Notice2024-13373
Request for Information on the National Institutes of Health Draft 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
June 18, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institutes of Health (NIH) is soliciting comments from the public on the NIH Draft Public Access Policy and two supplemental draft guidance documents regarding government use license and rights and costs for publications. The NIH Draft Public Access Policy builds upon NIH's long history of providing public access to scholarly publications resulting from the research it supports and proposes additional steps to accelerate access.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 118 (Tuesday, June 18, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51537-51543]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information on the National Institutes of Health
Draft Public Access Policy
AGENCY: National Institutes of Health, HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) is soliciting comments
from the public on the NIH Draft Public Access Policy and two
supplemental draft guidance documents regarding government use license
and rights and costs for publications. The NIH Draft Public Access
Policy builds upon NIH's long history of providing public access to
scholarly publications resulting from the research it supports and
proposes additional steps to accelerate access.
DATES: To ensure consideration, comments must be submitted in writing
by August 19, 2024.
ADDRESSES: Comments may be submitted electronically to <a href="https://osp.od.nih.gov/comment-form-national-institutes-of-health-draft-public-access-policy/">https://osp.od.nih.gov/comment-form-national-institutes-of-health-draft-public-access-policy/</a>. Comments are voluntary and may be submitted
anonymously. You may also voluntarily include your name and contact
information with your response. Other than your name and contact
information, please do not include in the response any personally
identifiable information or any information that you do not wish to
make public. Proprietary, classified, confidential, or sensitive
information should not be included in your response. After the NIH
Office of Science Policy (OSP) has finished reviewing the responses,
the responses may be posted to the OSP website without redaction.
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#b3e0d0dad6ddd0d6e3dcdfdad0caf3dcd79ddddadb9dd4dcc5"><span class="__cf_email__" data-cfemail="1f4c7c767a717c7a4f7073767c665f707b3171767731787069">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Increasing access to publications resulting from NIH funding offers
many benefits to the scientific community and the public who funded the
underlying work. The ability for patients, families, and members of the
public to access published findings resulting from NIH funding enables
them to better understand and address the most critical public health
concerns facing their communities. It also allows researchers,
students, and health care
[[Page 51538]]
providers 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 keep up more closely with
critical advances. Importantly, these goals also reflect NIH's
commitment to responsible stewardship of the Nation's investment in
biomedical research by improving transparency and accessibility of
taxpayer-funded research.
The NIH Public Access Policy,\1\ in effect since 2008, requires
that NIH-supported researchers submit their final peer-reviewed
manuscripts to the PubMed Central[supreg] digital archive of full-text
biomedical literature upon acceptance for publication. NIH makes
manuscripts 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 \2\ and 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.
---------------------------------------------------------------------------
\1\ <a href="https://sharing.nih.gov/public-access-policy/public-access-policy-overview#public-access-policy-details">https://sharing.nih.gov/public-access-policy/public-access-policy-overview#public-access-policy-details</a>.
\2\ <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>.
---------------------------------------------------------------------------
On August 25, 2022, the Office of Science and Technology Policy
(OSTP) released updated policy guidance (2022 OSTP Memorandum \3\) in
an effort 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 (hereinafter ``NIH Public Access
Plan'' or ``Plan'') in February 2023.\4\ The NIH Public Access Plan
provided a roadmap for how NIH proposed to accelerate access to
scholarly publications, consistent with the expectation to remove the
currently allowable 12-month embargo period before public availability.
Informed by public comments in response to the Plan, the NIH Draft
Public Access Policy accommodates novel elements of the 2022 OSTP
Memorandum related to scholarly publications.
---------------------------------------------------------------------------
\3\ <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>.
\4\ <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>.
---------------------------------------------------------------------------
Overview of Public Comments
A total of 143 written public comments \5\ were received on the NIH
Public Access Plan, released in 2023. In addition, NIH hosted a public
listening session on the Public Access Plan in April 2023,\6\ and in
November 2023, NIH sponsored a workshop held by the National Academies
of Science, Engineering and Medicine (NASEM) on Enhancing Public Access
to the Results of Research Supported by HHS.\7\ Commenters and
attendees came from academic institutions, including institutional
officials and researchers at various career stages, and professional
associations (many of whom also publish academic journals). They also
importantly included representatives of non-profit research
organizations, general members of the public, publishers, patient
advocates, health care organizations, advocacy organizations, and
biotechnology/pharmaceutical companies.
