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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_Main_Body_Instructions.docx | Thu May 17 00:40:44 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_Main_Body_Instructions.docx | Tue Jul 17 21:23:11 2018 UTC |
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1 | instructio ns for com pletion of the | |
2 | Animal Com ponent of Research P rotocol | |
3 | Main Body | |
4 | (ACORP Ins tructions) | |
5 | Version 4 | |
6 | ||
7 | ||
8 | These inst ructions p rovide det ailed guid ance on co mpleting t he Main Bo dy of the ACORP, and are refer enced to t he letters and numbe rs of the items in t he ACORP. The PI may use the A CORP Main Body templ ate provid ed in the RAMS appli cation by using the link avail able in qu estion 8 o f section M. | |
9 | ||
10 | Regulatory documents mentioned in the in structions are abbre viated as follows: | |
11 | ||
12 | 0730 – VA Handbook 0 730 Securi ty and Law Enforceme nt, August 11, 2000 | |
13 | 0730/2 – V A Handbook 0730/2 Se curity and Law Enfor cement, Ma y 27, 2010 | |
14 | 1108.01 – VHA Handbo ok 1108.01 Controlle d Substanc es (Pharma cy Stock), November 16, 2010 | |
15 | 1200.07 – VHA Handbo ok 1200.07 Use of An imals in R esearch, N ovember 23 , 2011 | |
16 | AAALAC FAQ s – Associ ation for Assessment and Accre ditation o f Laborato ry Animal Care Inter national F AQs, June 2011 | |
17 | AVMA Guide lines on E uthanasia – The AVMA Guideline s on Eutha nasia (for merly the 2000 Repor t of the A VMA Panel on Euthana sia), 2007 | |
18 | AWAR – USD A Animal W elfare Act Regulatio ns and Sta ndards, Co de of Fede ral Regula tions, Tit le 9, Chap ter 1) | |
19 | Form 7023 – USDA APH IS Form 70 23 | |
20 | Guide – Gu ide for th e Care and Use of La boratory A nimals, 8t h ed., 201 1 | |
21 | OLAW FAQs – Frequent ly Asked Q uestions – PHS Polic y on Human e Care and Use of La boratory A nimals (ht tp://grant s.nih.gov/ grants/ola w/faqs.htm ) | |
22 | PHS Policy – Public Health Ser vice Polic y on Human e Care and Use of La boratory A nimals | |
23 | US Governm ent Princi ples – US Government Principle s for the Utilizatio n and Care of Verteb rate Anima ls Used I Testing, R esearch, a nd Trainin g | |
24 | USDA APHIS Animal Ca re Policie s – Animal Care Reso urce Guide Policies, USDA APHI S, March 2 5, 2011 | |
25 | ||
26 | General In structions : | |
27 | Answer eac h question by comple ting the t able provi ded or ent ering the requested informatio n at the ► . Enter “N /A” for an y item tha t does not apply to this proto col. The sections o f the form will expa nd as need ed. | |
28 | To check a n item, ty pe “X” ins ide the ( ) provid ed. | |
29 | Define eac h abbrevia tion the f irst time it is used . | |
30 | ONLY inclu de the ind ividual ap pendices t hat are re levant to the protoc ol being s ubmitted f or review. | |
31 | ||
32 | ||
33 | Header for Every Pag e. The he ader infor mation for this appe ndix is pr e-populate d to match header fo r the Main Body of t he ACORP t o which it applies, to identif y each pag e of this Appendix w ith that A CORP: | |
34 | PI’s last name: The PI’s name is prepopu lated | |
35 | Protocol N o. Assigne d by the I ACUC – Thi s is a uni que identi fier for e ach protoc ol that is automatic ally gener ated by th e system t o the prot ocol as a whole | |
36 | ||
37 | Official D ate of App roval – Th is is the date of fi nal and un equivocal approval b y the IACU C, as defi ned in the PHS Assur ance, whic h determin es the due dates of the first annual con tinuing re view and t he trienni al de novo review, a s applicab le. The IA CUC commit tee will e nter this date into the form w hen a deci sion is ma de. | |
38 | ||
39 | ||
40 | ACORP Stat us. | |
41 | ||
42 | Full Name of Princip al Investi gator – Th e Full nam e of the P I is prepo pulated in the templ ate that i s generate d from RAM S. | |
43 | ||
44 | VA Station Name (Cit y) and 3-D igit Stati on Number – Enter th e name and 3-digit s tation num ber of the VA Statio n that wil l be respo nsible for overseein g the work to be per formed on this proto col, regar dless of t he locatio n where th e work wil l be perfo rmed. | |
45 | ||
46 | Protocol T itle – The Protocol Title is p repopulate d in the t emplate th at is gene rated from RAMS. | |
47 | ||
48 | Animal Spe cies cover ed by this ACORP – T he IACUC m ust determ ine whethe r multiple species m ay be cove red by any given ACO RP. When very simil ar procedu res are to be perfor med on mor e than one similar s pecies (e. g., the sa me surgica l procedur e on mice and rats), it may be appropria te to docu ment both species in a single ACORP. Wh en differe nt procedu res are to be perfor med on ver y differen t species (e.g., sur gery on mi ce and beh avioral te sting of c ats), it i s recommen ded that a separate ACORP be p repared fo r each spe cies. In any case, it should always be clearly st ated in th e response to each i tem, which part of e ach respon se applies to which procedure and which species. | |
49 | ||
50 | Funding So urce(s). Based on t he selecti on made in the RAMS applicatio n, the fun ding sourc e is pre-s elected. C heck each source of funds that will supp ort the wo rk on this protocol. These de termine th e regulato ry and rep orting req uirements that apply to the pr otocol. | |
51 | Related Do cumentatio n – Identi fy here an y related documentat ion that m ay be rele vant for t he IACUC t o referenc e in the p rocess of reviewing this proto col. | |
52 | ||
53 | If this AC ORP addres ses work o n a projec t that has already b een submit ted to the R&D Commi ttee for r eview, ide ntify the project: | |
54 | ||
55 | Title of p roject – e nter the t itle of th e project that has b een submit ted to the R&D Commi ttee for r eview | |
56 | ||
57 | Date of R& D Committe e approval – leave b lank if th e project has not ye t been app roved by t he R&D Com mittee | |
58 | ||
59 | Triennial review. P HS Policy (IV.C.5) r equires a complete d e novo rev iew of ani mal use pr otocols at least onc e every th ree years. If this ACORP is b eing submi tted for t riennial r eview, sum marize the work on t he previou sly approv ed protoco l that has already b een comple ted, and r eport the numbers of approved animals th at have be en used. Describe a ny study r esults tha t have pro mpted chan ges in the protocol, and brief ly summari ze the cha nges that have been incorporat ed, to gui de the rev iewers to the detail s document ed in othe r items of this ACOR P. | |
60 | ||
61 | For exampl e, describ e results that chang e the esti mated succ ess rate o f the proc edures, th e estimate d differen ces and/or variabili ty of the data (whic h impact t he numbers of animal s needed), the hypot heses to b e tested, or the spe cific proc edures to be perform ed. | |
62 | The Trienn ial review can be st arted from the previ ously appr oved appli cation. Op en the pre viously ap proved app lication a nd expand the approv ed toolbar . Please s elect Crea te Event i n the row correspond ing to Tri ennial rev iew. The P I will be re-directe d to the R esearch St udy Applic ation page and notic e a new ap plication with –Trie nnial revi ew appende d to the m ain study title will be create d. The PI may click on the cor responding study ID link to op en the Tri ennial rev iew applic ation, com plete it a nd submit it for rev iew. | |
