[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Notices]
[Page 16881-16895]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information: NIH Public Access Policy
AGENCY: The National Institutes of Health (NIH) of the U.S. Department
of Health and Human Services (HHS).
ACTION: Request for information.
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SUMMARY: With this notice, the National Institutes of Health (NIH) of
the U.S. Department of Health and Human Services (HHS) requests input
from the community regarding the NIH Policy on Enhancing Public Access
to Archived Publications Resulting From NIH-Funded Research (NIH Public
Access Policy). Complete and detailed information about the law at
Division G, Title II, section 218 of Public Law 110-161 (Consolidated
Appropriations Act, 2008), the NIH Public Access Policy, and
implementation procedures issued to date are available at http://
publicaccess.nih.gov/index.htm. This request for information (RFI)
seeks input on the Public Access Policy as described on the above Web
site. This RFI will be active from March 31, 2008 to May 31, 2008 on
http://publicaccess.nih.gov/comments.htm. The NIH will post analysis
and results from this RFI for public view onto http://
publicaccess.nih.gov by September 30, 2008.
Background: The National Institutes of Health (NIH)--The Nation's
Medical Research Agency--is comprised of 27 Institutes and Centers and
is a component of the U.S. Department of Health and Human Services. It
is the primary Federal agency for conducting and supporting basic,
clinical, and translational medical research, and investigates the
causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit http://www.nih.gov.
PubMed Central is an archive of full-text biomedical journal
articles available online without a fee. Articles on PubMed Central
contain links to other scientific databases such as GenBank (http://
www.ncbi.nlm.nih.gov/ Genbank/) and PubChem (http://
pubchem.ncbi.nlm.nih.gov/). Articles collected under the Public Access
Policy are archived on PubMed Central. More information about PubMed
Central is available at http://www.pubmedcentral.nih.gov/about/
faq.html.
Prior to the Consolidated Appropriations Act of 2008, NIH's
voluntary Public Access Policy (NOT-OD-05-022 available at http://
grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html and in the
section on SUPPLEMENTARY INFORMATION) encouraged but did not require
those receiving NIH funding to deposit their peer reviewed manuscripts
into PubMed Central.
Division G, Title II, section 218 of Public Law 110-161
(Consolidated Appropriations Act of 2008) states:
SEC. 218. The Director of the National Institutes of Health shall
require that all investigators funded by the NIH submit or have
submitted for them to the National Library of Medicine's PubMed
Central an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of
publication: Provided, That the NIH shall implement the public
access policy in a manner consistent with copyright law.
On January 11, 2008, NIH issued a revised policy implementing this
law. As described in the NIH Guide for Grants and Contracts (NOT-OD-08-
033 available at http://grants.nih.gov/grants/guide/notice-files/NOT-
OD-08-033.html and in the section on SUPPLEMENTARY INFORMATION), as of
April 7, 2008, applicable manuscripts arising from NIH funds must be
submitted to PubMed Central upon acceptance for publication. As of May
25, 2008, NIH applications, proposals, and progress reports must
include the PMC reference number when citing a manuscript that falls
under the policy. This policy includes applications submitted to the
NIH for the May 25, 2008 due date and subsequent due dates.
[[Page 16882]]
NIH has posted responses to frequently asked questions that provide
authors, their institutions, and their publishers with preliminary
guidance on the implementation of this policy, including guidance on
the transfer of copyright. This document can be viewed at http://
publicaccess.nih.gov/FAQ.htm#content and in the section on
SUPPLEMENTARY INFORMATION.
The NIH Public Access Policy is a point of interest and discussion
between NIH and many members of the public, including grantees
(institutions and their authors), publishers, libraries, medical
practitioners, patients and others with health concerns. For example,
some of these stakeholders have expressed concern about copyright
issues, and others about the length of time before manuscripts are made
publicly available. Still others have offered suggestions on NIH's
Public Access training materials, and have developed compliance
strategies that may benefit others.
The NIH is seeking to engage formally with the broader community on
the Public Access Policy in a transparent and participatory manner. The
first step of this process was an open meeting, conducted March 20,
2008 (announced in the March 10, 2008 Federal Register notice 73 FR
12745). Comments collected to date, can be found at http://
publicaccess.nih.gov/comments/comments--web--listing.htm. The NIH
intends to make comments publicly available as they are collected; and,
to facilitate independent analysis, the NIH will make comments
available for download in bulk at the end of the comment period.
Request for Information: Via this RFI, NIH is seeking information
from the public, including all stakeholders, about the NIH Public
Access Policy (NOT-OD-05-022 available at http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-05-022.html ), as revised by the NIH Guide
for Grants and Contracts (NOT-OD-08-033 available at http://
grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html ) to
incorporate requirements in Public Law 110-161, and the responses to
frequently asked questions available at http://publicaccess.nih.gov/
FAQ.htm#content. NIH will consider all comments and suggestions
regarding the Public Access Policy. Among other issues, the NIH is
particularly interested in information about the following:
Do you have recommendations for alternative implementation
approaches to those already reflected in the NIH Public Access Policy?
In light of the change in law that makes NIH's public
access policy mandatory, do you have recommendations for monitoring and
ensuring compliance with the NIH Public Access Policy?
In addition to the information already posted at http://
publicaccess.nih.gov/communications.htm, what additional information,
training or communications related to the NIH Public Access Policy
would be helpful to you?
As suggested above, previous comments have focused on such issues
as copyright, the length of time before articles are made publicly
available, and on NIH's training materials, and we anticipate that
comments would continue to address these issues.
Individuals, groups, and organizations interested in responding may
do so in their discretion at the following NIH Web site: http://
publicaccess.nih.gov/comments.htm. In voluntarily providing
information, respondents are consenting to its use and consideration by
the NIH. The following identifying information will be made publicly
available on the internet along with the information submitted by that
commenter: Name (first and last), Degree (if provided), Affiliation,
City, State, Country and Role. Roles are defined as: NIH-funded
Investigator; Representative of University and Other NIH Awardee
Organizations; Publisher (including Commercial Organizations,
Professional Societies and Journal Editors); Patient or Representative
of a Public Health Advocacy Organization; Other Member of the Public;
Other (not listed above). If respondents provide information through
alternative means, the entire submission will be made public. NIH will
not post responses that are not related to the Public Access Policy or
are otherwise inappropriate or offensive.
Report and Response: The NIH will analyze all submissions collected
through this RFI, along with comments collected before and during the
March 20th meeting. The NIH will report its analysis by September 30,
2008. This report will be made available at http://
publicaccess.nih.gov.
Contact Person for Information: Questions concerning this RFI may
be addressed to: Neil M. Thakur, Ph.D., Special Assistant to the NIH
Deputy Director for Extramural Research, Building 1, Room 134,
Bethesda, MD 20892, Telephone 301-496-1096, Fax 301-402-3469,
PublicAccessComments@NIH.gov. Note that this facility is not intended
to collect RFI responses. Please submit RFI responses via http://
publicaccess.nih.gov/comments.htm.
SUPPLEMENTARY INFORMATION:
Notice Number: NOT-OD-05-022.
Key Dates
Release Date: February 3, 2005.
Effective Date: May 2, 2005.
Issued By
National Institutes of Health (NIH), (http://www.nih.gov/).
Department of Health and Human Services Action
Notice; Final Policy Statement.
Update: The following update relating to this Notice has been
issued:
January 11, 2008 (NOT-OD-08-033)--Revised Policy on
Enhancing Public Access to Archived Publications Resulting from NIH-
Funded Research.
Summary
The National Institutes of Health (NIH) announces its policy on
enhancing public access to archived publications resulting from NIH-
funded research. Beginning May 2, 2005, NIH-funded investigators are
requested to submit to the NIH National Library of Medicine's (NLM)
PubMed Central (PMC) an electronic version of the author's final
manuscript upon acceptance for publication, resulting from research
supported, in whole or in part, with direct costs \1\ from NIH. The
author's final manuscript is defined as the final version accepted for
journal publication, and includes all modifications from the publishing
peer review process.
This policy applies to all research grant and career development
award mechanisms, cooperative agreements, contracts, Institutional and
Individual Ruth L. Kirschstein National Research Service Awards, as
well as NIH intramural research studies. The policy is intended to: (1)
Create a stable archive of peer-reviewed research publications
resulting from NIH-funded research to ensure the permanent preservation
of these vital published research findings; (2) secure a searchable
compendium of these peer-reviewed research publications that NIH and
its awardees can use to manage more efficiently and to understand
better their research portfolios, monitor scientific productivity, and
ultimately, help set research priorities; and (3) make published
results of NIH-funded research more readily accessible to the public,
health care providers, educators, and scientists.
This final NIH Public Access Policy (the Policy) reflects
modifications and clarifications to the proposed policy released
September 3, 2004, in the NIH Guide for Grants and Contracts and
September 17, 2004, in the Federal
[[Page 16883]]
Register and the more than 6,000 public comments received through
November 16, 2004. The most significant change in the Policy from that
originally proposed is to provide more flexibility for authors to
specify the timing of the posting of their final manuscripts for public
accessibility through PMC. The proposed policy indicated a six-month
delay of posting through PMC. The Policy now requests and strongly
encourages that authors specify posting of their final manuscripts for
public accessibility as soon as possible (and within 12 months of the
publisher's official date of final publication). The Policy also
clarifies that the publication date is the publisher's official date of
final publication.
Effective Date: May 2, 2005.
