[Federal Register Volume 74, Number 31 (Wednesday, February 18, 2009)]
[Notices]
[Pages 7603-7614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3442]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Analysis of Comments and Implementation of the NIH Public Access
Policy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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Background
The National Institutes of Health (NIH) Public Access Policy
requires investigators funded by the NIH to submit, or have submitted
for them, an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication to the National Library of
Medicine's digital archive, PubMed Central, to be posted publicly
within 12 months after the official date of publication. Congress
required the NIH to implement this funding limitation in Division G,
Title II, Section 218 of the Consolidated Appropriations Act of 2008
(``Section 218''). The Policy is intended to advance science, provide
public access to the published results of NIH-funded research, and
improve human health.
The current Public Access Policy is the culmination of years of
effort and community interaction. Prior to passage of Section 218, the
NIH undertook extraordinary public outreach concerning the issue of
public access to the published results of NIH-funded research. These
outreach efforts included a review of over six thousand public comments
and the establishment of an independent advisory group to review NIH's
implementation of a voluntary Public Access Policy. Additionally, as
part of the process to implement Section 218 in a transparent and
participatory manner, the NIH formally sought public input through an
open meeting and a Request for Information (RFI) seeking public
comment. This open meeting occurred on March 20, 2008, and was designed
to ensure that a discussion of stakeholder issues could occur. The
feedback from the open meeting helped define questions for an RFI,
which was published on the NIH Web site on March 28, 2008 and in the
Federal Register on March 31, 2008 (73 FR 16881-16895). The RFI was
designed to seek input on the NIH Public Access Policy, as it was
revised to incorporate Section 218, and the responses to frequently
asked questions (FAQs) concerning it. The RFI was open for sixty days
following publication in the Federal Register, from March 28 to May 31,
2008.
[[Page 7604]]
Overview of Feedback
In response to the open meeting and RFI, the NIH received 613
unduplicated comments from a broad cross-section of the public,
including NIH-funded investigators, members of the general public,
patient advocates, professional organizations, and publishers. This
report summarizes these comments.
Most comments offered broad support for the policy as written. Many
comments requested a reduction in the delay period before papers can be
made publicly available on PubMed Central. In some cases, commenters
expressed concern about the Policy, others asked for clarification, and
still others suggested alternatives to NIH's implementation. These
questions and concerns fall into several broad categories:
The potential administrative burden on Program Directors/
Principal Investigators and awardee institutions.
The details of implementing the Policy, including
applicability, cost reimbursement, compliance monitoring and
enforcement, and publisher support of the Policy.
Associated issues, such as submission procedures, tracking
submitted papers, version of the paper submitted, and managing and
protecting copyrights.
The accordance of the Policy Implementation with copyright
law and the Administrative Procedures Act.
Questions about Policy impact, such as financial impacts
on publishers and NIH.
The NIH also received comments describing implementation efforts by
numerous awardee institutions and publishers. In some cases, libraries
took the lead on educating their faculty and supporting them in
interpreting publishing agreements and submitting manuscripts to NIH.
In other cases, offices of sponsored research provided guidance on the
NIH Public Access Policy disseminated to their faculty community via
the Web, memos, seminars, and video casts. Still other institutions
described collaborations between libraries, offices of sponsored
research, university counsels, and technology transfer offices. Several
universities and private groups described the development of new
policies on scholarly communications and new publishing forms and
addenda that their faculty could use to ensure compliance with the
Policy.
NIH Response
The NIH carefully considered the views expressed by publishers,
patient advocates, scientists, university administrators, and others in
the comments submitted. Throughout the course of its analysis, the NIH
undertook various efforts to respond to concerns as it identified them.
The agency aimed these actions to clarify the Public Access Policy and
to facilitate compliance with Section 218. In May, July, and September
of 2008, NIH updated the Public Access Web site to clarify the
applicability, goals and anticipated impact of the policy, the
available methods to submit papers, and planned methods to document
compliance. In June 2008, NIH updated the NIH Manuscript Submission
System (NIHMS), the online mechanism for submission of manuscripts to
PubMed Central (PMC), to allow Program Directors/Principal
Investigators (PDs/PIs) to delegate all aspects of submission tasks to
authors, and to allow publishers who submit manuscripts to the NIHMS on
behalf of authors to exert greater control over manuscript delay
periods. In August, the National Library of Medicine issued a new Web
tool to help the scientific community obtain PubMed Central Identifiers
in bulk. In September 2008, NIH issued a Guide Notice (NOT-OD-08-119 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html)
reminding awardees about the compliance process and providing details
concerning NIH's monitoring plan for fiscal year 2008.
These efforts appear to be working. The NIH estimates approximately
80,000 papers arise from NIH funds each year, and this total serves as
the target for the Public Access Policy. During the voluntary policy,
from May 2005 to December 2007, the NIH was able to collect a total of
19 percent of targeted papers, from all sources. Under the first five
months of the Section 218 requirement (April to August 2008), this rate
jumped to an estimated 56 percent of papers per month. While NIH
expects to post all of the estimated 56 percent of these NIH papers,
most of them will not be publicly available until 2009.
These first few months show the promise of a Public Access Policy
requirement, its implementation, and the active support from the
academic and publishing communities. However, work still remains as
over 40 percent of applicable papers per month remain unsubmitted.
Implementation and process refinement will be continuing in the
coming months. The NIH has established voluntary partnerships with many
publishers to facilitate deposit of manuscripts and final published
papers and expects these partnerships to continue to expand and the
percentage of submitted papers to grow. The NIH will also continue to
engage the community as we proceed to implement the Policy in the most
efficient and effective manner possible.
Policy Overview
The NIH Public Access Policy, announced in January 2008, ensures
that the public has access to the published results of NIH-funded
research. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. It requires scientists to submit final peer-reviewed
journal manuscripts that arise from NIH funds to the digital archive
PubMed Central upon acceptance for publication. To help advance science
and improve human health, the Policy requires that these papers be
accessible to the public on PubMed Central no later than 12 months
after publication.
This Policy implements the Consolidated Appropriations Act of 2008,
which directed the NIH to require investigators funded by the NIH to
submit, or have submitted for them, an electronic version of their
final, peer-reviewed manuscripts upon acceptance for publication to the
National Library of Medicine's digital archive, PubMed Central (PMC),
to be posted publicly within 12 months after the official date of
publication. The Policy builds upon the experience with NIH's voluntary
Public Access Policy, which was published in 2005 and has three aims:
1. ARCHIVE. A central collection of NIH-funded research
publications preserves vital published research findings for years to
come.
2. ADVANCE. The archive is an information resource for scientists
to research publications and for NIH to manage better its entire
research investment.
3. ACCESS. The archive makes available to the public research
publications resulting from NIH-funded research.
Policy History
The original, voluntary Public Access Policy, implemented May 2005
(NOT-OD-05-022, available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html), encouraged but did not require investigators
receiving NIH funding to deposit their peer-reviewed manuscripts into
PubMed Central. It was shaped, in large part, through discussion with
the extramural community.
