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1 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Main_Body_59.docx | Wed May 2 23:25:58 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Main_Body_59.docx | Tue Jul 17 21:36:22 2018 UTC |
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1 | Official D ate of App roval► | |
2 | ||
3 | Animal Com ponent of Research P rotocol (A CORP) | |
4 | Main Body | |
5 | Version 4 | |
6 | ||
7 | See Instru ctions for Completio n of the A nimal Comp onent of R esearch Pr otocol (AC ORP Instru ctions), f or help in completin g specific items. | |
8 | ||
9 | ACORP Stat us. | |
10 | ||
11 | Full Name of Princip al Investi gator(s)► | |
12 | ||
13 | VA Station Name (Cit y) and 3-D igit Stati on Number► | |
14 | ||
15 | Protocol T itle► | |
16 | ||
17 | Animal Spe cies cover ed by this ACORP► | |
18 | ||
19 | Funding So urce(s). Check each source th at applies : | |
20 | ||
21 | Unfunde d | |
22 | ||
23 | CSRD (Cl inical Sci ence Resea rch and De velopment) | |
24 | ||
25 | RRD (Reh abilitatio n Research and Devel opment) | |
26 | ||
27 | Local VA MC (Local Veterans A ffairs Med ical Cente r) | |
28 | ||
29 | DOD (Dep artment of Defense) | |
30 | ||
31 | Affiliat e/Departme ntal Funds | |
32 | ||
33 | BLRD (Bi omedical L aboratory Research a nd Develop ment) | |
34 | ||
35 | HSRD (He alth Servi ces Resear ch and Dev elopment) | |
36 | ||
37 | QUERI (Q uality Enh ancement R esearch In itiative) | |
38 | ||
39 | NIH (Nat ional Inst itutes of Health) | |
40 | ||
41 | Commerci al | |
42 | ||
43 | ORD (Off ice of Res earch Deve lopment) | |
44 | ||
45 | Other (P lease Spec ify): | |
46 | ||
47 | Related Do cumentatio n for IACU C referenc e. | |
48 | ||
49 | If this pr otocol app lies to a project th at has alr eady been submitted to the R&D Committee for revie w, identif y the proj ect: | |
50 | ||
51 | Title of p roject► | |
52 | ||
53 | If approve d by the R &D Committ ee, give t he date of approval► | |
54 | ||
55 | Triennial review. I f this pro tocol is b eing submi tted for t riennial d e novo rev iew, compl ete the fo llowing: | |
56 | ||
57 | Identify t he studies described in the pr eviously a pproved AC ORP that h ave alread y been com pleted | |
58 | ► | |
59 | ||
60 | Indicate t he numbers of animal s of each breed/stra in/genotyp e that hav e already been used, and adjus t the numb ers shown in Item I accordingl y | |
61 | ► | |
62 | ||
63 | Describe a ny study r esults tha t have pro mpted chan ges to the protocol, and brief ly summari ze those c hanges, to guide the reviewers to the de tails docu mented in other Item s below. | |
64 | ► | |
65 | ||
66 | List any o ther relev ant previo usly appro ved animal use proto cols (copy the lines below as needed for each prot ocol liste d). | |
67 | ||
68 | Title of o ther proto col ► | |
69 | IACUC appr oval numbe r of other protocol ► | |
70 | Give the n ame of the VA statio n or other instituti on that ap proved it, if it was not appro ved by the IACUC tha t will rev iew this A CORP ► | |
71 | ||
72 | Indicate t he type(s) of animal use cover ed by this protocol (check all that appl y): | |
73 | ||
74 | ►( )Resea rch | |
75 | ►( )Teach ing or Tra ining | |
76 | ►( )Testi ng | |
77 | ►( )Breed ing and co lony manag ement only ; not for any specif ic researc h project | |
78 | ►( )Holdi ng protoco l (as spec ified by l ocal requi rements; n ot require d by VA, P HS, or USD A) | |
79 | ►( )Other . Please specify► | |
80 | ||
81 | Proposal O verview | |
82 | ||
83 | Descriptio n of Relev ance and H arm/Benefi t Analysis . Using n on-technic al (lay) l anguage th at a senio r high sch ool studen t would un derstand, briefly de scribe how this rese arch proje ct is inte nded to im prove the health of people and /or other animals, o r otherwis e to serve the good of society , and expl ain how th ese benefi ts outweig h the pain or distre ss that ma y be cause d in the a nimals tha t are to b e used for this prot ocol. | |
84 | ► | |
85 | ||
86 | Experiment al Design. | |
87 | ||
88 | Lay Summar y. Using non-techni cal (lay) language t hat a seni or high sc hool stude nt would u nderstand, summarize the conce ptual desi gn of the experiment in no mor e than one or two pa ragraphs. | |
89 | ► | |
90 | ||
91 | 2. Complet e descript ion of the proposed use of ani mals. Us e the foll owing outl ine to det ail the pr oposed use of animal s. | |
92 | ||
93 | a. Summar ize the de sign of th e experime nt in term s of the s pecific gr oups of an imals to b e studied. | |
94 | ► | |
95 | ||
96 | b. Justif y the grou p sizes an d the tota l numbers of animals requested . A power analysis i s strongly encourage d; see ACO RP instruc tions. | |
97 | ► | |
98 | ||
99 | c. Descri be each pr ocedure to be perfor med on any animal on this prot ocol. (Us e Appendix 9 to docu ment any o f these pr ocedures t hat involv e “departu res” from the standa rds in the Guide. C onsult the IACUC or the Attend ing Veteri narian for help in d etermining whether a ny “depart ures” are involved.) | |
100 | ► | |
101 | ||
102 | Species. Justify th e choice o f species for this p rotocol. | |
103 | ► | |
104 | ||
105 | Personnel | |
106 | ||
107 | Current qu alificatio ns and tra ining. (Fo r personne l who requ ire furthe r training , plans fo r addition al trainin g will be requested in Item F. ) | |
108 | ||
109 | 1. PI | |
110 | ||
111 | Name► | |
112 | Animal res earch expe rience ► | |
113 | ||
114 | Qualificat ions to pe rform spec ific proce dures | |
115 | Specific p rocedure(s ) that the PI will p erform per sonally | |
116 | Experience with each procedure in the sp ecies desc ribed in t his ACORP | |
117 | ||
118 | ||
119 | ||
120 | ||
121 | ||
122 | ||
123 | ||
124 | Table1 | |
125 | ||
126 | 2. Other research p ersonnel ( copy the l ines below for each individual ) | |
127 | ||
128 | Name► | |
129 | Animal res earch expe rience ► | |
130 | ||
131 | Qualificat ions to pe rform spec ific proce dures | |
132 | Specific p rocedure(s ) that thi s individu al will pe rform | |
133 | Experience with each procedure in the sp ecies desc ribed in t his ACORP | |
134 | ||
135 | ||
136 | ||