FOR FURTHER INFORMATION CONTACT: Office of Extramural Research,
National Institutes of Health, 6705 Rockledge Drive, Room 350,
Bethesda, MD 20892-7963 or by e-mail to: PublicAccess@nih.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Public Comments and NIH Response
III. Text of Final Policy Statement
I. Background
It has long been NIH policy that the results and accomplishments of
the activities that it funds should be made available to the public.
Principal Investigators (PI) and grantee organizations are expected to
make the results and accomplishments of their activities available to
the research community and to the public at large.\2\ It is estimated
that the results of NIH-supported research were described in 60,000-
65,000 published papers in 2003.\3\ We believe that widespread access
to and sharing of peer-reviewed research publications generated with
NIH support will advance science and improve communication of peer-
reviewed, health-related information to scientists, health care
providers, and the public.
As part of on-going efforts to gather perspectives on the issue of
public access to research publications, the NIH held a series of
meetings to hear and consider the opinions and concerns of publishers,
scientists, patient advocates, and representatives of scientific
associations and other organizations. The meetings were designed to
ensure that discussions of stakeholder issues could occur. The NIH
extended invitations to a broad base of participants to ensure balanced
representation of opinions. In many cases, a participant represented
more than one perspective, such as a scientist who was also a journal
editor and reviewer of scientific manuscripts.
After carefully considering the views of publishers, patient
advocates, scientists, university administrators, and others, the NIH
published its proposed NIH Public Access Policy in the NIH Guide for
Grants and Contracts on September 3, 2004, http://grants.nih.gov/
grants/guide/notice-files/NOT-OD-04-064.html and in the Federal
Register on September 17, 2004, http://a257.g.akamaitech.net/7/257/
2422/06jun20041800/edocket.access.gpo.gov/2004/04-21097.htm for public
comment. During the comment period, the NIH received over 6,000
comments via web, fax, mail, and e-mail. Many comments were received
from organizations representing multiple constituents. The NIH
developed Questions and Answers to clarify the proposal as issues were
raised regarding it; these are available at: http://www.nih.gov/about/
publicaccess/publicaccess_QandA.htm.
This final Policy reflects consideration of public comments
received on the proposed policy through November 16, 2004, i.e., 60
days from the date of publication of the proposed policy in the Federal
Register.
The Policy is intended to: (1) Create a stable archive of peer-
reviewed research publications resulting from NIH-funded research to
ensure the permanent preservation of these vital published research
findings; (2) secure a searchable compendium of these peer-reviewed
research publications that NIH and its awardees can use to manage more
efficiently and to understand better their research portfolios, monitor
scientific productivity, and ultimately, help set research priorities;
and (3) make published results of NIH-funded research more readily
accessible to the public, health care providers, educators, and
scientists.
II. Public Comments and NIH Responses
A. Need for the Policy
The public comments were largely supportive of the proposed policy
to enhance public access to archived publications resulting from NIH-
funded research. Comments noted that this policy provides equal and
timely access to all via the Internet and that this accessibility
should improve individual health outcomes. Many scientists appreciated
that the policy would improve the visibility of their work. A large
number of comments suggested that publicly funded research publications
should be made accessible to the public in full-text version in a
timely manner. Many commenters expressed support for the policy given
their concerns about the high and rising cost of subscriptions to
scholarly journals, especially in the areas of science, technology, and
medicine.
Other commenters questioned the need for the policy and considered
it redundant to existing information sources and systems. Some
questioned the added value of the policy and noted that journals
increasingly are making full-text articles available immediately upon
or within one year of publication through a variety of sources.
Commenters noted that many of these articles are already linkable
through the NLM PubMed web-based literature retrieval system that
contains citations and abstracts from thousands of journals, dating
back to 1950.\4\ A significant number of comments also questioned why
the NLM could not simply provide a link to the publisher's Web site, or
work with existing vendors to broaden offerings to include peer-
reviewed publications not associated with NIH funding.
The primary purpose of the NIH Public Access Policy is the creation
of a stable archive to ensure the permanent preservation of vital,
peer-reviewed research publications resulting from NIH-funded research
findings now and for future generations. While links exist to journal
articles that are publicly accessible, these are not sufficient because
publishers' Web sites are not permanently available nor consistently
maintained. Additionally, the formatting of journal articles may vary
significantly among publishers' Web sites. The Policy addresses this
deficiency in that all articles in PMC, regardless of their original
format, are converted into a single, explicit, and well-specified data
format. This format is known as the NLM Journal Article Extensible
Markup Language (XML) Document Type Definition (DTD). Further, as new
needs arise, and as technology and applications change, there is a
single, uniform base upon which to build.
Preservation of the biomedical literature is a responsibility that
is specifically mandated in NLM's authorizing legislation, found at 42
U.S.C. 286(b)(1), and one that has successfully been carried out by the
NLM since 1836. It is logical in this electronic era to expect
libraries, and particularly national libraries, to continue this vital
function, including keeping pace with the ever-changing technology
surrounding document preservation. Updating the data formats to keep up
with the changes in
[[Page 16884]]
technology and the needs of biomedical research requires an ongoing
investment in research and development, which is within the NIH
mission. As the electronic article increasingly becomes the
authoritative and most useful document for researchers and as
scientists are actually computing on the contents of these documents--
the text itself as well as the associated data--the impermanence of the
publishers' Web sites presents a substantial risk. Creating such an
archive is a historical and necessary NIH responsibility.
NIH believes that the NIH Public Access Policy will effectively
advance its stated goals. By storing research publications from diverse
sources in a searchable, electronic archive with a common format, PMC
facilitates greater integration with related resources in other NLM
databases such as DNA and protein sequences, protein structures,
clinical trials, small molecules (PubChem), and taxonomy, thus
providing the opportunity to develop unprecedented scientific search
and analysis capabilities for the benefit of science. One of the
primary goals of PMC is the creation of a permanent, digital archive of
journal literature, which by definition means the full text must be
deposited in PMC. This searchable archive will enable NIH program
officials to manage their research portfolios more efficiently, monitor
scientific productivity, and ultimately, help set research priorities.
This strategy also will enable NIH to advance its goal of creating an
end-to-end, paperless grants management process. Finally, it will make
the publications of NIH-funded research more accessible to and
searchable for the public, health care providers, educators, and
scientists.
A few commenters asked NIH to strengthen the proposed policy to
make submission to PMC a requirement instead of a request. We believe
that the voluntary nature of the final policy is preferable to a ``one
size fits all'' requirement, as it permits sufficient flexibility to
accommodate the needs of different stakeholders and leaves the ultimate
decision in the hands of our scientific investigators who are the best
to judge the scientific circumstances and the time frame under which
their work may be made accessible to the public at large. It is worth
clarifying that NIH does not require or expect that PMC be the sole
repository for NIH-funded research publications. Others may choose to
post and/or archive peer-reviewed publications resulting from NIH-
funded research, subject to applicable laws or permission from any
copyright holders.
B. Scope of the Policy
The NIH Public Access Policy applies only to peer-reviewed research
publications that have been supported, in whole or in part, with direct
costs from NIH. Numerous comments reflected misunderstandings about the
scope of the policy as it was proposed. Some comments sought to broaden
the Policy to include publications from non-NIH-supported
investigators, and others asked that it include publications that did
not contain original research findings, e.g., book reviews.
The Policy does not apply to contributed book chapters, editorials,
reviews, or conference proceedings. Although PMC does contain articles
from non-NIH-supported research, the Policy is focused on final, peer-
reviewed manuscripts and publications that result from research
supported, in whole or in part, with direct costs from NIH.
C. Potential for Public Misunderstanding of Research Findings
A number of comments questioned the lay public's ability to
understand fully original research publications, and expressed fear
that potential harm could result from misinterpretation of them.
We believe that individuals who seek to read publications
concerning a particular disease, health condition, or treatment should
not be denied access because of the possibility that they will
misunderstand the publications. Rather, NIH encourages such individuals
to become educated consumers about their health care and related
research, and to consult with health care professionals for specific
guidance. It is important that NIH-supported research publications be
made more readily available to provide credible information and to
improve public understanding of the benefits of scientific research.
The public demand for credible health information is clear. About 93
million Americans searched for at least one of 16 health topics online
within the past year.\5\ In a 2003 survey, 58 percent of Internet users
said they brought information obtained from the Internet to their
doctor's office.\6\
The NIH is strongly committed to conveying the importance of the
research it funds to the public. Each NIH Institute and Center has an
active staff that produces high-quality educational and informational
materials on various health and research topics, many of which
highlight the publications of NIH-funded researchers. Institute and
Center staff, often with the assistance of third parties and patient
advocacy groups, works diligently to develop, review, and disseminate
these products. For example, the National Library of Medicine's
consumer health site, Medline Plus (http://www.nlm.nih.gov/medlineplus/
) houses extensive information on over 650 health conditions. NIH
believes that these products effectively advance NIH's strong
commitment to improving public health through research.
The Policy specifically relates to original research publications.
NIH needs to compile these publications into a single archive in order
to manage its research portfolio better and monitor its funding
choices. NIH recognizes that providing public access to this electronic
archive may also help scientists, policymakers, doctors, patients and
the lay public to understand better the research that NIH funds.
D. Version Control and Quality of Manuscripts
Some commenters raised concerns about potential confusion resulting
from differences between the author's final manuscript within PMC and
the published version of the corresponding article at journal-sponsored
Web sites. Others questioned how corrections, retractions, and other
post-publication changes will be accommodated.