---------------------------------------------------------------------------
\5\ <a href="https://osp.od.nih.gov/wp-content/uploads/2023/06/NIH_Public_Access_to_the_Results_of_NIH-Supported_Research_RFI_FINAL_508.pdf">https://osp.od.nih.gov/wp-content/uploads/2023/06/NIH_Public_Access_to_the_Results_of_NIH-Supported_Research_RFI_FINAL_508.pdf</a>.
\6\ <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>.
\7\ <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>.
---------------------------------------------------------------------------
NIH considered all feedback to inform and develop a new NIH Draft
Public Access Policy. Upon finalization, the new Policy will replace
the current 2008 NIH Public Access Policy. Notably, commenters and
attendees were generally supportive of updating the 2008 Policy to
remove the embargo period, allowing for accelerated access to the
results of NIH-funded research.
Discussion of Public Comments and Key Provisions of the NIH Draft
Public Access Policy
A discussion of the public comments on the NIH Public Access Plan
and how they were incorporated into the NIH Draft Public Access Policy
is provided below. This section outlines the 2008 Public Access
Policy's approach on each issue, proposals in the NIH Public Access
Plan, followed by Public Comments on the NIH Public Access Plan, and
finally the approach proposed in the NIH Draft Public Access Policy.
Definition of ``Article''
Current Public Access Policy: The current Public Access Policy does
not have a general term or definition to describe the versions produced
in the various stages of writing and publishing.
NIH Public Access Plan: The Plan did not propose a term or
definition to describe the versions produced in writing and publishing.
Public Comments: Several commenters suggested clarity was needed to
distinguish the official published version of a manuscript from
previous draft versions, though no comments suggested a specific
definition or term to refer to these various versions.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
includes a definition of ``article'' to describe, in general, the
versions from the creation of the manuscript through the final
published article.
Definition of ``Official Date of Publication''
Current Public Access Policy: When determining the timing of public
release of an article, NIH bases the official date of publication on
the issue or ``print'' publication date.
NIH Public Access Plan: For consistency with expectations under the
NIH Policy for Data Management and Sharing (NIH DMS Policy) and to
reflect current practice in scholarly communications, NIH proposed to
interpret ``Official Date of Publication'' as the date on which the
publisher first makes an article available, either online or in print.
This is consistent with a relevant Frequently Asked Question (FAQ) \8\
on the NIH DMS Policy.\9\
---------------------------------------------------------------------------
\8\ <a href="https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56773">https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm?anchor=56773</a>.
\9\ <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>.
---------------------------------------------------------------------------
Public Comments: There were no public comments on the definition of
``Official Date of Publication.'' Many commenters noted the importance
of easing burden and providing clarity on methods of compliance.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
proposes to define ``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,'' which is
slightly modified from the proposal in the NIH Public Access Plan to be
more precise. Consistent understanding about what is meant by an
official date of publication between the NIH DMS Policy and NIH Public
Access Policy will provide clarity to those complying with both
policies. NIH notes that NIH's proposed implementation of public
availability without embargo will take into account processing time
that may be needed before public availability in PubMed Central.
Scope of the Public Access Policy
Current Public Access Policy: The current Public Access Policy's
scope includes the concept of ``direct'' funding by NIH. The scope of
the current Public Access Policy is also not limited to manuscripts
reporting research findings. Rather, the Policy's requirements apply
[[Page 51539]]
to any peer-reviewed manuscript that arises from direct funding from
the NIH and is accepted for publication in a journal on or after April
7, 2008. For example, a peer-reviewed manuscript that describes an
infrastructure project that was NIH funded may be subject to the
Policy, even if not reporting research findings.
