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Effective Date: May 2, 2005
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 costs1 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 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
E-Mail: 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,
and in the Federal Register on September 17, 2004,
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 website, 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' websites are not
permanently available nor consistently maintained. Additionally,
the formatting of journal articles may vary significantly among
publishers' websites. 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 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' websites 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
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 websites. 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 website 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.
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
websites, 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 million8 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 Regents9 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 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 websites 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 websites or on their
institution's website11. 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 website 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 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 website 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 websites 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 Regents12 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 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. 108-79213.
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 C.F.R. 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 C.F.R. 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 purpose14.
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 interested public has
access to the document, it would not be considered to be available
as a printed publication within the meaning of 35 USC §§ 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 415. 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 USC § 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 USC § 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 C.F.R. § 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 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 C.F.R. § 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 costs1 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):
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.
Additional details for the public and for submitting authors
pertaining to the implementation of this Policy are available
at:
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/nihgps_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_Health_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 C.F.R. § 5.65(b); available at:
http://www.hhs.gov/foia/45cfr5.html#Subf.
The full text of this notification is available
at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html
Notice Number: NOT-OD-05-045
Key Dates
Release Date: April 29, 2005 Effective Date: May 2, 2005
Issued by:
National Institutes of Health (NIH), ( http://www.nih.gov)
The National Institutes of Health (NIH) published its Public Access
Policy (Policy) in the NIH Guide for Grants and Contracts on February
3, 2005, and in the Federal Register on February 9, 2005. These
announcements and additional relevant information, including Questions
and Answers regarding copyright and other concerns, are available
at the NIH Public Access Web site:
The purpose of this Notice is to provide a summary of the Policy
and to furnish guidance to NIH investigators on the submission of
manuscripts.
Summary of the Policy
The Policy becomes effective May 2, 2005. The Policy requests and strongly encourages all NIH-funded
investigators to make their peer-reviewed author's final manuscripts
available to other researchers and the public at the NIH National
Library of Medicine's PubMed Central (PMC)
immediately after the final date of journal publication. At the
time of submission, authors are given the option to release their
manuscripts at a later time, up to 12 months after the official
date of final publication. NIH expects that only in limited cases
will authors deem it necessary to select the longest delay period.
The 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, original research publications that have been supported
in whole or in part with direct costs (1) from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
NIH is requesting that authors submit publications resulting from:
1.) Currently-funded NIH research projects or
2.) Previously-supported NIH research projects where manuscripts were accepted for publication
on or after May 2, 2005.
Publications resulting from non-NIH-supported research projects should not be submitted. We welcome comments and
suggestions about the submission process. Please contact us at mailto:PublicAccess@nih.gov.
The NIH Manuscript Submission System
The password-protected, Web-based, NIH Manuscript Submission (NIHMS) system:
has been developed to facilitate the submission process. This system
allows easy identification of NIH grant numbers (past and present)
and NIH intramural project numbers by associating them with the
corresponding extramural or intramural Principal Investigator (PI)
of the research study. Currently, manuscript files from NIH Intramural
PIs can be submitted to the NIHMS system by the PI or designated
NIH staff. Manuscript files from extramural PIs may be submitted
by the PI only. Beginning July 6, 2005, manuscript files may be
submitted to the NIHMS system by either the extramural PI or a third
party on the PI's behalf (e.g., administrative personnel, graduate
students, librarians, publishers, etc.).
In all cases, approval
of the submitted materials and the determination of the public release
date require the PI's review and authorization. Currently, the system
is designed for individual submissions, but procedures for batch
processing of multiple submissions are being explored and may be
developed in the future. No further formatting of the manuscript
is necessary beyond that required by the accepting journals. Special
arrangements will be available for unusual cases. Please see the
NIH Public Access Web site:
for more information about the Policy. How to Submit the Manuscript
Login to the NIHMS (http://www.nihms.nih.gov). Select the appropriate login option (Note: the same login should be used for all subsequent visits to the NIHMS system): Provide basic information, including the journal title, PI, contact information, and associated
NIH award number(s). Upload the complete text of your manuscript(s).
The NIHMS supports a wide variety of file types (MS Word, Word Perfect,
PDF, PowerPoint, Excel, etc.). Upload any corresponding, supplemental
image files that contain figures, tables, or supplementary information
along with the manuscript. Just as required by publishing journals,
submit high-resolution images to ensure that they can be viewed
properly in PMC. The supplemental material that has been submitted
to the accepting journal in support of the manuscript will be accepted.
The NIHMS will generate a receipt of the uploaded files in PDF format.
The PDF receipt summarizes the information entered into the system
and merges the manuscript's files into one viewable document. Confirm that the manuscript and any additional supporting documents
have been successfully received by NIHMS, and verify the document. Review and approve the terms and conditions of a submission agreement
and specify the timing of posting of the final manuscript for public
accessibility through PMC (this must be completed by the PI). Authors
and/or their institutions should ensure that their final manuscript
submissions to PMC are consistent with any other agreements, including
copyright assignments that they may have, or enter into, with publishers
or other third parties. Upon approval of the submission by the PI,
the manuscript will be converted into XML - the standardized digital
format used by PMC. Review the XML manuscript as it will appear
in PMC once the conversion has taken place (PIs will be notified
by e-mail when the document is ready for review) and correct any
errors, if necessary. After PI approval, the article will be publicly
accessible through PMC after the time-delay specified by the PI.
Note: Users are able to track the status of their manuscripts throughout
the process.
Need Help?
Do you have questions about the submission
process? Refer to the NIHMS FAQ. The NIHMS system also maintains
a help desk to assist users with manuscript submissions and answers
to any questions related to the submission process. Contact:
with your queries.
What is the NIH eRA Commons?
The NIH eRA Commons is a system developed to facilitate the discrete
exchange of essential information between NIH and applicant organizations.
The “Commons” is a Web interface, available at:
where NIH and the grantee community are able to conduct their extramural
research administration business electronically. For example, this
system allows PIs and institutional officials to have various degrees
of online access to the status of their grant applications and details
associated with their grant awards.
An NIH eRA Commons account is
required for PIs to enter into the NIHMS system and submit final
manuscripts. Submitting authors do not need to be a currently-funded
NIH investigator in order to create quickly a Commons account number.
If you have questions, problems, or comments regarding the NIH eRA
Commons system, please contact the Sponsored Research Office at your institution.
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]
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