The NIH began public discussions on this topic with three town hall
style meetings in 2004. From this feedback, the NIH developed a
proposal for a voluntary public access policy that would make final
peer-reviewed
[[Page 7605]]
manuscripts publicly available on PubMed Central within 6 months of
publication. The NIH issued the proposed NIH Public Access Policy for
comment in September 2004 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html or http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-21097.htm). In
response to its request for input on the proposed policy, NIH received
over 6,200 comments from interested parties, including grantees,
publishers and trade organizations. After carefully considering all the
comments received, the NIH published a final policy, NOT-OD-05-022, on
February 3, 2005 (also published at 70 FR 6891). Though 66 percent of
comments favored a six-month delay period, the NIH implemented a
voluntary Public Access policy with a 12-month delay period out of
deference to concerns from some members of the publishing community.
Implementation of this voluntary policy was marked by continued
engagement with multiple stakeholders in order to facilitate
participation. The NIH staff met dozens of times and exchanged hundreds
of letters with patient advocacy groups, awardee institutions and their
representatives, publishers, and scientific societies regarding the
Policy. (For a breakdown of meetings and correspondence, see slide 12
of NIH Director Elias Zerhouni's presentation at the March 20, 2008,
open meeting at http://publicaccess.nih.gov/comments/Overview_Context.pdf.) In collaboration with publishers, investigators,
grantees, and others, the NIH established systems to make it easy for
scientists to deposit their manuscripts directly and for interested
publishers to deposit manuscripts on scientists' behalf. For example,
the NIH Manuscript Submission System (NIHMS), a Web service built to
support the Policy, allows publishers to submit manuscripts on behalf
of authors in bulk. The NIH also developed new forms of PubMed Central
Journal agreements in collaboration with publishers, which enable
publishers to submit final, published articles to PubMed Central from
NIH-funded authors, only and/or from authors who pay open access fees
to the journals.
Thus, for almost three years, the NIH asked the scientists it
supports to deposit their NIH-funded scientific manuscripts in an NIH
online system that would make them accessible to the public, freely and
in perpetuity. But the compliance rate under the voluntary system
demonstrated that it would not achieve the goals of the Public Access
Policy. In December 2007, the Consolidated Appropriations Act of 2008
was signed into law, directing the NIH to require submission of
manuscripts.
Implementing the Consolidated Appropriations Act of 2008
The Consolidated Appropriations Act of 2008 (Pub. L. 110-161), at
Division G, Title II, Section 218, directs the NIH as follows: 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 the Public Access Policy
implementing this clear and unambiguous new statute. 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),
the Policy restates the statute and offers the following 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.
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\1\ ``Directly'' funded means costs that can be specifically
identified with a particular project or activity. See NIH Grants
Policy Statement, Rev. 12/2003.
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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, the NIH
includes this requirement in all R&D solicitations and awards under
Section H, Special Contract Requirements, in accordance with the
Uniform Contract Format.
In addition to announcing the Policy, the NIH established a Web
site and posted responses to frequently asked questions (FAQs) that
provide authors, their institutions, and their publishers with guidance
on the implementation of the policy.
As part of the process to implement Section 218 in a transparent
and participatory manner, the NIH formally sought public input through
an open meeting and a Request for Information seeking public comment.
The open meeting occurred on March 20, 2008 (NOT-OD-08-057), and was
designed to ensure that discussion of stakeholder issues could occur.
The feedback from the open meeting helped define questions for a
Request for Information (RFI), conducted from March 28 to May 31 (NOT-
OD-08-060). This report summarizes comments received at the meeting and
in response to the RFI.
Open Meeting
The purpose of the Thursday, March 20, 2008, meeting was to seek
comment from the public on implementation of the NIH Public Access
Policy. The meeting was open to all, including NIH-funded researchers,
representatives of universities and other NIH grantee organizations,
publishers (including commercial organizations, professional societies,
and journal editors), patients and public health advocates, and members
of the general public. The NIH desired broad participation and
commentary.
In particular, the NIH was interested in input concerning the
Public Access Policy and the effectiveness of the policy's
implementation. Individuals, groups, and organizations were also
invited to submit written pre-meeting comments on the NIH Policy.
The NIH made every effort to make the meeting and pre-meeting
comments open and transparent. Comments were made public as they were
received. The meeting was video cast, and everyone who wished to speak
was able to. All meeting materials, including the Guide Notice, Federal
Register Notice, video cast, transcript, and comments are available at
http://publicaccess.nih.gov/open_meeting_march_2008.htm.
[[Page 7606]]
Comments posted on this site are recorded as submitted and, in some
cases, include duplicates.
Request for Information (RFI)
The feedback from the open meeting helped define questions for a
Request for Information (RFI), which was published on the NIH Web site
on March 28, 2008, and in the Federal Register on March 31, 2008 (73 FR
1681-1695) (see NOT-OD-08-060). The NIH sought information from the
public, including all stakeholders, about the new NIH Public Access
Policy and the frequently asked questions developed to assist
investigators to implement it. Among other issues, the NIH particularly
sought information about the following questions:
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 on the NIH
Web site, what additional information, training or communications
related to the NIH Public Access Policy would be helpful to you?
Individuals, groups, and organizations interested in responding
were invited to do so via a Web site that would record their responses
for each question and make those responses publicly available. All
comments received via the Web and e-mail related to the Public Access
Policy RFI is now available at http://publicaccess.nih.gov/comments.htm.
Methodology for Analysis
Consolidating and Categorizing Comments
Comments were posted as they were collected, and commenters had the
opportunity to respond to other comments. This was a deliberate effort
on the part of NIH to encourage dialogue among stakeholders and to
provide a more synthesized set of ideas for analysis. Individuals and
organizations were allowed to submit multiple comments, and all
comments were treated equally, regardless of the source. Although the
NIH requested input on several open-ended questions at the meeting and
in the RFI, commenters did not restrict themselves to input on these
questions and offered a variety of opinions on other topics, either in
addition to responding to the questions or in lieu of responding to
them.
Combined, the open meeting and RFI yielded 613 unduplicated
comments. The comments include materials entered through the online
comment service, transcriptions of in-person statements offered at the
March 20 Open Meeting, and e-mails received at the Public Access
comments mail box.
Duplicates were identified by finding multiple comments from the
same individual that contained identical content. Comments that were
entirely off-topic (e.g., SPAM, selling products) were considered
nonresponsive and thus not counted. If an individual submitted multiple
responses and each submission contained new content, they were not
marked as duplicates and were separately counted and analyzed. In
addition, if the same comment or information (e.g., a form letter) was
received from two or more individuals those comments were counted
separately and not marked as duplicates.
All unduplicated comments underwent an initial review to identify
the topic(s) addressed and to gain a sense of the relative number of
commenters who addressed each topic. This initial analysis helped to
identify major themes for inclusion in this report.
The 613 unduplicated comments covered by this report, combining
comments from both the open meeting and the RFI, and including PDF
comments converted to text using optical character recognition, became
available in a single file at http://publicaccess.nih.gov/comments.htm
in October 2008. We invite our stakeholders to use these resources to
conduct independent analyses of these data.
The public comments were largely supportive of the Policy. Comments
clustered around several broad themes. We describe them below, followed
by NIH's analysis and response where appropriate.