NIH Public Access Plan: The Plan did not discuss the proposed scope
of the NIH Draft Public Access Policy regarding ``direct'' funding or
other related details.
Public Comments: Some public comments requested clarification on
situations where NIH funding does not directly support the research
reported in a publication or where researchers use NIH resources
without NIH funding. Other comments suggested that only awardees above
a certain funding threshold or level of contribution on a grant be
subject to the Public Access Policy.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
proposes to adopt the current NIH Public Access Policy's scope and is
intended to make available knowledge generated from NIH-supported
discoveries. Accordingly, the NIH Draft Public Access Policy applies to
any Manuscript \10\ accepted for publication in a journal that results
from funding by NIH in whole or in part. NIH intends to clarify in FAQs
that using NIH resources, such as datasets available through NIH
repositories and physical resources and infrastructure supported by the
NIH, when no NIH funds were used for the work upon which the Manuscript
is based, does not subject a resulting Manuscript to the NIH Public
Access Policy. However, NIH notes that some programs at NIH and
specific agreements may add in such a requirement independent of the
NIH Public Access Policy's scope.
---------------------------------------------------------------------------
\10\ Note that defined terms are capitalized throughout.
---------------------------------------------------------------------------
The NIH Draft Public Access Policy also applies regardless of
whether non-NIH funds contributed to developing or writing the
Manuscript. The applicability of the NIH Draft Public Access Policy
depends on whether the Manuscript is the result of NIH funding in whole
or in part and is not dependent on the funds that contributed to the
writing of the Manuscript itself.
Finally, the NIH Draft Public Access Policy, like the current
Public Access Policy, does not limit its scope to Manuscripts reporting
only on research (it can include, for example, a peer-reviewed
manuscript that describes an infrastructure project that was funded by
NIH).
Timeline of Public Access Policy Applicability
Current Public Access Policy: Neither the current Public Access
Policy nor the law that the Policy implements specifies an end date to
the Policy's applicability to Manuscripts within scope of the
Policy.\11\ This approach is consistent with publishing practices, in
which publication often happens after the end of an award.
---------------------------------------------------------------------------
\11\ <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>.
---------------------------------------------------------------------------
NIH Public Access Plan: The Public Access Plan did not indicate how
long the Public Access Policy would be applicable to Manuscripts.
Public Comments: There were no public comments on the Public Access
Policy's potential applicability to publications arising after the
closeout of the award. Some commenters requested guidance on how to
comply with the Policy when NIH-supported researchers submit articles
for publication long after their NIH funding has ended.
NIH Draft Public Access Policy: NIH is not proposing an end date
for applicability to Manuscripts arising out of awards. Non-compliance
with the NIH Public Access Policy may be considered by NIH regarding
future funding decisions for the recipient institution.
Policy Effective Date
Current Public Access Policy: The current 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 Public Access Plan: The NIH Plan indicates ``NIH plans to
update the NIH Public Access Policy no later than December 31, 2024,
with an effective date no later than December 31, 2025,'' adhering to
an expectation from the 2022 OSTP Memorandum.
Public Comments: Some public comments on the proposed effective
date, noted in the NIH Public Access Plan, argued for a two-year delay
in the effective date to allow time for publishers (particularly
smaller society-based publishers) to adjust. Some also suggested that
the timeline for an effective policy was too aggressive but did not
specify or suggest a specific delay. There were no comments regarding
how the effective date should align with the NIH award cycle.
NIH Draft Public Access Policy: Consistent with the current Public
Access Policy, the NIH Draft Public Access Policy is proposed to become
effective for Manuscripts accepted for publication on or after October
1, 2025. This approach has the benefit of capturing all Manuscripts
accepted for publication regardless of whether the award or contract is
new or ongoing. NIH is committed to working with the research community
to prepare for implementation of the final Policy.
The proposed effective date, October 1, 2025, will follow the
expectations of the 2022 OSTP Memorandum to be no later than the end of
calendar year 2025.