Through this Policy, NIH is requesting that NIH-funded
investigators submit an electronic version of the author's final
manuscripts resulting from research supported, in whole or in part,
with direct costs from NIH, after all changes resulting from the peer
review publication process have been incorporated. A growing number of
journals are currently posting final author manuscripts to provide
timely access to their subscribers prior to final publication of the
publisher's copy edited version. In addition, under the Policy, the
final manuscript will not be made available to the public through PMC
until after the copyedited version is published by the journal.
Corrections and other necessary revisions of author's final manuscripts
will be accommodated. Furthermore, when publicly available, the
published article on the journal-sponsored Web site and the author's
final manuscript in PMC will be appropriately linked through PubMed.
Corrections and post-publication comments referring to a publication
are currently identified and linked in PubMed, and this capability will
be linked to the corresponding manuscript in PMC. If publishers wish to
provide PMC with the publisher's final version, this version will
supersede the author's final manuscript in PMC.
[[Page 16885]]
E. Potential for Acceleration of Medical Cures
A few commenters questioned whether the proposed policy, and
enhanced access to NIH-funded publications, will facilitate scientific
progress and accelerate research for medical cures.
We believe that improved access through PMC to peer-reviewed, final
manuscripts of NIH-supported investigators will facilitate scientific
progress because it will enable NIH to manage better its research
portfolio and funding choices. The NIH encourages the sharing of ideas,
data, and research findings to help accomplish its important public
mission to uncover new knowledge that will lead to better health for
everyone. As such, we envision that the PMC resource will have
widespread and varied uses for the research community. It will create a
stable, permanent, and searchable archive of peer-reviewed research
publications that NIH and the public can access, without a fee, to
review scientific productivity, monitor the state-of-the-science, and
apply such knowledge in other ways to accelerate medical research.
Greater interconnectivity and functional integration between the
multiple and large research data bases (e.g., Genbank and PubChem) and
an archive of NIH-funded publications has the potential to enhance
research in novel ways.
F. Potential Economic Impact on Journal Publishers
Commenters contended that NIH had not carefully considered the
potential adverse economic impact of its proposed policy on publishers,
in particular, not-for-profit professional and learned societies and
associations that rely on subscriptions to cover costs. The
consequences of the proposed policy for many small journals, as well as
bimonthly and quarterly journals, were of particular concern to some.
Concern also was raised that relative to commercial publishers, not-
for-profit publishers would be more disadvantaged because they often
support highly specialized areas that tend to draw greater
representation by NIH-funded researchers. Others questioned the
fairness of allowing publishers to continue to profit by restricting
access to health-related information.
Publishing patterns vary from year to year and from one journal to
another. Using 2003 data, NLM estimates that, on an annual basis,
publications resulting from NIH-funded research represent approximately
10 percent of the articles in nearly 5,000 journals indexed by PubMed.
In addition, for only one percent of these journals do NIH-funded
articles account for more than half of the total published articles.\7\
As such, it is unlikely that scientists and libraries would use the NIH
Public Access Policy as the rationale for replacing their journal
subscriptions. If they did, they would be able to access only a
fraction of a journal's content. It also is important to note that
there are many other journal offerings, such as science news, industry
information, literature reviews, job announcements, functional Web
sites, and other time-sensitive products that bring value to the reader
but are not a part of the PMC archive. Access to journal articles
through the NIH archive might increase Internet traffic to those
journals, by both the scientific community and the general public.
The NIH supports the current publishing process by providing its
funded investigators with an estimated $30 million \8\ annually in
direct costs for publication expenses, including page and color charges
and reprints. In addition, NIH provides funds, through indirect costs,
to research institutions for library journal subscriptions and
electronic site licenses. NIH also supports the current process by
encouraging publication of NIH-supported original research in
scientific journals.
NIH has made modifications to the proposed policy to provide
greater flexibility to accommodate the range of business models
represented by large commercial publishing houses through the smaller
specialized journals of learned societies. The most significant change
is to allow authors to specify the timing of the posting for public
accessibility through PMC of their final manuscript. The NIH intends to
maintain its dialogue with publishers and professional and learned
societies as experience is gained with the Policy.
A NIH Public Access Advisory Working Group of the NLM Board of
Regents \9\ will be established. The Working Group will be composed of
stakeholders that will advise NIH/NLM on implementation and assess
progress in meeting the goals of the NIH Public Access Policy. Once the
system is operational, modifications and enhancements will be made as
needed with the Working Group, or a permanent subcommittee of the
Board, providing ongoing advice on improvements.
G. Potential Impact on Journal Peer Review
NIH recognizes the enormous value and critical role that peer-
reviewed journals play in the scientific quality control process. Only
peer-reviewed articles accepted for publication will be posted in PMC.
Some commenters asked if scientific integrity would be compromised if
journals were to go out of business, thus significantly narrowing
journal options for authors. A few commenters feared that the NIH
proposed policy would limit an author's freedom to publish how, when,
and where he or she chooses.
We do not believe that the Policy will compromise scientific
integrity or significantly narrow journal options for authors. While
NIH encourages investigators to publish and share the results of the
research that it funds, NIH does not dictate the means of publishing
the research it supports. This Policy is designed to preserve the
critical role of journals and publishers in peer review, editing, and
scientific quality control processes. It is not intended to alter in
any way the manuscript submission process, investigator choice of
journal for publication, or existing publication process.
NIH highly values traditional routes of research information
dissemination through publication in scientific, peer-reviewed
journals. Peer review is a hallmark of quality for journals and is
vital for validating the accuracy and interpretation of research
results. Publication in peer-reviewed journals is a major factor in
determining the professional standing of scientists; institutions use
publication in peer-reviewed journals in making hiring, promotion, and
tenure decisions. NIH also values the communities of research created
by scientific organizations and the journals they publish. By not
mandating but instead requesting from our investigators that access be
provided to the public within a range of acceptable delays extending
from 0 to 12 months, the NIH believes that its Public Access Policy
addresses the concerns raised by both for-profit and not-for-profit
publishers and will ensure that peer review of scientific articles is
preserved. The NIH believes that archiving and making publicly
accessible NIH-funded biomedical and behavioral literature after a
reasonable time delay can preserve the critical role of journals and
publishers in peer review, editing, and scientific quality control. The
policy should have no effect on the author's choice of journal. We
expect that greater access to research publications will increase the
impact of
[[Page 16886]]
the publicly-funded research. For example, there is emerging evidence
that easier access increases impact as measured by the number of times
a paper is cited.\10\
H. Potential Impact on Scientists
A number of comments expressed the concern that researchers would
be adversely affected by the proposed policy if publishers experienced
a decline in subscriptions and subsequently chose to increase charges
to authors. It was suggested that higher charges would disadvantage
disproportionately researchers with more limited resources. In
addition, some researchers were concerned that the proposed policy
would create an additional burden on them.
NIH-funded investigators are expected to make the results and
accomplishments of their activities available to the research community
and to the public at large. Consequently, NIH considers publication
costs, which include fees charged by a publisher, such as color and
page charges, or fees for digital distribution, to be allowable charges
to NIH research awards.
Concerning burden, public access submissions will provide NIH-
supported investigators with an alternate means by which they can meet
and fulfill the current requirement to provide a copy of each
publication in their progress reports and other application and close-
out procedures. It is anticipated that investigators applying for new
and competing renewal support from the NIH will utilize this resource
by providing links in their applications to their PMC-archived
information. NIH, therefore, anticipates that this process may reduce,
rather than increase, burden for investigators.
It is also worth noting that the development of a searchable
archive of published findings from NIH-supported research will be a
rich resource for all scientists. Access to such information not only
will make it easier to investigate a specific area of research, but
also may lead to identification of new research questions.
I. Open Access Publication and the NIH Public Access Policy
Some commenters believed that the NIH Public Access Policy
constitutes an open access model of publishing. The NIH Policy is not a
form of publishing; rather, it creates a stable archive of peer-
reviewed research publications resulting from NIH-funded research. In
addition, the Policy does not dictate the means of publishing but is
compatible with any publishing model that authors and journals choose
to employ. For example, some subscription journals already allow free
electronic access to published manuscripts directly from their Web
sites after an embargo period. In addition, one survey reports as many
as 92 percent of journals allow authors to self-archive either a
postprint (79 percent) or preprint (13 percent) of the article on
personal Web sites or on their institution's Web site. \11\ Copyright
to all material deposited in PMC remains with the publisher, individual
authors, or awardees, as applicable. PMC currently includes a copyright
notice alerting the public to the rights of copyright holders and will
continue to post this notice as it has done in the past.
J. Waiting Time to Public Access
The proposed policy published in September 2004 indicated that with
the author's permission, the NIH would make the author's final
manuscript available to the public no later than 6 months after the
date of official publication as determined by the publisher. Many
commenters considered the 6-month waiting time to be a reasonable
compromise, though some believed the waiting time should be
considerably shortened. Some recommended that the waiting time be 12
months or longer, particularly because 12 months rather than 6 months
is currently the prevailing model among journals that already provide
free, delayed, full-text access. Some commenters also noted that the
vast majority of journals currently offer no free public access at all,
thus arguing that a 6-month waiting time is too aggressive.
The NIH has tried to balance the legitimate needs of journal
publishers with its interest in creating a permanent archive of peer-
reviewed research publications resulting from NIH-funded research.
There is a wide range of time-to-access policies within the publishing
world. Some of the variables that affect time-to-access include
differences among scientific fields (e.g., clinical versus basic
research), and variability in business models determined by a range of
issues including number of article submissions, acceptance rate and
subscription base.
