Public Affairs
FY 2005
Budget Proposal Falls Short for Research
FY 2004 Funding Finally Approved
Facing the Challenge of Animal “Personhood”
NIGMS to Sponsor Short-term Training Opportunities
AAHRPP Accreditation Taking Hold
On March
16, 2004, the American Physiological Society, along with 47 other leading
scientific, health and medical organizations representing over 600,000
scientists and physicians, held a press briefing to offer their response
to advocates of “open access” to science. The participating
organizations publish 380 journals per year and have collectively archived
over 800,000 articles on their journal web sites with over half of the
articles available at no cost to the reader.
The Washington DC Principles for Free Access to Science grew
out of discussions the signatories have been having since 1996 about how
best to enhance the experience of readers who use our online journal
content. By last fall, however, these organizations began to wonder if the
voice of small, not-for-profit publishers could be heard above the noise
being generated by advocates of open access publishing, and concerns over
the high subscription prices charged by commercial publishers. Against
this backdrop it was decided that we could—and should—be heard.
As indicated during the press briefing, proponents of the DC Principles
see their mission as one which maintains and enhances the independence,
rigor, trust, and visibility that have established not-for-profit
scholarly journals as reliable filters of information emanating from
clinical and research laboratories.
Since the late 1990s, these not-for-profit publishers have
sought to make the content of their journals as accessible as possible to
their members, the scientific community and the public within the
framework of their business models. In some cases, that meant that content
was freely available almost immediately or after a short delay based on
the society’s business model. Even when the content is under access
control, non-subscribers can gain access to individual articles for a
small user fee. As not-for-profit publishers, we have to be fiscally
responsible to our organizations, to our members and to our disciplines to
ensure our ability to continue to publish the scientific and medical
research of our authors and to maintain the integrity of our online
journal collections.
The organizations who have signed the DC Principles are not
“for profit” organizations. . . .nor are they “for loss”
organizations. Many of the organizations, including the APS, do make
profits from their journals, or from their scientific meetings. However,
as “not-for-profit” publishers, any profit that is made goes back into
the organizations for the development of the next generation of
scientists, through awards, fellowships, meetings and conferences, and
outreach to the community.
The signatories of the DC Principles use business models that
derive revenue from multiple sources in order to make their content as
freely available as possible to their communities, to the public, as well
as to scientists in underserved countries. It is difficult for the
signatories to envision how a business model dependent on one revenue
source can succeed in an era of shrinking Federal support for science and
in which many US and foreign scientists are undertaking research on
limited budgets.
Those individuals participating in the press briefing
represent a collaborative effort to tell the story of the not-for-profit
publisher. The panelists for the press briefing on the DC Principles
included:
Robert D. Wells is President of the Federation of
American Societies for Experimental Biology (FASEB). FASEB represents 22
professional societies, consisting of more than 65,000 biomedical research
scientists. Wells is the former associate editor of the Journal of
Biological Chemistry and is currently the Director of the Center for
Genome Research at the Institute of Biosciences and Technology, Texas
A&M University, Houston, TX.
John K. Iglehart has been the editor of Health
Affairs, a journal he founded under the aegis of Project HOPE, since
1981. Health Affairs is a peer-reviewed, multidisciplinary journal, and is
the largest circulation health policy periodical published in the United
States. The bimonthly policy journal also counts subscribers in 25 foreign
countries. Iglehart holds a degree in journalism from the University of
Wisconsin-Milwaukee and has been a journalist-in-residence at Harvard
University.
Alice Villalobos is an Assistant Professor in the
Department of Environmental Medicine at the University of Rochester School
of Medicine and Dentistry, Rochester, NY. Since she was a graduate
student, she has been mentored by the American Physiological Society,
thanks to funds derived in part from the Society’s publication program
and has applied to education and training fellowships and minority
outreach programs. She has participated in the Explorations in Biomedicine
and Research Careers program and sits on the Perkins Committee that
oversees distribution of supplemental funds to international scientists
working in the US.
Karin Wittenborg has been University Librarian at the
University of Virginia since September 1993. Prior to joining the
university she held professional positions at the University of California
at Los Angeles (UCLA), Stanford University and the State University of New
York. She currently serves on the Advisory Council for Stanford’s
Academic Computing and Libraries, Brown University’s Committee on
Information Resources, and on the Executive Committee of the Digital
Library Federation.