Rights in Manuscripts
Current Public Access Policy: Currently, the FAQs to the Public
Access Policy describe how and when rights in manuscripts accrue and
what may be transferred. NIH provides sample language an author or
institution might add to a copyright agreement with a journal. In
addition, authors submitting Manuscripts to PubMed Central must agree
to the NIH Manuscript Submission (NIHMS) Statement \12\ that, in part,
allows the Manuscript to be appropriately tagged and made available on
the PubMed Central website. This ensures that Manuscripts are available
in machine-readable formats that support accessibility \13\ and
facilitate text mining.\14\
---------------------------------------------------------------------------
\12\ <a href="https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us">https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us</a>.
\13\ <a href="https://www.ncbi.nlm.nih.gov/pmc/about/accessibility/">https://www.ncbi.nlm.nih.gov/pmc/about/accessibility/</a>.
\14\ <a href="https://www.ncbi.nlm.nih.gov/pmc/tools/amdataset/">https://www.ncbi.nlm.nih.gov/pmc/tools/amdataset/</a>.
---------------------------------------------------------------------------
NIH Public Access Plan: In the Public Access Plan, NIH said it
would clarify how NIH-supported investigators may retain sufficient
rights to NIH-supported peer-reviewed manuscripts. NIH proposed to
develop language that NIH-supported investigators may use for
submission with their peer-reviewed manuscripts to journals to retain
rights to make the peer-reviewed manuscript available in PubMed Central
without an embargo period.
Public Comments: There were numerous public comments on rights
retention. These comments ranged from suggesting that NIH require
authors to retain rights to all versions of research products
(including the preprint, the author-accepted manuscript, and the
journal version of record) to advocating that NIH not provide guidance
or sample language on rights retention as it will interfere with
publisher practices. The most frequently observed responses referred
only to the author accepted
[[Page 51540]]
manuscript (to be submitted to PubMed Central) and argued that either
(1) NIH require authors to retain rights via the most open licenses
(e.g., Creative Commons [CC] BY) or (2) NIH should not mandate rights
retention or specific licenses but should allow authors to decide
whether and how to retain their rights in the manuscript. Many comments
were in favor of NIH publishing guidance around rights retention,
including some suggestions to ease administrative burden by providing
template language to be submitted alongside manuscript submission to
the publisher.
NIH Draft Public Access Policy: NIH proposes to focus on achieving
the Policy's goals regarding rights in Manuscripts through minimally
burdensome pathways. First, the NIH Draft Public Access Policy proposes
to clarify that government use rights are given to NIH upon acceptance
of funding. A statement granting NIH rights to make Manuscripts
publicly available in PubMed Central upon the Official Date of
Publication is proposed to be incorporated into Notices of Award and
applicable contracts. This ensures it is understood that NIH's rights
are automatically established at the acceptance of funding, without
requiring funded recipients to take additional steps.
Secondly, the NIH Draft Public Access Policy proposes that those
submitting Manuscripts to PubMed Central will provide a license to NIH
that mirrors the Government Use License as part of a revised Manuscript
Submission Statement, granting NIH the right to (1) make Manuscripts
publicly available in PubMed Central upon the Official Date of
Publication and (2) make Manuscripts available in machine-readable
formats to support accessibility and facilitate text mining, consistent
with current practice.
Beyond these measures, NIH does not propose requiring authors apply
a particular license to their Manuscripts. A particular license is not
needed to achieve the Policy's goal of making Manuscripts available
without an embargo.
In the Draft Guidance on Government Use License and Rights, NIH
encourages authors to clearly communicate NIH's rights through a
statement in the Manuscript itself. In this Guidance, NIH has proposed
standardized language authors may choose to place in their Manuscripts.
Publication Costs
Current Public Access Policy: According to the current 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.'' \15\ Importantly, even if such costs
were not incurred during a specific period of performance of an award,
an award may still be charged before its closeout for publication
costs.
---------------------------------------------------------------------------
\15\ <a href="https://sharing.nih.gov/faqs#/public-access-policy?anchor=50507">https://sharing.nih.gov/faqs#/public-access-policy?anchor=50507</a>.
