Congress Congress
Public Affairs
Proposes Smaller Increases For NIH In FY 2004
APS Asks USDA to Withdraw Prescriptive Animal Records Rule
APS Recommends NCRR Investment in Complex Systems Research
APS Panel to Develop Exercise Research Guidelines
NIH Proceeds With Study Section Revisions
Proposes Smaller Increases For
NIH In FY 2004
In June, Congress took the first significant steps towards determining fiscal
year (FY) 2004 funding levels for the National Institutes of Health (NIH) when
the House and Senate Labor Health and Human Services and Education (Labor HHS)
Subcommittees presented their legislation. These bills provide for the NIH and
other government agencies. So far, the news out of the committees is profoundly
disappointing when compared to previous fiscal years.
From FY 1999-2003, the NIH was awarded generous budget increases as part of a
five-year effort to double the agency’s budget. The culmination of these
increases, which averaged 15% per year, came in FY 2003 when the agency received
the final installment of funding to complete the doubling. However, the FY 2004
funding cycle got off to a bad start when the Bush administration put on the
breaks by proposing 2.5% increase for NIH’s first budget of the post-doubling
era. The research and patient advocacy communities looked to the Congress to do
better.
Unfortunately, the situation in both the House and Senate Labor-HHS
Appropriations Committees was no better. When the two committees drafted their
FY 2004 spending plans for the NIH in early June, the House panel recommended
$27.89 billion or a 2.5% increase for NIH in FY 2004, while the Senate panel
recommended $27.98 billion or a 3.7% increase. Increases for NIH research itself
are supposed to be higher in each case due to transfers of funds from what are
characterized as “one time costs” for non-research expenditures. These include
upgrades and new construction of advanced research laboratories, NIH campus
security enhancements, and anthrax vaccine procurement. The House and Senate
Appropriations Subcommittees used transfers of these FY 2003 expenditures to the
research line to enable NIH research to grow at an acceptable rate.
The Labor HHS appropriations bill is one of the biggest and most controversial
appropriations bills. Because of this complexity, it has often been taken up
late in the appropriations season in the hopes that additional funds will be
made available for its programs. Because of this year’s tight budget climate,
this strategy is unlikely to play out. Therefore, members of the House and
Senate Appropriations Committees are working hard to pass the legislation as
quickly as possible. It was rumored that the Senate bill would go to the floor
in the fall, but there has been no timetable set for action on the House
legislation. Thus, there may still be time to urge Congress to provide
additional funds for NIH research.
The ability of the NIH to take advantage of the benefits it has received through
the doubling will be threatened if a funding increase in the range of 2-4%
becomes law. Expert analysis developed by the Federation of American Societies
for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC),
and the Association of American Universities (AAU) showed that if the NIH
funding increases were to dip below 6%, the beneficial impacts of the doubling
would rapidly be dissipated. Writing in a May 2002 Science article, the experts
noted that annual funding increases below 6% would “squeeze competing funding
priorities and force retrogressive choices on NIH leadership.” Future research
would also be affected. The authors point out “at risk would be new research
support, maintenance of previous commitments, adequacy of support for equipment
and shrinking training opportunities.”
The APS supports the Ad Hoc Group for Medical Research Funding and FASEB in
calling on Congress to provide NIH with a 10% increase in FY 2004. In late June
the APS Legislative Action Center posted sample letters to Congress expressing
support for NIH funding to continue the progress that has been achieved due to
the doubling. The URL for these letters is http://www.the-aps.org/pub_affairs/leg_act_cntr/index.htm.
APS Asks USDA to Withdraw Prescriptive Animal Records Rule
The American Physiological Society urged the USDA to drastically revise a
proposed rule that would require extensive medical records to be kept as part of
Animal Welfare Act (AWA) compliance. While endorsing the need for animal health
records, the APS objected to the specifics of the proposal. “In the research
context, [animal] health records typically take a different form than what is
appropriate in a clinical veterinary setting, APS President John A. Williams
wrote in a comment letter to the USDA. “Nevertheless, the clinical setting seems
to be the model for the proposed rule.
“Prescriptive regulatory detail is inappropriate because this rule touches upon
an area that rightfully falls within the scope of the professional judgment of
the attending veterinarian,” Williams wrote. “Most attending veterinarians in
research facilities have been specially trained to manage health problems that
may arise in a research setting,” Williams noted. “APHIS does not claim animal
welfare in research facilities has been jeopardized due to poor record keeping,”
Williams pointed out. “Nevertheless, it proposes to require an expansive system
of animal health records and has seriously underestimated the amount of time
that will be needed and the volume of paperwork that will be generated to
implement it.”
Williams expressed concern that the proposed rule “has significant flaws that
need to be addressed since as presently written, it could hamper the work of
veterinarians and scientists alike.” The APS recommended that the proposed rule
be withdrawn and be “replaced with a simple statement requiring health records
to document an animal’s illness, veterinary, care, and treatment to promote
communication among all those responsible for its care.”