After considering the views of scientists, publishers, patient
advocates, librarians, research administrators, professional societies,
and others, the final Policy provides authors with the ability to
specify when their final manuscript will be made available to the
public through PMC. Posting for public accessibility through PMC is
strongly encouraged as soon as possible (and within twelve months of
the publisher's official date of final publication). This Policy
provides greater flexibility for participation. Further, it addresses
the agency's interest in establishing a permanent archive of peer-
reviewed research publications resulting from NIH-funded research in a
timely manner.
K. Politicization of Science
Some commenters suggested that a centralized, government-operated
repository could compromise the integrity of the scientific record, be
subject to government censorship, and be susceptible to the
politicization of science and the variability of funding levels and
changes in agency management.
Congress assigned to the NLM the responsibility to acquire,
organize, disseminate, and preserve biomedical information for the
benefit of public health. As part of this responsibility, the Policy
will create a stable archive of peer-reviewed research publications
resulting from NIH-funded research to ensure the permanent preservation
of these vital published research findings. Agency policy is not to
restrict or suppress the content of PMC.
L. Implementation Costs
Many commenters expressed concern that the costs associated with
archiving NIH-funded manuscripts in PMC have not been clarified, or
that costs are understated. Some publishers reported spending on the
order of hundreds of millions of dollars over the past decade to
improve online access to their journal offerings, which led to
skepticism about the validity of NIH's estimates. These commenters are
concerned that allocating funds for an expanded PMC archive would
compete with funds available to support original research. Other
commenters expressed concern that continued funding for the system may
not be available in the future.
By building on an existing information technology infrastructure
housed at the NLM, the NIH Public Access Policy can be an exceptionally
cost-effective means to accomplish its goals of archiving, facilitating
program management, and enhancing accessibility. Estimates of $2-$4
million per year reflect incremental costs to create and then maintain
a Web site for submitting authors' final manuscripts and for Extensible
Markup Language (XML) tagging of the manuscripts into PMC's archival
format. These estimates reflect PMC's experience with a back-scanning
project which has generated and tagged electronic versions of more than
200,000 printed articles in the last year. The roughly 50,000-70,000
[[Page 16887]]
manuscripts a year for the new NIH Policy will be tagged in a similar
manner and incorporated into PMC using a single, consistent digital
format. The NIH is committed to maintaining and enhancing the existing
PMC infrastructure to achieve the agency's goals.
Some questioned if additional support will be provided to
investigators to cover potential increases in publication costs. The
NIH awards direct costs to many investigators who request publication
costs in their proposed budgets. The NIH estimates that it pays over
$30 million annually in direct costs for publication and other page
charges in grants to its investigators. Generally, page charges for
publications in professional journals are allowable, if the published
paper reports work supported by the grant and the charges are levied
impartially on all papers published by the journal, whether or not they
are submitted by government-sponsored authors. As with all other costs,
NIH expects its investigators to be careful stewards of Federal funds
and to manage these resources appropriately. Grantees may rebudget
funds to support these costs, but NIH will consider all other options
to ensure that budgets are not affected unduly which should be
achievable given the voluntary nature of this request.
M. PMC's Capacity and Functionality
Comments supporting the proposed policy noted that online access
was desirable because it was centralized, cheaper than accessing a
print version, and easier to access. Some comments expressed limited
confidence in PMC's ability to keep pace with the current volume of
publications, or to handle a large influx of additional manuscripts.
Several comments requested that PMC add more functionality to address
the increased amount of content.
NLM's National Center for Biotechnology Information supports many
large production services, including GenBank, PubMed, and PMC, handling
over 3 million queries daily from more than 1.2 million unique users.
Since PMC went live in 2000, there have been no delays for any active
production PMC journal due to production lags or technical problems at
PMC. In addition to incorporating content provided by publishers, the
PMC back-scanning project has generated and tagged electronic versions
of more than 200,000 printed articles in the last year. The roughly
60,000 manuscripts a year for the new NIH Policy will be tagged in a
similar manner and incorporated into PMC using a single, consistent
digital format.
A commercial service monitors PMC's Web site performance and
reliability. Based on over 22,000 measurements in a recent two-week
period, articles were successfully returned for 98.5 percent of the
requests to PMC. This compared during the same two-week period to a 92
percent average success rate for 40 of the largest commercial Web sites
monitored by the same service. The average response time to download a
PMC article has been 2.8 seconds.
Another key advantage of PMC is that the articles returned by a PMC
search are automatically linked to a variety of research-related
resources in other NLM databases, such as DNA and protein sequences,
protein structures, clinical trials, small molecules (PubChem), and
taxonomy. These databases also provide linkage to a broad collection of
other biological and health-related information resources.
Investigators applying for new and competing renewal support from the
NIH can also utilize this resource by providing links in the
applications to their PMC-archived information.
N. Domestic and International Coordination
A number of commenters urged the NIH to coordinate with other
scientific agencies in the United States and internationally, while
others countered that providing unrestricted access to non-U.S.
individuals would represent a subsidization of scientific knowledge
outside the United States that disadvantages American scientists.
We believe that American scientists and global health will benefit
from greater access to research publications leading to increased
collaborative efforts worldwide. In an increasingly interdependent
world, the United States and nations around the globe not only share
the risk of diseases, but also the challenge to respond. This can best
be accomplished in an environment in which rapid communication is
possible, wherein scientific knowledge is readily available to all, and
where research is conducted based on partnership. This environment will
also foster continued U.S. leadership in science.
O. Timing of the Policy's Implementation
Many commenters sought to delay the Policy's implementation,
expressing strong concerns that the proposed policy had not been
adequately analyzed for short- and long-term impacts. Commenters called
for more dialogue and consideration. Others called for more formal
studies before Policy implementation.
The request for investigators to submit the authors' final
manuscripts to PMC is not a requirement. The NIH instead is providing
guidance to conform to a long-standing NIH policy that the results and
accomplishments of NIH-funded research activities should be made
available to the public. The Policy encourages voluntary cooperation of
investigators, and it does not penalize investigators who choose not to
use PMC to submit pre-print hard copy versions of their manuscripts as
part of their progress reporting requirements.
Timely implementation of the Policy will allow NIH to manage more
efficiently and to understand better its research portfolio, monitor
scientific productivity, and ultimately, help set research priorities.
Also, because many commenters highlighted the public's desire for
enhanced access to scientific publications in a timely manner, NIH is
confident that this Policy will not only advance science but will
benefit the scientific community, the public, and the NIH.
This Policy is subject to periodic review based upon lessons
learned in the course of its implementation. Issuance of this Policy is
the beginning of a process that will include refinement as experience
develops, outcomes are evaluated, and public dialogue among all the
stakeholders is continued.
A NIH Public Access Advisory Working Group of the NLM Board of
Regents \12\ will be established. The Working Group will be composed of
stakeholders that will advise NIH/NLM on implementation and assess
progress in meeting the goals of the NIH Public Access Policy. Once the
system is operational, modifications and enhancements will be made as
needed with the Working Group, or a permanent subcommittee of the
Board, providing ongoing advice on improvements.
P. Legal Issues
NIH received several comments and objections of a legal nature.
1. Request vs. Required: Some commenters argued that the proposal
is mandatory, even though the proposal requests, rather than requires,
submission of final manuscripts to NIH. As evidence, they note that NIH
plans to monitor submissions as part of the grants close-out process
and that the proposal states that the submission will fulfill the
current requirement to submit one copy of each publication in the
annual or final progress reports. One commenter also asserted that
reading the proposal as a requirement would be consistent with House
Appropriations
[[Page 16888]]
Committee Report language in H.R. Rep. No. 108-636.
The final Policy reiterates that submission of the electronic final
manuscript is voluntary and that it can serve as an alternate means for
meeting current progress reporting requirements as well as application
and close-out submissions in the future. The monitoring referred to in
the proposed policy referred to determining whether the final
manuscripts had already been submitted electronically. We have removed
that language from the final Policy to avoid any confusion. The House
Appropriations Report did propose requiring submission; however, the
NIH Policy requesting, rather than requiring, submission is consistent
with the final report language found on page 1177 of the Joint
Explanatory Statement in H.R. Rep. No. 108-792.\13\
2. Copyright: NIH received comments that the proposal infringes on
copyright interests of Federal grantees. These commenters argued that
copyright interests are well-established under Federal law, that NIH
has no authority to alter them, and that the proposal is not consistent
with controlling Department of Health and Human Services (HHS)
regulations. They believe the proposal fails to recognize the need for
copyright permission from authors and/or publishers. They argue that
neither the principle of fair use, nor the Federal purpose license, can
be used by NIH to implement the proposal. Finally, they argue that the
PMC open access submission agreement constitutes a forced license and
undermines copyright.
The Policy explicitly recognizes and upholds the principles of
copyright. First, submission of final manuscripts is voluntary rather
than mandatory; the voluntary submission to NIH by authors and
institutions under the Policy constitutes permission to post the
manuscripts on PMC and release to the public after the submitter's
specified post-publication delay time. The fair use exemption to
copyright infringement does not apply to the government's request for
the manuscripts. It applies to the public use of the manuscripts as
posted on PMC and provides a limitation on such use consistent with the
terms of that exemption.
NIH does not need to seek permission from journals who may acquire
copyrights from authors or institutions because any copyright transfer
or assignment is currently subject to the government purpose license
pursuant to 45 CFR 74.36. Although the NIH is relying on permission,
rather than the government purpose license, as the basis for its
Policy, the government purpose license is fully available as a legal
authority under which manuscripts could be reproduced, published, or
otherwise used for Federal purposes. The comment that the proposal is
not consistent with controlling HHS regulations granting copyright is
not persuasive, since those same regulations grant the agency its
government purpose license.