---------------------------------------------------------------------------
NIH Public Access Plan: NIH stated in the Public Access Plan the
intent to continue to allow reasonable publication costs for all NIH-
supported or authored scholarly publications consistent with current
policy and guidance. NIH proposed to continue monitoring trends in
publication fees and policies to ensure that they remain reasonable and
do not disproportionally burden one or more segments of the NIH-
supported community, and that opportunities to publish are equitable
and consistent with NIH's strategic priorities.
Public Comments: Many respondents argued that removal of the
embargo would drive publishers to business models that charge fees to
make articles openly and immediately available, and that as these fees
rise, so will inequity for lower resourced institutions and
investigators. Some publishers suggested that these models are the only
way forward as subscriptions diminish. Others sought assurances that
authors would be able to comply with the revised NIH Public Access
Policy without cost through repository deposition models. Some
publishers suggested that removal of the embargo and subsequent
diminished subscriptions could have a significant negative effect on
their operations, leading to limited choices of where to publish, which
would limit accessibility.
Many comments favored monitoring the costs of publications. Some
suggestions included examining application budgets and annual reports
to the NIH, working with publishers to understand publishing model and/
or discipline specific requirements, and exploring currently existing
cost assessments. Some suggested that any appearance of dictating
business models would be inappropriate and could interfere with a
publisher's ability to remain in business.
Several respondents perceived fees to make articles openly and
immediately available to be too high and to lack transparency. Some of
these comments encouraged NIH to cap publication-related costs. Several
publishers argued that cost-capping could lead to an increase in
``predatory'' publishing.
Many argued that NIH should define which publication costs would be
permissible under regulations and the Grants Policy Statement (GPS).
Some suggested that it would be helpful to define ``reasonable'' costs,
while others suggested that such definitions would be entirely context
dependent and would necessarily evolve.
NIH Draft Public Access Policy: In the NIH Draft Public Access
Policy, NIH clarifies that compliance with the Policy is free. While
allowable publication costs may be budgeted, as publishing itself may
incur costs, NIH maintains a free pathway for compliance with the NIH
Draft Public Access Policy by submission of the Manuscript to PubMed
Central. This free pathway for policy compliance helps to support the
goals of equitable public access. Additionally, the benefits of
eliminating costs and delays in access to publications will likely be
greatest for lower resourced institutions, researchers, and the public.
The NIH Draft Public Access Policy notes that if authors are asked
to pay a fee by a third party for submission of Manuscripts to PubMed
Central, the NIH Draft Public Access Policy would not permit this fee
to be paid from NIH funds because it is not a legitimate publication
expense. The NIH Draft Public Access Policy indicates reasonable costs
associated with publication that are allowable may be requested in the
budget for the project as direct or indirect costs.
The Draft Guidance on Publication Costs contains examples of
unallowable costs, based on existing cost principles and existing
sections of the GPS. Regarding the ability to pay publication costs
after an award has ended, NIH cannot pay publication costs after
closeout of an award (as recently affirmed in revisions to 2 CFR
200.461 \16\). Points to Consider are provided for authors and
institutions to inform whether a publication cost is reasonable.
---------------------------------------------------------------------------
\16\ <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>.
---------------------------------------------------------------------------
NIH will continue to consider appropriate methods to monitor costs
for potential impacts on relevant communities once the final Public
Access Policy has been implemented and any downstream effects are more
readily apparent.
[[Page 51541]]
Compliance and Enforcement
Current Public Access Policy: The current NIH Public Access Policy
notes that the awardee institution is responsible for complying with
the terms and conditions of the award. Compliance may be achieved
through submission of the Manuscript or through journals submitting
Final Published Articles to PubMed Central based on existing
agreements. NIH may take one or more enforcement actions, depending on
the severity and duration of the non-compliance, in accordance with
applicable statutes, regulations, and policies.
NIH Public Access Plan: The Public Access Plan did not specify
enforcement actions but rather outlined the pathways to compliance of
submission of the Manuscript or Final Published Article.
Public Comments: Many commenters requested that compliance with the
NIH Public Access Policy be as simple as possible and not place undue
burden on investigators. There were no public comments on the
consequences for non-compliance.
