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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App5Instructions.docx | Thu May 17 00:41:10 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App5Instructions.docx | Tue Jul 17 21:20:37 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 5 – S urgery | |
3 | (ACORP App . 5 Instru ctions) | |
4 | Version 4 | |
5 | ||
6 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 5 of the ACO RP, and ar e referenc ed to the numbers of the items in Append ix 5. ONLY complete this appen dix if it is relevan t to the p rotocol be ing submit ted for re view. The PI may use the ACORP Appendix 5 template provided in the RAM S applicat ion by usi ng the lin k availabl e in quest ion 10 of section M. | |
7 | ||
8 | Regulatory documents mentioned in the in structions are abbre viated as follows: | |
9 | ||
10 | Guide – Gu ide for th e Care and Use of La boratory A nimals, 8t h ed., 201 1 | |
11 | 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 ) | |
12 | USDA APHIS Animal Ca re Policie s – Animal Care Reso urce Guide Policies, USDA APHI S, March 2 5, 2011 | |
13 | ||
14 | General In structions : | |
15 | 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. | |
16 | To check a n item, ty pe “X” ins ide the ( ) provid ed. | |
17 | Define eac h abbrevia tion the f irst time it is used . | |
18 | ||
19 | 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: | |
20 | PI’s last name: The PI’s name is prepopu lated | |
21 | 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 | |
22 | ||
23 | 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. | |
24 | ||
25 | Surgery Cl assificati on. List as a singl e “surgery ” all of t he procedu res to be performed in a singl e session, from indu ction of, to recover y from, an esthesia. If more t han a sing le species is covere d by this protocol, list the s urgeries s eparately for each s pecies, an d identify which spe cies will undergo ea ch surgery . | |
26 | ||
27 | Terminal s urgery is any surger y during w hich the a nimal is e uthanatize d without being allo wed to rec over from anesthesia . | |
28 | ||
29 | Survival s urgery is any surger y after wh ich the an imal will be allowed to regain conscious ness. This requires that provi sions be m ade for re covery fro m anesthes ia, and fo r post-ope rative car e. | |
30 | ||
31 | Major surv ival surge ry is defi ned in the Guide (p. 117-118) as a surgi cal proced ure in whi ch a major body cavi ty is pene trated and exposed, produces s ubstantial impairmen t of physi cal or phy siological functions , or invol ves extens ive tissue dissectio n or trans ection. E xamples of major sur geries inc lude thora cotomy, cr aniotomy, joint repl acement, a nd limb am putation. | |
32 | ||
33 | One of mul tiple surg eries is e ach surviv al surgery (includin g any mino r surgical procedure s that may induce su bstantial post-proce dural pain or impair ment, as w ell as any major sur geries) th at will be performed as part o f this pro tocol, in addition t o any othe r such sur gery (on t his or ano ther proto col) on th e same ind ividual an imal. For each surg ery that i s one of m ultiple su rgeries to be perfor med on a s ingle anim al, comple te items 1 .a and 1.b , below th e table, t o describe why it is necessary to perfor m the mult iple surge ries on a single ani mal, the t ime interv al(s) betw een succes sive surge ries, and the ration ale for th e time int ervals ind icated. T he multipl e surgerie s may be r epetitions of the sa me surgery , or more than one d ifferent s urgery. N OTE: If a n animal r egulated b y USDA is to undergo survival surgery on this prot ocol in ad dition to undergoing surgery o n a separa te unrelat ed researc h protocol , the IO m ay be requ ired to su bmit a req uest to th e USDA for pre-appro val (Guide , p 30; OL AW FAQs, F .9; USDA A PHIS Anima l Care Pol icies, #14 ). | |
34 | ||
35 | Descriptio n of Surge ries. Des cribe each surgery i n enough d etail for the IACUC reviewers to be able to evalua te what th e effects on the ani mals will be. (Deta ils about pre-operat ive prepar ation, ane sthesia, a nd post-op erative re covery wil l be reque sted in It ems 5, 6, and 7, res pectively, so it is sufficient to provid e only sum maries of these here .) | |
36 | ||
37 | Personnel. Include any resear ch personn el and any VMU anima l care per sonnel who will part icipate in performin g any of t he surgeri es listed in Item 1, above. E ach of the se individ uals, and their qual ifications for their roles in the surger ies should be includ ed in Item E of the main body of the ACO RP. | |
38 | ||
