ࡱ > bjbj 06 { { R 7 7 l Hj # % % % % & X * | d- @ Gh Ih Ih Ih Ih Ih Ih $ 2l n mh . n& " & . . mh 7 7 % % k j 7 7 7 . 7 8 % % Gh 7 . Gh 7 7 b o 3g % Ș3 . p e H 3h j 0 Hj e h lo $/ lo 3g lo 3g . . 7 . . . . . mh mh 7 . . . Hj . . . . lo . . . . . . . . . : B H S U A N I M A L S T U D Y P R O P O S A L
L e a v e B l a n k
P r o p o s a l # :
A p p r o v a l D a t e :
E x p i r a t i o n D a t e :
P L E A S E T Y P E :
A D M I N I S T R A T I V E D A T A
D e p a r t m e n t : F O R M T E X T
P r i n c i p a l I n v e s t i g a t o r : F O R M T E X T
M a i l i n g A d d r e s s : F O R M T E X T
T e l e p h o n e : F O R M T E X T F a x : F O R M T E X T E - M a i l : F O R M T E X T
P r o j e c t T i t l e : F O R M T E X T S t a r t D a t e : F O R M T E X T
I n i t i a l Submission: FORMCHECKBOX Renewal: FORMCHECKBOX or, Modification: FORMCHECKBOX
List the names of all individuals authorized to conduct procedures involving animals under this proposal and identify key personnel (e.g., co-investigator(s), providing their department, telephone, fax, and email: FORMTEXT
F u n d i n g S o u r c e : F O R M T E X T
A N I M A L R E Q U I R E M E N T S
G e n u s : [ e . g . , m u s ] F O R M T E X T S p e c i e s : [ e . g . m u s c u l u s ] F O R M T E X T
S t r a i n , s u b s p e c i e s , o r b r e e d : [ e . g . , C 5 7 B L ] F O R M T E X T C o m m o n n a m e : [ e . g . , b l a c k l a b o r a t o r y m o u s e ] F O R M T E X T
A p p r o x i m a t e a g e : F O R M T E X T W e i g h t : F O R M T E X T o r , S i z e : F O R M T E X T S e x : F O R M T E X T
B a c t e r i o l o g i c a l s t a t u s : [ e . g . , g e r m f r e e ( a x e n i c ) , d e f i n e d f l o r a ( g n o t o b i o t i c ) , s p e c i f i c p a t h o g e n f r e e , c o n v e n t i o n a l ] : F O R M T E X T
V i r a l s t a t u s : [ e . g . , s i m i a n i m m u n o d e f i c i e n c y v i r u s , s i m i a n r e t r o v i r u s ] F O R M T E X T
S o u r c e ( s ) : [ e . g . , n a m e o f v e n d o r , o r b r e e d e r , b r e d i n - h o u s e ] F O R M T E X T
P r i m a r y h o u s i n g l o c a t i o n ( s ) : [ F a c i l i t y manager must certify below that facility has the resource capability to support the study. If animals will be housed in lab or anywhere else outside central facility for more than 12 hours, provide building and room number.]
Location(s) where manipulation will be conducted: FORMTEXT
N u m b e r o f A n i m a l s t o b e U s e d : Y e a r 1 : F O R M T E X T Y e a r 2 : F O R M T E X T Y e a r 3 : F O R M T E X T T o t a l : F O R M T E X T
T R A N S P O R T A T I O N
T r a n s p o r t a t i o n o f a n i m a l s m u s t c o n f o r m t o a l l i n s t i t u t i o n a l g u i d e l i n e s / p o l i c i e s a n d f ederal regulations. If animals will be transported on public roads or out of state, describe efforts to comply with USDA regulations. If animals will be transported between facilities, describe the methods and containment to be utilized. If animals will be transported within a facility, include the route and elevator(s) to be utilized. FORMTEXT
S T U D Y O B J E C T I V E S
B r i e f l y e x p l a i n i n l a n g u a g e u n d e r s t a n d a b l e t o a l a y p e r s o n , t h e a i m o f t h e s t u d y a n d w h y t h e s t u d y i s i m p o r t a n t t o h u m a n o r a n i m a l h e a l t h , t h e a d v a n c e m e n t o f k n o w l e d g e , o r t h e g o o d o f s o c i e t y . F O R M T E X T
R A T I O N A L E F O R A N I M A L U S E ( U s e a d d i t i o n a l s h e e t s i f n e c e s s a r y . )
E x p l a i n y o u r r a t i o n a l e f o r a n i m a l u s e . [ T h e r a t i o n a l e s h o u l d i n c l u d e r e a s o n s w h y n o n - a n i m a l m o d e l s c a n n o t b e u s e d . ] F O R M T E X T
J u s t i f y t h e a p p r o p r i a t e n e s s o f t h e s p e c i e s s e l e c t e d . [ T h e s p e c i e s s e l e c t e d s h o u l d b e t h e l o w e s t p o s s i b l e o n t h e p h y l o g e n e t i c s c a l e . ] F O R M T E X T