137 | ||
138 | ||
139 | ||
140 | ||
141 | 3. VMU an imal care and veteri nary suppo rt staff p ersonnel ( copy the l ines below for each individual ) | |
142 | ||
143 | Name► | |
144 | ||
145 | Qualificat ions to pe rform spec ific suppo rt procedu res in the animals o n this pro tocol | |
146 | Specific s upport pro cedure(s) assigned t o this ind ividual | |
147 | Qualificat ions for p erforming each suppo rt procedu re in the species de scribed in this ACOR P (e.g., A ALAS certi fication, experience , or compl etion of s pecial tra ining) | |
148 | ||
149 | ||
150 | ||
151 | ||
152 | ||
153 | ||
154 | ||
155 | 4. For ea ch of the research p ersonnel l isted in i tems 1 and 2 above, enter the most recen t completi on date fo r each cou rse | |
156 | ||
157 | Name of In dividual | |
158 | Working wi th the VA IACUC | |
159 | ORD web-ba sed specie s specific course (I dentify th e species) | |
160 | Any other training r equired lo cally (Ide ntify the training) | |
161 | ||
162 | ||
163 | ||
164 | ||
165 | ||
166 | ||
167 | ||
168 | ||
169 | ||
170 | ||
171 | ||
172 | ||
173 | Training t o be provi ded. List here each procedure in Item E for which anyone is shown as “to be tra ined”, and describe the traini ng. For e ach proced ure, descr ibe the ty pe of trai ning to be provided, and give the name(s ), qualifi cations, a nd trainin g experien ce of the person(s) who will p rovide it. If no fu rther trai ning is re quired for anyone li sted in It em E, ente r “N/A” | |
174 | ► | |
175 | ||
176 | Occupation al Health and Safety . | |
177 | ||
178 | Complete o ne line in the table below for each of t he personn el identif ied in Ite m E: | |
179 | ||
180 | Name | |
181 | Enrollment in OHSP | |
182 | Declined o ptional se rvices | |
183 | Current on Interacti ons with O HSP? | |
184 | (yes/no) | |
185 | ||
186 | VA program | |
187 | Equivalent Alternate Program – identify the progra m | |
188 | ||
189 | ||
190 | ||
191 | ||
192 | ( ) | |
193 | ( ) | |
194 | ( ) | |
195 | ||
196 | ||
197 | ( ) | |
198 | ( ) | |
199 | ( ) | |
200 | ||
201 | ||
202 | ( ) | |
203 | ( ) | |
204 | ( ) | |
205 | ||
206 | ||
207 | ||
208 | 2.Are ther e any non- routine OH SP measure s that wou ld potenti ally benef it, or are otherwise required for, perso nnel parti cipating i n or suppo rting this protocol? | |
209 | ||
210 | ► ( ) Yes . Describ e them ► | |
211 | ||
212 | ► ( ) No. | |
213 | ||
214 | Animals Re quested | |
215 | ||
216 | Animals to be Used. Complete the follow ing table, listing t he animals on separa te lines a ccording t o any spec ific featu res that a re require d for the study (see ACORP Ins tructions, for guida nce, inclu ding speci fic termin ology reco mmended fo r the “Hea lth Status ” column): | |
217 | ||
218 | Descriptio n (include the speci es and any other spe cial featu res not sh own elsewh ere in thi s table) | |
219 | Gender | |
220 | Age/Size o n Receipt | |
221 | Source | |
222 | (e.g., Nam e of Vendo r, Collabo rator, or PI of loca l breeding colony) | |
223 | Health Sta tus | |
224 | ||
225 | ||
226 | ||
227 | ||
228 | ||
229 | ||
230 | ||
231 | ||
232 | ||
233 | ||
234 | ||
235 | ||
236 | ||
237 | ||
238 | Numbers of animals r equested. See ACORP Instructio ns, for de scriptions of the ca tegories a nd how to itemize th e groups o f animals. | |
239 | ||
240 | USDA Categ ory B | |
241 | Procedures ► | |
242 | Species / Experiment al Group / Procedure s(s) | |
243 | Year 1 | |
244 | Year 2 | |
245 | Year 3 | |
246 | Year 4 | |
247 | Year 5 | |
248 | Category B TOTAL | |
249 | ||
250 | ||
251 | ||
252 | ||
253 | ||
254 | ||
255 | ||
256 | ||
257 | ||
258 | ||
259 | ||
260 | ||
261 | ||
262 | ||
263 | ||
264 | ||
265 | ||
266 | USDA Categ ory C | |
267 | Procedures ► | |
268 | Species / Experiment al Group / Procedure (s) | |
269 | Year 1 | |
270 | Year 2 | |
271 | Year 3 | |
272 | Year 4 | |
273 | Year 5 | |
274 | Category C TOTAL | |
275 | ||
276 | ||
277 | ||
278 | ||
279 | ||
280 | ||
281 | ||
282 | ||
283 | ||
284 | ||
285 | ||
286 | ||
287 | ||
288 | ||
289 | ||
290 | ||
291 | ||
292 | USDA Categ ory D | |
293 | Procedures ► | |
294 | Species / Experiment al Group / Procedure (s) | |
295 | Year 1 | |
296 | Year 2 | |
297 | Year 3 | |
298 | Year 4 | |
299 | Year 5 | |
300 | Category D TOTAL | |
301 | ||
302 | ||
303 | ||
304 | ||
305 | ||
306 | ||
307 | ||
308 | ||
309 | ||
310 | ||
311 | ||
312 | ||
313 | ||
314 | ||
315 | ||
316 | ||
317 | ||
318 | USDA Categ ory E | |
319 | Procedures ► | |
320 | Species / Experiment al Group / Procedure (s) | |
321 | Year 1 | |
322 | Year 2 | |
323 | Year 3 | |
324 | Year 4 | |
325 | Year 5 | |
326 | Category E TOTAL | |
327 | ||
328 | ||
329 | ||
330 | ||
331 | ||
332 | ||
333 | ||
334 | ||
335 | ||
336 | ||
337 | ||
338 | ||
339 | ||
340 | ||
341 | ||
342 | ||
343 | ||
344 | TOTALS ove r all Cate gories | |
345 | Species / Experiment al Group / Procedure( s) | |
346 | Year 1 | |
347 | Year 2 | |
348 | Year 3 | |
349 | Year 4 | |
350 | Year 5 | |
351 | GRAND TOTA L | |
352 | ||
353 | ||
354 | ||
355 | ||
356 | ||
357 | ||
358 | ||
359 | ||
360 | ||
361 | ||
362 | ||
363 | ||
364 | ||
365 | ||
366 | ||
367 | ||
368 | ||
369 | Management of USDA C ategory D procedures . Indicat e which st atement be low applie s, and pro vide the i nformation requested . | |
370 | ||
371 | ► ( ) Th is protoco l does NOT include a ny Categor y D proced ures. | |
372 | ||
373 | ► ( ) Thi s protocol INCLUDES Category D procedure s. List e ach Catego ry D proce dure and p rovide the informati on request ed. (For s urgical pr ocedures d escribed i n Appendix 5, only i dentify th e procedur e(s) and e nter “See Appendix 5 for detai ls.) | |
374 | ||
375 | Procedure | |
376 | Monitoring | |
377 | (indicate the method (s) to be used, and the freque ncy and du ration of monitoring through p ost-proced ure recove ry) | |
378 | Person(s) responsibl e for the monitoring | |
379 | Method(s) by which p ain or dis tress will be allevi ated durin g or after the proce dure (incl ude the do se, route, and durat ion of eff ect of any agents to be admini stered) | |
380 | ||
381 | ||
382 | ||
383 | ||
384 | ||
385 | ||
386 | ||
387 | ||