39 | Location o f surgery. Provide the buildi ng and roo m number(s ) where ea ch surgica l procedur e listed i n Item 1, above, wil l be perfo rmed. In general, a ny surviva l surgical procedure should be conducted in a dedi cated surg ical facil ity or spa ce (Guide, p. 116 an d 118). M ajor survi val surger y on nonro dents must be perfor med only i n dedicate d surgical facilitie s (USDA AP HIS Animal Care Poli cies, #3). If local policy al lows, surv ival surge ry may be performed on rodents in dedica ted surgic al space, which may be in anim al procedu re rooms o r laborato ries (Guid e, p. 144) . For each surgery t hat will b e conducte d in space other tha n in a ded icated sur gical faci lity, prov ide the ju stificatio n below th e table. NOTE: Use Appendix 9 to docume nt each “d eparture” from a “sh ould” stan dard in th e Guide. C onsult the IACUC or the Attend ing Veteri narian for help in d etermining whether a ny “depart ures” are involved. | |
40 | ||
41 | Pre-operat ive protoc ol. | |
42 | ||
43 | Pre-operat ive proced ures. For each surg ery listed in Item 1 , above, m ark each p rocedure t hat is to be perform ed before induction of anesthe sia, to pr epare the animal(s) for surger y, and ent er the inf ormation r equested. Medicatio ns to be a dministere d pre-oper atively wi ll be docu mented sep arately, i n Item 5.b , below. | |
44 | ||
45 | Fast – Pre -operative fasting i s standard for large r animals, but is ra rely requi red in rod ents or ra bbits. If fasting i s necessar y for this protocol, enter the duration of the fas ting perio d. | |
46 | ||
47 | Withhold w ater – Wit hholding w ater pre-o peratively is requir ed for som e procedur es in some species. If it is necessary for this p rotocol, e nter the l ength of t ime that w ater will be withhel d. | |
48 | ||
49 | Intravenou s catheter placement -- Indica te the sit e(s) where any intra venous cat heter(s) w ill be pla ced before surgery b egins, for vascular access dur ing surger y. Do not include h ere any ca theters to be implan ted as par t of the s urgery. | |
50 | ||
51 | Other – De scribe any other pre paratory p rocedures to be perf ormed on t he animals before in duction of anesthesi a. | |
52 | ||
53 | Pre-operat ive medica tions. In clude all sedatives, tranquili zers, and other agen t(s) to be used for induction of anesthe sia, as we ll as any antibiotic s or other pre-treat ments to b e administ ered in pr eparation for surger y, regardl ess of whe ther they are admini stered imm ediately b efore, or over longe r periods before, pr eparation of the sur gical site on the an imal. Eac h of these agents sh ould also be include d in Item 1 of Appen dix 3. | |
54 | ||
55 | Pre-operat ive prepar ation of t he surgica l site. I nclude det ails about hair remo val (such as whether clippers or chemica l hair rem oval produ cts will b e used, an d how the clipped ha ir or chem icals will be cleane d away), s kin disinf ection, an d the use of surgica l drapes. | |
56 | ||
57 | Intra-oper ative mana gement. P rovide det ails of ho w the anim als will b e maintain ed during surgery. | |
58 | ||
59 | Intra-oper ative medi cations. Include al l anesthet ic agents, paralyzin g agents, fluids, an d other ph armaceutic als that w ill be adm inistered to the ani mal during surgery. Also in clude any experiment al pharmac euticals t hat will b e administ ered durin g surgery. Each of these shou ld also be included in Item 1 of Appendi x 3. | |
60 | ||
61 | Type “X” i n the “Par alytic” co lumn for e ach agent that is a neuromuscu lar blocki ng agent. | |
62 | Federal re gulations prohibit t he use of these agen ts for sur gery unles s other ap propriate anesthetic agents ar e used to induce a s urgical pl ane of ane sthesia. Paralytics do not pr ovide any pain relie f, but ani mals are u nable to r espond phy sically to pain beca use motor control is blocked. Very Impo rtant: If any paral ytics are to be admi nistered, explain be low the ta ble why th eir use is necessary , and desc ribe how t he animals will be m onitored t o ensure t hat the de pth of ane sthesia is sufficien t to preve nt pain. | |
63 | ||
64 | Intra-oper ative phys ical suppo rt. Provi de details about the physical support th at will be provided during sur gery, incl uding info rmation ab out, for e xample, th e type of heating pa ds to be u sed, and h ow appropr iate posit ioning of the animal will be m aintained. | |
65 | ||
66 | Intra-oper ative moni toring. I nclude the variables that will be monito red (e.g., mucous me mbrane col or, heart rate, bloo d pressure , motor re sponses), the criter ia for adj usting the level of anesthesia or other support, a nd the add itional me asures tha t may be t aken, as a ppropriate . | |
67 | ||
68 | Survival s urgery con sideration s. | |
69 | ||
70 | Survival P eriod – En ter how lo ng the ani mal(s) are expected to survive after sur gery (numb er of hour s, days, w eeks, etc. ). For an imals that will unde rgo multip le repetit ions of an y one surv ival surge ry, enter the length of time a fter the l ast repeti tion befor e euthanas ia. | |
71 | ||
72 | Measures f or Maintai ning Steri lity – Che ck each co lumn that applies. Provide a descriptio n of any “ other” mea sures to b e taken. | |