Finally, authors can indicate what copyright restrictions, if any,
apply to their manuscripts when submitting them to PMC and can choose
an appropriate PMC submission agreement that recognizes those rights.
3. Government Purpose Copyright License: NIH received a comment
that the government purpose license of 45 CFR 74.36 cannot be used by
the government as a basis to post final manuscripts on PMC.
Although the NIH, at this time, is not relying on the government
purpose license, it is an available means for NIH to reproduce, publish
or otherwise use copyrighted works resulting from NIH funding for
Federal purposes, as well as to authorize others to do so. Arguments
put forth and cases cited by the commenter as support for the premise
that the government purpose license could not be used as a basis for
PMC to post the manuscripts are not persuasive. None of the cases
address circumstances where a government agency is acting to fulfill
its own statutory purposes with regard to publications resulting from
its own research funding. Creation of a publicly accessible, permanent
archive of NIH-funded research publications is squarely within the
statutory authorities of the NIH and the NLM and clearly constitutes a
Federal purpose.\14\
4. Other Intellectual Property Concerns: One commenter suggested
that the proposed policy undermines other aspects of intellectual
property because problems would result if the principle that ``the
taxpayers have already paid for the research'' were also applied to
patents, pharmaceuticals, and other products of government-funded
research.
The NIH Public Access Policy is not based on the principle of
delivering a product to the taxpayer in return for research support.
The Policy calls for the voluntary submission of final author
manuscripts; it does not affect the ability to copyright. Funding
recipients may continue to assert copyright in works arising from NIH-
funded research, and they may assign these rights to journals as is the
current practice. Copyright holders may enforce these copyrights as
before. A member of the public viewing or downloading a copyrighted
document from PMC is subject to the same rights and restrictions as
when copying an article from the library. For example, making a copy of
an article for personal use is generally considered to be a ``fair
use'' under copyright law. For uses that fall outside of the fair use
principle, permission to reproduce copyrighted materials must be
obtained directly from the copyright holders. PMC currently includes a
copyright notice alerting the public to the rights of copyright holders
and will continue to post this notice as it has done in the past.
5. Bayh-Dole Act: NIH received a comment that the proposal
undercuts the Bayh-Dole Act by interfering with technology transfer,
because scientific publications are an important component of
technology transfer, and the proposal weakens that component. This
commenter also suggested the proposal undermines the Bayh-Dole
principle that the private sector is the preferable vehicle to move
research to the marketplace.
The NIH Public Access Policy serves to establish a permanent
archive of NIH-funded research publications. It is not expected to
supersede any private sector publication activity or create competition
with publishers. Manuscripts that are submitted by authors will be
available to the public through PMC after the time specified by the
author post-publication. As such, we do not believe that the Policy
will interfere with publications as a technology transfer vehicle, or
that it will supersede the private sector as a vehicle to move research
to the marketplace.
6. Patent Application Filing Concerns: NIH received comments that
because final manuscripts as submitted to NIH will be subject to
Freedom of Information Act (FOIA) disclosure, they will likely be
considered printed publications for purposes of the timing of filing
patent applications. Commenters suggested this would be a change from
current practice, which relies on the date of journal publication.
The NIH Policy requests authors to submit final manuscripts after
the peer review process has been completed. Although each research
institution must determine the timing of the filing of any patent
applications arising from their NIH-funded work, NIH does not believe
that submission to PMC under the Public Access Policy will constitute a
printed publication, nor otherwise interfere with the timing of filing
of patent applications. The manuscripts will not have the indicia of
``public accessibility'' that are generally relied upon as criteria by
which prior art references have been judged. Until the
[[Page 16889]]
interested public has access to the document, it would not be
considered to be available as a printed publication within the meaning
of 35 U.S.C. 102(a) or (b). The primary journal publication constitutes
the date of publication for patent filing purposes, as it has
traditionally served.
Courts have found it helpful to rely on distribution and indexing
as proxies for public accessibility, and one commenter argued that the
final manuscripts will be indexed by PMC prior to journal publication.
However, even if indexed in preparation for posting, the publication
itself will not be available to the public. Once final manuscripts are
posted in the archive, indexing and search capabilities will assist
user access.
Other aspects of the process of scientific publication do not
establish statutory bars to patentability. For example, processes such
as oral presentations at scientific meetings and submission of
manuscripts and information to peer reviewers or to a journal for
review have not been considered to establish a publication date for
patent purposes, because these activities have not been considered to
result in public availability. Similarly, there is no reason to believe
submission to NIH with the expectation of confidentiality until after
publication will be treated differently by the U.S. Patent and
Trademark Office.
7. Freedom of Information Act (FOIA): Some commenters expressed
concern that the final manuscripts would be subject to disclosure to
the public under FOIA prior to journal publication.
NIH believes the manuscript information is protected from release
under FOIA by Exemption 4.\15\ In accordance with HHS FOIA regulations,
if NIH receives a FOIA request for such a document, it will notify the
submitter of the manuscript of the FOIA request in order to provide an
opportunity for the manuscript submitter to object to any potential
disclosure of the record. If the final publication is requested after
the journal publication date but prior to the posting date on PMC, NIH
believes that these publications are not agency records subject to
FOIA. See 45 CFR 5.5, stating that definition of record for purposes of
the HHS FOIA regulation does not include ``books, magazines, pamphlets,
or other reference material in formally organized and officially
designated HHS libraries where such materials are available under the
rules of the particular library.''
8. Administrative Procedures Act (APA) Rule-Making: Some have
commented that the proposed policy constitutes a rule-making under the
Administrative Procedures Act (APA) and that NIH lacks legislative
authority to adopt this policy because it is without rule-making power.
They also argue that the notice and comment opportunity for the
proposal was insufficient to meet rule-making requirements.
NIH agrees that authority to adopt new regulations is retained by
the Secretary, Health and Human Services, and has not been delegated to
NIH. However, the proposed policy is not a rule-making for which APA
notice and comment, and other procedural requirements for final agency
actions, attach. The APA defines a rule as the whole or a part of an
agency statement of general or particular applicability and future
effect designed to implement, interpret, or prescribe law or policy
describing the organization, procedure, or practice requirements of an
agency. 5 U.S.C. 551. Exempt from the formal rule-making requirements
of the law are matters relating to agency management* * * and matters
concerning interpretative rules, general statements of policy, or rules
of agency organization, procedure, or practice. 5 U.S.C. 553.
The Policy does not require investigators to do anything other than
what the current rules require. While funding recipients may follow the
Policy to fulfill some of their existing reporting requirements they
need not do so and may continue to provide hard copies of publications.
The Policy will allow the agency to manage better its research award
process and will also enable it to advance further its public health
mission to support high-quality biomedical, behavioral, and clinical
research and improve public health. In order to help it develop the
Policy, the agency provided public notice and sought public comment on
a draft policy. This notice and comment procedure were not undertaken
to comply with the APA rule-making requirements; the agency does not
believe that they apply because the Policy is not a rule.
9. Regulatory Flexibility Act: Some commenters asserted that the
NIH must comply with the Regulatory Flexibility Act before it
implements the proposed policy. The Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., was enacted to ensure that when adopting
regulations, Federal agencies seek to achieve statutory goals as
effectively and efficiently as possible without imposing unnecessary
burdens on the public. In particular, in accordance with the RFA,
Federal agency regulations should not disproportionately affect small
entities. Under the RFA, Federal agencies must determine the impact of
their regulations on small entities and consider alternatives to
alleviate burdens while achieving the agency's policy goals. By
definition, the RFA applies when a Federal agency publishes a general
notice of proposed rule-making under 5 U.S.C. 553(b); in other words,
it is triggered when an agency engages in rule-making under the APA. As
noted above, this Policy is not a rule-making. Accordingly, the RFA
does not apply.
10. Paperwork Reduction Act: Some commenters suggested that NIH
must comply with the Paperwork Reduction Act (PRA) and cannot penalize
investigators until Office of Management and Budget (OMB) clearance
under the law is completed.
The PRA requires OMB review before an agency undertakes a
collection of information, regardless of whether the collection is
mandatory or voluntary. Under the regulations implementing the law, a
collection of information includes obtaining...information by or for an
agency by means of * * * identical reporting * * * or disclosure
requirements imposed on ten or more people or entities in any given
year. 5 CFR 1320.3. While the request to provide copies of manuscripts
or publications may not fall within this definition, even if the
definition is met, we need not obtain any new OMB clearance because the
Policy falls within the existing, approved information collection
activities concerning applications, progress and final reporting, (OMB
NO. 0925-0001, Expires 9/2007 and 0925-0002, Expires 6/2005).
Furthermore, while some commenters focused their PRA criticism on the
fact that the agency would be unable to penalize investigators if PRA
review is not conducted, we note that the Policy serves as an
alternative to compliance with existing reporting activities and,
therefore, a discussion of any new penalties is misplaced.
The PRA also requires that agencies ensure the public has timely
and equitable access to agency public information. The final
manuscripts will be submitted under confidentiality agreements and will
be posted on PMC only with the permission of submitting authors.
Therefore, NIH does not believe that the final manuscripts submitted by
authors constitute agency public information within the meaning of the
PRA until the terms of the confidentiality agreement are met and an
author permits posting on PMC. At that time, NIH expects to ensure
timely and equitable access. As discussed above, submission is not
expected to constitute a publication for purposes of
[[Page 16890]]
filing patent applications, nor are the documents expected to be
available to the public under FOIA. Thus, the absence of public
availability prior to author permission does not constitute an
improperly restrictive agency arrangement.
