October 21, 2004
Public Access Comments
National Institute of Health (NIH)
Office of Extramural Research
6705 Rockledge Dr., Room 350
Bethesda, MD 20892-7963
Attention: Dr. Elias Zerhouni, Director
RE: FR Notice, September 17, 2004
Vol. 69, No. 180, Page 56074
Enhanced Public Access to NIH Research Information
Dear Dr. Zerhouni:
We understand that NIH plans to develop a process that is designed to ensure
that scientific information arising from federally-funded research will be made
available to the public within six months after publication in a journal. We
fully endorse NIH's goal of providing public access to information about federally-funded
research, and we applaud NIH's announced intent to implement this goal. We are
concerned, however, that whatever process the NIH adopts does not result in
unintended consequences that may ultimately compromise this goal of public access
to peer-reviewed, credible information.
The National Organization for Rare Disorders (NORD) is the primary non-profit
consumer organization representing 25 million Americans affected by rare diseases.
NORD advocated for, and succeeded in having written into law, the "clinicaltrials.gov"
Web site. Making research information available to the public and scientific
community is of utmost importance to our constituents, and certainly all taxpayers
deserve open access.
The public, including people with rare diseases and their families, need timely
access to peer-reviewed reports of research findings that have been edited in
response to reviewers’ and editors’ recommendations. The NIH process
that is adopted should not result in unintended consequences that in the long
run may undermine the public’s access to the current scientific quality
control process, and that depends on “ability to pay” as an arbiter
of what is published. We caution, in particular, that any government changes
to the existing publication processes should not adversely affect access to
publications that contain articles that do not have broad public interest, such
as articles reporting on research on specific rare diseases. Additionally, we
caution that any process that the government adopts does not compromise the
ability of researchers working on rare diseases to publish in peer-reviewed
journals.
Among the possible unintended consequences of the NIH process currently under
consideration could be erosion of copyright protection, and of financing from
advertisers and subscribers that currently supports peer-review, editing, and
prompt publication of manuscripts reporting on federally-funded research, including
that for rare diseases. These consequences, in turn, could result in selective
publication of only privately-financed research, publishing of only positive
results of clinical trials, or publishing of articles based on researchers’
ability to pay.
Concerning this last point, for instance, the current NIH proposal may cause
more journals to move towards a pay-to-publish system, such as the one utilized
by PLoS, which requires investigators to pay $1,500 to cover the costs of peer
review and editing. NORD receives donations to support small pilot research
grants, selected by expert scientific advisors, on various rare diseases, and
we and our donors and our funded researchers would not be well served by a policy
that requires each grantee to spend $1,500 of our hard earned donations to get
published. From the perspective of an organization such as ours, the current
system of journal publications financed by advertising and subscriptions may
have its faults, but it enables us to maximize the amount of research we can
fund.
The NIH and journal editors will have a better grasp of the issues and likely
consequences than will NORD, so we do not here try to envision the many outcomes
of various approaches. Rather, NORD urges that whatever process is adopted ultimately
serves the public’s access to credible information, including results
of research on rare diseases.
The implications for copyright protection are not clear. Some publishers already
provide full texts of journal articles, a practice we welcome. However, it is
unreasonable to believe that all journal publishers should forfeit their copyright
after providing peer review and editorial services. We agree with the New
England Journal of Medicine editorial (Sept. 23, 2004, Vol. 351:1343, No.
13, Drazen & Curfman) that in the absence of copyright, portions of journal
articles could be used for commercial purposes, and publishers "could not
seek recourse in the courts to halt this misuse of scientific data and potential
danger to the public." We would like to see the system evolve so that more
publishers are willing to provide free access to articles, but we recognize
the seriousness of the concerns that have been raised with respect to the NIH
plan, and urge the NIH to clarify how the plan would affect copyright issues.
Other problems that we see in the current environment include:
- Without credible peer review, scientists may make unfounded claims that
could circulate on the Internet forever. We see this now in the context of
trials published in biased journals with hidden commercial sponsorship.
- When researchers ignore the negative aspects of a study while stressing
only the positive findings, patients are placed at risk.
NORD appreciates the NIH’s efforts to improve access to peer reviewed
research study results. We urge you to:
- Assure journal publishers that they will be permitted to maintain their
copyright under the current NIH plan, if that is indeed the case.
- Clarify whether NIH is requesting or requiring the participation of journal
publishers
- If NIH is requiring participation of federally-funded researchers, will
PubMed Central accept unedited articles that have not been peer reviewed?
If the answer is yes, will the public be notified that the unedited article
has not passed the riggers of peer review?
- The new federal policy should not adversely affect the ability for rare
disease investigators, with or without federal funding, to publish their study
results.
We appreciate your attention to our suggestions, and hope they are helpful
in informing the discussion about the proposed plans as they relate to public
access to rare disease research results.
Sincerely,
Abbey S. Meyers
President
National Organization for Rare Disorders (NORD)
P.O. Box 1968
Danbury, CT 06813-1968
203-744-0100
http://www.rarediseases.org
Check here to read about events on Capitol Hill, funding for rare-disease research, and other topics of interest from NORD's office in Washington, DC.