388 | ||
389 | ||
390 | ||
391 | ||
392 | ||
393 | ||
394 | ||
395 | Justificat ion of Cat egory E pr ocedures. Indicate which stat ement belo w applies, and provi de the inf ormation r equested. | |
396 | ||
397 | ► ( ) Th is protoco l does NOT include a ny Categor y E proced ures | |
398 | ||
399 | ► ( ) Th is protoco l INCLUDES Category E procedur es. Ident ify each C ategory E procedure included i n this ACO RP and jus tify scien tifically why the pa in or dist ress canno t be relie ved. | |
400 | ► | |
401 | ||
402 | Veterinary Care and Husbandry | |
403 | ||
404 | Veterinary Support. | |
405 | ||
406 | Identify t he laborat ory animal veterinar ian who is responsib le for ens uring that the anima ls on this protocol receive ap propriate veterinary medical c are. | |
407 | ||
408 | Name► | |
409 | Institutio nal affili ation► | |
410 | email cont act► | |
411 | ||
412 | Veterinary consultat ion during the plann ing of thi s protocol . | |
413 | ||
414 | Name of th e laborato ry animal veterinari an consult ed► | |
415 | Date of th e veterina ry consult ation (mee ting date, or date o f written comments p rovided by the veter inarian to the PI) ► | |
416 | ||
417 | Husbandry. As a ref erence for the anima l husbandr y staff, s ummarize h ere the hu sbandry re quirements of the an imals on t his protoc ol. (Use Appendix 6 to justif y the use of any spe cial husba ndry and t o detail i ts effects on the an imals. Use Appendix 9 to docum ent any as pects of t he husband ry that in volve “dep artures” f rom the st andards in the Guide . Consult the IACUC or the Att ending Vet erinarian for help i n determin ing whethe r any “dep artures” a re involve d.) | |
418 | ||
419 | Caging nee ds. Comple te the tab le below t o describe the housi ng that wi ll have to be accomm odated by the housin g sites fo r this pro tocol: | |
420 | ||
421 | a. Species | |
422 | b. Type of housing* | |
423 | c. Number of individ uals per h ousing uni t** | |
424 | d. Is this housing c onsistent with the G uide and U SDA regula tions? | |
425 | (yes/no*** ) | |
426 | e. Estimat ed maximum number of housing u nits neede d at any o ne time | |
427 | ||
428 | ||
429 | ||
430 | ||
431 | ||
432 | ||
433 | ||
434 | ||
435 | ||
436 | ||
437 | ||
438 | ||
439 | ||
440 | *See ACORP Instructi ons, for g uidance on describin g the type of housin g needed. If animals are to be housed ac cording to a local S tandard Op erating Pr ocedure (S OP), enter “standard (see SOP) ” here, an d enter th e SOP into the table in Item Y . If the local stan dard housi ng is not described in a SOP, enter “sta ndard, see below” in the table and descr ibe the st andard hou sing here: | |
441 | ► | |
442 | ||
443 | ** The Gui de states that socia l animals should gen erally be housed in stable pai rs or grou ps. Provi de a justi fication i f any anim als will b e housed s ingly (if species is not consi dered “soc ial”, then so note) | |
444 | ► | |
445 | ||
446 | ***Use App endix 9 to document “departure s” from th e standard s in the G uide. | |
447 | ||
448 | Enrichment . Complete the table below to indicate w hether “st andard” ex ercise and environme ntal enric hment will be provid ed to the animals on this prot ocol, or w hether any special s upplements or restri ctions wil l be requi red (See A CORP Instr uctions, f or more in formation on enrichm ent requir ements. U se Appendi x 9 to doc ument any enrichment s requirem ents that represent “departure s” from th e standard s in the G uide.): | |
449 | ||
450 | a. Species | |
451 | b. Descrip tion of En richment* | |
452 | c. Frequen cy | |
453 | ||
454 | ||
455 | ||
456 | ||
457 | ||
458 | ||
459 | ||
460 | ||
461 | ||
462 | *If enrich ment will be provide d accordin g to a loc al SOP, en ter “stand ard (see S OP)” and e nter the S OP into th e table in Item Y. If the loc al standar d enrichme nt is not described in a SOP, enter “sta ndard, see below”, a nd describ e the stan dard speci es-specifi c enrichme nt here. | |
463 | ► | |
464 | ||
465 | Customized routine h usbandry. Check all of the st atements b elow that apply to t he animals on this p rotocol, a nd provide instructi ons to the animal hu sbandry st aff with r egard to a ny customi zed routin e husbandr y needed. | |
466 | ||
467 | ► ( ) Thi s ACORP IN CLUDES gen etically m odified an imals. | |
468 | List each group of g enetically modified animals, a nd describ e for each any expec ted charac teristic c linical si gns or abn ormal beha vior relat ed to the genotype a nd any cus tomized ro utine husb andry requ ired to ad dress thes e. For ge netic modi fications that will be newly g enerated o n or for t his protoc ol, descri be any spe cial atten tion neede d during r outine hus bandry to monitor fo r unexpect ed clinica l signs or abnormal behavior t hat may re quire cust omized rou tine husba ndry. | |
469 | ► | |
470 | ||
471 | ► ( ) De vices that extend ch ronically through th e skin WIL L be impla nted into some or al l animals on this pr otocol. D escribe an y customiz ed routine husbandry to be pro vided by a nimal husb andry staf f to minim ize the ch ances of c hronic inf ection whe re the dev ice(s) pen etrate the skin. | |
472 | ► | |
473 | ||
474 | ► ( ) So me or all of the ani mals on th is protoco l WILL req uire other customize d routine husbandry by the ani mal husban dry staff, beyond wh at has bee n describe d above. D escribe th e special husbandry needed. | |
475 | ► | |
476 | ||
477 | ► ( ) Th is ACORP d oes NOT in clude use of any ani mals that will requi re customi zed routin e husbandr y. | |
478 | ||
479 | Housing Si tes. Docu ment in th e tables b elow each location w here anima ls on this protocol may be hou sed. | |
480 | ||
481 | ► ( ) Hou sing on VA property. Identify each loca tion on VA property where anim als on thi s protocol will be h oused, and indicate whether or not each location i s inside t he VMU. | |
482 | ||
483 | Building | |
484 | Room numbe r | |
485 | Inside of VMU? | |
486 | ||
487 | ||
488 | Yes | |
489 | No | |
490 | ||
491 | ||
492 | ||
493 | ( ) | |
494 | ( ) | |
495 | ||
496 | ||
497 | ( ) | |
498 | ( ) | |
499 | ||
500 | ||
501 | ( ) | |