NIH Draft Public Access Policy: The NIH Draft Public Access Policy
minimizes burden by proposing to adopt the same pathways to compliance
as under the current Public Access Policy. It also reinforces the
requirement to properly communicate and acknowledge federal funding in
Manuscripts. Importantly, the NIH Draft Public Access Policy states
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. It notes that non-compliance may delay non-
competing award processing and potentially affect future funding for
the institution.
Accessibility and Understandability
Current Public Access Policy: NIH currently makes content in PubMed
Central available in accessible and machine-readable formats. In
addition, NIH currently has multiple ways to make research and research
results available to the public,\17\ including through press releases,
the Public Health Relevance Statement in grant applications, and the
Outcomes section in RePORTER.
---------------------------------------------------------------------------
\17\ <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/general/g.100-how-to-use-the-application-instructions.htm#6">https://grants.nih.gov/grants/how-to-apply-application-guide/forms-h/general/g.100-how-to-use-the-application-instructions.htm#6</a>.
---------------------------------------------------------------------------
NIH Public Access Plan: The Public Access Plan proposed to continue
making articles available in formats that allow for machine-readability
and through assistive devices.
Public comments: Public comments indicated that making information
available is necessary but not sufficient to meet goals concerning
equitable access. Consumers of the information resulting from NIH-
supported studies need to be able to process and understand what they
are reading. Many public comments supported NIH's goals to make
information machine-readable and available on assistive devices, but
there were also comments about the need to enhance understanding, such
as by translating articles into multiple languages and accompanying
articles with plain language summaries.
NIH Draft Public Access Policy: Accessibility of PubMed Central
content is paramount and NIH will continue to make content accessible
for those using 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.
While NIH does not currently plan to require that authors develop or
submit plain language summaries of Manuscripts or translate their
content into languages other than English, as supporting technologies
continue to develop, NIH will consider additional approaches to
increase understanding of NIH-funded scientific research.
NIH Draft Public Access Policy
Purpose
Increasing access to publications resulting from NIH funding offers
many benefits to the scientific community and the public who funded the
underlying work. The ability for patients, families, and members of the
public to access published findings resulting from NIH funding enables
them to better understand and address the most critical public health
concerns facing their communities. It also allows researchers,
students, and health care providers 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 keep up more closely with critical advances. Importantly,
these goals also reflect NIH's commitment to responsible stewardship of
the Nation's investment in biomedical research by improving
transparency and accessibility of taxpayer-funded research.
Per the NIH Public Access Policy, effective October 1, 2025, NIH is
requiring Manuscripts to be submitted to PubMed Central upon acceptance
for publication, for public availability without embargo upon the
Official Date of Publication.
Definitions
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
Article: A general term that encompasses the versions resulting
from writing and publishing, from creation of the manuscript through
final published article in a journal
Journal: A periodical publication that is either (1) included in
the ``journal'' section of the National Library of Medicine (NLM)
Catalog \18\ or (2) meets all of the following criteria:
---------------------------------------------------------------------------
\18\ <a href="https://www.ncbi.nlm.nih.gov/nlmcatalog/journals?term=periodical%5BPublication+Type%5D+AND+open%5BPublication+Status%5D">https://www.ncbi.nlm.nih.gov/nlmcatalog/journals?term=periodical%5BPublication+Type%5D+AND+open%5BPublication+Status%5D</a>.
---------------------------------------------------------------------------
<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 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 Manuscript accepted for
publication in a journal, on or after October 1, 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 Manuscript. Upon the effective date, this Policy replaces
the prior 2008 NIH Public Access Policy.
Requirements
The Public Access Policy requires:
<bullet> Submission of an electronic version of the final peer-
reviewed Manuscript to
[[Page 51542]]
PubMed Central upon its acceptance for publication, for public
availability without embargo upon the Official Date of Publication;
<bullet> 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,\19\ as well as analogous requirements for acknowledging
federal funding as incorporated into Other Transactions and applicable
contracts; and
---------------------------------------------------------------------------
\19\ NIH Grants Policy Statement 4.2.1 Acknowledgment of Federal
Funding (<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 8.2.1
Rights in Data (Publication and Copyrighting) (<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>).