63 | ||
64 | Any other relevant p reviously approved a nimal use protocol – If you wo uld like t he IACUC t o be able to refer t o any othe r approved animal us e protocol when revi ewing this one, iden tify the o ther proto col. | |
65 | ||
66 | Indicate t he type(s) of animal use cover ed by this protocol (check all that appl y): | |
67 | ||
68 | Research – This incl udes all u se of anim als for a specific r esearch st udy, inclu ding train ing of per sonnel to perform pr ocedures r equired fo r the stud y, testing that is p art of the experimen tal design , collecti on of spec imens from donor ani mals, and breeding a nd colony management specifica lly for th e purposes of the re search stu dy. | |
69 | ||
70 | Teaching o r Training – This in cludes all use of an imals spec ifically f or teachin g or train ing purpos es, as in workshops or for stu dent labor atory exer cises. | |
71 | ||
72 | Testing – This inclu des all us e of anima ls specifi cally for routine te sting, as in safety studies re quired for FDA appro val. | |
73 | ||
74 | Breeding a nd colony management – This in cludes bre eding and management of coloni es being m aintained as resourc es; breedi ng and col ony manage ment speci fically to supply an imals requ ired for a research project sh ould be de signated “ research”, above. | |
75 | ||
76 | Holding pr otocol – L ocal polic y may spec ify the us e of holdi ng protoco ls for ani mals trans ferred fro m expired or suspend ed protoco ls; There are no VA, PHS, or U SDA regula tory requi rements fo r such pro tocols. | |
77 | ||
78 | Other – De scribe the other typ e(s) of an imal use c overed by this proto col. | |
79 | ||
80 | ||
81 | Proposal O verview | |
82 | ||
83 | Descriptio n of Relev ance and H arm/Benefi t Analysis . (US Gov ernment Pr inciples, Principle II). Langu age that i s informat ive to the general p ublic is i mportant b ecause the ACORP ser ves to doc ument the relevance of this wo rk to the tax-paying public. A scientif ic abstrac t from a g rant propo sal is not appropria te. The I ACUC is ob ligated to weigh the benefits to be gain ed from th e work aga inst poten tial conce rns about animal wel fare (AAAL AC FAQs, C .3; Guide, p. 27), s o it is im portant fo r the prot ocol to pr ovide the informatio n that the IACUC nee ds to asse ss this. | |
84 | ||
85 | Experiment al Design – Describe the proce dures to b e performe d, how the y fit into the seque nce of eve nts for ea ch group o f animals, and why t hey are ne cessary to the resea rch object ives. | |
86 | ||
87 | Lay Summar y. Langua ge that is informati ve to the lay reader is import ant for or ienting th e lay memb er(s) of t he IACUC w ith regard to the co nceptual d esign of t he experim ent. | |
88 | ||
89 | 2. Complet e descript ion of the proposed use of ani mals (PHS Policy, IV .D.1.c.). Describe the propos ed use of animals as it relate s to the e xperimenta l design, providing sufficient detail an d using la nguage sui table for scientific colleague s who may not be exp erts in yo ur discipl ine. For agricultur al animals used in r esearch, s pecify whe ther the r esearch is biomedica l or agric ultural, a nd explain why (Guid e, p. 32-3 3). VA pol icy requir es that al l procedur es planned for the p eriod of a VA award (even if t hat period is longer than thre e years) b e included in the AC ORP, even though the IACUC is required t o perform a new revi ew three y ears after the initi al approva l date (PH S Policy, IV.C.5). | |
90 | ||
91 | a. Summari ze the des ign of the experimen t in terms of the se quence of events tha t animals in each gr oup will e xperience, including which pro cedures an d manipula tions will be perfor med, and w hy these p rocedures and manipu lations ar e necessar y. Approv al of this ACORP wil l apply sp ecifically to the de scriptions given her e. Any di fferences from the p rocedures that were proposed i n the gran t proposal should be explained – for exa mple, chan ges requir ed by the IACUC must be design ated as su ch (PHS Po licy, IV.D .2), and t he basis f or other c hanges (su ch as new informatio n obtained after sub mission of the grant ) should b e describe d. For co mplicated experiment al designs , a flow c hart, diag ram, or ta ble is str ongly reco mmended to help the IACUC unde rstand wha t is being proposed. | |
92 | ||
93 | b. Justify the group sizes and the numbe rs of anim als reques ted. (US Government Principle s, Princip le III) To show th at the pro posed work conforms to applica ble US and VA requir ements reg arding num bers of an imals used , describe how the n umber of a nimals nee ded for th e experime nts was es timated. Explain ho w this est imate is r elated to the experi mental and control g roups desc ribed in I tem C.2.a, above, an d how the optimal nu mber of an imals to b e included in each g roup was e stimated. The Guide (p. 25) s tates that whenever possible, the number of animal s requeste d should b e justifie d statisti cally. A power anal ysis is st rongly enc ouraged to justify g roup sizes when appr opriate. | |
94 | ||
95 | c. Describ e each of the proced ures to be performed on any an imal on th is protoco l. For ea ch procedu re, descri be specifi cally what will be d one, what the animal s will be expected t o experien ce if no s pecial mea sures are taken to a ddress pot ential pai n or distr ess, and w hat measur es are pla nned to ad dress any potential pain or di stress. D etails are requested in separa te appendi ces for an tibody pro duction (A ppendix 2) , surgica l procedur es (Append ix 5), and behaviora l training (Appendix 6), so su mmary desc riptions o f those pr ocedures a re suffici ent here. It is als o sufficie nt to prov ide summar y descript ions of an y procedur es that ar e detailed in SOPs a pproved by the IACUC , provided the SOPs are docume nted in It em Y. NOTE : Use Appe ndix 9 to document e ach of the procedure s that inv olves a “d eparture” (as define d by OLAW) from a “m ust” or “s hould” sta ndard in t he Guide. Consult w ith the IA CUC or Att ending Vet erinarian in case of questions about whe ther speci fic proced ures repre sent “depa rtures”. | |
96 | ||
97 | Species. Explain wh y the spec ies indica ted is/are particula rly approp riate to t he work pr oposed (PH S Policy, IV.D.1.b) Consider such chara cteristics as body s ize, avail ability of specific strains, b reeds, or mutants, d ata from p revious st udies, and unique an atomic or physiologi c features . Explain why these are impor tant to th e work pro posed. | |
98 | ||
99 | Personnel | |
100 | ||
101 | Qualificat ions and t raining -- Document the curren t qualific ations of all person nel for pe rforming t he procedu res for wh ich they a re to be r esponsible (PHS Poli cy, IV.C.1 .f). If an y personne l are not yet approp riately tr ained, pla ns for pro viding the additiona l required training will be re quested in Item F. | |
102 | ||
103 | 1. PI – T he PI is r esponsible for super vising all of the ot her person nel and en suring tha t the use of animals is approp riate, and therefore must be q ualified t o work wit h research animals ( 1200.07, p ar. 8.m). | |