502 | ( ) | |
503 | ||
504 | ||
505 | ► ( ) Hou sing in no n-VA facil ities. Id entify eac h location not on VA property where anim als on thi s protocol will be h oused, and provide t he informa tion reque sted in th e table. | |
506 | ||
507 | Name of No n-VA Facil ity | |
508 | Is this fa cility acc redited by AAALAC? | |
509 | Building | |
510 | Room Numbe r | |
511 | ||
512 | Yes -- en ter status * | |
513 | No** | |
514 | ||
515 | ||
516 | ||
517 | ||
518 | ( ) | |
519 | ( )** | |
520 | ||
521 | ||
522 | ||
523 | ( ) | |
524 | ( )** | |
525 | ||
526 | ||
527 | ||
528 | ( ) | |
529 | ( )** | |
530 | ||
531 | ||
532 | ||
533 | ||
534 | *See ACORP Instructi ons, for a list of A AALAC accr editation status opt ions. | |
535 | ||
536 | **For any facility l isted abov e that is not accred ited by AA ALAC, atta ch documen tation tha t a waiver has been granted by the CRADO . | |
537 | ||
538 | Special Fe atures | |
539 | ||
540 | Antibody Production . Will an y of anima ls on this protocol be used fo r the prod uction of antibodies ? | |
541 | ||
542 | ► ( ) So me or all of the ani mals on th is protoco l WILL be used in th e producti on and har vesting of antibodie s. Check “Appendix 2” in Item Y, below, and compl ete and at tach Appen dix 2, “An tibody Pro duction”. | |
543 | ||
544 | ► ( ) NO animals on this prot ocol will be used in the produ ction and harvesting of antibo dies. | |
545 | ||
546 | Biosafety. Will any substance s (other t han those used in ro utine husb andry or v eterinary care) be a dministere d to the a nimals on this proto col? | |
547 | ||
548 | ► ( ) Thi s protocol INVOLVES administra tion of su bstances t o the anim als other than those used in r outine hus bandry and veterinar y care. C heck “Appe ndix 3” in Item Y, b elow, and complete a nd attach Appendix 3 , “Biosafe ty”. | |
549 | ||
550 | ► ( ) Thi s protocol does NOT involve ad ministrati on of any substances to the an imals othe r than tho se used in routine h usbandry a nd veterin ary care. | |
551 | ||
552 | Locations of procedu res. Comp lete the t able below , listing the locati on(s), ins ide or out side of th e animal f acility, f or each of the proce dures to b e performe d on anima ls on this protocol. | |
553 | ||
554 | Procedure | |
555 | Surgical? | |
556 | Bldg/Room Number | |
557 | Requires t ransport t hrough non -research areas? | |
558 | ||
559 | Yes | |
560 | No | |
561 | ||
562 | Yes – desc ribe metho d of discr eet transp ort | |
563 | No | |
564 | ||
565 | ||
566 | ( ) | |
567 | ( ) | |
568 | ||
569 | ( ) | |
570 | ( ) | |
571 | ||
572 | ( ) | |
573 | ( ) | |
574 | ||
575 | ( ) | |
576 | ( ) | |
577 | ||
578 | ( ) | |
579 | ( ) | |
580 | ||
581 | ( ) | |
582 | ( ) | |
583 | ||
584 | ( ) | |
585 | ( ) | |
586 | ||
587 | ( ) | |
588 | ( ) | |
589 | ||
590 | ||
591 | Body Fluid , Tissue, and Device Collectio n. List e ach body f luid, tiss ue, or dev ice to be collected, and compl ete the ta ble below to indicat e the natu re of the collection . Check t he relevan t Appendic es in Item Y, below, and compl ete and at tach them, as shown in the col umn headin gs. | |
592 | ||
593 | ||
594 | Body Fluid , Tissue, or Device to be Coll ected | |
595 | Collected AFTER Euth anasia | |
596 | Collected BEFORE Eut hanasia | |
597 | ||
598 | ||
599 | Blood Coll ection Ass ociated wi th Antibod y Producti on | |
600 | (Appendix 2, “Antibo dy Product ion”) | |
601 | Collected as Part of a Surgica l Procedur e | |
602 | (Appendix 5, “Surger y”) | |
603 | Other Coll ection fro m Live Ani mals (Appe ndix 4, “A ntemortem Specimen C ollection” ) | |
604 | ||
605 | ||
606 | ( ) | |
607 | ( ) | |
608 | ( ) | |
609 | ( ) | |
610 | ||
611 | ( ) | |
612 | ( ) | |
613 | ( ) | |
614 | ( ) | |
615 | ||
616 | ( ) | |
617 | ( ) | |
618 | ( ) | |
619 | ( ) | |
620 | ||
621 | ||
622 | Surgery. Does this protocol i nclude any surgical procedure( s)? | |
623 | ||
624 | ► ( ) Su rgery WILL BE PERFOR MED on som e or all a nimals on this proto col. Che ck “Append ix 5” in I tem Y, bel ow, and co mplete and attach Ap pendix 5, “Surgery”. | |
625 | ||
626 | ► ( ) NO animals o n this pro tocol will undergo s urgery. | |
627 | ||
628 | Endpoint c riteria. Describe t he criteri a that wil l be used to determi ne when an imals will be remove d from the protocol or euthana tized to p revent suf fering. ( Use Append ix 9 to do cument any “departur es” from t he standar ds in the Guide repr esented by these cri teria. Con sult the I ACUC or th e Attendin g Veterina rian for h elp in det ermining w hether any “departur es” are in volved.) | |
629 | ► | |
630 | ||
631 | Terminatio n or remov al from th e protocol . Complet e each of the follow ing that a pplies: | |
632 | ||
633 | ► ( ) Som e or all a nimals wil l NOT be e uthanatize d on this protocol. Describe the dispos ition of t hese anima ls. (Use A ppendix 9 to documen t any “dep artures” f rom the st andards in the Guide represent ed by thes e methods of disposi tion. Cons ult the IA CUC or the Attending Veterinar ian for he lp in dete rmining wh ether any “departure s” are inv olved.) | |
634 | ► | |
635 | ||
636 | ► ( ) Som e or all a nimals MAY be euthan atized as part of th e planned studies. Complete t he table b elow to de scribe the exact met hod(s) of euthanasia to be use d. (Use Ap pendix 9 t o document any depar tures from the stand ards in th e Guide re presented by these m ethods. Co nsult the IACUC or t he Attendi ng Veterin arian for help in de termining whether an y “departu res” are i nvolved.) | |
637 | ||
638 | Check each method th at may be used on th is protoco l | |
639 | Method of Euthanasia | |
640 | Species | |
641 | AVMA Class ification | |
642 | ||
643 | ||
644 | ||
645 | Acceptable | |
646 | Conditiona lly Accept able | |
647 | Unacceptab le | |
648 | ( ) | |
649 | CO2 from a compresse d gas tank | |
650 | Duratio n of expos ure after apparent c linical de ath► | |
651 | Method for verify ing death► | |
652 | Seconda ry physica l method► | |
653 | ||
654 | ( ) | |
655 | ( ) | |
656 | ( ) | |
657 | ( ) | |
658 | Anesthetic overdose | |
659 | Agent► | |
660 | Dose► | |
661 | Route o f administ ration► | |
662 | ||