---------------------------------------------------------------------------
<bullet> When a Manuscript is submitted to NIH,\20\ providing NIH
with a standard license that mirrors that of the Government Use License
at 45 CFR 75.322(b),\21\ 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.
---------------------------------------------------------------------------
\20\ This happens typically through the NIH Manuscript
Submission (NIHMS) System.
\21\ <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR78b08d9c95aad03/section-75.322">https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR78b08d9c95aad03/section-75.322</a>.
---------------------------------------------------------------------------
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. This includes making Manuscripts
publicly available in PubMed Central upon the Official Date of
Publication. A statement that conveys this point is incorporated into
Notices of Award and applicable contracts.
<bullet> NIH encourages inclusion of 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. NIH provides standardized language in the Draft
Guidance on Government Use License and Rights that authors may include
in Manuscripts. Such a statement ensures transparency and awareness
that NIH has the right to make the 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. However, as noted in ``Compliance and
Enforcement,'' NIH will accept submission of the Final Published
Article to PubMed Central from journals with formal agreements with NLM
as compliant with the Policy when its release meets public access
requirements outlined in this Policy.
Costs
Reasonable costs associated with publication that are allowable may
be requested in the budget for the project as direct or indirect costs,
as specified in the NIH Grants Policy Statement \22\ and as
incorporated into Other Transactions and applicable contracts (see the
Draft Guidance on Publication Costs for more information). Submission
of 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 Manuscript to
PubMed Central, such costs are not allowable.
---------------------------------------------------------------------------
\22\ <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> (See Publication
and Printing Costs).
---------------------------------------------------------------------------
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 final peer-
reviewed manuscript (i.e., Manuscript as defined above) 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 a journal with a formal agreement with NLM, upon the Official Date
of Publication, for public availability without embargo
Communicating and acknowledging federal funding enables a clear,
public-facing indication of NIH funding in Manuscripts and Final
Published Articles. Failure to include required acknowledgments may
result in non-compliance with the NIH Public Access Policy, in addition
to resulting in non-compliance with terms and conditions of funding
regarding communicating and acknowledging federal funding.
Non-compliance 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 Grants Policy Statement, Section 8.5,
Special Award Conditions and Remedies for Noncompliance (Special Award
Conditions and Enforcement Actions)).\23\ Non-competing continuation
grant awards are subject to a delay in award processing for non-
compliance with the NIH Public Access Policy.
---------------------------------------------------------------------------
\23\ <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>.
---------------------------------------------------------------------------
Draft 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., manuscripts) under the
Government Use License (45 CFR 75.322(b)), or its successor regulation,
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 Other Transactions and applicable contracts (e.g., the rights in
data clause within the contract).
NIH proposes this Draft Guidance to assist authors in navigating
compliance with the NIH Public Access Policy with minimal burden. NIH
also encourages authors to be clear with the journals to which they
submit their Articles, to ensure journals understand that NIH has a
right to make Manuscripts publicly available upon the Official Date of
Publication.
Public Access Policy Requirements Related to Rights
Upon accepting NIH funding, recipients grant to NIH the right to
make Manuscripts arising 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 and applicable contracts.
Authors approving Manuscripts for inclusion in PubMed Central must
agree to a submission statement \24\ as part of the standard PubMed
Central Manuscript submission process. Under the NIH Draft Public
Access Policy, authors submitting a Manuscript to PubMed Central must
provide NIH with a standard license that mirrors the Government Use
License. This language will be included as part of this submission
statement to PubMed Central and states:
---------------------------------------------------------------------------
\24\ <a href="https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us">https://support.nlm.nih.gov/knowledgebase/article/KA-05252/en-us</a>.
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 create derivative works and make
[[Page 51543]]
the final, peer-reviewed manuscript publicly available upon the
---------------------------------------------------------------------------
Official Date of Publication.