1. Need for the Policy
The most common theme among comments, expressed in a large majority
of all comments, was support for the Policy as written. When reasons
for support were offered, the most common were as follows: (1) The
perceived benefit to patients and their families, (2) the belief that
the American public has a right to access papers arising from NIH
funds, and (3) the expected potential of the policy to advance
scientific discovery. A small minority of comments expressed general
disagreement with the Policy and/or felt that increasing access to
papers arising from NIH funds was unnecessary.
2. The Length of the Delay Period
The second largest number of comments, second only to general
support for the Policy, were comments advocating reducing the period of
time before papers are made publicly available on PubMed Central. A
large number of commenters argued for a shorter maximum delay period--
many suggested 6 months, many no delay period at all, and a few
suggested 3 months. Advocates for reducing the period of time explained
that doing so would provide greater benefits to the public and to
science. Some further claimed, and provided examples of how, shorter
delay periods would not harm publisher interests. A few commenters
suggested that the maximum delay period should be greater than 12
months. These commenters claimed that a longer delay period was needed
to protect journals in certain disciplines.
The NIH appreciates the concerns of all commenters concerning the
maximum delay period between journal publications and posting on PubMed
Central. The Consolidated Appropriations Act of 2008 specifies the
maximum delay period at 12 months. Copyright holders may always post
materials with a shorter delay period, at their discretion.
3. Actions Taken by Institutions to Support Implementation
Many commenters shared their efforts to implement and promote the
Policy. Several publishers described their efforts to support
implementation, either by facilitating submission of papers on behalf
of their authors, or by offering new guidance and publishing agreements
so that their authors may understand how to comply with the Policy.
A number of awardee institutions offered their implementation
strategies as well. In some cases, libraries were taking the lead in
educating their faculty and supporting them in interpreting publishing
agreements and submitting manuscripts to the NIH. In other cases,
offices of sponsored research described guidance on the NIH Public
Access Policy disseminated to their faculty community via the Web,
memos, seminars, and video casts. Still other institutions described
collaborations between libraries, offices of sponsored research,
university counsel, and technology transfer offices. Several
universities and private groups also described institutional policies
on scholarly communication and new publishing forms and addenda that
their
[[Page 7607]]
faculty could use to ensure compliance with the Policy.
The NIH is interested in the role institutions may play in
supporting the Policy and appreciates the efforts of these commenters
to both support the policy and share their strategies. In January 2008,
the NIH published an article outlining key questions institutions may
wish to consider as they implement the Policy (http://grants.nih.gov/grants/partners/0108Nexus.htm#investigator). Based on the comments
submitted, it appears that the community has developed multiple
approaches to issues described in this article, but it is too early in
the implementation of the Policy to determine if some approaches are
more successful than others.
NIH employees publish several thousand peer-reviewed papers each
year, and the NIH has to support the Policy as an investigator
institution as well. Our approach to ensure compliance among our own
faculty involves support from the NIH Library, a unit of the NIH Office
of Research Services; NIH technology transfer representatives; and the
NIH Office of Intramural Research. The NIH offers employees guidance on
our Web site, a publishing agreement addendum, centralized negotiation
of publishing agreements, help desk support for manuscript submission
and policy questions, and staff training upon request. See http://publicaccess.nih.gov/nih_employee_procedures.htm for more
information.
4. Administrative Burden for Institutions and Principal Investigators
Some comments expressed concern that the Policy would create undue
burdens on authors, investigators, and institutions. The comments are
described below.
A. Negotiating Publisher Agreements
Some comments suggested the Policy required authors and individual
investigators to negotiate with publishers directly. They felt
individual authors lacked the skills or bargaining power to develop an
agreement with a publisher that met their needs under the Policy.
Investigators are central to implementing the Policy and usually
are the initial copyright holder of the manuscripts that fall under the
Policy. They may need to negotiate the terms of publishing agreements
with publishers directly. However, the NIH expects that institutions
will support their investigators in complying with terms and conditions
of award. The NIH Public Access Policy states ``Institutions and
investigators are responsible for ensuring that any publishing or
copyright agreements concerning submitted articles fully comply with
this Policy.'' The NIH underscores the importance of institutional
support throughout the Frequently Asked Questions (FAQ). For example,
FAQ C4 addresses publishing agreements or publishers that may not
support compliance with the Policy. FAQ C11, released in May 2008 in
response to this feedback, addresses another aspect of this concern. In
both cases, the NIH encourages authors and investigators to work with
their institution's office of sponsored research.
With regard to particular agreement terms, individual copyright
arrangements can take many forms, and authors and their institutions
should continue to manage such arrangements as they have in the past.
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 (as described in
FAQ C3):
``Journal acknowledges that Author retains the right to provide a
copy of the final peer-reviewed 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.''
There are many other potential models, some of which were described
in other comments and are available for viewing therein.
B. Ability for Investigators to Publish in the Journal of Their Choice
A few comments expressed concern that some journals would refuse to
allow manuscripts to be posted to PMC in accordance with the Policy,
and authors would not be able to publish in those journals. They
claimed this could occur despite an author's best efforts to negotiate
with a publisher.
The NIH agrees that author choice of publication is a very
important issue, but if this situation were to occur, an author might
have to find an alternate journal. Therefore, the NIH encourages
authors to clearly communicate with and address these issues before
they may transfer their copyright and potentially lose their ability to
comply with the Policy. The Public Access Home page states: ``Before
you sign a publication agreement or similar copyright transfer
agreement, make sure that the agreement allows the paper to be
submitted to NIH in accordance with the Public Access Policy.''
The NIH has also engaged the publishing community in order to
minimize copyright concerns when possible. The NIH has established
voluntary partnerships with many publishers who agree to facilitate
deposit of manuscripts and final published papers. The number of papers
submitted via these agreements has grown since the Public Access Policy
took effect. The NIH issued guidance to authors to clarify these
various arrangements in July 2008. The guidance can be found at http://publicaccess.nih.gov/submit_process.htm. Whether because of NIH's
direct efforts, clear communication from authors and institutions or
because of publisher support for the Policy, NIH did not receive
comments indicating that publishers or publishing agreements have
actually prevented authors from complying with the Policy. To the best
of our knowledge, this concern currently remains a hypothetical risk
and not a manifest problem.
C. Cost Reimbursement
Some commenters raised the issue of investigators or awardees
needing to pay potential publishing costs and fees associated with the
Policy (e.g., fees for posting to PubMed Central, fees to reduce delay
periods). Some commenters suggested that the NIH should cover these
costs, others requested clarification concerning costs, and still
others thought the NIH would offer no financial support to either
institutions or publishers. As such, the commenters felt that the
Policy was an unfunded mandate that might harm author or publisher
interests, with junior authors (new investigators and trainees) being
especially vulnerable. However, several commenters thought any
unrecovered costs associated with the Policy were worth the benefits,
and one commenter even requested that the NIH stipulate that costs not
be covered.
As with other costs, 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. Generally, page charges for publication
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,
[[Page 7608]]
whether or not they are submitted by Government-sponsored authors.
