October 13, 2004
Questions & Answers
1. What is the NIH public access policy proposal?
The public access policy proposal requests NIH-supported investigators
to provide the agency with electronic copies of scientific publications
upon acceptance for publication if the research was supported in whole
or in part by NIH funding. The policy will provide the public, who have
invested substantially in NIH-supported research, with better access to
NIH-funded research publications. This will be accomplished by establishing
a comprehensive, searchable electronic archive of NIH-funded research
publications, providing publicly available access to all.
2. Is the NIH draft public access policy a requirement?
No. It is a request to NIH funding recipients that will enable them also
to meet and fulfill the existing requirement to provide one copy of each
publication in the annual or final progress reports. Submission of electronic
versions of final manuscripts will be monitored as part of the annual
grant progress review and close-out process.
3. What is wrong with the current system?
The current system does not provide NIH with the stable archive of publications
that it needs to manage its research portfolio and ensure the permanent
preservation of these vital published findings. Nor does it provide the
public with the ready access to these records that the draft public access
policy is intended to give.
Currently, individuals who are not affiliated with an academic medical
library or research hospital generally gain access to the peer-reviewed
publications of NIH-funded scientists by visiting a medical library or
by paying for a subscription to journals themselves. NIH's proposed public
access policy would allow individuals to access the peer-reviewed and
published scientific works of NIH-funded scientists through the internet
and without a fee.
4. Why should there be a public resource of published
peer-reviewed research findings of NIH-funded research?
The proposed NIH public access policy is intended to meet several important
goals:
- Creating a stable archive of peer-reviewed research publications to
ensure the permanent preservation of these vital published findings;
- Securing for NIH a searchable compendium of peer-reviewed research
publications that the agency can use to manage its research portfolio
and monitor scientific productivity; and
- Giving the public better access to a time-delayed archive of published
results of NIH-funded research.
5. Rather than archive manuscripts in NIH's PubMed
Central, why not provide links to an entity such as "HighWire"
which contains 650 journals? What about simply linking to another website?
Contrary to private sector databases, PubMed Central (PMC) is a permanent
and stable archive of peer-reviewed research publications.
NIH's policy does not state that PMC, NIH's digital repository for biomedical
and behavioral research, will be the sole repository for these manuscripts
and publications. Others may also choose to post and/or archive them,
subject to permission from any copyright holders.
6. How many publications are associated with NIH-supported
research each year?
NIH funding contributed to research involved in an estimated 60,000 -
65,000 published papers in 2003. NIH developed this estimate by using
information collected through the National Library of Medicine's MeSH-indexing
process, a function supported by PubMed. Additional information on MeSH-indexing
can be found at http://www.nlm.nih.gov/mesh/.
7. What are NIH's Public Access operating costs
likely to be?
For fiscal year 2005, NIH expects that operating costs will be about two
million dollars and between two to four million dollars per year thereafter.
8. What role does NIH have in the current publishing
process?
NIH supports the current publishing process by providing direct costs
to its funded investigators for publication costs. In addition, NIH provides
funds, through indirect costs, to institutions that use these funds for
library journal subscriptions and site licenses. NIH also supports the
current process by encouraging publication of NIH-supported original research
in scientific journals.
9. Is the NIH mandating changes to science, medical,
and technical publishing?
No. NIH is not proposing changes for publishing. The NIH has considered
the wide range of issues related to public access to publications, and
it is NIH’s intent that the policy will preserve the critical role
of journals and publishers in peer review, editing, and scientific quality
control processes. The NIH has established and intends to maintain a dialogue
with publishers, investigators, representatives from scientific associations,
and the public to help ensure that the quality and success of the current
peer-review system is preserved.
10. What are the current time-to-access policies
for science, medical, and technical journals?
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 vs. basic research) and variability
in business models determined by a range of issues including number of
article submissions, acceptance rate, subscription base, and many other
factors. Examples include 7 journals with immediate free access, 23 journals
with free access within 6 months, and more than 100 journals providing
free access at 12 months.
11. What is the anticipated timeframe for providing
the public with access to publications that have been submitted to the
NIH by its investigators?
Currently, many journals provide free access to research papers after
6 months. After listening to the views of publishers, patient advocates,
and scientists, the NIH draft policy requests that 6 months after an NIH-supported
study is published, the publication be made available freely to the public
through PubMed Central (PMC).
12. Will NIH’s draft public access policy
harm scientific publishing?
At this time, NIH is not aware that there will be a substantial impact.
For example, only a portion of articles published in scientific journals
result from research funded by the NIH. As such, it is unlikely that scientists
and libraries would use the draft public access policy in lieu of their
journal subscriptions because they would only receive a fraction of the
journal’s published literature through PubMed Central (PMC). An
increasing number of journals already provide access to the published
article immediately or within one year of the publication. Most of the
highly cited journals provide some form of public access within this timeframe.
Many publishers have apparently determined that public access after six
months is a viable business option.
NIH is currently seeking comments on its draft policy, and we welcome
comments on this issue. In addition, NIH is planning to conduct a study
to evaluate the effects of this policy.
13. How much does it cost to publish a scientific
article?