104 | ||
105 | Name: | |
106 | Animal res earch expe rience – D escribe th e PI’s edu cation, tr aining, an d other ex perience w ith animal research in general . A listi ng of acad emic degre es alone i s not an a dequate re sponse. | |
107 | Qualificat ions to pe rform spec ific proce dures – co mplete the table to document t he PI’s ex perience w ith each o f the spec ific proce dures that the PI is to perfor m, in the species de scribed in this ACOR P. If the PI needs f urther tra ining, ent er “to be trained”, and provid e the deta ils of the planned t raining in Item F, b elow. Qua lification s to perfo rm euthana sia will b e requeste d in Item U.3, and n eed not be given her e. | |
108 | ||
109 | 2. Other research p ersonnel - - Provide the inform ation requ ested for each addit ional memb er of the research s taff who w ill be inv olved in t he work wi th the ani mals on th is protoco l. Includ e members of the VMU staff who will be r esponsible for perfo rming any of the exp erimental procedures on the an imals on t his protoc ol. | |
110 | ||
111 | Name: | |
112 | Animal res earch expe rience – D escribe th e individu al’s educa tion, trai ning, and other expe rience wit h animal r esearch in general. A listing of academ ic degrees alone is not an ade quate resp onse. | |
113 | Qualificat ions to pe rform spec ific proce dures – co mplete the table to document t he individ ual’s expe rience wit h each of the specif ic procedu res that h e or she i s to perfo rm, in the species d escribed i n this ACO RP. If the individua l needs fu rther trai ning, ente r “to be t rained”, a nd provide the detai ls of the planned tr aining in Item F, be low. Quali fications to perform euthanasi a will be requested in Item U. 3, and nee d not be g iven here. | |
114 | ||
115 | 3. VMU an imal care and veteri nary suppo rt staff p ersonnel – Provide t he informa tion reque sted for e ach member of the VM U animal c are and ve terinary s taff who w ill perfor m support procedures in the an imals on t his protoc ol. “Supp ort proced ures” incl ude specia l husbandr y, pre-ope rative pre paration, post-opera tive care, and other such serv ices that go beyond routine hu sbandry bu t do not i nclude per formance o f experime ntal proce dures. Me mbers of t he VMU ani mal care s taff who w ill perfor m specific experimen tal proced ures on an imals on t his protoc ol should be documen ted as res earch pers onnel in i tem E.2, a bove. | |
116 | ||
117 | Name: | |
118 | Qualificat ions to pe rform spec ific proce dures – co mplete the table to document t he individ ual’s qual ifications for perfo rming each support p rocedure i n the spec ies descri bed in thi s ACORP (e .g., AALAS certifica tion, expe rience, co mpletion o f special training). If the in dividual n eeds furth er trainin g, enter “ to be trai ned”, and provide th e details of the pla nned train ing in Ite m F, below . Qualifi cations to perform e uthanasia will be re quested in Item U.3, and need not be giv en here. | |
119 | ||
120 | 4. Complet ion of req uired trai ning (1200 .07, par. 8.m(2)) – document t hat each o f the rese arch perso nnel invol ved in thi s protocol is curren t on his/h er require d training at the ti me of subm ission of this proto col by ent ering the most recen t completi on date fo r each cou rse. If al ternate tr aining to the standa rd courses identifie d on the C ollaborati ve Institu tional Tra ining Init iative (CI TI) or AAL AS Learnin g Library (ALL) webs ites has b een approv ed by the CVMO, iden tify the c ourse and the provid er of the training ( website, o rganizatio n, instruc tor, etc.) as well a s the comp letion dat e. | |
121 | ||
122 | Training t o be provi ded. If a ny of the personnel in Item E need furth er trainin g to perfo rm the exa ct procedu res assign ed to them in the sp ecies addr essed by t his ACORP, describe the additi onal train ing that w ill be pro vided. Id entify eac h procedur e for whic h training is needed and descr ibe the ty pe of trai ning that will be pr ovided (e. g., classr oom, semin ar, worksh op, observ ation of a n experien ced indivi dual, and/ or supervi sed practi ce). Then give the n ame, the q ualificati ons, and t he trainin g experien ce of each trainer. If not ap plicable, enter “N/A ”. | |
123 | ||
124 | Occupation al Health and Safety . The ins titutional Occupatio nal Health and Safet y Program (OHSP) for protectin g personne l involved in the us e of anima ls in rese arch (PHS Policy, IV .A.1.f, an d OLAW FAQ s G.2) sh ould inclu de not onl y training , but also on-going surveillan ce element s (1200.07 , par. 10. c and Appe ndix C par . 4.a(2)). | |
125 | ||
126 | Each indiv idual incl uded in It em E must be “enroll ed” in an OHSP (1200 .07, par. 10.a, and Appendix C par. 4.a) . An “enr olled” ind ividual mu st have th e opportun ity to par ticipate f ully in th e Prevent ive Medici ne Program (PMP) pro vided by t he institu tion, but may elect to sign a waiver to decline pa rticipatio n in the o ptional co mponents o f such a p rogram. | |
127 | ||
128 | The freque ncy of int eractions with the O HSP requir ed for any individua l depends on the ris ks relevan t to that individual ’s duties as well as the indiv idual’s he alth statu s, and mus t be deter mined by O HSP person nel (1200. 07, par. 1 0.c; OLAW FAQs G.2; and Guide, p. 17-19) . | |
129 | ||
130 | Non-routin e OHSP mea sures incl ude specia l vaccines , prophyla ctic measu res (e.g., selegilin e for MPTP or stable iodine fo r radioact ive iodine ), educati on, or add itional he alth scree ning techn iques. Th ese may be required or may be optional b ut potenti ally benef icial to r esearch, h usbandry, or veterin ary staff participat ing in or supporting some prot ocols. Fo r field st udies, ide ntify any relevant z oonotic di seases, sa fety issue s, or laws or regula tions that apply, be yond those common to routine u se of labo ratory ani mals, and describe h ow these c oncerns wi ll be addr essed. Ro utine meas ures alrea dy include d in the O ccupationa l Health a nd Safety Program (e .g., vacci nation for tetanus, rabies, an d hepatiti s B, and T B screenin g) need no t be menti oned here. | |
131 | ||
132 | Animals Re quested | |
133 | ||
134 | Animals to be Used. Complete t he table, listing on a separat e line eac h group of animals w ith any sp ecific fea tures that are requi red for th e study. List each species on a separat e line, an d further subdivide the animal s by any s urgical al terations to be perf ormed by t he vendor (e.g., “ov ariectomiz ed rats”) and any ot her featur es such as strain, s tock, geno type, bree d, gender, age/size, and/or he alth statu s, if thes e are spec ified for the study. Combinat ions (“eit her” for g ender) or ranges (fo r ages or sizes) may be entere d if the s tudy does not requir e specific s. | |
135 | ||
136 | Identify t he source from which animals o n each lin e in the t able will be obtaine d, giving the name o f any comm ercial ven dor or col laborator who will p rovide the animals, or specify that the animals wi ll be obta ined from a local br eeding col ony and id entify the PI respon sible for maintainin g the colo ny. | |
137 | ||