The full text of the APS comments is available on the web at http://www.the-aps.org/pub_affairs/leg_act_cntr/letter.htm.
APS Recommends NCRR Investment in Complex Systems Research
The American Physiological Society submitted recommendations to NIH’s National
Center for Research Resources (NCRR) in conjunction with the updating of the
center’s 1998-2003 strategic plan. The NCRR published a Federal Register notice
on January 29, 2003, asking for input concerning important trends that will
drive biomedical research in the near future, research resources and
technologies critical to addressing those trends, and strategies to eliminate
barriers to progress. NCRR intends to use these comments to develop a new
strategic plan.
In its response, the APS emphasized “the need to translate genomic information
into clinical strategies” and to “transfer knowledge gained from cellular and
molecular studies to the level of actual states of health and disease in entire
organisms.” The complete APS statement is available on the web.
“The mapping of the human genome and the genomes of other organisms has
currently provided biomedical science with an enormous amount of what is
essentially raw information,” the APS noted. “The challenge now is to turn
genomic information into medically useful knowledge.” This will entail
“clarify[ing] how specific genes function in living organisms.” However, because
“the biomedical research community is sorely lacking in the knowledge and skills
needed to assess these findings at the level of living tissues in organs, organ
systems, and whole organisms,” the APS urged NCRR meet this challenge by
investing in the development of complex systems research capacity.
“The future development of our health care capabilities requires that we
transfer knowledge gained from cellular and molecular studies to the level of
actual states of health and disease in entire organisms,” the APS said. This
will require “confirm[ing] insights gained through cellular and molecular
biology in complex physiological systems, namely whole animals.”
The APS recommended that the NCRR develop programs to promote physiological and
functional genomics. NCRR should also “foster coordination of research efforts
at all levels ranging from cellular and molecular through whole animal studies
into clinical application.”
NCRR will hold a retreat this fall to discuss the recommendations it has
received and to formulate a new strategic plan for its programs in biomedical
technology, clinical research, comparative medicine, and research
infrastructure.
APS Panel to Develop Exercise Research Guidelines
A group of exercise physiologists and lab animal veterinarians met in Bethesda
on June 18, 2003 to begin developing a set of “Guidelines for the Care and Use
of Animals in Physical Exercise Research.”
The impetus for this project came from the Steering Committee of the
Environmental and Exercise Physiology (EEP) Section. The initial purpose of the
document was to assist APS journal editors and manuscript reviewers in
determining whether exercise research studies had been conducted with
appropriate consideration for minimizing discomfort and pain for research
animals.
A small planning committee met in December 2002 and decided that the document
would be most useful as a resource that researchers and IACUCs could use in
developing and reviewing the design of exercise studies in conjunction with the
requirements of the Animal Welfare Act, the ILAR Guide for the Care and Use of
Laboratory Animals, etc. The idea is to identify the relevant scientific and
animal welfare considerations to address in developing exercise research
protocols.
The June 18 meeting included an expanded group of exercise researchers as well
as lab animal veterinarians with specialized experience in protocol review.
Topics to be addressed in the guidelines will include reasons why exercise
research is important, study design considerations, and practical advice on
conducting exercise research studies with the most commonly-used animal species.
A first draft of the document is expected later this summer. The NIH Office of
Laboratory Animal Welfare has agreed to provide support for this project.
NIH Proceeds With Study Section Revisions
NIH’s Center for Scientific Review (CSR) effort to revise study sections passed
several milestones in the late spring and early summer when it completed the
final Study Section Boundaries (SSB) Team review meetings, and the first
restructured IRGs was put into place.
The last of the planned 17 SSB Team meetings took place in April 2003 and were
posted for comments. Two months later, the new study sections created under the
restructured Hematology IRG held their first meetings. This marks the beginning
of the implementation phase.
Study sections created as part of the new the Biology of Development and Aging
will hold their first meetings in October. Also in October, the new study
sections under the reorganized Oncological Sciences and Musculoskeletal, Oral
and Skin Sciences (formerly Musculoskeletal and Dental Sciences) IRGs will meet
for the first time.
The CSR Advisory Committee has also granted permission for CSR to proceed with
implementation plans for the following IRGs which will hold their first study
section meetings in February 2004: Cardiovascular Sciences, Digestive Sciences,
Bioengineering Sciences and Technologies, Respiratory Sciences, and Renal and
Urological Sciences.
CSR intends to implement these and other new IRGs as listed in the schedule on
the Implementation Timeline and Developing Study Section Rosters page.
Meeting this timetable will depend upon the availability of appropriate
resources are available to support and staff these IRGs.
For further information on CSR Reorganization Activities, see
http://www.csr.nih.gov/review/reorgact.asp.
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