11. OMB Circular A-76: Some commenters argued that the agency must
undertake a cost-comparison under OMB Circular A-76 to determine that
the cost of the plan is less expensive than the cost of the present
system of scientific publishing before implementing the Policy.
This criticism is based on the assumption, in the words of one
commenter, that NIH wants PMC to become an in-house electronic
publisher of these final manuscripts. This conclusion misstates the
Policy and NIH's goals. The NIH Policy is to maintain copies of final
manuscripts in a permanent, public archive so that the published
results of NIH-funded research are permanently and readily accessible
to NIH and others. This archive will be contained in the NIH's
existing, electronic archive for scientific publications, PMC. The PMC
archive has provided this service for the agency and others when
articles are voluntarily provided to it. Electronic copies of
publications are available through PMC in the same way that hard copies
of publications are available from the NIH's National Library of
Medicine.
The NIH Policy does not create any new obligations under OMB
Circular A-76. Insofar as the activities of PMC are subject to the
requirements of the Circular and related laws, those activities will
continue to be reviewed and all applicable requirements will be met.
The NIH Public Access Policy is to establish a permanent archive of
NIH-funded research publications. It is not expected to supersede any
private sector publication activity or create competition with
publishers.
12. Constitutional concerns/Executive Order (E.O.) 12630: One
commenter suggested that the proposal implicates Executive Order 12630,
which requires government officials to review actions that may have
takings implications and to be sensitive to, anticipate, and account
for, the obligations imposed by the Just Compensation Clause of the
Fifth Amendment in planning out and carrying out governmental actions
.* * *
The purpose of E.O. 12630 is to ensure that government officials do
not unintentionally exercise the government's power of eminent domain,
resulting in an unanticipated or undue drain on the government
treasury. NIH believes that its Policy is consistent with E.O. 12630
and that no additional review is required. The private property at
issue is the funding recipient's ability to assert copyright pursuant
to 45 CFR 74.36. The NIH Policy does not interfere with that right, as
authors and institutions will be voluntarily submitting copies of final
manuscripts to NIH, and copyright may be asserted and enforced as it
has been traditionally. Further, the same regulation that allows the
funding recipient to assert copyright grants the government
corresponding rights to reproduce, publish, or otherwise use the work
for Federal purposes and to authorize others to do so. A voluntary
request for the same use already allowed to the government by
regulation is consistent with E.O. 12630 and does not trigger
additional review.
13. Information Quality Act: One commenter asked whether the
Federal Information Quality Act (IQA), 44 U.S.C. 3516 note, applies to
documents contained in the electronic archive of publications created
through the NIH Public Access Policy.
The NIH Public Access Policy calls for the centralized storage of
NIH-funded scientific publications in PMC, an electronic archive of
scientific publications operated by the National Library of Medicine.
The NIH will include in its electronic archive a statement explaining
that the views contained in the archived publications and manuscripts
are those of the authors, and do not necessarily reflect the views of
the government. Thus, publication in PMC does not make an article/
scientific manuscript subject to the NIH Information Quality
Guidelines.
III. Text of Final Policy Statement
The NIH Public Access Policy (the Policy) on enhancing public
access to archived publications resulting from NIH-funded research
follows:
Beginning May 2, 2005, NIH-funded investigators are requested to
submit an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported, in whole
or in part, with direct costs from NIH. The author's final manuscript
is defined as the final version accepted for journal publication, and
includes all modifications from the publishing peer review process.
This Policy applies to all research grant and career development
award mechanisms, cooperative agreements, contracts, Institutional and
Individual Ruth L. Kirschstein National Research Service Awards, as
well as NIH intramural research studies. The Policy applies to peer-
reviewed research publications, resulting from research supported in
whole or in part with direct costs from NIH, but it does not apply to
book chapters, editorials, reviews, or conference proceedings.
Under this Policy, electronic submission will be made directly to
the NIH National Library of Medicine's (NLM) PubMed Central (PMC):
http://www.pubmedcentral.nih.gov. PMC is the NIH digital repository of
full-text, peer-reviewed biomedical, behavioral, and clinical research
journals. It is a publicly-accessible, stable, permanent, and
searchable electronic archive.
At the time of submission, the author will specify the timing of
the posting of his or her final manuscript for public accessibility
through PMC. Posting for public accessibility through PMC is requested
and strongly encouraged as soon as possible (and within twelve months
of the publisher's official date of final publication).
The publisher may choose to furnish PMC with the publisher's final
version, which will supersede the author's final version. Also, if the
publisher agrees, public access to the publisher's final version in PMC
can occur sooner than the timing originally specified by the author for
the author's final version.
Effective with progress reports submitted for Fiscal Year 2006
funding, this Policy provides an alternative means, via PMC, for NIH-
supported investigators to fulfill the existing requirement to provide
publications as part of progress reports. Though the NIH anticipates
that investigators will use this opportunity to submit their
manuscripts, sending electronic copies is voluntary and will not be a
factor in the review of scientific progress.
By creating an archive of peer-reviewed, NIH-funded research
publications, NIH is helping health care providers, educators, and
scientists to more readily exchange research results and the public to
have greater access to health-related research publications. As the
archive grows, the public will be more readily able to access an
increasing number of these publications.
Once the system is operational, modifications and enhancements will
be made as needed. An NIH Public Access Advisory Working Group will be
established to advise NIH/NLM on implementation and assess progress in
meeting the goals of the NIH Public Access Policy.
This Policy is intended to improve the internal management of the
Federal government, and is not intended to create any right or benefit,
substantive or procedural, enforceable at law by a party against the
United States, its agencies, its officers, or any person.
[[Page 16891]]
Additional details for the public and for submitting authors
pertaining to the implementation of this Policy are available at:
http://www.nih.gov/about/publicaccess/index.htm.
Footnotes
\1\ Costs that can be specifically identified with a particular
project or activity. NIH Grants Policy Statement, Rev. 12/2003;
http://grants.nih.gov/grants/policy/nihgpslowbar;2003/NIHGPS--
Part2.htm#--Toc54600040.
\2\ NIH Grants Policy Statement, Rev. 12/2003; http://
grants.nih.gov/grants/policy/nihgps--2003/NIHGPS--Part7.htm.
\3\ These figures are derived from searching the PubMed database
for citations with 2003 publication dates that include a reference
to a specific NIH grant number. The data provide useful estimates of
articles funded by NIH, although individual journal counts may vary
slightly if calculations are performed using other sources or search
strategies.
\4\ PubMed includes links to full-text articles in PMC and to
several thousand journal websites. PMC is an electronic archive for
full-text journal articles, offering unrestricted access to its
contents. Every full-text article in PMC has a corresponding entry
in PubMed.
\5\ Internet Health Resources, Pew Internet and American Life
Project, Washington, DC 2003: http://www.pewinternet.org/pdfs/PIP--
Healthlowbar;Report--July--2003.pdf.
\6\ Cybercitizen Health 3.0 Survey, Table 10 (Manhattan
Research, New York, 2003).
\7\ These data are derived from searching the PubMed database
for citations with 2003 publication dates that acknowledge funding
from either NIH specifically or from an agency of the Public Health
Service (PHS). Because some journal citations do not include a
reference to the specific NIH grant number, a broader search was
done for citations where the Public Health Service (PHS) is
identified as the sponsor of the research. These data provide useful
estimates of articles funded by NIH/PHS, although individual journal
counts may vary slightly if calculations are based on other sources.
\8\ The estimated $30 million is a conservative figure based on
amounts spent on page charges and other publication costs on a
sample of R01 grant application budgets, scaled up to provide an
estimate of direct costs paid on all research grants.
\9\ Established pursuant to 42 U.S.C. 286a, section 466 of the
Public Health Service Act, as amended. The Board is governed by the
provisions of the Federal Advisory Committee Act, as amended (5
U.S.C. Appendix 2).
\10\ http://opcit.eprints.org/oacitation-biblio.html.
\11\ http://romeo.eprints.org/stats.php.
\12\ Established pursuant to 42 U.S.C. 286a, section 466 of the
Public Health Service Act, as amended. The Board is governed by the
provisions of the Federal Advisory Committee Act, as amended (5
U.S.C. Appendix 2).
\13\ http://thomas.loc.gov/home/omni2005/index.htm.
\14\ See, e.g., 42 U.S.C. 241(a)(1); 42 U.S.C. 286.
\15\ HHS FOIA Regulations, 45 CFR 5.65(b); available at: http://
www.hhs.gov/foia/45cfr5.html#Subf.
Notice Number: NOT-OD-08-033--(See Notice NOT-OD-08-057).
Key Dates
Release Date: January 11, 2008.
Effective Date: April 7, 2008.
Issued By
National Institutes of Health (NIH), (http://www.nih.gov/) .
Department of Health and Human Services Action
Notice; Revised Policy Statement.
Summary
In accordance with Division G, Title II, section 218 of Public Law
110-161 (Consolidated Appropriations Act, 2008 ), the NIH voluntary
Public Access Policy (NOT-OD-05-022) is now mandatory. The law states:
The Director of the National Institutes of Health shall require
that all investigators funded by the NIH submit or have submitted
for them to the National Library of Medicine's PubMed Central an
electronic version of their final, peer-reviewed manuscripts upon
acceptance for publication, to be made publicly available no later
than 12 months after the official date of publication: Provided,
That the NIH shall implement the public access policy in a manner
consistent with copyright law.
Specifics
1. The NIH Public Access Policy applies to all peer-reviewed
articles that arise, in whole or in part, from direct costs 1 funded by
NIH, or from NIH staff, that are accepted for publication on or after
April 7, 2008.