138 | Specify th e least st ringent he alth statu s acceptab le for all of the an imals on t he same li ne of the table as f ollows: | |
139 | rodents an d rabbits – “specifi c-pathogen -free (SPF )”, “gnoto biotic” (“ germ-free” or “free of defined flora”), “conventio nal”, “fer al”, or ot her descri ption | |
140 | dogs, cats , pigs, an d other “l arge anima ls” – “spe cific-path ogen-free (SPF)”, “c onditioned ”, “conven tional”, “ feral”, or other des cription. | |
141 | non-human primates – specify v iral statu s (e.g., h erpes B ne gative, SI V negative , etc.) an d TB statu s. | |
142 | ||
143 | Numbers of animals r equested, itemized b y species, and categ orized acc ording to the pain a nd/or dist ress assoc iated with the proce dures to b e performe d (USDA AP HIS Animal Care Poli cy #11). T he total i n each cat egory, for each spec ies, will be the tot al number approved b y the IACU C for use over the l ife of the protocol. The USD A (AWAR, § 2.36(b)(3- 8)) and th e VA (1200 .07, par. 8.l(4)) re quire that the numbe rs of all animals ac tually use d each yea r at a res earch faci lity be re ported ann ually, cat egorized a ccording t o pain and /or distre ss. The c olumns sho wn here, b reaking do wn the num bers by ye ar, only s how the pr ojected es timates, w hich may d iffer from the actua l usage. These esti mates may be require d by the l ocal IACUC , but the yearly col umns are o therwise s hown only for the co nvenience of the PI. | |
144 | ||
145 | Notes: | |
146 | For comple x protocol s involvin g many dif ferent pro cedures, l ist for ea ch categor y the proc edures tha t account for the as signment o f animals to that ca tegory. | |
147 | Use a sepa rate row i n each tab le for eac h species and, withi n species, for each experiment al group o r combinat ion of exp erimental groups tha t undergoe s a differ ent set of procedure s. This sh ould make it clear h ow the num bers shown in Item I relate to the anima ls describ ed in Item C. It is not necess ary to ite mize by st rain unles s the diff erent stra ins underg o differen t sets of procedures . | |
148 | No animal should be assigned t o more tha n one USDA category. If sever al differe nt procedu res are to be perfor med in a s ingle anim al, the an imal shoul d be assig ned to the category correspond ing to the most pain ful/distre ssing proc edure. | |
149 | If you hav e question s about th e appropri ate catego ry assignm ents, plea se contact the Atten ding Veter inarian or IACUC Cha ir for ass istance. | |
150 | Be sure to include a ll of the animals th at will be used in c onnection with this protocol, including not only t he actual study subj ects, but also all a dditional individual s such as (but not e xclusive t o) breeder s, tissue donors, an d those ge nerated in breeding colonies a nd culled because of unusable gender, ge notype, or date of b irth. | |
151 | ||
152 | USDA Categ ory B: In clude in C ategory B all animal s that wil l be bred or purchas ed exclusi vely for b reeding, a nd that wi ll not und ergo any p rocedures other than those req uired by c urrently a ccepted st andards of medical c are. This includes breeders, and any yo ung that m ay be cull ed because of unusab le gender, genotype, or date o f birth. If numbers cannot be determine d exactly, estimate the maximu m expected , as close ly as poss ible. (No te: Animal s that mus t undergo tail snips for genot yping must be assign ed to cate gory C, D, or E.) | |
153 | USDA Categ ory C: In clude in C ategory C all animal s that wil l only und ergo proce dures that involve n o more tha n very bri ef or mino r pain or distress, for which no pain re lieving dr ugs are ne eded. Exa mples incl ude observ ational st udies, mos t intraven ous and pa renteral i njections of non-irr itating ag ents, most blood col lections f rom periph eral vesse ls, and eu thanasia f or post-mo rtem colle ction of c ells and/o r tissues. | |
154 | USDA Categ ory D: In clude in C ategory D all animal s that wil l only und ergo no mo re than pr ocedures t hat are po tentially painful or distressi ng, but fo r which th e pain or distress i s prevente d or relie ved by app ropriate a nesthetics , sedative s, analges ics, or ot her means (e.g., acu puncture). Examples include s urgery per formed und er anesthe sia (major or minor, survival or non-sur vival), ti ssue or or gan collec tions or o ther painf ul procedu res perfor med on liv ing animal s under an esthesia ( such as re tro-orbita l blood co llection i n rodents) , prolonge d restrain t accompan ied by tra nquilizers or sedati ves, and e xperiments with prov isions for immediate euthanasi a to effec tively pre vent pain and/or suf fering in animals th at are bec oming sick . If an e ndpoint is defined s uch that t he animals are likel y to exper ience sign ificant pa in or dist ress, Cate gory E is more appro priate. | |
155 | USDA Categ ory E: In clude in C ategory E all animal s that wil l undergo procedures in which pain or di stress CAN NOT be rel ieved. An important rule of t humb for d eciding wh ether an a nimal shou ld be assi gned to Ca tegory E i s to consi der whethe r a human experienci ng a compa rable cond ition woul d be expec ted to see k relief. Examples include st udies in w hich anima ls must be allowed t o die with out interv ention (e. g. LD50, m ortality a s an end-p oint), stu dies that require en dpoints th at may be painful or stressful , studies that requi re withdra wal from a ddictive d rugs (with out pallia tive treat ment), pai n research , and stud ies that i nvolve nox ious stimu li that ar e not imme diately es capable, f ood or wat er depriva tion beyon d that nec essary for standard pre-surgic al prepara tion, or p aralysis o r immobili ty in cons cious anim als. | |
156 | ||
157 | TOTALS: Br ing down t otals for each speci es, over a ll groups and/or pro cedures in all categ ories, for each year (if using the yearl y columns) and for t he protoco l as a who le. | |
158 | ||
159 | Management of USDA C ategory D procedures . For any protocol that inclu des Catego ry D proce dures, lis t each Cat egory D pr ocedure an d provide the inform ation requ ested in t he table. | |
160 | ||
161 | Describe h ow the ani mals will be monitor ed for evi dence of p ain or dis tress duri ng the pro cedure and through p ost-proced ure recove ry, includ ing the me thod(s) by which the animals w ill be mon itored, th e frequenc y with whi ch they wi ll be moni tored, and how long post-proce dure monit oring will continue. | |
162 | ||
163 | The person (s) identi fied as re sponsible for monito ring must be documen ted in Ite m E, above . | |
164 | ||
165 | Describe e ach method to be use d to allev iate pain and/or dis tress duri ng the pro cedure or the post-p rocedure r ecovery pe riod, givi ng dose, r oute, and duration o f effect o f any anal gesic, sed ative, tra nquilizer, or anesth etic to be administe red, and p roviding c omparable details fo r any othe r method(s ) by which pain or d istress wi ll be alle viated | |
166 | ||
167 | For any su rgical pro cedure tha t you will describe in Appendi x 5, only identify t he procedu re(s) in t he “Proced ure” colum n, and ind icate “See Appendix 5 for deta ils.” | |
168 | ||