The language in this statement may evolve as regulations change,
but it includes a grant of rights to NIH such that NIH may make the
Manuscript publicly available in PubMed Central without an embargo,
upon the Official Date of Publication.
Guidance for Communicating Rights in Manuscripts
NIH highly encourages authors to be transparent when submitting
Articles \25\ for consideration for publication by indicating to the
journal or publisher that the Article 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. NIH does not require that
authors demonstrate to NIH what was communicated to publishers.
---------------------------------------------------------------------------
\25\ Term used because they represent the pre-peer review stage.
---------------------------------------------------------------------------
NIH suggests that authors submit the points above as a statement in
the Manuscript. Such a statement may accompany the required funding
acknowledgment. NIH provides the following sample language that may be
included in the Manuscript:
This manuscript is the result of funding in whole or in part by
the National Institutes of Health. 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, defined by NIH
as ``The date on which the article is first made available in final,
edited form, whether in print or electronic (i.e., online) format.
Draft Guidance on Publication Costs
Purpose
NIH recognizes that authors publishing in peer-reviewed journals
may incur associated costs, such as article processing charges (APCs)
or other charges. Publication costs are allowable when they comport
with the existing NIH cost principles.\26\ Cost principles clarify when
costs should be allocated as direct versus indirect costs, and they
clarify charges and fees that are allowable under the conditions
outlined.
---------------------------------------------------------------------------
\26\ Grants Policy Statement Section 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 Section 7.9 (https://
grants.nih.gov/grants/policy/nihgps/HTML5/section_7/
7.9_allowability_of_costs_activities.htm).
---------------------------------------------------------------------------
This Draft Guidance clarifies publication costs that are not
allowable based on existing cost principles that provide a framework
for allowable publication costs. It also provides points to consider to
assist authors and institutions as they assess whether publishing costs
are reasonable.
Public Access Policy Requirements Related to Costs
All costs must comport with 45 CFR 75, or its successor regulation,
as implemented in NIH GPS Sections 7.2 and 7.9.1. These principles also
apply as analogous requirements in Other Transactions and applicable
contracts.
The NIH Draft 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 Other Transactions and applicable contracts.
Importantly, the NIH Draft Public Access Policy also states that
submission of Manuscripts to PubMed Central remains free for authors.
Journal or publisher fees for submitting the Manuscript to PubMed
Central that may arise during the course of the publication process are
not allowable costs.
Other Unallowable Costs
In addition to not allowing payment of fees to submit Manuscripts
to PubMed Central, examples of other unallowable costs are listed below
in the context of 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 publication 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 publication costs (e.g., an agreement the institution has with a
publisher whereby authors from that institution 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)
<bullet> Costs for publishing services that are charged differentially
because an author's Manuscript is subject to the NIH Public Access
Policy are unallowable because charges must be levied impartially on
all items published by the journal, whether or not under a federal
award (GPS 7.9.1, Publication and Printing Costs)
<bullet> Costs for services incurred after closeout of the award, even
for a publication subject to the NIH Public Access Policy, are
unallowable because the costs of publications must be incurred before
closeout (GPS 7.9.1, Publication and Printing Costs)
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.
While NIH may modify this approach in the future, NIH encourages
researchers and institutions to consider, when determining whether
costs are reasonable:
<bullet> Size of publication cost in relation to NIH award
<bullet> Other publications researchers may wish to produce during an
award period
<bullet> Professional and institutional priorities
<bullet> Sustainability in terms of the library budget, laboratory
budget, etc., if such costs were to be consistently paid
In addition, NIH reiterates its Statement on Article Publication
Resulting from NIH Funded Research,\27\ a 2017 NIH Guide Notice that
encourages authors to publish papers arising from NIH-funded research
in reputable journals. Fees paid to journals that have characteristics
described in this Statement may be considered unreasonable.
---------------------------------------------------------------------------
\27\ <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>.
---------------------------------------------------------------------------
NIH seeks public comments on any aspect of the NIH Draft Public
Access Policy and supplemental Draft Guidance.
Dated: June 7, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-13373 Filed 6-17-24; 8:45 am]
BILLING CODE 4140-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 18, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.