J u s t i f y t h e n u m b e r o f a n i m a l s t o b e u s e d . [ T h e n u m b e r o f a n i m a l s s h o u l d b e t h e m i n i m u m n u m b e r r e q u i r e d t o o b t a i n s t a t i s t i c a l l y v a l i d r e s u l t s . ] F O R M T E X T
D E S C R I P T I O N O F E X P E R I M E N T A L D E S I G N A N D A N I M A L P R O C E D U R E S
( U s e a d d i t i o n a l s h e e t s i f n e c e s s a r y . ) F O R M T E X T
B r i e f l y e x p l a i n t h e e x p e r i m e n t a l d e s i g n a n d s p e c i f y a l l a n i m a l p r o c e d u r e s . T h i s d e s c r i p t i o n s h o u l d a l l o w t h e I A C U C t o u n d e r s t a n d t h e e x p e r i m e ntal course of an animal from its entry into the experiment to the endpoint of the study. Specifically address the following:
Experimental injections or inoculations (substances, e.g., infectious agents, adjuvants, etc.; dose, sites, volume, route, and schedules). FORMTEXT
B l o o d w i t h d r a w a l s ( v o l u m e , f r e q u e n c y , w i t h d r a w a l s i t e s , a n d m e t h o d o l o g y ) . F O R M T E X T
S u r g i c a l p r o c e d u r e s ( p r o v i d e d e t a i l s o f s u r v i v a l a n d n o n - s u r v i v a l s u r g i c a l p r o c e d u r e s i n S e c t i o n G . ) . F O R M T E X T
R a d i a t i o n ( d o s a g e a n d s c h e d u l e ) . F O R M T E X T
M e t h o d s o f r e s t r a i n t ( e . g . , r e s t r a i n t c h a i r s , c o l l a r s , v e s t s , h a r n e s s e s , s l i n g s , e t c . ) . I n c l u d e h o w a n i m a l s a r e r e s t r a i n e d f o r r o u t i n e p r o c e d u r e s l i k e b l o o d w i t h d r a w a l s . P r o l o n g e d r e s t r a i n t m u s t b e j u s t i f i e d w i t h a p p r o p r i a t e o v e r s i g h t t o e n s u r e i t i s m i n i m a l l y d i s t r e s s i n g . D e s c r i b e a n y s e d a t i o n , a c c l i m a t i o n o r t r a i n i n g t o b e u t i l i z e d . F O R M T E X T
A n i m a l i d e n t i f i c a t i o n m e t h o d s ( e . g . , e a r t a g s , t a t t o o s , c o l l a r , c a g e c a r d , i m p l a n t , e t c . ) . F O R M T E X T
O t h e r p r o c e d u r e s ( e . g . , s u r v i v a l s t u d i e s , t a i l b i o p s i e s , e t c . ) . F O R M T E X T
R e s u l t a n t e f f e c t s , i f a n y , t h a t t h e a n i m a l s a r e e x p e c t e d t o e x p e r i e n c e ( e . g . , p a i n o r d i s t r e s s , a s c i t e s p r o d u c t i o n , e t c . ) . F O R M T E X T
O t h e r p o t e n t i a l s t r e s s o r s ( e . g . , f o o d o r w a t e r d e p r i v a t i o n , n o x i o u s s t i m u l i , e n v i r o n m e n t a l s t r e s s ) a n d p r o c e d u r e s t o m o n i t o r a n d m i n i m i z e d i s t r e s s . I f a s t u d y i s U S D A C l a s s i f i c a t i o n E , i n d i c a t e a n y n o n - p h a r m a c e u t i c a l m e t h o d s t o m i n i m i z e p a i n a n d d i s t r e s s . F O R M T E X T
E x p e r i m e n t a l e n d p o i n t criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities, clinical symptomatology, or signs of toxicity) must be specified when the administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are expected to cause significant symptomatology or are potentially lethal. List the criteria to be used to determine when euthanasia is to be performed. Death as an endpoint must always be scientifically justified. FORMTEXT
V e t e r i n a r y c a r e ( i n d i c a t e d e s i r e d p l a n o f a c t i o n i n c a s e o f a n i m a l i l l n e s s , e . g . , i n i t i a t e t r e a t m e n t , c a l l i n v e s t i g a t o r p r i o r t o i n i t i a t i n g t r e a t m e n t , e u t h a n i z e ) . F O R M T E X T
S U R G E R Y
I f p r o p o s e d , c o m p l e t e t h e f o l l o w i n g : ( U s e a d d i t i o nal sheets if necessary.)