D. Compliance Burden
Some commenters expressed concern about the time Program Directors/
Principal Investigators (PDs/PIs) and authors will need to spend to
submit papers. A few commenters said that a simple submission system
was critical to the success of the policy. Among those commenting on
the potential burden of the submission process, a portion said the
existing NIH Manuscript Submission System (NIHMS) was easy to use, a
portion said it was complex and burdensome, and a portion were unaware
of how it worked. Some commenters also expressed concern or offered
suggestions related to the notification and management of PubMed
Central Identifiers (PMCIDs), which are assigned to papers after they
are submitted and can be used to demonstrate compliance with policy on
applications, proposals, and reports.
The NIH agrees with the need to have a simple manuscript submission
process to minimize the time associated with deposit of manuscripts
into PubMed Central. NIH has worked diligently since the adoption of
the voluntary Public Access Policy in 2005 to develop a streamlined and
efficient process. During the voluntary Policy, NIH found it took
authors about 10 minutes to deposit a paper in the NIH Manuscript
Submission System (NIHMS); the time decreased for submitters as they
began to submit more papers and gained experience with the system.
The NIH continues to refine the NIHMS as necessary. For example,
starting in June 2008, NIH eliminated the need for PDs/PIs to review
each deposit. Instead, the NIHMS now allows authors to complete all
aspects of manuscript submission, with the idea that greater
flexibility in delegation will minimize PD/PI burden. The NIH gives
specific guidance on these submission processes on its Web site at
http://publicaccess.nih.gov/submit_process.htm. This guidance also
describes how authors can delegate some submission tasks to someone in
the author's organization (e.g., an assistant or a librarian), or to
their publisher, and how all aspects of submission can be delegated to
a publisher that participates in PubMed Central.
The NIH has developed Policy compliant alternatives to manuscript
deposit that require less author effort. For example, as described at
http://publicaccess.nih.gov/submit_process.htm, some publishers sign
agreements with the NIH to submit final published articles directly to
PubMed Central without author involvement. Since the passage of the
2008 Consolidated Appropriations Act, the number of publishers signing
such agreements has significantly increased.
The NIH has also made changes to the way it reports PubMed Central
reference numbers (PMCID), and how authors and delegates can use the
NIHMS system. For example, as described in FAQ C9, issued May 2008, the
PMCID is posted in PubMed as soon as an article has been successfully
processed by PMC, which usually occurs around the time of publication.
PMCIDs are listed in the lower right corner of the Abstract Plus view
of PubMed (http://www.ncbi.nlm.nih.gov/PubMed/). If the paper is not
yet publicly available on PMC, PubMed will also list the date the paper
will become available. The NIH provides other methods of obtaining
PMCIDs (e.g., http://www.ncbi.nlm.nih.gov/sites/pmctopmid, created in
August 2008), as do several bibliography management software packages.
E. Collaborations With Institutional Repositories
As a way to relieve compliance burdens on their faculty, a few
institutions requested direct feeds from their repositories to PubMed
Central or the NIH Manuscript Submission system.
The NIH believes that these are worthwhile suggestions, but it is
concerned that they raise important technical and logistical challenges
regarding author approval, copyright permissions, quality control, and
formats for electronic transfer. The NIH remains open to closer
collaboration with institutional archives and will consider this issue
as the Policy matures. National Library of Medicine representatives met
with representatives from academic communities to discuss this issue in
November 2008.
5. Expanding the Scope of the Public Access Policy
Some commenters suggested the Policy be expanded in several ways
from investigators and research funded by additional or all Federal
research funds to papers published before April 7, 2008, or to the data
and unpublished results associated with an award. A few comments
suggested a specific alternative approach to expand the scope of the
policy to exempt all works arising from NIH/Government funds from
copyright protection.
The NIH understands and appreciates the strongly held views of many
commenters concerning access to works funded by the NIH and the
Government generally. The NIH Public Access Policy implements the
Consolidated Appropriations Act of 2008, Division G, Title II, Section
218 (Pub. L. 110-161), a Federal statute that was passed by Congress
and signed by the President of the United States. This statute is very
specific--it indicates what is to be submitted and when, and when and
where submissions are made publicly available.
The NIH's new Access Policy took effect a few months after passage
of the law to allow copyright holders to make arrangements to post
directly and in accordance with copyright law. Regarding the suggestion
that works funded through the NIH should be denied copyright
protection, we note that works of Government employees, including NIH
investigators, are not subject to copyright protection in the United
States (17U.S.C. 105). The works of Government awardees, however, are
subject to copyright protection.
6. Issues About the Policy and Its Implementation Requiring
Clarification
A number of issues were raised that resulted in NIH providing
clarifications.
A. Compliance Monitoring and Enforcement
A number of comments suggested that investigators should include
evidence of compliance with the Policy in applications, proposals or
reports submitted to the NIH. A few comments simply asked what is the
process for enforcing compliance.
It is unclear whether the commenters proposing reference within NIH
applications, proposals, or reports were endorsing the Policy as
implemented, as it already specifies that investigators should do so,
or were unaware of the compliance procedure described in the January
11, 2008 Guide notice. As is made clear therein, the NIH expects that
investigators citing their NIH-funded papers subject to the Policy in
NIH applications, proposals, or progress reports will include the
PubMed Central reference number for each applicable paper.
The NIH clarified the compliance reporting process with an update
to the Web site in May 2008 and further clarified the compliance
documentation and monitoring processes in a Guide Notice (OD-NOT-08-119
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html).
FAQ C8, also part of the May 2008 release, clarifies that the Policy
reporting requirement for applicants and PDs/PIs only applies to papers
that are authored by them or arose from their NIH award and fall under
the policy.
[[Page 7609]]
Some commenters also asked about consequences for PDs/PIs and
institutions if manuscripts are not submitted as required by the law
and the Policy. Generally, and as specified in the NIH Guide for Grants
and Contracts, a grantee's failure to comply with the terms and
conditions of award may cause the NIH to take one or more enforcement
actions, depending on the severity and duration of the noncompliance.
The NIH will undertake any such action in accordance with applicable
statutes, regulations, and policies. The NIH generally will afford the
grantee an opportunity to correct the deficiencies before taking
enforcement action unless public health or welfare concerns require
immediate action. However, even if a grantee is taking corrective
action, the NIH may take proactive action to protect the Federal
Government's interests, including placing special conditions on awards
or precluding the grantee from obtaining future awards for a specified
period, or may take action designed to prevent future noncompliance,
such as closer monitoring. See Enforcement Actions in the NIH Grants
Policy Statement (11/03): http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600145.
B. Preventing Copyright Violations on PMC
The NIH received feedback on the potential copyright implications
of posting papers to PubMed Central (PMC), which cluster into two
themes. Some comments asked how the NIH will prevent inappropriate
posting of materials to PMC without permission of the copyright holder
or posting prior to expiration of the delay period specified by the
submitter. Other comments, described below, expressed concern about the
operation of PMC and the protections it offers copyright holders
against inappropriate use of their works.
The comments about inappropriate posting primarily focused on
individuals posting content without copyright permission. The NIH
manuscript submission system is the only way in which authors may
deposit manuscripts to PMC. That process requires the author to confirm
he or she has the right or permission for the specific version
submitted to be posted to PMC after the specific delay period.