William Rosner is Professor of Medicine and Associate
Dean, College of Physician and Surgeons, Columbia University, and
Director, Institute of Health Sciences, St. Luke’s-Roosevelt Hospital,
New York, NY. Rosner is also the past Chair of the Publications Committee
for the Endocrine Society. His major area of clinical interest is
androgenic disorders in women.
Martin Frank spokesperson for the Principles and
Executive Director of the American Physiological Society (APS), one of the
oldest biomedical sciences research societies in America. The non-profit
association has published the American Journal of Physiology since 1898
and presently publishes 13 other journals.
FY 2005 Budget Proposal Falls Short For Research
Facing an
expensive war in Iraq, pressure from fiscal conservatives in Congress, and
a soaring federal budget deficit, President George Bush unveiled his FY
2005 budget plan on February 2, 2004. Unfortunately, Mr. Bush’s promise
to hold the line on federal spending came at the expense of biomedical
research and other domestic programs.
The article below provides highlights of the FY 2005 budget proposal for
selected biomedical research agencies. The accompanying article describes
final FY 2004 spending levels that were approved by the 108th Congress on
January 23, 2004.
National Institutes of Health
With an election year looming at the end of 2004
and the deficit rising, the Administration was looking for ways to keep
spending down. The President is proposing a $28.7 billion budget for NIH
in FY 2005. This is a 2.6% increase or $900 million over the FY 2004
level. After enjoying double-digit budget increases from FY 1998 through
FY 2003, NIH came in for a hard landing in FY 2004 with a budget increase
of only 2.8%, and the FY 2005 proposal continues this trend by
recommending another minimal increase.
Under President Bush’s budget proposal, NIH would
fund 258 additional research project grants (RPGs), but this growth in
grant numbers means cuts in the size of grants. The proposed budget would
allow NIH to fund a total of 10,393 new and competing awards. This is a
2.5% increase over FY 2004.
However, to help shore up grant numbers, the NIH is
squeezing the size of the grants. The new batch of NIH grants will be only
1% bigger than this year’s. Continuing grants will grow by 1.9%, which
is well below the projected 3.5% inflation rate for biomedical research
costs. The total number of grants including 27,351 ongoing projects would
be 37,744 grants in FY 2005.
Last year, NIH Director Elias Zerhouni unveiled his
Roadmap Initiative. Under the FY 2005 budget, this project is allocated
$237 million, an increase of $109 million over FY 2004. Of this total, the
Office of the Director would receive $60 million (up from $35 million in
FY 2004). These are funds Zerhouni can distribute. The remaining $177
million is to come from NIH institutes and centers, each of which would
contribute .63% of its budget to Roadmap projects.
The budget plan also recommends funding levels for
three Roadmap initiatives. New Pathways to Discovery would get $137
million, Multidiscipli-nary Research Teams for the Future would be funded
at $39 million and Re-engineering the Clinical Research Enterprise would
receive $61 million.
In response to the possible threat of bioterror attacks, the FY 2005
budget includes $1.7 billion for bioterror countermeasures. This is an
increase of $121 million or 7.5% over FY 2004. Within that amount $150
million is targeted for construction of an additional 20 Biolevel 3
laboratories at universities and research institutes across the country.
In an effort to boost funding for the NIH, APS joined
with FASEB and the Ad Hoc Group for Medical Research Funding in calling on
the President and Congress to keep the momentum of the doubling alive by
providing NIH with $30.6 billion in FY 2005. This would provide a 10%
increase over FY 2004 levels. In late February, Congress had its first
chance to declare its budget priorities when the Senate Budget Committee
met to mark up its FY 2005 budget resolution. (The budget resolution sets
broad spending targets intended to guide the appropriations process.)
The Senate Budget Committee’s original draft
resolution contained $9 billion less than the President’s budget for
non-defense spending—including NIH. Calling upon the Senate to correct
this deficiency, FASEB President Robert Wells asked the Senate Budget
Committee to add more money for scientific research. “If we reduce our
commitments to scientific research,” he said in a press statement, “We
compromise our future prosperity.”
Senate biomedical research champion Arlen Specter
(R-PA) took the lead in seeking an increase. When the budget resolution
came to the floor, Sen. Specter offered an amendment to increase funding
for the NIH by an additional $1.3 billion to bring the resolution’s
overall allocation for the NIH to approximately $29.9 billion. This would
be an increase of 7.2% over FY 2004 levels. In the early morning hours of
March 12, Senator Specter’s amendment passed by a margin of 72-24. The
additional funds are scheduled to come from a one-sixth of one percent cut
in travel and administrative expenses throughout the federal government.