Identify and describe the surgical procedure(s) to be performed. Include preoperative procedures (e.g., fasting, analgesic loading), and monitoring and supportive care during surgery. Include the aseptic methods to be utilized. FORMTEXT
W h o w i l l p e r f o r m s u r g e r y a n d w h a t a r e t h e i r q u a l i f i c a t i o n s a n d / o r e x p e r i e n c e ? F O R M T E X T
W h e r e w i l l s u r g e r y b e p e r f o r m e d a n d p o s t o p e r a t i v e c a r e p r o v i d e d ( b u i l d i n g a n d r o o m s ) ? F O R M T E X T
I f s u r v i v a l s u r g e r y , d e s c r i b e p o s t o p e r a t i v e c a r e r e q u i r e d , f r e q u e n c y o f o b s e r v a t i o n , a n d i d e n t i f y t h e r e s p o n s i b l e i n d i v i d u a l ( s ) . I n c l u d e d e t e c t i o n a n d m a n a g e m e n t o f p o s t o p e r a t i v e c o m p l i c a t i o n s d u r i n g w o r k h o u r s , a f t e r h o u r s , w e e k e n d s a n d h o l i d a y s . F O R M T E X T
I f n o n - s u r v i v a l s u r g e r y , d e s c r i b e h o w h u m a n e e u t h a n a s i a i s e n a c t e d a n d h o w d e a t h i s d e t e r m i n e d . F O R M T E X T
6 . A r e p a r a l y t i c a g e n t s u s e d d u r i n g s u r g e r y ? I f y e s , p l e a s e d e s c r i b e h o w v e n t i l a t i o n w i l l b e m a i n t a i n e d a n d h o w p a i n w i l l b e a s s e s s e d . F O R M T E X T
H as major survival surgery been performed on any animal prior to being placed on this study? [Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, crainotomy, joint replacement, or limb amputation).] Yes FORMCHECKBOX No FORMCHECKBOX
If yes, please explain: FORMTEXT
W i l l m o r e t h a n o n e m a j o r s u r v i v a l s u r g e r y b e p e r f o r m e d o n a n a n i m a l w h i l e o n t h i s s t u d y ? Y e s F O R M C H E C K B O X N o F O R M C H E C K B O X
I f y e s , p l e a s e j u s t i f y : F O R M T E X T
P A I N O R D I S T R E S S C L A S S I F I C A T I O N A N D C O N S I D E R A T I O N O F A L T E R N A T I V E S
1 . P a i n o r D i s t r e s s C l a s s i f i c a t i o n :
S p e c i e s
( C o m m o n N a m e ) U S D A C l a s s i f i c a t i o n *
B , C , D , o r E N u m b e r o f A n i m a l s U s e d E a c h Y e a r 3 - Y e a r T o t a l N u m b e r o f A n i m a l s Y e a r 1 Y e a r 2 Y e a r 3 F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T F O R M T E X T T o t a l n u m b e r o f a n i m a l s ( s h o u l d e q u a l t o t a l f r o m S e c t i o n B ) : F O R M T E X T { = s u m ( a b o v e ) } 0
* U S D A Classifications and Examples
Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes.
Examples:
Breeding colonies of any animal species (USDA does not require listing of rats, mice, birds) that are held in legal sized caging and handled in accordance with the Guide and other applicable regulations. Breeding colony includes parents and offspring.
Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations.
Animals held under proper captive conditions or wild animals that are being observed.
Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs.
Examples:
Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic, cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances.
Euthanasia performed in accordance with the recommendations of the most recent AVMA Panel on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death.
Manual restraint that is no longer than would be required for a simple exam; short period of chair restraint for an adapted nonhuman primate.
Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used.
Examples:
Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy.
Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs.
Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics.
Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.
Examples:
Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain.
Surgical and postsurgical sequella from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress.
Negative conditioning via electric shocks that would cause pain in humans.
Chairing of nonhuman primates not conditioned to the procedure for the time period used.
NOTE REGARDING CLASSIFICATION E: An explanation of the procedures producing pain or distress in these animals and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided on Attachment 1. This information is required to be reported to the USDA, will be available from USDA under the Freedom of Information Act, and may be publicly available through the Internet via USDAs website.
2. Consideration of Alternatives
If any procedures fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the animals, describe your consideration of alternatives and your determination that alternatives are not available. Delineate the methods and sources used in the search. Database references must include databases searched, the date of the search, period covered, and the keywords used. Alternatives include methods that (1) refine existing tests by minimizing animal distress, (2) reduce the number of animals necessary for an experiment, or (3) replace whole animal use with in vitro or other tests. When ascites production is used to produce antibodies, justification needs to be given as to why in vitro systems cannot be used. Note that you must certify in Section Q.5. that no valid alternative was identified to any described procedures which may cause more than momentary pain or distress, whether relieved or not.
ANESTHESIA, ANALGESIA, TRANQUILIZATION, OTHER AGENTS
For animals indicated in Section H.1., Classification D, specify the anesthetics, analgesics, sedatives or tranquilizers that are to be used. Include the name of the agent(s), the dosage, route and schedule of administration. If information is provided in Section G. above, please cross-reference. Describe tracking and security of controlled drugs (Drug Enforcement Agency requirements). FORMTEXT
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