663 | ( ) | |
664 | ( ) | |
665 | ( ) | |
666 | ( ) | |
667 | Decapitati on under a nesthesia | |
668 | Agent► | |
669 | Dose► | |
670 | Route o f administ ration► | |
671 | ||
672 | ( ) | |
673 | ( ) | |
674 | ( ) | |
675 | ( ) | |
676 | Exsanguina tion under anesthesi a | |
677 | Agent► | |
678 | Dose► | |
679 | Route o f administ ration► | |
680 | ||
681 | ( ) | |
682 | ( ) | |
683 | ( ) | |
684 | ( ) | |
685 | Other (Des cribe) ► | |
686 | ||
687 | ||
688 | ( ) | |
689 | ( ) | |
690 | ( ) | |
691 | ( ) | |
692 | Other (Des cribe) ► | |
693 | ||
694 | ||
695 | ( ) | |
696 | ( ) | |
697 | ( ) | |
698 | ||
699 | For each o f the meth ods above that is de signated a s “Conditi onally Acc eptable” b y the AVMA , describe how the c onditions for accept ability wi ll be met: | |
700 | ► | |
701 | ||
702 | For each o f the meth ods above that is de signated a s “Unaccep table” by the AVMA, give the s cientific reason(s) that justi fy this de viation fr om the AVM A Guidelin es: | |
703 | ► | |
704 | ||
705 | Identify a ll researc h personne l who will perform e uthanasia on animals on this p rotocol an d describe their tra ining and experience with the methods of euthanasi a they are to use in the speci es indicat ed. | |
706 | ► | |
707 | ||
708 | Instructio ns for the animal ca re staff i n case an animal is found dead . | |
709 | Describe t he disposi tion of th e carcass, including any speci al safety instructio ns. If di sposition is to be h andled acc ording to a local SO P, enter “ according to local S OP” and en ter the in formation requested about the SOP into t he table i n Item Y. | |
710 | ► | |
711 | ||
712 | Describe h ow the PI’ s staff sh ould be co ntacted. | |
713 | ► ( ) Ple ase contac t a member of the PI ’s staff i mmediately . (Copy th e lines be low for ea ch individ ual who ma y be conta cted) | |
714 | Name► | |
715 | Contact In formation► | |
716 | ||
717 | ► ( ) The re is no n eed to con tact the P I’s staff immediatel y. Descri be the rou tine notif ication pr ocedures t hat will b e followed . If the routine no tification procedure s are desc ribed in a local SOP , enter “a ccording t o local SO P” and ent er the inf ormation r equested a bout the S OP into th e table in Item Y. | |
718 | ► | |
719 | ||
720 | Special Pr ocedures. List each special pr ocedure (i ncluding s pecial hus bandry and other spe cial proce dures) tha t is a par t of this protocol, and specif y where th e details of the pro cedure are documente d. See AC ORP Instru ctions, fo r examples . | |
721 | ||
722 | Name of Pr ocedure | |
723 | Identify W here the D etails of the Proced ure are Do cumented | |
724 | ||
725 | SOP (title or ID num ber)* | |
726 | Other Item s in this ACORP -- s pecify the Item lett er(s) | |
727 | Appendix 6 | |
728 | ||
729 | ||
730 | ||
731 | Items: | |
732 | ( )** | |
733 | ||
734 | ||
735 | Items: | |
736 | ( )** | |
737 | ||
738 | ||
739 | Items: | |
740 | ( )** | |
741 | ||
742 | ||
743 | Items: | |
744 | ( )** | |
745 | ||
746 | ||
747 | *If any sp ecial proc edure is d etailed in a SOP, id entify the SOP and e nter the i nformation requested about the SOP in th e table in Item Y. | |
748 | ||
749 | **If any s pecial pro cedure is detailed i n Appendix 6, check “Appendix 6” in Item Y, below, and compl ete and at tach Appen dix 6. | |
750 | ||
751 | (Use Appen dix 9 to d ocument an y “departu res” from the standa rds in the Guide rep resented b y these pr ocedures. Consult th e IACUC or the Atten ding Veter inarian fo r help in determinin g whether any “depar tures” are involved. ) | |
752 | ||
753 | Considerat ion of Alt ernatives and Preven tion of Un necessary Duplicatio n. These are import ant to min imizing th e harm/ben efit to be derived f rom the wo rk. | |
754 | ||
755 | Document t he databas e searches conducted . | |
756 | List each of the pot entially p ainful or distressin g procedur es include d in this protocol. | |
757 | ► | |
758 | ||
759 | Then compl ete the ta ble below to documen t how the database s earch(es) you conduc t to answe r Items W. 2 through W.5 below address(es ) each of the potent ially pain ful or dis tressing p rocedures. | |
760 | ||
761 | Name of th e database | |
762 | Date of se arch | |
763 | Period of years cov ered by th e search | |
764 | Potentiall y painful or distres sing proce dures addr essed | |
765 | Key words and/or sea rch strate gy used | |
766 | Indicate w hich manda te each se arch addre ssed | |
767 | ||
768 | ||
769 | ||
770 | ||
771 | ||
772 | Replacemen t of anima ls (item W .2) | |
773 | Reduction in numbers of animal s used (i tem W.3) | |
774 | Refinement to minimi ze | |
775 | pain or di stress (it em W.4) | |
776 | Lack of un necessary duplicatio n (item W. 5) | |
777 | ||
778 | ||
779 | ||
780 | ||
781 | ||
782 | ||
783 | ( ) | |
784 | ( ) | |
785 | ( ) | |
786 | ( ) | |
787 | ||
788 | ||
789 | ||
790 | ||
791 | ||
792 | ( ) | |
793 | ( ) | |
794 | ( ) | |
795 | ( ) | |
796 | ||
797 | ||
798 | ||
799 | ||
800 | ||
801 | ( ) | |
802 | ( ) | |
803 | ( ) | |
804 | ( ) | |
805 | ||
806 | ||
807 | ||
808 | ||
809 | ||
810 | ( ) | |
811 | ( ) | |
812 | ( ) | |
813 | ( ) | |
814 | ||
815 | ||
816 | Replacemen t. Descri be the rep lacements that have been incor porated in to this wo rk, the re placements that have been cons idered but cannot be used, and the reaso n(s) that further re placements are not a cceptable. | |
817 | ► | |
818 | ||
819 | Reduction. Describe how the n umber of a nimals to be used ha s been min imized in this proto col and ex plain why further re duction wo uld dispro portionate ly comprom ise the va lue of the data. | |
820 | ► | |
821 | ||
822 | Refinement . Describ e the refi nements th at have be en incorpo rated into this work and expla in why no further re finements are feasib le. | |
823 | ► | |
824 | ||
825 | Describe h ow it was determined that the proposed w ork does n ot unneces sarily dup licate wor k already documented in the li terature. | |
826 | ► | |
827 | ||
828 | Other Regu latory Con sideration s. | |
829 | ||
830 | Controlled drugs. | |
831 | ||