169 | Justificat ion of Cat egory E pr ocedures. The USDA and the VA require e ach facili ty to incl ude in the annual re port of an imal use t he justifi cation for each Cate gory E pro cedure per formed (Fo rm 7023, 1 200.07 par . 8.l(4)). Indicate whether t his protoc ol include s any Cate gory E pro cedures. If so, ide ntify each Category E procedur e included and justi fy scienti fically wh y the pain and/or di stress can not be rel ieved. Fo r example, give the evidence t hat drugs available for reliev ing the an ticipated pain or di stress wou ld make th e results uninterpre table. If animals must be o bserved un til natura l death (e .g. in som e studies of infecti ous diseas e or oncol ogy), or i f the endp oint that must be us ed otherwi se allows the animal s to exper ience more than very brief or slight pai n or distr ess, you m ust explai n why an a lternate e ndpoint (s uch as mod erate weig ht loss, c linical si gns, tumor size, etc .) prior t o death or the onset of pain o r distress cannot be used. Th e justific ations giv en here wi ll be incl uded in th e annual r eports sub mitted to the USDA a nd the VA. (If anima ls will un dergo cate gory D pro cedures as well as C ategory E procedures , give the details a bout the C ategory D procedures in Item J .) | |
170 | ||
171 | Veterinary Care and Husbandry | |
172 | ||
173 | Veterinary Support. | |
174 | ||
175 | (US Govern ment Princ iples, Pri nciple VII ). Identi fy and pro vide conta ct informa tion for 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. This may be a supervisin g Attendin g Veterina rian, or t he veterin arian spec ifically a ssigned to the anima ls on this protocol. | |
176 | Veterinary consultat ion during the plann ing of thi s protocol . VA Poli cy (1200.7 , par. 8.f (2)(b)) re quires tha t a labora tory anima l veterina rian be co nsulted du ring the p lanning st ages of ev ery protoc ol, so tha t the vete rinarian’s recommend ations can be incorp orated int o the ACOR P before t he protoco l is submi tted for I ACUC revie w. To be valid, the most rece nt consult ation must have occu rred no mo re than 3 years befo re the pro tocol was submitted for IACUC review. As an alte rnative to a face-to -face meet ing, the v eterinaria n may perf orm a pre- review of a draft of the ACORP and provi de comment s to the P I so that the ACORP can be rev ised prior to IACUC review. D ocument th at this ha s been don e by provi ding the i nformation requested . | |
177 | ||
178 | Husbandry. This ite m focuses on the equ ipment and services that will be require d for the husbandry of the ani mals on th is protoco l. It may be useful to consul t with the VMU staff for speci fics on th e housing and servic es that ar e availabl e. The det ails and j ustificati ons for an y special husbandry required w ill be req uested in Appendix 6 . Any “de partures” from “shou ld” or “mu st” standa rds in the Guide tha t are appr oved by th e IACUC fo r this pro tocol must be docume nted as su ch in Appe ndix 9. C onsult wit h the IACU C or Atten ding Veter inarian in case of q uestions a bout wheth er the hus bandry req uired invo lves “depa rtures”. | |
179 | ||
180 | Caging nee ds. To hel p the anim al care st aff plan, complete t he table t o describe the housi ng that wi ll be need ed for thi s protocol . | |
181 | ||
182 | Species. Enter the species fo r which ea ch type of housing i s requeste d. | |
183 | Type of ho using. En ter any sp ecial feat ures requi red. Thes e may incl ude featur es such as (but not limited to ): | |
184 | ||
185 | Gnotobioti c (germ-fr ee or defi ned flora) isolation | |
186 | Biohazard or other s pecial haz ard contai nment | |
187 | Sterile mi croisolato r caging, with filte red cage t op | |
188 | Non-steril e microiso lator cagi ng, with f iltered ca ge top | |
189 | Wire-botto m | |
190 | ||
191 | If no spec ial featur es are req uired, ent er “standa rd (see SO P)” for ho using acco rding to a ny local S OP and ent er the req uested inf ormation a bout the S OP into th e table in Item Y; o r enter “s tandard, s ee below” and descri be the sta ndard hous ing below the table. | |
192 | ||
193 | Number of individual s to be ho used in ea ch housing unit. Gi ve the ran ge of numb ers of ind ividual an imals that may be ho used in an y one hous ing unit. The Guide recommend s that soc ial animal s be house d in stabl e pairs or groups un less they must be ho used alone for exper imental re asons or b ecause of social inc ompatibili ty (Guide, p. 51 and 64). Pro vide the j ustificati on if any animals ar e to be ho used singl y (if spec ies is not considere d “social” , then so note). | |
194 | ||
195 | Indicate w hether the housing d escribed i s consiste nt with th e standard s in the G uide and w ith AWAR ( for USDA-r egulated s pecies). D ocument as a “depart ure”( in A ppendix 9) any housi ng that is not consi stent with the stand ards in th e Guide. | |
196 | ||
197 | Estimated maximum nu mber of ho using unit s needed a t any one time. Thi s allows t he VMU sta ff to eval uate wheth er existin g housing is suffici ent to mee t the need s of this protocol. | |
198 | ||
199 | Enrichment . PHS Pol icy (IV.C. 1) require s the IACU C to confi rm that wo rk involvi ng animals is consis tent with the requir ements of the Animal Welfare A ct. Enter here any s pecial res trictions or additio ns to stan dard enric hment that will be r equired. If no spec ial modifi cations ar e required , and the enrichment will be p rovided ac cording to a local S OP, enter “standard (see SOP)” in the ta ble, and e nter the i nformation requested about the SOP into the table in Item Y. If the s tandard en richment i s not desc ribed in a SOP, ente r “standar d, see bel ow” and de scribe it in the sec tion below the table . Note tha t USDA req uires an i nstitution al exercis e plan for dogs (AWA R, §3.8), and enviro nmental en hancement to promote psycholog ical well- being for nonhuman p rimates (A WAR, §3.81 ). | |
200 | ||
201 | Customized routine h usbandry. Enter her e informat ion or ins tructions that may b e importan t for the animal hus bandry sta ff to be a ware of, i n providin g appropri ate routin e monitori ng and car e. | |
202 | ||
203 | “Genetical ly modifie d animals” include s pecially i n-bred str ains as we ll as gene tically en gineered, transgenic , knock-in , or knock -out anima ls. Genet ic modific ations tha t are to b e newly ge nerated on or for th is protoco l may resu lt in unex pected phe notypic ch anges, so the first generation s of such animals sh ould be ca refully mo nitored. | |
204 | ||
205 | “Devices” that exten d chronica lly throug h the skin may inclu de, but ar e not limi ted to, ca nnulae, ac rylic impl ants, and catheters. Details about spe cial care to be prov ided by th e research staff wil l be reque sted in Ap pendix 6. | |
206 | ||
207 | Other cust omized rou tine husba ndry may i nclude suc h features as specia l bedding material, alternate watering d evices, or a modifie d schedule of beddin g changes. | |
208 | ||
209 | Housing Si tes. The IACUC is r equired to inspect s emi-annual ly all sit es where a nimals are housed (A WAR, §1.1” study area ” and §2.3 1(c)(2); P HS Policy, IV.B.2; O LAW FAQs, E.1; 1200. 07, par. 8 f(1)(a)). | |
210 | ||
