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Science Policy |
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APS Offers Advice on ILAR Guide Update
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In January, the APS Animal Care and Experimentation Committee
submitted comments to a panel convened by the National Academy of Sciences’
Institute for Laboratory Animal Research (ILAR) that has been asked to
update the Guide for the Care and Use of Laboratory Animals. The panel has
been asked to bring the 1996 edition of the Guide into line with “new
scientific information related to the issues already covered in the Guide.”
It is also supposed to “add discussion and guidance on new topics of
laboratory animal care and use related to state-of-the-art animal research
programs.” Several organizations, including FASEB and the American
Association of Immunologists and the American Association of Anatomists,
endorsed the APS statement. The Guide update is expected to be completed in
the fall of 2010. The APS recommended that the updated Guide continue to rely upon “performance-based standards and the exercise of professional judgment” because this approach “represents the best way to optimize animal welfare and the successful achievement of the research objective while minimizing non-productive regulatory burden.” Specific topics addressed in the APS statement included study design; minimizing pain and distress; environmental enrichment; multiple major surgeries; housing; and exercise research. Under Study Design, the APS recommended that the updated Guide encourage IACUCs to rely on outside experts and prior reviews from funding agencies, if needed, to assist them in assessing the scientific merits of a proposal. The statement also noted that “[r]epeating studies to validate or build upon published literature is an important part of the scientific process.” The section on Minimizing Pain and Distress endorsed the general guidelines provided by the 1996 Guide, noting that updated references are needed and should be made available online. The APS cautioned against mandating Environmental Enrichment because many interventions intended as enrichment may have unintended consequences. These include deleterious effects on animal well-being itself or adding confounding variables to the research. The addition of confounding variables leads to a tension between the drive to refine procedures and the drive to reduce the number of animals needed to obtain statistically valid data. The APS also noted that the definition of Major Surgery as “penetrate[ing] and expos[ing] a body cavity” does not take into account newer surgical techniques that are less invasive and produce relatively little post-operative pain or distress. The APS urged that the definition of major surgical procedure be revised to focus on the actual pain or distress of a given procedure because this has the potential to reduce the number of animals needed. Under Housing, the APS provided numerous post-1996 references on the topic of housing densities and noted that there have been many innovations in caging systems. The APS suggested that the Guide eschew setting specific parameters and instead offer “information to help institutions develop and assess performance-based standards” and consider densities, temperatures, and humidity levels, and environmental enrichments as “parts of an integrated environment” instead of as discrete variables. The APS also recommended that the updated Guide incorporate the APS Resource Book for the Design of Animal Exercise Protocols [http://www.the-aps.org/pa/resources/additional/exercise.htm]. |
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In February the APS submitted comments to USDA on a proposal to
require contingency plans to care for animals regulated under the Animal Welfare
Act in the event of an emergency or natural disaster. Under the proposal,
facilities would be required to develop a plan for situations it “might
experience” and to provide training to personnel on plan implementation. USDA
inspectors would also review contingency plans and training as part of regular
AWA compliance inspections. According to the Federal Register notice, the goal
of the proposal was to “heighten the awareness of licensees and registrants
regarding their responsibilities and help ensure a timely and appropriate
response should an emergency or disaster occur.” In the comments submitted on this proposal, APS President Irving Zucker told USDA’s Animal and Plant Health Inspection Service (APHIS) that while the APS concurs that contingency planning is important, the Society has “serious concerns about how APHIS proposes to implement planning and training requirements.” In the Federal Register notice, APHIS acknowledged that due to differences in circumstances among regulated entities it would not try to specify what should be included in contingency plans. The APS concurred that flexibility is appropriate, while noting that it also produces a situation where there are no objective criteria for facilities to develop plans or for APHIS inspectors to evaluate them. The APS also echoed concern raised in comments submitted by National Association for Biomedical Research (NABR) and the Council on Government Relations (COGR) in which they pointed out that the phrase “situations the facility might experience” would create an impossible planning burden for facilities. APS concurred with their recommendation that the phrase “likely to experience” as more appropriate. The proposal also failed to distinguish between contingency planning for emergencies such as a fire, power outage, or equipment failure, as opposed to planning for pervasive natural disasters such as hurricanes, floods, wildfires or earthquakes. One of the lessons to be learned from catastrophic events such as Hurricane Katrina is the fact that while planning is necessary, it may not be sufficient. In extreme cases, effective response may ultimately depend upon timely and accurate information. |
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On February 17, 2009, President Barack Obama signed the American
Recovery and Reinvestment Act of 2009 (H.R. 1). The $789 billion stimulus
measure is aimed at reviving the American economy by providing an infusion of
funds for infrastructure priorities, including scientific research. The National
Institutes of Health (NIH), National Science Foundation (NSF), Veterans Affairs
(VA) and NASA will all receive additional funding under the provisions of the
stimulus. The terms of the legislation stipulate that most of the funds must be
spent before September 30, 2010, and recipients of stimulus money will be
subject to new reporting requirements aimed at increasing government
transparency (1). NIH Thanks to the leadership and vision of Senators Arlen Specter (R-PA) and Tom Harkin (D-IA), the NIH will receive a total of $10.4 billion of stimulus funding. $8.2 billion is allocated to the Office of the Director, $7.4 billion of which will go to the Institutes and Centers and to the Common Fund. The remaining $800 million will be retained in the Office of the Director to fund priority areas of science that can be expected to make measurable progress within two years. The National Center for Research Resources (NCRR) will receive $1 billion for construction and renovation of extramural research facilities and $300 million for shared instrumentation and other capital research equipment. Another $500 million will fund high-priority repair, construction and improvement projects for the NIH intramural campus. The remaining $400 million will go to conduct comparative effectiveness research. The fact that the stimulus money must be spent in the next two years represents a significant challenge for the NIH. With many details yet to be worked out, the NIH has released a broad outline of how the money will be allocated. The research funding will be spent in three categories:
NSF |
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Wondering where newly elected Members of Congress stand on
research issues? Check out FASEB’s new online guide to the 111th Congress. The
website compiles a wealth of resources with information about the more than
sixty freshman Members of Congress, including their statements and positions on
issues such as federal funding for science, stem cell research, regulatory
issues and science, technology, engineering and mathematics (STEM) education, as
well as the amount of federal research money that flows into their state or
district. The online guide also includes links to:
The 111th Congress Information and Advocacy Center can be
accessed at:
http://opa.faseb.org/pages/Publications/ |
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