832 | Complete t he table b elow for e ach drug t hat is use d in anima ls on this protocol and that i s classifi ed as a co ntrolled s ubstance b y the DEA. See ACOR P Instruct ions, for explanatio ns about t he informa tion reque sted. | |
833 | ||
834 | Controlled substance s | |
835 | Storage | |
836 | Personnel Authorized to Access | |
837 | Location f or Use | |
838 | Procuremen t | |
839 | ||
840 | Double-loc ked | |
841 | Not Double -locked* | |
842 | ||
843 | VA Propert y | |
844 | Not on VA Property | |
845 | VA Phar-ma cy | |
846 | Non- VA | |
847 | ||
848 | ||
849 | ( ) | |
850 | ( )* | |
851 | ||
852 | ( ) | |
853 | ( ) | |
854 | ( ) | |
855 | ( ) | |
856 | ||
857 | ( ) | |
858 | ( )* | |
859 | ||
860 | ( ) | |
861 | ( ) | |
862 | ( ) | |
863 | ( ) | |
864 | ||
865 | ( ) | |
866 | ( )* | |
867 | ||
868 | ( ) | |
869 | ( ) | |
870 | ( ) | |
871 | ( ) | |
872 | ||
873 | ||
874 | *For any c ontrolled substance that will NOT be sto red under double loc k, with li mited acce ss, descri be how it will be st ored, and explain wh y this is necessary. | |
875 | ► | |
876 | ||
877 | Check each statement below tha t applies, to confir m that all controlle d substanc es used on this prot ocol will be procure d accordin g to VA ph armacy pol icies: | |
878 | ||
879 | ► ( ) So me control led substa nces will used on VA property, and all o f these wi ll be obta ined throu gh the loc al VA phar macy. | |
880 | ||
881 | ► ( ) So me control led substa nces will not be obt ained thro ugh the lo cal VA pha rmacy, but none of t hese will be used on VA proper ty. See t he ACORP I nstruction s, for fur ther infor mation. | |
882 | ||
883 | ► ( ) Ot her. Expla in► | |
884 | ||
885 | Human pati ent care e quipment o r procedur al areas. Does this protocol involve us e of any h uman patie nt care eq uipment or procedura l areas? | |
886 | ||
887 | ► ( ) Ye s, some hu man patien t care equ ipment or procedural area(s) w ill be use d for the animal stu dies on th is protoco l. Check “Appendix 7” in Item Y, below, and compl ete and at tach Appen dix 7, “Us e of Patie nt Procedu ral Areas for Animal Studies”. | |
888 | ||
889 | ► ( ) No human pat ient care equipment or procedu ral areas will be us ed for the animal st udies on t his protoc ol. | |
890 | ||
891 | Explosive agents. D oes this p rotocol in volve use of any exp losive age nt? | |
892 | ||
893 | ► ( ) Ye s, some ex plosive ag ent(s) wil l be used on this pr otocol. C heck “Appe ndix 3” an d “Appendi x 8” in It em Y, belo w, and co mplete and attach Ap pendix 8, “Use of Ex plosive Ag ent(s) wit hin the An imal Facil ity or in Animals”, as well as Appendix 3, “Biosaf ety”. | |
894 | ||
895 | ► ( ) No explosive agent(s) w ill be use d as part of this pr otocol. | |
896 | ||
897 | Summary of Attachmen ts. To as sist the r eviewers, summarize here which of the fo llowing ap ply to thi s ACORP. | |
898 | ||
899 | Appendices . Indicat e which of the Appen dices are required a nd have be en complet ed and att ached to t his protoc ol. Do no t check of f or attac h any appe ndices tha t are not applicable to this A CORP. | |
900 | ||
901 | ► ( ) Ap pendix 1, “Additiona l Local In formation” | |
902 | ► ( ) Ap pendix 2, “Antibody Production ” | |
903 | ► ( ) Ap pendix 3, “Biosafety ” | |
904 | ► ( ) Ap pendix 4, “Ante-mort em Specime n Collecti on” | |
905 | ► ( ) Ap pendix 5, “Surgery” | |
906 | ► ( ) Ap pendix 6, “Special H usbandry a nd Procedu res” | |
907 | ► ( ) Ap pendix 7, “Use of Pa tient Care Equipment or Areas for Animal Studies” | |
908 | ► ( ) Ap pendix 8, “Use of Ex plosive Ag ent(s) wit hin the VM U or in An imals” | |
909 | ► ( ) Ap pendix 9, “Departure s from “Mu st” and “S hould” Sta ndards in the Guide” | |
910 | ||
911 | Standard O perating P rocedures (SOPs). Li st in the table belo w, each of the SOPs referred t o in this protocol, providing the inform ation requ ested for each one. The appro ved SOPs m ust be inc luded when the appro ved ACORP and Append ices are s ubmitted f or Just-in -Time proc essing bef ore releas e of VA fu nding supp ort. | |
912 | ||
913 | Item | |
914 | SOP | |
915 | Approval D ate | |
916 | ||
917 | Title | |
918 | ID | |
919 | ||
920 | C.2.c | |
921 | ||
922 | ||
923 | ||
924 | M.1 | |
925 | ||
926 | ||
927 | ||
928 | M.2 | |
929 | ||
930 | ||
931 | ||
932 | U.4.a | |
933 | ||
934 | ||
935 | ||
936 | U.4.b | |
937 | ||
938 | ||
939 | ||
940 | V | |
941 | ||
942 | ||
943 | ||
944 | ||
945 | ||
946 | ||
947 | ||
948 | ||
949 | ||
950 | ||
951 | ||
952 | ||
953 | ||
954 | ||
955 | ||
956 | ||
957 | Certificat ions. Sig natures ar e required here for any ACORP that is to be submit ted to VA Central Of fice in su pport of a n applicat ion for VA funding. Include t he typed n ames and d ated signa tures as s hown below for the M ain Body o f the ACOR P and for each of th e Appendic es that ap ply to thi s protocol . Do NOT i nclude sig natures fo r, or atta ch, any ap pendices t hat do NOT apply. | |
958 | ||
959 | Main Body of the ACO RP. | |
960 | ||
961 | Certificat ion by Pri ncipal Inv estigator( s): | |
962 | ||
963 | I certify that, to t he best of my knowle dge, the i nformation provided in this AC ORP is com plete and accurate, and the wo rk will be performed as descri bed here a nd approve d by the I ACUC. I u nderstand that IACUC approval must be re newed at l east annua lly, and t hat the IA CUC must p erform a c omplete de novo revi ew of the protocol a t least ev ery three years, if work is to continue without in terruption . I under stand furt her that I am respon sible for providing the inform ation requ ired by th e IACUC fo r these an nual and t riennial r eviews, al lowing suf ficient ti me for the IACUC to perform th e reviews before the renewal d ates, and that I may be requir ed to comp lete a new er version of the AC ORP that r equests ad ditional i nformation , at the t ime of eac h triennia l review. | |
964 | ||
965 | I understa nd that fu rther IACU C approval must be s ecured bef ore any of the follo wing may b e implemen ted: | |
966 | ||
967 | Use of add itional an imal speci es, number s of anima ls, or num bers of pr ocedures p erformed o n individu al animals ; | |