211 | Housing on VA proper ty. Inclu de all loc ations on VA propert y where an y animals on this pr otocol wil l be house d, regardl ess of whe ther they are purcha sed with V A funds, o r used by personnel on officia l VA duty time. | |
212 | ||
213 | Housing in non-VA fa cilities. Include a ll locatio ns not on VA propert y where an y animals on this pr otocol wil l be house d, regardl ess of whe ther they will be pu rchased wi th VA fund s or used by personn el on offi cial VA du ty time. Be sure to consider affiliated instituti ons and co ntract fac ilities th at purchas e and hous e animals on your be half to ma ke custom antibodies or other biological products. Consult with your Attending Veterinari an or IACU C to deter mine which instituti ons must b e entered. USDA pol icies and PHS policy clarifica tions may also be he lpful. | |
214 | ||
215 | For the st atus of AA ALAC accre ditation, enter one of the fol lowing (Co nsult your Attending Veterinar ian or IAC UC for the status of the non-V A facility .): | |
216 | ||
217 | “CFA” (Con tinued Ful l Accredit ation) | |
218 | “DCA” (De ferred Acc reditation ) | |
219 | “PROB” (Pr obation) | |
220 | “RFA” (Res tored Full Accredita tion) | |
221 | “Other” – please exp lain | |
222 | ||
223 | VA Policy (1200.07, par. 7.e) requires t hat all fa cilities h ousing VA research a nimals be accredited by AAALAC . Under e xceptional circumsta nces, a wa iver may b e requeste d in writi ng from th e CRADO (C hief Resea rch and De velopment Officer) o r designee , through the CVMO ( Chief Vete rinary Med ical Offic er). See Appendix A of 1200.0 7 for info rmation on how to co ntact the CVMO. | |
224 | ||
225 | ||
226 | Special Fe atures | |
227 | ||
228 | Antibody Production – Include any anima ls on this protocol that will be used fo r the prod uction of monoclonal or polycl onal antib odies (inc luding for growing e xisting hy bridoma ce ll lines). | |
229 | ||
230 | Biosafety – Include ALL substa nces that are to be administer ed, regard less of wh ether they are consi dered haza rdous. T hese inclu de, but ar e not limi ted to, ch emicals, r adioisotop es, infect ious agent s, biomate rials, pro sthetic de vices, and cells, ti ssues, or body fluid s. Also i nclude ane sthetics, analgesics , antibiot ics, etc., administe red in con nection wi th surgery or any ot her proced ure on thi s protocol . Hazardo us materia ls will be distingui shed from nonhazardo us materia ls in Appe ndix 3, “B iosafety”. | |
231 | ||
232 | Locations of procedu res. The IACUC is r equired to inspect s emi-annual ly all loc ations whe re procedu res are pe rformed on animals ( OLAW FAQs E.1; 1200. 07, par. 8 f(1)(a)). If any an imals must be transp orted to o r from any of these locations, the trans portation must be in accordanc e with the Guide, th e AWAR, an d PHS Poli cy, in cli mate-contr olled vehi cles and s anitizable transport cages, as appropria te. Such transport must be d iscreet, s uch that h ospital st aff and pa tients are not aware of the tr ansport, a nd are not exposed t o allergen s and/or b ody fluids from the transporte d animal(s ). | |
233 | ||
234 | Body Fluid , Tissue, and Device Collectio n. Comple te Appendi x 2, 4, an d/or 5, as appropria te for eac h collecti on, accord ing to the columns c hecked in the table. Tail clip ping perfo rmed for g enotyping may be a s urgical pr ocedure (d etailed in Appendix 5) or a no n-surgical antemorte m tissue c ollection (detailed in Appendi x 4), depe nding on t he age of the animal and the a mount of t issue remo ved. Do no t include tissue tha t is remov ed and dis carded (e. g., ovarie s removed in ovariec tomy). | |
235 | ||
236 | Surgery. “Surgery” includes a ny major o r minor, s urvival or non-survi val surgic al procedu re. | |
237 | ||
238 | Endpoint c riteria. US Governm ent Princi ples (Prin ciple VI) require th at “animal s that wou ld otherwi se suffer severe or chronic pa in or dist ress that cannot be relieved s hould be p ainlessly killed at the end of the proce dure or, i f appropri ate, durin g the proc edure.” The endpoi nt criteri a specifie d should i nclude bot h general criteria t hat apply to animals that get sick unrel ated to an y experime ntal proce dures, and criteria specific t o this pro tocol. Ex amples of appropriat e criteria that shou ld be cons idered inc lude weigh t loss to less than a specifie d percenta ge of init ial or exp ected body weight, a norexia fo r longer t han a spec ified allo wable dura tion, tumo r size gre ater than a specifie d size or total tumo r burden g reater tha n a specif ied percen tage of bo dy weight, the prese nce of hea lth proble ms refract ory to med ical inter vention, a nd severe psychologi cal distur bances. F or genetic ally modif ied animal s to be ne wly genera ted on or for this p rotocol, t he possibi lity of un expected p henotypic changes sh ould be ad dressed in the endpo int criter ia (Guide, p. 28-29) . Other s pecies-spe cific crit eria shoul d also be considered , and prov isions sho uld be mad e for addr essing une xpected pa in or dist ress. (The Guide, p. 5, requir es “veteri nary consu ltation … when pain or distres s is beyon d the leve l anticipa ted” in th e ACORP “o r when int erventiona l control is not pos sible’.) | |
239 | ||
240 | Terminatio n or remov al from th e protocol . The dis position o f each ani mal on thi s protocol must be s pecified. Transfer of animals to other protocols, and each method of euthanasia that may be used, m ust be spe cifically approved b y the IACU C. | |
241 | ||
242 | Check each method th at may be used on th is protoco l and prov ide the sp ecific inf ormation r equested f or each. If more th an one ver sion of an y given me thod may b e used (e. g., overdo se by eith er of two different anesthetic s), copy t he relevan t row of t he table a s needed f or the add itional ve rsions. | |
243 | ||
244 | For euthan asia by CO 2 narcosis , the AVMA Guideline s on Eutha nasia (p. 9) require that deat h be verif ied and a secondary method of euthanasia be applie d if the a nimal is n ot yet dea d when it is removed from the chamber. E nter the m ethod to b e used to verify dea th, and en ter a seco ndary phys ical metho d that wil l be used if necessa ry. | |
245 | ||
246 | Indicate h ow each me thod of eu thanasia i s classifi ed accordi ng to the recommenda tions of t he latest AVMA Guide lines on E uthanasia (acceptabl e, conditi onally acc eptable, o r unaccept able). If you are u nsure of t he classif ication of any of th e methods of euthana sia that w ill be use d on this protocol, contact yo ur Attendi ng Veterin arian or I ACUC for g uidance. | |
247 | ||
248 | For each o f the meth ods that i s designat ed “Condit ionally Ac ceptable” by the AVM A, describ e the cond itions spe cified by the AVMA G uidelines on Euthana sia and do cument how these con ditions wi ll be met. | |
249 | ||
250 | For each o f the meth ods that i s designat ed “Unacce ptable” by the AVMA, PHS Polic y (IV.C.1. g) require s that the investiga tor give t he scienti fic reason (s) that j ustify thi s deviatio n from the AVMA Guid elines on Euthanasia . | |
251 | ||
