relation to NIH award
<bullet> Other works researchers may wish to produce during an award
period
<bullet> Professional and institutional priorities
<bullet> Sustainability in terms of the library budget, laboratory
budget, and other relevant budgets, if such costs were to be
consistently paid
<bullet> Relevance of the journal in communicating findings to advance
science and/or improve health outcomes
<bullet> Suitability of the journal's target readership for the
dissemination of the content
Other Public Works for Which Allowable Costs May Be Requested
This Guidance is primarily to help funded authors and institutions
understand what costs are allowable under the NIH Public Access Policy.
NIH acknowledges that the public dissemination of results from NIH
funding does not occur only through peer-reviewed publications. Models
for sharing research findings are evolving and allowable costs may be
requested for publicly disseminating works reporting on the results of
NIH funding that are not subject to the NIH Public Access Policy.
As a reminder, the unallowable costs listed above continue to
apply, and works must be made publicly available to qualify for costs.
Reputable Journals and Responsible Conduct of Research
In addition, NIH reiterates its Statement on Article Publication
Resulting from NIH Funded Research <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-011.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-011.html</a>, a 2017 NIH Guide Notice that
encourages authors to publish papers resulting from NIH-funded research
in reputable journals. Fees paid to journals that have characteristics
described in the Statement may be considered unreasonable.
Finally, NIH also reiterates the importance of maintaining
integrity in science in its Guidance on the requirement for Instruction
in the Responsible Conduct of Research <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-055.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-055.html</a>, which includes responsible
authorship and publication.
Dated: December 12, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-29929 Filed 12-17-24; 8:45 am]
BILLING CODE 4140-01-P
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