968 | Changing a ny procedu re in any way that h as the pot ential to increase t he pain/di stress cat egory to w hich the a nimals sho uld be ass igned, or that might otherwise be consid ered a sig nificant c hange from the appro ved protoc ol; | |
969 | Performing any addit ional proc edures not already d escribed i n this ACO RP; | |
970 | Use of any of these animals on other pro tocols, or by other investigat ors. | |
971 | ||
972 | I further certify th at: | |
973 | ||
974 | No personn el will pe rform any animal pro cedures on this prot ocol until the IACUC has confi rmed that they are a dequately trained an d qualifie d, enrolle d in an ac ceptable O ccupationa l Health a nd Safety Program, a nd meet al l other cr iteria req uired by t he IACUC. When new or additio nal person nel are to work with the anima ls on this protocol, I will pr ovide this informati on to the IACUC for confirmati on before they begin work; | |
975 | I will pro vide my af ter-hours contact in formation to the ani mal care s taff for u se in case of emerge ncy. | |
976 | ||
977 | Name(s) of Principal Investiga tor(s) | |
978 | Signature | |
979 | Date | |
980 | ||
981 | ||
982 | ||
983 | ||
984 | ||
985 | ||
986 | ||
987 | ||
988 | ||
989 | Certificat ion by IAC UC Officia ls. | |
990 | ||
991 | We certify that: | |
992 | ||
993 | We, with t he IACUC, have evalu ated the c are and us e of anima ls describ ed on this ACORP, in accordanc e with the provision s of the U SDA Animal Welfare A ct Regulat ions and S tandards, PHS Policy , the Guid e for the Care and U se of Labo ratory Ani mals, and VA Policy; | |
994 | The IACUC has determ ined that the care a nd use of animals de scribed in this ACOR P is appro priate, an d has ther efore appr oved the p rotocol; | |
995 | The full t ext of any minority opinions i s document ed here as indicated below: | |
996 | ||
997 | ► ( ) No minority opinions w ere submit ted by any IACUC par ticipant f or inclusi on. | |
998 | ||
999 | ► ( ) Mi nority opi nions subm itted by I ACUC parti cipants ar e copied h ere | |
1000 | ► | |
1001 | ||
1002 | ► ( ) Min ority opin ions submi tted by IA CUC partic ipants are attached on separat e pages la beled “IAC UC Minorit y Opinion” (indicate the numbe r of pages ► ) | |
1003 | ||
1004 | Name of At tending Ve terinarian (VMO or V MC) | |
1005 | Signature | |
1006 | Date | |
1007 | ||
1008 | ||
1009 | ||
1010 | Name of IA CUC Chair | |
1011 | Signature | |
1012 | Date | |
1013 | ||
1014 | ||
1015 | ||
1016 | ||
1017 | Appendix 2 . Antibod y Producti on. No si gnatures r equired. | |
1018 | ||
1019 | Appendix 3 . Biosafe ty. | |
1020 | ||
1021 | Certificat ion by PI( s) and IAC UC Officia ls: | |
1022 | ||
1023 | We certify that: | |
1024 | Before any animal ex periments involving hazardous agents (id entified i n Item 10. a of Appen dix 3) are performed , SOPs des igned to p rotect all research and animal facility staff as w ell as non -study ani mals will be develop ed and app roved by t he appropr iate VA or affiliate d universi ty safety committee and by the IACUC; | |
1025 | ||
1026 | All person nel who mi ght be exp osed to th e hazardou s agents ( identified in Item 1 0.a of App endix 3) w ill be inf ormed of p ossible ri sks and wi ll be prop erly train ed ahead o f time to follow the SOPs to m inimize th e risks of exposure. | |
1027 | ||
1028 | Name(s) of Principal Investiga tor(s) | |
1029 | Signature( s) | |
1030 | Date | |
1031 | ||
1032 | ||
1033 | ||
1034 | ||
1035 | ||
1036 | ||
1037 | Name of In stitutiona l Veterina rian | |
1038 | Signature | |
1039 | Date | |
1040 | ||
1041 | ||
1042 | ||
1043 | Name of IA CUC Chair | |
1044 | Signature | |
1045 | Date | |
1046 | ||
1047 | ||
1048 | ||
1049 | ||
1050 | Certificat ion by Bio safety Off icial. I certify th at: | |
1051 | Each agent to be adm inistered to animals on this p rotocol ha s been pro perly iden tified in Item 1 of Appendix 3 as to whe ther it is “toxic”, “infectiou s”, “biol ogical”, o r “contain s recombin ant nuclei c acid”; | |
1052 | The use of each of t he agents thus ident ified as “ toxic”, “i nfectious” , or “bio logical”, or “contai ns recombi nant nucle ic acid” i s further documented as requir ed in Item s 4, 5, 6, and/or 8, as applic able, and in Item 10 .a of Appe ndix 3; | |
1053 | The use of each of t hese agent s has been approved by the app ropriate c ommittee(s ) or offic ial(s), as shown in Item 10.a of Appendi x 3. | |
1054 | ||
1055 | Name of th e Biosafet y Officer, or of the Chair of the Resear ch Safety or Biosafe ty Committ ee | |
1056 | Signature | |
1057 | Date | |
1058 | ||
1059 | ||
1060 | ||
1061 | ||
1062 | ||
1063 | ||
1064 | ||
1065 | Certificat ion by Rad iation Saf ety Offici al. I cer tify that: | |
1066 | Each agent to be adm inistered to animals on this p rotocol ha s been pro perly iden tified in Item 1 of Appendix 3 as to whe ther it is “radioact ive”; | |
1067 | The use of each radi oactive ag ent is fur ther docum ented as r equired in Items 7 a nd 10.a of Appendix 3; | |
1068 | The use of each radi oactive ag ent has be en approve d by the a ppropriate committee (s), as sh own in Ite m 10.a of Appendix 3 . | |
1069 | ||
1070 | Name of th e Radiatio n Safety O fficer, or of the Ch air of the Radiation Safety or Isotope C ommittee | |
1071 | Signature | |
1072 | Date | |
1073 | ||
1074 | ||
1075 | ||
1076 | ||
1077 | ||
1078 | ||
1079 | ||
1080 | ||
1081 | ||
1082 | Appendix 4 . Ante-mo rtem Speci men Collec tion. No signatures required. | |
1083 | ||
1084 | Appendix 5 . Surgery . Certifi cation by the PI(s). I certif y that: | |
1085 | ||
1086 | To the bes t of my kn owledge, t he informa tion provi ded in App endix 5 of this ACOR P is compl ete and ac curate; | |
1087 | The surgic al procedu res will b e performe d and the post-opera tive care (including administr ation of p ost-operat ive analge sics) will be provid ed as desc ribed; | |
1088 | The spaces where any survival surgical p rocedures will be pe rformed (l isted in I tem 4 of A ppendix 5) are suita ble for st erile/asep tic surger y; | |
1089 | The names and contac t informat ion for re search per sonnel to notify or consult in case of e mergencies will be p rovided to the VMU s upervisor and veteri nary staff ; | |