Publishers and authors have occasionally disagreed on the terms of
their publishing agreements. Publishers have submitted final peer-
reviewed manuscripts on behalf of their authors requesting a specific
delay period, and in the course of approving the manuscript for
posting, authors have selected a shorter delay period. In June 2008,
NIH modified the NIH Manuscript Submission System to allow a publisher
to fix the delay period when they submit a manuscript on behalf of
their authors. Authors now have to contact NIH and their publisher if
they wish to change the delay. We expect this more direct communication
will result in fewer disagreements about delay periods.
Commenters also asked how NIH safeguards privately copyrighted
materials on PubMed Central once it is posted. NIH has eight years of
experience in safeguarding copyrighted material on the PMC Web site,
the host archive of the Public Access Policy. There are over 1.5
million full-text articles on the Web site. PMC has algorithms to
detect inappropriate use, such as bulk downloading, and sites
responsible for inappropriate use are warned of the consequences of
violating copyright provisions and blocked from further access.
C. Applicability of the Policy
Some commenters asked questions or expressed confusion about the
papers to which the Policy applies. Applicability was clarified in the
May 2008 FAQ B1. The Policy applies to any manuscript that:
Is peer-reviewed;
And, is accepted for publication in a journal on or after
April 7, 2008.
And, arises from:
Any direct funding \2\ from an NIH grant or cooperative
agreement active in fiscal year 2008, or;
---------------------------------------------------------------------------
\2\ ``Directly'' funded means costs that can be specifically
identified with a particular project or activity. See NIH Grants
Policy Statement, Rev. 12/2003.
---------------------------------------------------------------------------
Any direct funding from an NIH contract signed on or after
April 7, 2008, or;
Any direct funding from the NIH Intramural Research
Program, or;
An NIH employee.
Consistent with the NIH's long-standing interest in developing a
full and complete database, however, authors may also submit final
peer-reviewed manuscripts accepted before April 7, 2008, that arise
from NIH funds, if they have appropriate copyright permission or
authority.
D. Version Control
The NIH received comments with questions or concerns about the
version of the paper posted to PMC. Some commenters suggested that only
final, published versions of articles should be posted as they felt
final peer-reviewed manuscripts may contain scientific errors corrected
during the copy-editing process. A few commenters expressed concern
that the formatting processes that are part of PubMed Central may
change the meaning of the paper.
The NIH has been posting final peer-reviewed manuscripts on PMC for
years and found them to offer the same scientific information as the
final published article. The NIH obtains the permission of the author
before each author manuscript is posted to PMC. We ask authors to
review the specific document to be posted, and allow them to correct
any scientific issues during the approval process and afterwards. To
date, we are unaware of uncorrected errors in PubMed Central.
In response to questions about the version of a paper that may be
posted on PMC, the NIH issued FAQ D6 in May 2008. It explains that the
NIH Public Access Policy is based on a law (Division G, Title II,
Section 218 of Pub. L. 110-161) that requires investigators to submit
``their final, peer-reviewed manuscripts'' to PubMed Central. The NIH
will accept the final published article in lieu of the final peer-
reviewed manuscript, provided that the submitter has the right to
submit this version. Some journals post final published articles
directly to PMC. See http://publicaccess.nih.gov/submit_process_journals.htm for more information.
Papers need to be converted into the PMC Archival format in order
to be posted. This process does not change the meaning or the content
of the paper. However, it does further the goals of the Public Access
Policy and is a fundamental feature of the PMC database. Once posted to
PubMed Central, results of NIH funded research become more prominent,
integrated, and accessible, making it easier for all scientists to
pursue NIH's research priority areas competitively. PubMed Central
materials are integrated with large NIH research databases such as
Genbank and PubChem, which helps accelerate scientific discovery.
Finally, the Policy allows the NIH to monitor, mine, and develop its
portfolio of taxpayer-funded research more effectively and archive its
results in perpetuity.
The NIH should provide guidance on copyright issues.
Some commenters requested explicit guidance on copyright issues.
The NIH provides an example in FAQ C3 (http://publicaccess.nih.gov/FAQ.htm#c3), which states that ``* * * Individual copyright
arrangements can take many forms, and authors and their institutions
should continue to manage such arrangements as they have in the past.''
[[Page 7610]]
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 peer-reviewed 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.''
7. Requests for Additional Information About the Policy and
Implementation Procedures.
A. NIH Should Disseminate Information About Publisher Support of the
Policy
Some commenters asked for a list of publishers that allow their
authors to comply with the policy. NIH has developed and maintains two
lists of publishers and journals. Hundreds of journals make the final
published version of every NIH-funded article publicly available in
PubMed Central within 12 months of publication without author
involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals. Some publishers will deposit
an individual final published article in PubMed Central upon author
request, and generally for a fee. See the list of publishers at http://publicaccess.nih.gov/select_deposit_publishers.htm. All other
publisher policies and procedures require active author involvement to
finalize submission, as described in Methods C and D of the Policy Web
site (see http://publicaccess.nih.gov/submit_process.htm).
B. Frequently Asked Questions
Some commenters specifically highlighted the Frequently Asked
Questions as a helpful resource. A few mentioned the Public Access
Policy Web site in its entirety as helpful. The NIH also offers
additional resources to support training efforts, including complete
slide presentations that may be downloaded and adopted for stakeholder
use. These are available at http://publicaccess.nih.gov/communications.htm.
8. Implementation Alternatives
A. Administrative Procedure Act
Some commenters felt the implementation of the Public Access Policy
was in violation of the Administrative Procedure Act. They claimed the
NIH should not have implemented the Policy without going through a
notice and comment rulemaking and that the January 11 Guide Notice
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
was issued inappropriately.
The NIH believes the initiation of notice and comment rulemaking to
implement the new statute is unwarranted and contrary to the interests
of science and the public health. The mandatory access requirement now
adopted in NIH Public Access Policy derives from Public Law 110-161,
Sec. 218, a Federal statute that was passed by Congress and signed by
the President of the United States. This statutory provision is a clear
and unambiguous directive to the NIH Director to require NIH grantees
to provide their manuscripts to PubMed Central after the date of
publication.
Where, as is true in this case, a statute clearly directs an agency
to execute a congressional objective, and Congress has not directed the
agency to promulgate implementing regulations, an agency's
interpretation or statement of policy or procedure regarding the
statute does not trigger a requirement for notice and comment
rulemaking. 5 U.S.C. 553(b)(3)(A); see also Shalala v. Guernsey Mem.
Hosp., 514 U.S. 87, 99 (1995); American Mining Congress v. Mine Safety
& Health Admin., 995 F.2d 1106, 1112 (D.C. Cir. 1993). Further, the
only significant difference between the new law and the NIH's former
voluntary public access policy is implementation of the legal directive
to require provision of the manuscripts; there is no ``gap'' left by
Congress that would require a rule to implement the statute. See
Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 843-44 (1984). The
mechanics of implementing the former policy were widely understood as
described in published agency policy and in widely accessible Internet
resources maintained by the NIH. Furthermore, the mechanics of
implementing the new statute are substantially the same as, and
consistent with, the NIH's earlier policy implementation. Agency
implementation of a plainly worded Congressional mandate--particularly
where consistent with established agency policy--does not require a
rulemaking proceeding. See, e.g., Gray Panthers Advocacy Cmte. v.