Because the budget resolution is only a blueprint for the appropriators to
follow when assigning money to government programs, the Specter
amendment—while a positive step forward—does not guarantee that NIH
will ultimately get a 7.2% increase.
As of this writing, the House Budget Committee has not
scheduled a mark-up of its budget resolution.
National Science Foundation
The National Science Foundation (NSF) also saw a
smaller proposed budget increase in the President’s budget plan. Under
Bush’s proposal, the NSF would receive $5.7 billion in FY 2005. This is
a 3% increase or $167 million over FY 2004 levels. This falls well short
of the $7.3 billion that would be needed to bring about a five year
doubling of the NSF budget, a goal both the president and Congress
endorsed in the NSF reauthorization bill that the president signed in
December 2002.
The NSF’s Research and Related Activities (R&RA)
account overall would receive $4.5 billion, a 4.7% increase or $201
million more than FY 2004. However the Biological Sciences Directorate
(BIO) would receive an increase of only 2.2%.
The small increases for the research directorates would
squeeze NSF funding of competitively awarded research grants. This year
NSF expects to fund only 6,145 research grants, a decline of 72 from this
year’s expected total. The BIO directorate would be able to fund 2.6%
fewer grants than FY 2004.
VA Medical and Prosthetic Research
The President’s FY 2005 budget proposal includes $770
million for VA Medical and Prosthetics Research. Of that total, however,
only $385 million will go towards the direct costs of research. This is a
decrease of 5.1% or $20.6 million less than FY 2004 levels.
The FASEB Consensus Conference and the Friends of VA Medical Care and
Health Research (FOVA) are recommending an FY 2005 funding level of $460
million for the direct cost of research. This would represent a $52
million or 13% increase over the FY 2004 funding level.
NASA
On January 14, 2004, President Bush unveiled his new
space exploration policy called “A Renewed Spirit of Discovery.” This
plan calls for completing the International Space Station by 2010,
replacing the shuttle with a new crew vehicle and establishing an extended
presence on the moon to serve as a launching point for future human space
flight missions to far off places, such as Mars.
The FY 2005 budget reflects these near-term priorities.
NASA’s FY 2005 budget is $16.2 billion, a 5 % increase over FY 2004.
However, most of the increase will go for the non-R&D priority of
making safety improvements needed to return the shuttle to flight and
construction on the international space station.
Under President Bush’s FY 2005 budget, NASA’s
Office of Biological and Physical Research would get $1 billion, an
increase of 6% over FY 2004.
FY 2004 Funding Finally Approved
On
January 23, 2004, the Senate approved omnibus legislation to fund
government agencies for the fiscal year that began October 1, 2003. The
$820 billion spending bill provides funding for biomedical research
programs at the NIH, NSF, VA, and NASA. The highlights of the budget are
provided below.
National Institutes of Health
The NIH’s FY 2004 budget effectively marks the end of the
agency’s five-year run of 14 to 15 percent annual increases. The
legislation officially provides NIH with $28.0 billion in FY 2004, but it
also calls for various fund transfers and an across-the-board cut that
reduces the amount available for NIH programs to $27.8 billion. This
amount represents a 2.8% increase or $763 million above the FY 2003 level.
Although other federal programs did not fare even this well, the increase
is well below the 10% advocated by the biomedical research community. Both
FASEB and the Ad Hoc Group that NIH had recommended a $30.6 billion budget
for the NIH in FY 2004 to move forward with research opportunities.
The omnibus bill included $128 million for activities related
to NIH Director Elias Zerhouni’s NIH Roadmap Initiative. Of this total,
$35 million will come from the Office of the Director, while the
Institutes will fund the remaining $93 million.
The legislation also instructed the Director to use $7.5
million in Roadmap funds to support innovative projects such as those
funded in the Department of Defense’s Defense Advanced Research Projects
Agency (DARPA). On January 20, 2004, NIH announced the first such
initiative. The Director’s new “Pioneer Awards” will provide up to
$500,000 a year for five years in direct costs to researchers “who have
the potential to make extraordinary contributions to medical research.”
According to the NIH, applicants will have the intellectual freedom to
pursue their ideas and follow them in expected or even unexpected
directions. (See
http://nihroadmap.nih.gov/highrisk/initiatives/pioneer/.)