252 | List all r esearch pe rsonnel wh o will per form eutha nasia on a nimals on this proto col, and d o not incl ude VMU an imal care personnel who will p erform rou tine eutha nasia as a service. If VMU ani mal care p ersonnel a re to perf orm highly specializ ed euthana sia techni ques speci fic to thi s protocol , it may b e appropri ate to inc lude them as members of the re search sta ff. | |
253 | ||
254 | If any of the person nel requir e training on any of the metho ds they wi ll be expe cted to pe rform, ide ntify the individual s and expl ain how th ey will be trained b efore bein g permitte d to perfo rm the eut hanasia pr ocedure(s) without s upervision . | |
255 | ||
256 | Regardless of whethe r any anim als are ex pected to die other than by eu thanasia, provide in structions for the a nimal care staff in case an an imal is fo und dead ( including during any post-proc edural rec overy peri od). | |
257 | ||
258 | Describe w hat should be done w ith the ca rcass. In clude whet her the ca rcass shou ld be refr igerated o r frozen f or later e xamination by the re search sta ff, and pr ovide any special in structions to be fol lowed for the protec tion of th e staff, i n the case of animal s that hav e been tre ated with hazardous materials. If no sp ecial inst ructions a re require d, and the carcass m ay be hand led accord ing to a l ocal SOP, enter “acc ording to local SOP” and enter the infor mation req uested abo ut the SOP in the ta ble in Ite m Y. | |
259 | ||
260 | Provide in structions about con tacting a member of the PI’s s taff in ca se an anim al is foun d dead. I f there is no need t o contact the PI’s s taff immed iately, de scribe the routine n otificatio n procedur es followe d by the V MU. If th ose proced ures are d etailed in a local S OP, enter “according to local SOP” and e nter the i nformation requested about the SOP in th e table in Item Y. | |
261 | ||
262 | Special Pr ocedures. Special pr ocedures i nclude bot h special husbandry and other non-husban dry proced ures that are requir ed by the experiment al design. Details a bout these procedure s must be provided i n SOP(s) o r elsewher e in this ACORP (sur gical proc edures are documente d in Appen dix 5, and need not be include d here). Refer to A ppendix 6, “Special Husbandry and Proced ures” for the level of detail and specif ic informa tion that are requir ed. | |
263 | ||
264 | Examples o f special husbandry include no n-standard … | |
265 | methods fo r monitori ng animal health, | |
266 | diets, | |
267 | caging, | |
268 | environmen tal condit ions such as lighti ng cycles or tempera tures, | |
269 | enrichment , and | |
270 | means of i dentificat ion. | |
271 | ||
272 | Examples o f other pr ocedures i nclude: | |
273 | restraint practices such as ch airing of non-human primates, | |
274 | applicatio n of noxio us stimuli , | |
275 | forced exe rcise, | |
276 | behavioral condition ing, | |
277 | total body irradiati on, and | |
278 | radiograph y or other imaging p rocedures. | |
279 | ||
280 | For each s pecial pro cedure det ailed in a n approved SOP, iden tify the S OP and ent er the inf ormation r equested a bout the S OP into th e table in Item Y. | |
281 | ||
282 | For each s pecial pro cedure det ailed in t he main bo dy of this ACORP, sp ecify the Item(s) in which the details a re given. | |
283 | ||
284 | For each s pecial pro cedure not detailed in an appr oved SOP o r elsewher e in the m ain body o f this ACO RP, check “Appendix 6” in Item Y, and co mplete and attach Ap pendix 6, “Special H usbandry a nd Procedu res”. | |
285 | ||
286 | Considerat ion of Alt ernatives and Preven tion of Un necessary Duplicatio n. This it em address es minimiz ing the ha rm/benefit (AAALAC F AQs, C.3; Guide, p. 27) to be derived fr om this wo rk by decr easing the potential for causi ng pain or distress in the res earch anim als. USDA APHIS Anim al Care Po licies (#1 2) defines “alternat ives or al ternative methods … as those t hat incorp orate some aspect of replaceme nt, reduct ion, or re finement o f animal u se in purs uit of the minimizat ion of ani mal pain a nd distres s consiste nt with th e goals of the resea rch”, and addresses the requir ement for a written narrative about how alternativ es to pain ful and di stressful procedures were cons idered (AW AR, §2.31( d)(1)(ii)) . VA Poli cy (1200.0 7, par. 8. f(2)(a)3) requires t hat the IA CUC review documenta tion that alternativ es have be en conside red for ea ch of the potentiall y painful or distres sing anima l procedur es propose d. Comple te items W .1 through W.5 below , keeping copies of computer d atabase se arch resul ts in your files to demonstrat e your com pliance wi th the law if regula tory autho rities or the IACUC should cho ose to aud it your pr oject. | |
287 | ||
288 | The AWAR ( §2.31(d)(1 )(ii-iii)) require i nvestigato rs to cons ider less painful or less stre ssful alte rnatives t o each pot entially p ainful or distressin g procedur e, and pro vide assur ance that proposed r esearch do es not unn ecessarily duplicate previous work. Perf orm one or more data base searc hes to mee t these ma ndates unl ess compel ling justi fications can be mad e without doing so. You must provide co mplete inf ormation i n the firs t five col umns of th e table to comply wi th USDA AP HIS Animal Care Poli cies (#12) . | |
289 | ||
290 | Replacemen t refers t o the use of non-ani mal system s (for exa mple, comp uter, mech anical, or chemical models) or in vitro techniques instead o f animals, use of no n-mammalia n species instead of mammalian species, and use of less-sent ient mamma ls for mor e-sentient mammals. | |
291 | ||
292 | Reduction refers to the use of smaller n umbers of animals to obtain sc ientifical ly valid r esults. T his is typ ically ach ieved by o ptimizing the experi mental des ign – for example, b y minimizi ng the num ber of con trol group s needed, by minimiz ing uncont rolled var iability b y collecti ng paired data, by m aximizing the amount of data c ollected f rom each a nimal, and /or by usi ng more so phisticate d measurin g techniqu es or more sensitive equipment to improv e precisio n so as to minimize the group sizes need ed. | |
293 | ||
294 | Refinement refers to use of ap proaches t hat lessen or elimin ate pain o r distress in the an imals that are used. This inc ludes (1) choosing p rocedures that preve nt or reli eve pain o r distress likely to be associ ated with the experi mental des ign, (2) s etting the earliest possible e ndpoints f or the exp eriments, (3) approp riate use of analges ics, anest hetics, an d tranquil izers, inc luding sel ection of better age nts (more effective, with fewe r or less severe pot ential sid e effects) as they b ecome avai lable, (4) improving post-surg ical care with new t echnology as it beco mes availa ble, and ( 5) special husbandry such as p roviding s oftened fo od after p rocedures likely to cause disc omfort wit h swallowi ng, soft b edding, ea sier acces s to food, or enviro nmental en richment, as appropr iate. | |
295 | ||
296 | The propos ed researc h cannot b e approved if it unn ecessarily duplicate s previous work. | |
297 | ||
298 | Other Regu latory Con sideration s. | |
299 | ||
300 | Controlled drugs – I nclude in Appendix 3 all contr olled subs tances to be adminis tered on t his protoc ol, and ch eck “Appen dix 3” in Item Y, be low. | |
301 | ||