2. Institutions and investigators are responsible for ensuring that
any publishing or copyright agreements concerning submitted articles
fully comply with this Policy.
3. PubMed Central (PMC) is the NIH digital archive of full-text,
peer-reviewed journal articles. Its content is publicly accessible and
integrated with other databases (see: http://www.pubmedcentral.nih.gov/
).
4. The final, peer-reviewed manuscript includes all graphics and
supplemental materials that are associated with the article.
5. Beginning May 25, 2008, anyone submitting an application,
proposal or progress report to the NIH must include the PMC or NIH
Manuscript Submission reference number when citing applicable articles
that arise from their NIH funded research. This policy includes
applications submitted to the NIH for the May 25, 2008 due date and
subsequent due dates.
Compliance
Compliance with this Policy is a statutory requirement and a term
and condition of the grant award and cooperative agreement, in
accordance with the NIH Grants Policy Statement For contracts, NIH
includes this requirement in all R&D solicitations and awards under
Section H, Special Contract Requirements, in accordance with the
Uniform Contract Format.
Inquiries
Send questions concerning this Notice or other aspects of the NIH
Public Access Policy to: Office of Extramural Research, National
Institutes of Health, 1 Center Drive, Room 144, Bethesda, MD 20892-
0152, E-mail: PublicAccess@nih.gov, Web site: http://
publicaccess.nih.gov.
\1\ Costs that can be specifically identified with a particular
project or activity. NIH Grants Policy Statement, Rev. 12/2003;
http://grants.nih.gov/grants/policy/nihgps--2003/NIHGPS--
Part2.htm#--Toc54600040.
Public Access Frequently Asked Questions
Posted: January 11, 2008
General Information
A. General Information
1. What is the NIH Public Access Policy?
2. What is PubMed Central?
3. Where can I get information about a medical or health related
topic?
For Investigators, Awardees, and NIH Staff
B. Scope of the Policy
1. Does the NIH Public Access Policy apply to me?
2. To what types of articles does the NIH Public Access Policy
apply?
3. My article is based on research only partially funded by NIH. Is
the article required to be submitted?
4. My article is based on research funded by a grant or cooperative
agreement that expired before Fiscal Year 2008. Is the article required
to be submitted?
5. My article is based on research funded by a contract awarded
before April 7, 2008. Is the article required to be submitted?
6. Can I submit articles accepted for publication prior to April 7,
2008?
7. Am I responsible for articles that arise from my NIH funded
project for which I am not an author?
8. Is the NIH Public Access Policy a condition of award?
9. Will compliance with the NIH Public Access Policy affect the
outcome of the application review?
[[Page 16892]]
C. How to Comply With the Policy
1. What do I have to do to comply with the NIH Public Access
Policy?
2. Whose approval do I need to submit my article to PubMed Central?
3. Can NIH provide language that could be used in a copyright
agreement between an author or institution and a publisher?
4. A publisher says that an NIH-funded article cannot be deposited
under the NIH Public Access Policy. What should I do?
5. What is the difference between a final peer-reviewed manuscript
and final published article?
6. How do I include the PubMed Central reference number in my
citations?
D. What Needs to Be Submitted
1. The journal that published my work routinely deposits its
articles in PubMed Central. Do I have to submit my article myself?
2. I plan to publish in an open access journal. Do I have to submit
my article?
3. My article is already listed in PubMed. Do I have to submit my
article?
4. My article is available on the publisher's web site. Do I have
to submit my article?
E. How to Submit Articles to NIH/PubMed Central
1. How do I submit an article to NIH/PubMed Central?
2. What is the relationship between PubMed Central and the NIH
Manuscript Submission system?
3. Will NIH pay for publication costs?
4. My article has multiple authors and/or is funded from multiple
NIH sources. Who should submit the article?
Policy Background
F. Policy Background
1. Can authors and publishers continue to assert copyright in
scientific publications resulting from NIH funding?
2. What is the difference between the NIH Public Access Policy and
Open Access?
3. How does the NIH Public Access Policy differ from the 2003 NIH
Data Sharing Policy?
4. How many publications arise from NIH funds each year?
A. General Information
1. What is the NIH Public Access Policy?
The Policy implements Division G, Title II, section 218 of Public
Law 110-161 (Consolidated Appropriations Act, 2008) which states:
SEC. 218. The Director of the National Institutes of Health shall
require that all investigators funded by the NIH submit or have
submitted for them to the National Library of Medicine's PubMed
Central an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of
publication: Provided, That the NIH shall implement the public
access policy in a manner consistent with copyright law.
The Public Access Policy ensures that the public has access to the
published results of NIH funded research. It requires scientists to
submit journal articles that arise from NIH funds to the digital
archive PubMed Central (http://www.pubmedcentral.nih.gov/). The Policy
requires that these articles be accessible to the public on PubMed
Central to help advance science and improve human health.
2. What is PubMed Central?
PubMed Central is an archive of full-text biomedical journal
articles available online without a fee. Articles on PubMed Central
contain links to other scientific databases such as GenBank (http://
www.ncbi.nlm.nih.gov/ Genbank/) and PubChem (http://
pubchem.ncbi.nlm.nih.gov/). Articles collected under the Public Access
Policy are archived on PubMed Central. More information about PubMed
Central is available at http://www.pubmedcentral.nih.gov/about/
faq.html.
3. Where can I get information about a medical or health related topic?
NIH provides information on health topics at http://
health.nih.gov/.
B. Scope of the Policy
1. Does the NIH Public Access Policy apply to me?
The Policy applies to you if your peer-reviewed article is based on
work in one or more of the following categories:
1. Directly \1\ funded by an NIH grant or cooperative agreement
active in Fiscal Year 2008 (October 1, 2007-September 30, 2008) or
beyond;
2. Directly \1\ funded by a contract signed on or after April 7,
2008;
3. Directly funded by the NIH Intramural Program.
4. If NIH pays your salary.
2. To what types of articles does the NIH Public Access Policy apply?
The Policy applies to all peer-reviewed journal articles, including
research reports and reviews. The Policy does not apply to non-peer-
reviewed materials such as correspondence, book chapters, and
editorials.
3. My article is based on research only partially funded by NIH. Is the
article required to be submitted?
Yes. The NIH Public Access Policy applies to all peer-reviewed
journal articles that arise from the NIH intramural program or any
amount of direct costs1 funded by NIH, regardless of the source or
amount of other funding.
4. My article is based on research funded by a grant or cooperative
agreement that expired before Fiscal Year 2008. Is the article required
to be submitted?
No, submission is not required. But you may submit your article if
you want to and have appropriate copyright permission.
5. My article is based on research funded by a contract awarded before
April 7, 2008. Is the article required to be submitted?
No, submission is not required. But you may submit your article if
you want to and have appropriate copyright permission.
6. Can I submit articles accepted for publication prior to April 7,
2008?
Yes. You may submit your article if you want to and have
appropriate copyright permission.
7. Am I responsible for articles that arise from my NIH funded project
for which I am not an author?
Principal Investigators and their Institutions are responsible for
ensuring all terms and conditions of awards are met. This includes the
submission of articles that arise directly from their awards, even if
they are not an author or co-author of the publication. Principal
Investigators and their Institutions should ensure that the authors are
aware of and comply with the NIH Public Access Policy.
8. Is the NIH Public Access Policy a condition of award?
The NIH Public Access Policy is a Term and Condition of Award for
all grants and cooperative agreements active in Fiscal Year 2008
(October 1, 2007-September 30, 2008) or beyond, and for all contracts
awarded after April 7, 2008.
9. Will compliance with the NIH Public Access Policy affect the outcome
of the application review?
Compliance with the Public Access Policy is not a factor in the
evaluation of grant applications. Non-compliance will be addressed
administratively, and may delay or prevent awarding of funds.
[[Page 16893]]
C. How to Comply With the Policy
1. What do I have to do to comply with the NIH Public Access Policy?
Compliance is a three-step process.
(1) Address Copyright. Before you sign a publication agreement or
similar copyright transfer agreement, make sure that the agreement
allows the article to be submitted to NIH in accordance with the Public
Access Policy. See FAQ on approval for submitting articles.
(2) Submit the article to NIH. This can be done in a number of
ways:
a. You or someone in your organization (e.g., an assistant or your
library) may deposit a copy of the peer reviewed manuscript in the NIH
Manuscript Submission (NIHMS) system (http://www.nihms.nih.gov/).
b. Your publisher may send the peer-reviewed manuscript files to
the NIH Manuscript Submission system for you.
In both cases above (a and b), you still will have to verify and
approve the manuscript personally via the NIH Manuscript Submission
system, which will send you an email message requesting this action.
See FAQ on using NIHMS.
c. Some publishers have agreed to make the final published article
of every NIH-funded article publicly available in PubMed Central within
12 months of publication (see FAQ on journals that deposit articles).
For these journals, you do not need to do anything to fulfill the
submission requirement of the NIH Public Access Policy. See http://
publicaccess.nih.gov/submit--process--journals.htm for a list of these
journals.
3) Cite. As of May 25, 2008, when citing an article in NIH
applications, proposals, and progress reports that falls under the
Policy, and was authored or co-authored by you or arose from your NIH
award, you must include the PubMed Central reference number (PMCID).
This policy includes applications submitted to the NIH for the May 25,
2008 due date and subsequent due dates.
Intramural researchers must ensure a PubMed Central reference
number is included in the Institute's Annual Report for any publication
they have authored or co-authored. See FAQ on how to cite articles.