Developing defenses against biological terrorism is a high
priority. Biodefense research and development will account for $1.6
billion of the NIH budget, down slightly from the $1.7 billion allocated
for this in FY 2003. Most of these funds will go to the National Institute
of Allergy and Infectious Diseases (NIAID), which received a 16.3%
increase, bringing its budget to $4.3 billion. Funds for
investigator-initiated biodefense research grants will more than double in
FY 2004.
National Science Foundation
The NSF budget for FY 2004 is $5.6 billion. This is an
increase of $300 million or 5% over FY 2003 levels. Although this total is
well above the President’s request of $5.48 billion, it still falls short
of the $6.39 billion recommended by the FASEB Consensus Conference to
achieve a doubling of the NSF budget by FY 2007.
NSF’s Research and Related Activities (R&RA) will be funded
at $4.3 billion in FY 2004. This is $195 million or 4.8% more than the FY
2003 level. The various NSF research directorates received increases
between 3% and 7%, with the Biological Science Directorate (BIO) coming in
at the low end with a 3% increase. The NSF’s Education and Human Resources
programs will be funded at $939 million. This represents a 4% increase or
$36 million above the FY 2003 level.
VA Medical and Prosthetic Research
The omnibus legislation provides the VA medical and
prosthetics research with $406 million. This represents an $8 million
increase over FY 2003 levels.
NASA Office of Biological and Physical Research
The Office and Biological and Physical Research within NASA
will be funded at $990 million in FY 2004, an increase of 55 million or
5.9% over FY 2003 funding levels.
Facing the Challenge of Animal “Personhood”
For many
years animal activists have argued that animals deserve rights. This
viewpoint was once considered extreme, but it has begun attracting
attention from mainstream legal thinkers who are exploring the notion that
animals deserve more protection than the legal system currently provides.
For
the most part, the law considers animals to be property. This means that
the owner must take legal and financial responsibility if an animal
destroys property or causes harm to a person. On the other hand, if
someone harms an animal, the owner is entitled to damages. However, these
damages are generally limited to the economic value of the animal. Owners
also have significant latitude concerning the fate of an animal, i.e.,
decisions about its living environment, medical treatment, etc.
The
law provides some notable exceptions to the treatment of animals as
property. For example, anti-cruelty laws allow the government to intervene
if people mistreat their animals. Although in most states research is
exempt from anti-cruelty laws, it is still subject to government
oversight. However, since many activists distrust researchers and consider
research to be inherently cruel, this arrangement is unsatisfactory to
them.
There
is growing interest in the field of animal rights law. Nearly three dozen
law schools offer classes in animal rights law, and a number of local bar
associations have established interest sections on animal rights law.
These efforts are aimed at passing laws and using the courts to revisit
the legal status of animals and provide greater protection for them.
Some
of these efforts may seem benign enough. A number of localities have
passed ordinances changing the term pet “owner” to “guardian.”
While this change alone does not affect the content of the laws, some see
this change in terminology as a preliminary step toward getting the courts
to consider animals as legal “persons.” Advocates argue that it is
only intended to encourage a greater sense of responsibility towards
animals.
The long-term goal of the animal rights legal strategists is to get the
law to recognize that animals have interests apart from human beings’
interest in them. The traditional view is that human beings have legal
privileges such as rights, certain mental characteristics such as the
ability to make tools, use language, and be self-aware. However, as our
understanding of animal cognition has progressed, these distinctions are
falling by the wayside as animals demonstrate mental abilities and social
behaviors once seen as characteristically human.
One
line of animal rights argumentation goes that if an animal has mental
characteristics similar to those of humans, then for the sake of fairness,
society ought to provide it with the same kinds of rights that a human
being of similar mental characteristics would be guaranteed. The argument
is not that these animals should vote, but rather that they should have
certain protections, such as the right to be governed by their own
preferences or by what is in their own best interests. If this view were
adopted, it could well mean that an increasing number of animal species
could no longer be used as subjects of biomedical research.
One
of the intermediate goals of animal rights law activists is to have the
courts accept animals as “persons” and to allow court cases to be
brought on their behalf. This is known as granting legal “standing,”
which provides access to the courts for the resolution of grievances. Such
a move could open the door to an endless stream of court cases objecting
to biomedical research and every other human endeavor that involves
animals.
The
biomedical research community must find a way to address these challenges.
What should be the status of animals before the law? Is there a meaningful
distinction between humans and animals, and if so, what is it? Is this a
matter of “fairness” or should it be decided on some other grounds?