302 | VA policy (1108.01, par. 20.e; 0730, par . 6.b) req uires all drugs clas sified as controlled substance s by the D EA to be s tored rout inely unde r double l ock, and b e accessib le only to authorize d personne l. If any substance s will NOT be stored this way, an explan ation must be given of how the y will be stored and secured, and why th is is nece ssary. | |
303 | ||
304 | VA policy (1108.01, par. 20.a) requires that all c ontrolled substances that are used on VA property must be or dered thro ugh and re ceived by the local VA pharmac y prior to issue for research use. This means for example, that VA po licy does not permit any contr olled subs tances obt ained thro ugh an aff iliate ins titution t o be broug ht onto VA property to be admi nistered t o animals in the VMU . | |
305 | ||
306 | If the con trolled su bstances w ill only b e used at non-VA loc ations, 11 08.01 stat es that, “ the local Chief of P harmacy Se rvices mus t be consu lted to de termine wh ether cont rolled sub stances ar e to be ob tained thr ough the V A pharmacy .” | |
307 | ||
308 | If any con trolled su bstances t hat are to be used o n VA prope rty will N OT be proc ured throu gh the loc al VA phar macy, plea se explain how they will be pr ocured and why this is necessa ry. | |
309 | ||
310 | Human pati ent care e quipment o r procedur al areas. Human pat ient care equipment or procedu ral areas may be use d for anim al studies only if a pproved by the offic ials respo nsible for the patie nt care eq uipment an d space, a nd if docu mented in Appendix 7 . | |
311 | ||
312 | Explosive agents. T hese inclu de explosi ve anesthe tics and a ny other p otentially explosive agents to be used i n the work with the animals on this prot ocol. Eac h of these must be d ocumented in Appendi x 8 as wel l as in Ap pendix 3. | |
313 | ||
314 | Summary of Attachmen ts. The a ttachments that are required d epend on t he protoco l, and on local poli cies. Thi s section summarizes the docum ents that apply to t his protoc ol. | |
315 | ||
316 | Appendices . Each Ap pendix tha t is requi red accord ing to the responses given in the Items above must be comple ted and at tached to this proto col. Do n ot attach blank appe ndices tha t are not applicable to this A CORP. Che ck with yo ur IACUC a s to wheth er complet ion of App endix 1, “ Additional Local Inf ormation”, is a loca l requirem ent. | |
317 | ||
318 | Appendix 1, “Additi onal Local Informati on” | |
319 | Appendix 2, “Antibo dy Product ion” (see Item O) | |
320 | Appendix 3, “Biosaf ety” (see Items P, X .1 and X.3 ) | |
321 | Appendix 4, “Ante-m ortem Spec imen Colle ction” (se e Item R) | |
322 | Appendix 5, “Surger y” (see It em S) | |
323 | Appendix 6, “Specia l Husbandr y and Proc edures” (s ee Item V) | |
324 | Appendix 7, “Use of Patient C are Equipm ent or Are as for Ani mal Studie s” (see It em X.2) | |
325 | Appendix 8, “Use of Explosive Agent(s) within the VMU or in Animals” (see Item X.3) | |
326 | Appendix 9, “Depart ures from “Must” and “Should” Standards in the Gui de” | |
327 | ||
328 | Standard O perating P rocedures (SOPs). E ach of the SOPs refe rred to el sewhere in this ACOR P must be listed in the table provided, including the follow ing inform ation: | |
329 | ||
330 | Item. Ide ntify the Item (by l etters and numbers, as applica ble) in wh ich the SO P is refer enced. It ems that c ommonly re fer to SOP s are show n, as prom pts. Addi tional lin es may be added to t he table a s needed. | |
331 | ||
332 | SOP Title and ID. I dentify ea ch SOP by its title and any lo cal identi fier (such as an ID number). Use a sepa rate line for each S OP. | |
333 | ||
334 | Approval D ate. Ente r the date of the mo st recent IACUC appr oval of th e SOP. 12 00.07 (par . 7.c) req uires that each SOP be reviewe d and appr oved by th e IACUC at least ann ually to r emain in e ffect. | |
335 | ||
336 | The full t ext of eac h of the a pproved an d dated SO Ps referen ced in the ACORP mus t be uploa ded onto t he JIT man agement we bsite when the ACORP is submit ted for Ju st-in-Time processin g before V A funding support is released. Please s ee your lo cal resear ch adminis trators fo r instruct ions regar ding wheth er to atta ch copies of the SOP s when sub mitting th e ACORP fo r local IA CUC review . | |
337 | ||
338 | Certificat ions. The typed nam es and dat ed signatu res certif y agreemen t with the terms of the ACORP, and are r equired as shown bel ow for the Main Body and each of the att ached Appe ndices for any ACORP that is t o be submi tted to VA Central O ffice for Just-In-Ti me approva l prior to release o f VA fundi ng to supp ort the wo rk. Do no t include signatures for any A ppendices that do no t apply, a nd which t herefore s hould not be attache d. | |
339 | ||
340 | Main Body of the ACO RP. The P rincipal I nvestigato r(s) must certify th e accuracy of the in formation presented in the ACO RP, and th e agreemen t to perfo rm the wor k as descr ibed. The IACUC Cha ir and the Attending Veterinar ian must s ign to cer tify revie w and appr oval of th e protocol . All si gnatures s hould appe ar on the final vers ion of the ACORP, wh ich incorp orates all changes r equired by the IACUC for appro val. | |
341 | ||
342 | Appendix 2 . Antibod y Producti on. No si gnatures r equired. | |
343 | ||
344 | Appendix 3 . Biosafe ty. The P rincipal I nvestigato r(s) and t he IACUC o fficials m ust certif y their ag reement to ensure th at personn el will be informed of the ris ks involve d and prov ided with the SOPs a nd trainin g needed t o minimize their ris ks of expo sure to ha zardous ag ents. The Biosafety Official and the Ra diation Sa fety Offic ial must c ertify tha t the haza rdous agen ts that ar e included on this p rotocol ar e correctl y identifi ed, and th at their u se has bee n approved by the re levant ove rsight com mittees or officials . | |
345 | ||
346 | Appendix 4 . Ante-mo rtem Speci men Collec tion. No signatures required. | |
347 | ||
348 | Appendix 5 . Surgery . The Pri ncipal Inv estigator( s) must ce rtify the accuracy o f the desc ription of the surgi cal proced ures descr ibed in Ap pendix 5, and the ag reement to perform a nd documen t the work as descri bed. | |
349 | ||
350 | Appendix 6 . Special Husbandry and Proce dures. No signature s required . | |
351 | ||
352 | Appendix 7 . Use of Patient Ca re Equipme nt or Area s for Anim al Studies . The Pri ncipal Inv estigator( s) must ce rtify the accuracy o f the info rmation pr esented in Appendix 7, and the agreement to perfor m the work as descri bed. The officials responsibl e for the use of the patient c are equipm ent and/or areas for these stu dies must sign to ve rify their approval. | |
353 | ||
354 | Appendix 8 . Use of Explosive Agent(s) w ithin the Animal Fac ility or i n Animals. The Prin cipal Inve stigator(s ) must cer tify the a ccuracy of the infor mation pre sented in Appendix 8 , and the agreement to perform the work as describ ed. The o fficials r esponsible for overs eeing the use of exp losive age nt(s) in t his protoc ol must si gn to veri fy their a pproval. | |
355 | ||
356 | Departures from “Mus t” and “Sh ould” Stan dards in t he Guide. No signat ures requi red. |
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