Publication costs have been reported to range from a few hundred dollars
per article to several thousand dollars per article. For example, see
the analysis in two reports commissioned by the Wellcome Trust, "An
Economic Analysis of Scientific Research Publishing" and "Costs
and Business Models in Scientific Research Publishing" which may
be found at: http://www.wellcome.ac.uk/en/1/awtpubrepcos.html.
14. Can authors and journals continue to assert
copyright in scientific publications resulting from NIH funding?
Yes. The proposed policy does not affect the ability to assert copyright.
Funding recipients may continue to hold copyright in works resulting from
NIH-funded research, and they may assign these rights to journals in accordance
with current practice. Copyright holders may enforce these copyrights
as before. A member of the public viewing or downloading a copyrighted
document from PubMed Central (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.
15. What steps has NIH taken in order to solicit
opinions from its stakeholders regarding this issue and will they have
an opportunity to comment on the proposed NIH policy before it is made
final?
The NIH Director, Elias A. Zerhouni, M.D., has held a series of discussion
meetings to consider the opinions and concerns of representative groups.
These include publishers, scientists, patient advocates, scientific associations,
and other organizations. All of the meetings were open and were designed
to ensure that in-depth discussions of stakeholder issues could occur.
Invitations were extended to a broad base of participants to ensure adequate
and balanced representation of opinions. In many cases, participants represented
more than one stakeholder group, such as scientists who were also editors
and reviewers of prestigious scientific journals.
The NIH intends to maintain this dialogue and encourages public comment
regarding its proposed public access policy. The policy was posted in
the NIH Guide for Grants and Contracts on September 3, 2004, and
in the Federal Register on September 17, 2004. Public comments
on the draft policy are encouraged and will be accepted for 60 days from
the date of publication of the policy in the Federal Register,
which is until November 16, 2004. Comments on short term impacts and suggestions
for mitigating these are especially welcome. We encourage that all comments
be directed to the following NIH website: http://grants.nih.gov/grants/guide/public_access/add.htm.
As an alternative, comments may be submitted by email to the following
address: PublicAccess@nih.gov
or sent by mail to the following address: NIH Public Access Comments,
National Institutes of Health, Office of Extramural Research, 6705 Rockledge
Drive, Room 350, Bethesda, MD 20892-7963.
16. How is the potential impact on publishers
being considered?
Through open meetings with publishers and a public comment period on the
proposed policy, the NIH has established, and will continue, a dialogue
with publishers to help ensure that their opinions and concerns are considered.
The NIH recognizes that the rising global role and importance of the internet
has caused many industries, including publishers of peer-reviewed scientific
articles, to shift business practices to accommodate a changing world.
Currently, a variety of business models exist within the publishing industry
some of which already involve immediate or delayed electronic access
to published scientific works.
17. Are other funding organizations considering
this issue?
Yes. Many other organizations and countries are considering the public
access issue including France, Japan, Germany, the United Kingdom, Australia,
and Canada.
Howard Hughes Medical Institute and the Wellcome Trust are on the record
encouraging and supporting public access for their scientists.
18. Aren't scientific abstracts, which are currently
freely available, sufficient? Why does the public need full text articles?
The public encompasses a wide array of individuals, ranging from the lay
public and educators to health care providers. Many of these individuals
require more information than is provided in an article summary and must
gain access to the complete article. In addition, the goal is to establish
and maintain a centralized, permanent archive of all scientific publications
arising from NIH-funded research.
19. Will this policy be an added burden to NIH-supported
investigators and research institutions?
Public access submissions will provide NIH-supported investigators with
an alternate means by which they will meet and fulfill the requirement
to provide one copy of each publication in their annual progress report.
It is anticipated that investigators applying for new and competing renewal
support from the NIH will also utilize this resource by providing links
in their applications to their PubMed Central (PMC) archived information.
20. Is the NIH draft public access policy related
to the public registration of clinical trials?
The policy does not influence whether or not a clinical trial is posted
on clinicaltrials.gov. However, if it is an NIH-funded trial to test the
effectiveness of a drug to treat a serious or life-threatening disease
or condition, it would likely be posted to clinicaltrials.gov, and a link
would be provided to the full text of the article for the benefit of the
public.
21. Will the draft public access policy apply
to NIH-supported investigators in foreign countries? Will these investigators
be able to access manuscripts and publications on PubMed Central (PMC)?
Yes. The policy is expected to apply to all NIH-funded investigators,
including those in foreign countries
The PMC archive will be available through the Internet, so all investigators
can access it in identical manner. NIH appreciates that the scientific
community is truly global and interchange among scientists worldwide is
essential for professional and scientific advancement. Thus, the policy
will encourage the maximum availability of research publications to scientists
worldwide.
22. Will the NIH draft public access policy harm
the quality of peer review?
No. NIH does not anticipate that its policy will harm or otherwise affect
the peer review process for scientific papers. The draft public access
policy requests that NIH-funded investigators submit their final manuscripts
after acceptance in a peer-reviewed journal.
NIH is aware of the importance of peer review as a hallmark of quality
for journals. NIH also knows that publication in peer-reviewed journals
is a major factor in determining the professional standing of scientists,
and in making hiring, promotion, and tenure decisions. These important
corollary benefits of peer review will not be affected by the draft public
access policy, as the policy preserves and relies on the peer review process.
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