73 | ||
74 | Immediate post-opera tive suppo rt -- List all measu res that w ill be tak en to supp ort each a nimal imme diately af ter surger y, until i t recovers sufficien tly from a nesthesia to ambulat e without danger to itself. T his common ly include s the use of circula ting warm water heat ing pads a nd blanket s, adminis tration of fluids, e tc. | |
75 | ||
76 | Post-opera tive analg esia. Unl ess specif ically jus tified to the satisf action of the IACUC, you are o bligated t o routinel y provide post-opera tive pain relief for all verte brate anim als underg oing survi val surger y (USDA AP HIS Animal Care Poli cies, #3; VA policy makes this applicabl e to roden ts as well ). Identi fy the ana lgesic(s) to be admi nistered, and descri be the pro tocol(s) o f administ ration. Ea ch of thes e should a lso be inc luded in I tem 1 of A ppendix 3. | |
77 | ||
78 | If post-op erative an algesics w ill be wit hheld from the anima ls after a ny of the surgeries on this pr otocol, en ter “none” in the “A gent” colu mn for tha t surgery, and provi de the jus tification for withh olding ana lgesics, i n the spac e below th e table. | |
79 | ||
80 | Other post -operative medicatio ns. Descr ibe the ad ministrati on of any other medi cations (i ncluding, but not li mited to, fluids, an tibiotics, anti-coag ulants, an d other ph armacologi cal agents ) as part of post-op erative ca re. (Each of these should als o be inclu ded in Ite m 1 of App endix 3.) Include as “post-ope rative car e” all car e that is specifical ly related to recove ry from su rgery. | |
81 | ||
82 | Post-opera tive monit oring. Th e experien ce of each of the in dividuals responsibl e for post -operative monitorin g should b e listed i n Item E o f the main body of t he ACORP. (The name s and afte r-hours co ntact info rmation fo r these in dividuals must be pr ovided to the VMU st aff for us e in case of any eme rgencies.) | |
83 | ||
84 | Immediate post-opera tive monit oring – De scribe how each anim al will be monitored until it recovers s ufficientl y from ane sthesia to ambulate without da nger to it self. | |
85 | ||
86 | Post-opera tive monit oring afte r the imme diate post -operative period – Describe h ow each an imal will continue t o be monit ored until it fully recovers f rom surger y. Includ e the pers onnel who will be re sponsible for the po st-operati ve monitor ing and ca re after-h ours, and on weekend s and holi days. | |
87 | ||
88 | Post-opera tive conse quences an d complica tions. | |
89 | ||
90 | Surgery ma y have int ended cons equences f or the hea lth of the animals, or may be associated with comm on post-op erative co mplication s. This p rotocol mu st address how each of these w ill be man aged or tr eated. | |
91 | ||
92 | Animals ma y not reco ver as exp ected from surgery, so the cri teria for euthanasia to preven t sufferin g must be specified. The endp oint crite ria given here shoul d be speci fic to the post-oper ative cond ition of t he animals . The gen eral endpo int criter ia given i n Item T o f the main ACORP app ly in any case. | |
93 | ||
94 | In case of any emerg ency medic al situati on, VMU pe rsonnel wi ll attempt to contac t research personnel on this p rotocol, a ccording t o the stan dard opera ting proce dures of t he VMU. I f none of the resear ch personn el can be reached, V MU personn el are req uired to p rovide tre atment as directed b y the resp onsible ve terinarian , consiste nt with cu rrently ac cepted sta ndards of veterinary care and the approv ed ACORP, to allevia te unaccep table leve ls of pain or distre ss. Provi de as much guidance as possibl e to allow the VMU p ersonnel t o avoid an y drugs or classes o f drugs th at would i nvalidate the data t hat could be collect ed from th e animal. It is und erstood th at, if the condition of the an imal is su ch that th ese agents cannot be avoided, the animal will have to be rem oved from the study and will b e euthanat ized inste ad. | |
95 | ||
96 | Maintenanc e of post- surgical m edical rec ords. The PI is res ponsible f or ensurin g that acc urate, dai ly, post-s urgical wr itten medi cal record s are main tained and accessibl e to the I ACUC and t o all rese arch perso nnel and v eterinary staff invo lved in th e care and use of th e animals on this pr otocol. T he PI must therefore assign at least one individua l (this ma y be the P I) to main tain the r ecords, an d must ide ntify an a ccessible location w here the r ecords wil l be kept. Each ind ividual in volved in maintainin g the reco rds should be listed in Item E of the ma in body of the ACORP (Items E. 1 and E.2 for resear ch personn el, and It em E.3 for VMU staff ). | |
97 | ||
98 | Certificat ion. The P I must sig n the cert ification in Item Z. 5 of the m ain body o f the ACOR P. |
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