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991). To the extent the NIH
has offered, and continues to offer, interpretative policy guidance or
procedural assistance with regard to the new law, such guidance is not
of free-standing legal effect but rather is intended to assist grantees
to comply with their statutory obligations. See American Mining
Congress, 995 F.2d at 1112. The impact of the mandatory submission
requirement arises from the statute, and rulemaking is not necessary to
implement this statutory requirement.
B. America Competes Act
Some commenters suggested the America Competes Act as an
alternative to the NIH's implementation. Relying on dissemination of
reports and abstracts as described in the America Competes Act is not
consistent with the Consolidated Appropriations Act of 2008.
C. A ``Dark Archive'' or Linking to Publisher or Other Web Sites
A few comments suggested that awardees should submit manuscripts to
the NIH for internal NIH reporting and portfolio management, and public
access could be provided by links to freely available materials on
publisher sites. Some comments suggested that the NIH only provide
public access via publisher sites, and not maintain an internal archive
at all. Many comments explicitly repudiated these ``dark archive'' or
linking approaches and argued that the policy should require deposit to
PubMed Central. One comment suggested that the Public Access Policy
mandate deposit to institutional archives (i.e., those maintained by
universities), and that these repositories could submit papers to
PubMed Central.
The Consolidated Appropriations Act of 2008 explicitly states that
papers should be submitted to and made publicly available on PubMed
Central and the NIH must follow this law. PubMed Central (PMC) is the
NIH National Library of Medicine's (NLM) digital repository of full-
text, peer-reviewed biomedical, behavioral, and clinical research
journals. NLM and its predecessor organizations have been archiving the
biomedical literature for over 150 years and are experienced in
maintaining a stable archive of scientific information. PMC is
currently used by approximately 400,000 users per day.
There are several critical advantages to the scientific community
for making papers publicly available on PMC. Once posted to PMC,
results of NIH-funded research become more prominent, integrated, and
accessible, making it easier for all scientists to pursue NIH's
research priority areas competitively. PMC materials are integrated
with large NIH research databases such as Genbank and PubChem, which
helps accelerate scientific discovery. Clinicians, patients, educators,
and students can better reap
[[Page 7611]]
the benefits of papers arising from NIH funding by accessing them on
PMC at no charge. Finally, the Policy allows NIH to monitor, mine, and
develop its portfolio of taxpayer-funded research more effectively, and
archive its results in perpetuity.
The Public Access Policy does not state that PMC will be the sole
repository for these manuscripts and publications. The NIH has always
pointed to journal and publisher sites from PMC and PubMed and will
continue to do so. See http://www.ncbi.nlm.nih.gov/projects/linkout/
for more information. Others may also post and/or archive papers
arising from NIH funds at other locations, subject to permission from
copyright holders, as appropriate.
9. Copyright Issues
A. Consistency With Copyright Law
The Consolidated Appropriations Act of 2008 requires that the NIH
implement the policy consistent with copyright law. Some commenters
suggested that that might not be possible.
The NIH disagrees with commenters' suggestions that it will be
difficult to implement the new statute in a manner that is consistent
with copyright law. To the contrary, the effect of the new statute is
merely that an author of a work that was funded by grants from the NIH
must retain, from the entire ``bundle of rights'' \3\ inherent in a
copyrightable work, a right to provide the author's manuscript to
PubMed Central for display on its Web site. The author (or his or her
employer) could, for instance, address this point in the agreement with
the publisher by a simple statement that reserves, on behalf of the
assignor, the right to provide the manuscript to PubMed Central for
display. Such a reservation of rights by the author is clearly
consistent with copyright law and the Consolidated Appropriations Act
of 2008.\4\
---------------------------------------------------------------------------
\3\ See 17 U.S.C. 106.
\4\ Copyright in a manuscript vests initially with the author
and remains with the author unless the rights are expressly
assigned. 17 U.S.C. 201(a). Of course, the author may be hired to
write the manuscript or may otherwise enter into an arrangement that
assigns the rights to an employer, making the employer the author
for purposes of the Copyright Act. 17 U.S.C. 201(b). Nevertheless,
the author owns all of the rights in the manuscript, and a potential
publisher owns no rights, unless and until they are conveyed by the
author to the publisher. A publisher that subsequently obtains
copyright to the work can continue to hold and enforce all of the
rights transferred by the author, subject to the principles of the
fair use doctrine, as are all copyrights. PubMed Central includes
many copyrighted works, and public use of a work on PubMed Central
is constrained by copyright, including the principles of fair use,
just as it would be if a member of the public viewed the publication
in a library, for example. Further, the public is alerted that the
works they are viewing may be subject to copyright, with the
following statement: ``This site also contains resources such as
PubMed Central, Bookshelf, OMIM, and PubChem which incorporate
material contributed or licensed by individuals, companies, or
organizations that may be protected by U.S. and foreign copyright
laws. All persons reproducing, redistributing, or making commercial
use of this information are expected to adhere to the terms and
conditions asserted by the copyright holder. Transmission or
reproduction of protected items beyond that allowed by fair use
(http://www.copyright.gov/fls/fl102.html) as defined in the
copyright laws requires the written permission of the copyright
owners.'' [http://www.ncbi.nlm.nih.gov/About/disclaimer.html]
---------------------------------------------------------------------------
U.S. Copyright law anticipates the transfer of ownership rights in
a copyright by agreement among parties or by operation of law (17
U.S.C. 201(d)). Publishers do not own any portion of a copyright in a
work that is not transferred to them by the author, or, if it is a work
for hire, under an employment agreement with the employing institution.
Similarly, the Federal Government, through OMB Circular A-110, grants
federally funded institutions the right to retain intangible property
(including copyright) as part of the terms and conditions of a Federal
grant. Congress could, if it wished, require grantees to assign all
rights to intangible property to the Federal funding agency, as indeed
was the case for patent rights prior to the Bayh-Dole Act of 1980.
However, in recognition of the public interest in having biomedical
scientific publications widely accessible, Congress has required only
that NIH-funded authors reserve the right to post works on PubMed
Central. As one among dozens of conditions imposed on a grantee by
Congress in return for taxpayer support of the grantee's work, the
reservation of this small sliver of the entire bundle of rights
inherent in the work is completely consistent with U.S. Copyright law.
B. Value of Publisher-Held Copyrights if Other Aspects of Copyright Are
Retained by Authors
A few comments indicated concern that posting the final peer-
reviewed manuscript to PubMed Central undermines the value of all other
aspects of copyright that a Publisher may have obtained under the
Policy.
As described above, it is acceptable from a copyright perspective
for investigators to ensure their papers can be posted to PubMed
Central. However, the NIH Public Access Policy applies to awardees, not
publishers. The NIH implemented the Public Access Policy prospectively
to ensure that publishers have the ability to refuse to publish any
paper they wish, for any reason they wish, including not obtaining all
the rights they may prefer from authors of papers arising from NIH
funds. The 12-month delay period and the ability of NIH awardees to
cover publication-related costs from their awards are important aspects
of the Policy created specifically to address concerns of some
publishers and ensure their interests are protected.