The answer to these questions clearly will not be found in science alone.
The APS has joined with a number of other scientific societies in seeking
guidance from legal experts on how to answer these questions.
NIGMS to Sponsor Short-term Training Opportunities
In
January, the NIGMS Council approved the concept for a new program of
grants to develop short-term graduate level training program in
integrative and organ systems pharmacology and physiology. A Request for
Applications is expected to be published this spring with an application
deadline some time in the summer.
NIGMS
Council approved the concept after hearing evidence that both academia and
industry are concerned about the low numbers of graduate students
receiving training in how to choose and use whole animal models. It
was noted further that this problem is complicated by the fact that many
academic institutions no longer have the faculty and facilities to provide
appropriate training.
The goal of these R-25 Educational Project grants would
be to foster the creation of short-term, intensive training. Awards are
expected to be in the range of $100,000 to $200,000 per year, with funds
available to help cover PI and faculty salaries, organizing expenses,
course development, equipment, supplies, student room and board, and
travel expenses.
NIGMS will set aside $500,000 for this program and will
seek additional funding from other NIH components, participating
institutions and industry. NIGMS would like to fund at least two or three
awards in the first year of the program. The grants will run for three
years.
Specific course design requirements will be outlined in
the RFA, but the concept paper suggested that programs should provide a
two to three week total immersion experience including lectures, labs, and
seminars. The training should be designed to meet the needs of academia,
industry, and government. Institutions in academia as well as industry are
encouraged to apply for these training grants. For more information,
contact Peter Preusch of NIGMS at 301-594-5938 or preuschp@nigms.nih.gov.
AAHRPP Accreditation Taking Hold
The
Association for the Accreditation of Human Research Protection Programs (AAHRPP),
founded in 2001 as a means for organizations to demonstrate their
commitment to protecting research participants, is making progress in its
efforts to create a voluntary, peer-reviewed, and educational
accreditation program.
Since
May 2003, accreditation has been awarded to six organizations: Baylor
Research Institute, Catholic Medical Center, Hunter Holmes McGuire VA
Medical Center, New England Institutional Review Board, The University of
Iowa, and Western Institutional Review Board. AAHRPP purposefully designed
its program and accreditation standards to be applicable in the diverse
settings where human research occurs.
Many institutions are engaged in some stage of the accreditation process:
reviewing policies and procedures, conducting the self-assessment,
preparing for a site visit, or responding to the AAHRPP site visit report.
The
Department of Energy recently announced that its laboratories that conduct
significant amounts of human research will seek accreditation in 2004.
In
September, the Centers for Disease Control and Prevention awarded AAHRPP a
three-year grant to assess the role of accreditation in enhancing the
protection of participants in public health research. Pilot measures will
be developed and implemented in several locations, and then refined and
made available to public health research partners to document and evaluate
the impact of accreditation.
The
Secretary’s Advisory Commission on Human Research Protection issued a
preliminary report on accreditation in December: “The [Accreditation]
Subcommittee supports the concept of accreditation of Human Research
Protection Programs (HRPP’s) for the protection of human subjects in
research. Accreditation promises to be a useful mechanism for all
organizations involved in human research that, like education and
certification, leads to self-improvement of systems and outcomes.” The
subcommittee interviewed institutional officials from two AAHRPP-accredited
organizations in its deliberations.
All
of these activities indicate that accreditation is beginning to fulfill
its promise as an effective mechanism for insuring that research
organizations comply with federal regulations governing research, but more
importantly, that they maintain comprehensive human research protection
programs.
AAHRPP
was founded three years ago by FASEB and six other national organizations
in an environment of grave concern: because of the shutdowns of major
research programs by the federal government, research programs overall
were being intensely scrutinized by lawmakers and by the media.
Congressional bills to regulate research more rigorously were introduced
in both the House and the Senate.
AAHRPP
came together as a means for self-regulation by the research community. If
research organizations were willing to subject themselves to a rigorous
process of peer review and education, then further regulation could be
avoided. Although high-profile research incidents have not occurred in
several years, there is still interest among legislators in further
regulating in this area, as demonstrated by Rep. Diana DeGette’s
introduction of a bill in the House last November.
We
welcome your questions about any aspect of the AAHRPP accreditation
program.
Information: Marjorie Speers, mspeers@aahrpp.org,
202-783-1112; Todd Bentsen, tbentsen@aahrpp.org,
202-783-8133.
Marjorie A. Speers,
Executive Director,
AAHRPP