2. Whose approval do I need to submit my article to PubMed Central?
Authors own the original copyrights to materials they write.
Consistent with individual arrangements with authors' employing
institutions, authors often transfer some or all of these rights to the
publisher when the journal agrees to publish their article. Some
publishers may ask authors to transfer copyrights for a manuscript when
it is first submitted to a journal for review.
Authors should work with the publisher before any rights are
transferred to ensure that all conditions of the NIH Public Access
Policy can be met. Authors should avoid signing any agreements with
publishers that do not allow the author to comply with the NIH Public
Access Policy.
Federal employees always may submit their final peer-reviewed
manuscript to PubMed Central, because government works are not subject
to copyright protection in the United States.
3. Can NIH provide language that could be used in a copyright agreement
between an author or institution and a publisher?
NIH can provide an example. Individual copyright arrangements can
take many forms, and authors and their institutions should continue to
manage such arrangements as they have in the past. However, in order to
comply with the NIH Public Access Policy, you must make sure that the
agreement allows the accepted peer-reviewed manuscript to be deposited
with the NIH upon acceptance of publication and made available for
public posting on PubMed Central no later than 12 months after journal
publication.
Institutions and investigators may wish to develop particular
copyright agreement terms in consultation with their own legal counsel
or other applicable official at their institution, as appropriate. As
an example, the kind of language that an author or institution might
add to a copyright agreement includes the following:
``Journal acknowledges that Author retains the right to provide
a copy of the final manuscript to the NIH upon acceptance for
Journal publication, for public archiving in PubMed Central as soon
as possible but no later than 12 months after publication by
Journal.''
Your institution or professional society may have developed
specific model language for this purpose, as well.
4. A publisher says that an NIH-funded article cannot be deposited
under the NIH Public Access Policy. What should I do?
Publishers may ask authors to transfer copyrights for a manuscript
when it is first submitted to a journal for review, and/or at the time
it is accepted for publication. Authors should work with the publisher
before any rights are transferred, to ensure that all conditions of the
NIH Public Access Policy can be met. You should check with your
institutional official, who may wish to consult with your institution's
legal counsel, to determine how the copyright transfer agreement that
the publisher proposes you sign impacts your ability to comply with the
Policy.
5. What is the difference between a final peer-reviewed manuscript and
final published article?
Final peer-reviewed manuscript: The Investigator's final manuscript
of a peer-reviewed article accepted for journal publication, including
all modifications from the peer review process.
Final published article: The journal's authoritative copy of the
article, including all modifications from the publishing peer review
process, copyediting and stylistic edits, and formatting changes.
6. How do I include the PubMed Central reference number in my
citations?
List the PubMed Central reference number (PMCID) at the end of the
already-required full journal citation for the article. If a PubMed
Central reference number is not yet available, include the NIH
Manuscript Submission system reference number (NIHMS ID) instead.
Examples:
Varmus H, Klausner R, Zerhouni E, Acharya T, Daar A, Singer P.
2003. PUBLIC HEALTH: Grand Challenges in Global Health. Science
302(5644): 398-399. PMCID: 243493
Zerhouni, EA. (2003) A New Vision for the National Institutes of
Health. Journal of Biomedicine and Biotechnology (3), 159-160.
PMCID: 400215
D. What Needs To Be Submitted?
1. The journal that published my work routinely deposits its articles
in PubMed Central. Do I have to submit my article myself?
It depends on which version of the article the journal is
depositing--the final published article or the final peer reviewed
manuscript--and on the terms of any agreement that the journal may have
with NIH. There are three possible cases, described below. In the first
case you do not have to take any action. In the other two, you do have
to take certain actions.
(a) Journal deposits final published article and makes it available
within 12 months: If your journal deposits the final published article
in PubMed Central and allows NIH to make it available to the public
within 12 months of publication, you do not have to do anything to
fulfill the submission requirement of the NIH Public Access Policy.
[[Page 16894]]
(b) Journal deposits final published article but does not make it
available within 12 months: If the journal deposits the final published
article in PubMed Central, but delays its release to the public for
more than 12 months after publication, you will have to deposit a copy
of your manuscript yourself.
(c) Journal deposits final peer-reviewed manuscript: If the journal
is only depositing a copy of your final peer-reviewed manuscript files
via the NIH Manuscript Submission system, you will still have to sign
on to the NIH Manuscript Submission system (http://www.nihms.nih.gov/)
to review and approve release of the article to PubMed Central. Also
see FAQ on submit an article to NIH/ PubMed Central.
Check http://publicaccess.nih.gov/submit_process_journals.htm for
a list of the journals that deposit the final published article in PMC
with an embargo of 12 months or less, relieving you of the need to do
anything further.
2. I plan to publish in an open access journal. Do I have to submit my
article?
Yes, unless the journal has an agreement to deposit its articles in
PubMed Central. Not all open-access journals have agreements with
PubMed Central. Check (http://publicaccess.nih.gov/submit--process--
journals.htm) to see which journals do.
3. My article is already listed in PubMed. Do I have to submit my
article?
Yes, you must submit the article to PubMed Central. PubMed includes
only citations and abstracts of articles, while PubMed Central carries
the entire article.
4. My article is available on the publisher's Web site. Do I have to
submit my article?
Yes, you must submit the article to PubMed Central. Articles
available through publishers' Web sites do not fulfill the authors'
obligations under the NIH Public Access Policy.
E. How To Submit Articles to PubMed Central
1. How do I submit an article to NIH/PubMed Central?
You must use the NIH Manuscript Submission (NIHMS) system to submit
an article.
You deposit the manuscript files (e.g., Microsoft Word document and
figures) in the NIHMS.
You indicate the NIH award(s) to which the article is related.
After the NIHMS converts your deposited files to a standard PubMed
Central (PMC) format, NIHMS will email you to review the PMC formatted
article to approve its release.
Some journals will deposit the manuscript files for you. In that
case, you still have to provide the associated award information, and
review and approve the article. The NIHMS will notify you via e-mail
when these actions are needed and include a link to the NIHMS web site.
For more information about the NIHMS, go to http://
www.nihms.nih.gov/. There is an online tutorial at http://
www.nihms.nih.gov/web-help/index.html.
2. What is the relationship between PubMed Central and the NIH
Manuscript Submission system?
PubMed Central (PMC) is NIH's digital journal archive, which gives
the public access to its articles at no cost.
The NIH Manuscript Submission system (NIHMS) takes in manuscripts
covered by the NIH Public Access Policy and formats them for inclusion
into PMC. You deposit the files for a manuscript (e.g., Microsoft Word
document and figures) into the NIHMS. The files are converted to a
standard PMC format, and then reviewed by you to confirm that the
converted article is faithful to the original. The NIHMS transfers the
article to PMC when it is ready to be made available publicly.
3. Will NIH pay for publication costs?
Yes. The NIH will reimburse publication costs, including author
fees, for 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.
4. My article has multiple authors and/or is funded from multiple NIH
sources. Who should submit the article?
Any author may submit the article, but each Principal Investigator
and Institution is responsible for ensuring that the terms and
conditions of their award are met. An article need only be submitted
once to the NIH Manuscript Submission system. Authors will be notified
during the submission process if they try to submit an article that has
already been submitted.
Articles can be assigned multiple NIH award numbers during
submission. They can also be linked to an award electronically via the
Commons when completing an electronic Progress Report, or listed as
arising from any NIH award in writing when submitting an application,
proposal or progress report.
F. Policy Background
1. Can authors and publishers continue to assert copyright in
scientific publications resulting from NIH funding?
Yes. The NIH Public Access Policy does not affect the ability of
the author, the author's institution, or the publisher to assert
ownership in the work's copyright. Authors, consistent with their
employment arrangements, may assign these rights to journals (as is the
current practice), subject to the limited right that must be retained
by the funding recipient to post the works in accordance with the
Policy, or the provision that the journal submits the works in
accordance with the Policy on the author's behalf.
2. What is the difference between the NIH Public Access Policy and Open
Access?
The Public Access Policy ensures that the public has access to the
peer reviewed and published results of all NIH funded research through
PubMed Central (PMC). United States and/or foreign copyright laws
protect most of the articles in PMC; PMC provides access to them at no
cost, much like a library does, under the principles of Fair Use.
Generally, Open Access involves the use of a copyrighted document
under a Creative Commons or similar license-type agreement that allows
more liberal use (including redistribution) than the traditional
principles of Fair Use. Only a subset of the articles in PMC are
available under such Open Access provisions. See the PMC Copyright
page, http://www.pubmedcentral.nih.gov/about/copyright.html, for more
information.
3. How does the NIH Public Access Policy differ from the 2003 NIH Data
Sharing Policy?
The NIH Public Access Policy covers only peer-reviewed articles
arising from NIH funds. The 2003 NIH policy on data sharing applies to
certain NIH-funded research and is not focused on access to peer-
reviewed articles. The 2003 NIH policy on data sharing is available at
http://grants.nih.gov/grants/policy/data--sharing/.
4. How many publications arise from NIH funds each year?
We estimate that there are approximately 80,000 articles published
each year that arise from NIH funds.
1. Costs that can be specifically identified with a particular
project or
[[Page 16895]]
activity. NIH Grants Policy Statement, Rev. 12/2003; http://
grants.nih.gov/grants/policy/nihgps--2003/NIHGPS--Part2.htm#--
Toc54600040
Dated: March 25, 2008.
Sally J. Rockey,
Deputy Director, Office of Extramural Research, National Institutes of
Health.
[FR Doc. E8-6579 Filed 3-28-08; 8:45 am]
BILLING CODE 4140-01-P