These comments concerning loss of value of the copyrighted work
were not supported by data and run contrary to NIH's experience. The
voluntary support of hundreds of journals to collect papers under the
Policy is, perhaps, a reflection of publisher protections in the Public
Access Policy. A significant number of journals support their authors
by volunteering to submit manuscripts, and many more go beyond the
policy by submitting final published articles. Hundreds even deposit
final published articles that do not arise from NIH funds. Many of
these journals also permit their papers to be posted to PubMed Central
before the 12-month maximum delay period. The NIH appreciates the
efforts of all these journals to support the Policy.
C. Section 201(E) of the Copyright Act
One comment raised a concern that Section 201(e) of the Copyright
Act prohibits a requirement for NIH awardees to retain a right to
deposit in PMC. Section 201(e) of the Copyright Act states that when an
individual author's ownership of a copyright has not previously been
transferred voluntarily by that individual author, no action by any
governmental body purporting to seize copyright shall take effect.
Section 201(e) does not apply to the PMC situation for many
reasons. First, the works at issue here are for the most part works in
which the author has already expressly agreed how copyright will be
handled through the employment agreement with their employing
institution (see 201(b) works made for hire). Second, the employing
institution will have previously accepted, as a term and condition of
the grant, the obligation to submit a work created under the grant to
PMC. Third, Congress did not require an involuntary transfer of rights,
or otherwise ``seize'' rights. Rather, it required submission of the
manuscript to PMC. One way of complying with this requirement would be
for the author to retain the right to post, rather than transfer that
right to a third party. Such retention by the author does not
constitute a seizure or involuntary transfer of rights. Copyrighted
material on PMC remains
[[Page 7612]]
fully subject to copyright, and copyright owners may fully enforce
their rights. Fourth, to the extent that the PMC requirement can be
read as a Government-retained interest, Congress often requires funding
agencies to retain certain rights in the public interest in tangible
and intangible property first produced with public funds. To read the
patent or copyright laws as preventing such action would overturn many
long-standing provisions of OMB Circular A-110 as well as the Federal
Acquisition Regulation (F.A.R.) (e.g., rights in data first produced in
its procurement contracts, rights in inventions, rights in computer
software).
D. International Copyright Issues
A few comments suggested that copyright concerns stem from making
materials available on the Internet, and therefore internationally
available. The NIH appreciates that the scientific community is truly
global and interchange among scientists worldwide is essential for
professional and scientific advancement. The Policy applies to all NIH-
funded investigators, including those in foreign countries. The PMC
archive is available through the Internet, and therefore globally.
Copyrights on works displayed in PMC are fully enforceable by the
copyright owners in the U.S. and abroad. The NIH notes that many
publishers post materials to their Web site, which also makes them
globally available.
One comment raised specific concerns about the Berne Convention and
the World Trade Organization (WTO) TRIPS provision. The Berne
Convention's provisions require that member countries provide
protection for literary and artistic works, including scientific
publications. Such protection is of course provided in the United
States by its Copyright Act. The PMC deposition requirement does not
undermine copyright protection of the grantee's work. Copyrights on
works displayed in PMC are fully enforceable by the copyright owners.
Article 2(1) of the Berne Convention is consistent with the widespread
practice of reservation of rights in works by the funders of those
works, which is essentially what Congress did when it required, as a
condition of a grant award, the reservation of the right to place a
grantee's manuscript in PMC. The concern about the Public Access Policy
and potential conflict with Article 13 of the WTO TRIPS is unwarranted
because the requirement does not interfere with the author's commercial
use of the work. Article 13 directs member countries to confine
limitations on exclusive rights to special cases that do not conflict
with the normal exploitation of the work. But the deposition
requirement makes no limitation on the exclusive rights attached to the
work. It merely requires, as a reasonable and mutually agreed condition
of the grant award, that the author or its institution reserves the
right to display the author's manuscript on PMC. If the PMC deposition
requirement violates TRIPS, then any Government procurement contract
that secures rights to works made under the contract would also violate
TRIPS. No compelling argument for that proposition has been presented
to the NIH.
10. Evaluation and Impact
A. Costs to the NIH
Some commenters asked about the operation and implementation costs
of the policy. By building on an existing information technology
infrastructure housed at the NLM, the NIH Public Access Policy is an
exceptionally cost-effective means to accomplish its goals of
archiving, advancing science, and enhancing accessibility. At full
compliance, Public Access would cost the NLM $4.5 million per year
(i.e., submission of 80,000 articles per year). Costs may decrease as a
greater portion of journals submit papers directly to PMC. The NIH
spent an additional $250,000 in fiscal year 2008 in policy-related
staffing costs and contracts, the Request for Information issuance, and
the March 20 Open Meeting. These costs will reduce once implementation
is complete. The NIH does not have estimates on the cost of compliance
and monitoring per grant for NIH staff. Compliance monitoring may add a
few minutes to managing active projects for a subset of NIH extramural
staff and, as such, cannot be assigned to a specific Public Access cost
center.
B. Potential Impact on Publishers
Many commenters touched on potential financial impacts of this
Policy on publishers. Some claimed that the Policy would be harmful. A
subset of these commenters further argued that if journals are
adversely affected by the Policy, it would harm peer review as a whole.
No data demonstrating harm to journals or peer review was submitted.
Some commenters claimed the Policy would not be harmful to
publishers. A few publishers described their experience making papers
publicly available at 12 months or less, both on and off PubMed
Central, without adverse financial impact.
The NIH recognizes the enormous value and critical role that peer-
reviewed journals play in the scientific quality control process. Only
peer-reviewed papers accepted for publication will be posted in PMC.
This Policy is designed to preserve the critical role of journals and
publishers in peer review, editing, and scientific quality control
processes.
As described in FAQ F10, released September 2008, the NIH is not
aware that there will be a substantial impact of the policy on
Publishers. An increasing number of journals already provide the public
with free access to the published article immediately or within one
year of the publication.
The NIH Public Access Policy does not affect authors' freedom to
choose the vehicle or venue for publishing their results. The NIH
expects that its awardees will continue to publish the results of their
research consistent with their professional autonomy and judgment in
order to advance science as efficiently and comprehensively as
possible.
The NIH has posted thousands of papers to PubMed Central under the
NIH Public Access Policy without evidence of harm to scientific
publishing or to journals. Only a portion of articles published in
scientific journals result from research funded by the NIH. Of these
articles, only the final peer-reviewed manuscript is required to be
posted, and it need not be made publicly available for up to 12 months
post publication. Further, the NIH continues its practice of allowing
publication costs, including author fees, to be reimbursed from NIH
awards (see http://publicaccess.nih.gov/FAQ.htm#e3 for more
information).
C. Impact on Science
Many commenters supported the idea that the policy will support the
advance of science. A few asked for measurement of these impacts. The
NIH will consider exploring this issue as compliance rates rise and
more NIH funded papers become available on PubMed Central. The NIH also
encourages the scientific community to explore this issue
independently.
Changes to Date
In response to the feedback received, the NIH communications and
procedures regarding the Public Access Policy have evolved. These
changes are summarized chronologically below.
May 2008
On May 2, 2008, NIH made the changes listed below to the NIH Public
Access Policy Frequently Asked Questions (FAQs). These changes
[[Page 7613]]
provide clarifications and do not signify any changes in policy.
Questions C7, C9, and C10 are new and reflect improvements
to PubMed. These clarify and simplify how awardees can comply with the
fifth specification of the NIH Public Access Policy, which states:
``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.''