1090 | Post-opera tive medic al records will be m aintained and readil y availabl e for the veterinary staff and the IACUC to refer to, and wi ll include the follo wing: | |
1091 | ||
1092 | Identifica tion of ea ch animal such that care for i ndividual animals ca n be docum ented. | |
1093 | Daily post operative medical re cords for each anima l, that in clude docu mentation of daily e valuation of overall health an d descript ions of an y complica tions note d, treatme nts provid ed, and re moval of d evices suc h as sutur es, staple s, or woun d clips; | |
1094 | Documentat ion of the administr ation of a ll medicat ions and t reatments given to t he animals , includin g those gi ven to red uce pain o r stress. | |
1095 | Daily reco rds coveri ng at leas t the peri od defined as “post- operative” by local policy. | |
1096 | The signat ure or ini tials of t he person making eac h entry. | |
1097 | . | |
1098 | Name(s) | |
1099 | of Princip al Investi gator(s) | |
1100 | Signature( s) | |
1101 | Date | |
1102 | ||
1103 | ||
1104 | ||
1105 | ||
1106 | ||
1107 | ||
1108 | ||
1109 | ||
1110 | ||
1111 | Appendix 6 . Special Husbandry and Proce dures. No signature s required . | |
1112 | ||
1113 | Appendix 7 . Use of Patient Ca re Equipme nt or Area s for Anim al Studies . | |
1114 | ||
1115 | Certificat ion by the Principal Investiga tor(s). I certify t hat, to th e best of my knowled ge, the in formation provided i n Appendix 7 of this ACORP is complete a nd accurat e, and the use of pa tient care equipment or areas for these animal stu dies will be as desc ribed. | |
1116 | ||
1117 | Name(s) | |
1118 | of Princip al Investi gator(s) | |
1119 | Signature( s) | |
1120 | Date | |
1121 | ||
1122 | ||
1123 | ||
1124 | ||
1125 | ||
1126 | ||
1127 | ||
1128 | ||
1129 | ||
1130 | Certificat ion by the officials responsib le for the use of an y human pa tient care equipment in animal procedura l areas. Each of th e followin g must sig n to indic ate that t hey have g ranted app roval for the human patient ca re equipme nt to be m oved to th e VMU or o ther anima l procedur al area to be used o n animals and then r eturned to the human patient c are area, as describ ed in Appe ndix 7. L eave this section bl ank, if no t applicab le. | |
1131 | ||
1132 | Name of IA CUC Chair | |
1133 | Signature | |
1134 | Date | |
1135 | ||
1136 | ||
1137 | ||
1138 | Name of th e Manager of the Hum an Patient Care Equi pment | |
1139 | Signature | |
1140 | Date | |
1141 | ||
1142 | ||
1143 | ||
1144 | ||
1145 | Certificat ion by the officials responsib le for the use of th e equipmen t in human patient c are areas for these animal stu dies. Eac h of the f ollowing m ust sign t o indicate that they have gran ted approv al for ani mals to be transport ed into hu man patien t care are as for stu dy or trea tment, as described in Appendi x 7. Leav e this sec tion blank , if not a pplicable. | |
1146 | ||
1147 | Name of IA CUC Chair | |
1148 | Signature | |
1149 | Date | |
1150 | ||
1151 | ||
1152 | ||
1153 | Name of At tending Ve terinarian (VMO or V MC) | |
1154 | Signature | |
1155 | Date | |
1156 | ||
1157 | ||
1158 | ||
1159 | Name of th e Chair of the Clin ical Execu tive Board , or the S ervice Chi ef respons ible for t he Patient Care Area and Equip ment | |
1160 | Signature | |
1161 | Date | |
1162 | ||
1163 | ||
1164 | ||
1165 | Name of AC OS for R&D | |
1166 | Signature | |
1167 | Date | |
1168 | ||
1169 | ||
1170 | ||
1171 | Name of Ch ief of Sta ff | |
1172 | Signature | |
1173 | Date | |
1174 | ||
1175 | ||
1176 | ||
1177 | Name of Di rector or CEO of the Facility (Hospital or Clinic) | |
1178 | Signature | |
1179 | Date | |
1180 | ||
1181 | ||
1182 | ||
1183 | ||
1184 | Appendix 8 . Use of Explosive Agent(s) w ithin the Animal Fac ility or i n Animals. | |
1185 | ||
1186 | Certificat ion by the Principal Investiga tor(s). | |
1187 | ||
1188 | I certify that, to t he best of my knowle dge, the i nformation provided in Appendi x 8 of thi s Animal C omponent o f Research Protocol (ACORP) is complete and accura te, and th e use of e xplosive a gents in t hese anima l studies will be as described . | |
1189 | ||
1190 | I further certify th at: | |
1191 | ||
1192 | Procedures involvin g explosiv e agent(s) will be p erformed w ithin a pr operly ope rating, ve ntilated s afety hood ; | |
1193 | All electr ical equip ment opera ting when explosive agent(s) a re in use will be po sitioned a nd powered outside o f the hood ; | |
1194 | Once the s eal is bro ken on any container s of explo sive agent s, they wi ll be kept in a safe ty hood th roughout u se, stored in an exp losion-pro of refrige rator or o ther appro ved storag e area, an d discarde d properly once comp letely emp tied; | |
1195 | Proper pro cedures wi ll be used for safe and approp riate disp osal of it ems (inclu ding anima l carcasse s) that ma y contain residual t races of t he explosi ve agent(s ). | |
1196 | ||
1197 | Name(s) | |
1198 | of Princip al Investi gator(s) | |
1199 | Signature( s) | |
1200 | Date | |
1201 | ||
1202 | ||
1203 | ||
1204 | ||
1205 | ||
1206 | ||
1207 | ||
1208 | ||
1209 | ||
1210 | Certificat ion by the officials responsib le for ove rseeing th e use of e xplosive a gent(s) in this prot ocol. Eac h of the f ollowing m ust sign t o verify t hat they o r the comm ittee they represent have gran ted approv al. | |
1211 | ||
1212 | Name of IA CUC Chair | |
1213 | Signature | |
1214 | Date | |
1215 | ||
1216 | ||
1217 | ||
1218 | Name of At tending Ve terinarian (VMO or V MC) | |
1219 | Signature | |
1220 | Date | |
1221 | ||
1222 | ||
1223 | ||
1224 | Name of Sa fety/Biosa fety Offic er for the Facility | |
1225 | Signature | |
1226 | Date | |
1227 | ||
1228 | ||
1229 | ||
1230 | Name of AC OS for R&D | |
1231 | Signature | |
1232 | Date | |
1233 | ||
1234 | ||
1235 | ||
1236 | Name of VI SN Regiona l Safety O fficer | |
1237 | Signature | |
1238 | Date | |
1239 | ||
1240 | ||
1241 | ||
1242 | ||
1243 | Departures from “Mus t” and “Sh ould” Stan dards in t he Guide. No signat ures requi red. |
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