Questions A4, B10-B12, C8, C11, D5, E4, E5, F5, and F6
were developed based on questions received by NIH.
NIH has responded to a number of questions about issues
already addressed by the January 11, 2008, version of the FAQs and has
made a number of small changes to many of these FAQ questions to
improve their clarity. The biggest changes are in the wording of FAQs
B1-B5.
The January 11, 2008, FAQ uses the term ``article'' as a
generic word for a peer-reviewed scientific publication and all its
versions. At the March 20, 2008, Open Meeting, some stakeholders
commented that ``article'' could be confused with the term ``final
published article.'' Therefore, this FAQ uses the term ``paper''
instead of ``article.'' The Web site will be updated to reflect this
change as well.
June 2008
The NIH updated the NIH Manuscript Submission System (NIHMS) in two
ways:
Authors, and not Program Directors/Principal Investigators
(PDs/PIs), now approve manuscripts for posting. This change reduces the
effort for PDs/PIs who are not authors of papers that arise from their
award. It also allows these PDs/PIs to more effectively delegate
submission duties to the author who is most familiar with the paper.
PDs/PIs are now notified by e-mail when a manuscript is linked to one
of their awards via the NIHMS.
The NIH modified the NIHMS to allow publishers to fix the
delay period when they submit a manuscript on behalf of their authors.
Authors now must contact the NIH and their publisher if they wish to
change the delay. The NIH expects this direct communication to result
in fewer disagreements about delay periods. In response to concerns
from NIH employee authors, the NIH developed procedures its employees
can use to ensure any manuscripts they write will be submitted in
compliance with the Public Access Policy. These procedures are
accessible at http://publicaccess.nih.gov/nih_employee_procedures.htm.
July 2008
The NIH made several updates to the NIH Public Access Web page to
clarify the submission process. The Web site explains that there are
four methods to ensure that a manuscript is submitted to PubMed Central
in compliance with the NIH Public Access Policy. These methods vary
based on the version of the paper submitted, and the actions undertaken
by the author and publisher.
Method A: Publish in a journal that deposits all NIH-funded final
published articles in PubMed Central (PMC) without author involvement.
Method B: Make arrangements to have a publisher deposit a specific
final published article in PubMed Central.
Method C: Deposit the final peer-reviewed manuscript in PMC
yourself via the NIH Manuscript Submission System (NIHMS).
Method D: Complete the submission process for a final peer-reviewed
manuscript that the publisher has deposited in the NIH Manuscript
Submission System (NIHMS).
August 2008
In response to questions and advice about identifying PubMed
Central Identifiers (PMCIDs), the National Library of Medicine created
a new utility (http://www.ncbi.nlm.nih.gov/sites/pmctopmid) that uses
PubMed IDs (PMIDs) to look up PMCIDs, and vice versa. Users can enter
PMIDs manually or from their PubMed clipboard. The utility will provide
a table of PMIDs with corresponding PMCIDs. For example, an author
could look up all his/her publications in PubMed, save them to the
clipboard, and use the utility to see which ones have PMCIDs.
September 2008
The Request for Information analysis indicated that a number of
FAQs developed in support of the previous voluntary policy remained
relevant under the new Policy requirement. Accordingly these were
slightly modified and reposted to the FAQs. They are:
A5. What are the benefits of posting peer-reviewed papers to PubMed
Central?
F7. Why should there be a public resource of published peer-
reviewed research findings of NIH-funded research?
F8. Rather than archive manuscripts in NIH's PubMed Central, why
not provide links to other Web sites?
F9. Aren't scientific abstracts, which are currently freely
available, sufficient? Why does the public need full-text articles?
F10. Will NIH's Public Access Policy harm scientific publishing?
F11. Will the NIH Public Access Policy harm the quality of peer
review?
NIH also issued a Guide Notice NOT-OD-08-119 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html) informing
PDs/PIs and Institutional Business Officials that they may receive e-
mails from NIH staff if their applications, proposals, or reports
appear to be noncompliant with the NIH Public Access Policy. The Guide
Notice also provides reminders about the instructions for citing
literature in key NIH forms (e.g., the PHS398, SF424, PHS2590) and
through eSNAP.
Current Status
The NIH Public Access Policy requirement took effect April 7, 2008,
during the Request for Information, and after the Open Meeting. The NIH
made a number of improvements based on the feedback it was receiving;
the results of these efforts appear promising. The months following
April 7, 2008, have been marked by increased participation from both
publishers and authors, which has led to increased collection rates for
eligible papers.
The NIH estimates that approximately 80,000 papers arise from NIH
funds each year, and this total serves as the target for the Public
Access Policy. One can gauge the progress of the implementation of the
mandatory Policy by comparing the percentage of NIH-funded papers
collected in the period April 2008 to August 2008 with the rate that
was achieved under the voluntary Policy (May 2005 to December 2007).
As described at http://publicaccess.nih.gov/submit_process.htm,
the NIH provides four methods for submitting papers under the Policy.
With two of these (methods A and B) publishers voluntarily submit final
published articles directly to PubMed Central. With the other two,
(methods C and D) authors and publishers can submit final peer-reviewed
manuscripts to PMC via the NIH Manuscript Submission System (NIHMS). As
Figure 1 indicates, the estimated percentage of final published
articles submitted directly to PubMed Central (methods A and B) has
more than doubled under the new requirement as compared to the earlier
voluntary policy. Rates rose from 12 percent to 26 percent.
[[Page 7614]]
The percentage of manuscripts collected via the NIH Manuscript
Submission System (NIHMS, using methods C and D) more than quadrupled,
from 7 percent under the voluntary policy to an estimated 30 percent
under the requirement.
Overall, the Public Access success rate rose from 19 percent of all
NIH-funded papers to 56 percent of all NIH-funded papers after the
requirement took effect. These first five months show the promise of a
Public Access Policy requirement, though the NIH and its awardees
remain over 40 percent short of their statutory obligation to make NIH-
funded papers available on PubMed Central. Also, while the NIH expects
to post all 56 percent of these NIH papers, most of them will not be
publicly available until 2009.
Future Activities
The NIH expects to continually monitor and refine the
communications and procedures surrounding the NIH Public Access Policy.
These changes will be governed by advice and feedback from
stakeholders, questions to the help desk, and paper collections rates.
The NIH is exploring ways to enhance the utilities on PubMed and
integrate them with bibliographic information on the eRA Commons
Profile. For example, NLM just updated its search management tool
(http://www.ncbi.nlm.nih.gov/sites/myncbi/). This service could
eventually provide a way for PDs/PIs and other authors to track their
papers that arise from NIH funds, associate them with NIH awards, and
automatically obtain PMCIDs as they become available.
The NIH also is exploring ways to facilitate the reporting of
papers arising from NIH awards by NIH project number. These services
will help investigators and their institutions monitor compliance
policy.
The NIH looks forward to continued interaction and advice from the
many public access stakeholders. Comments and questions may be directed
to [email protected].
Note: a full version of this report is available at http://publicaccess.nih.gov/analysis_of_comments_nih_public_access_policy.pdf.
Dated: February 10, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
[FR Doc. E9-3442 Filed 2-17-09; 8:45 am]
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