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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App6Instructions.docx | Thu May 17 00:41:40 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App6Instructions.docx | Tue Jul 17 21:21:09 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 6 – S PECIAL HUS BANDRY AND PROCEDURE S | |
3 | (ACORP App . 6 Instru ctions) | |
4 | Version 4 | |
5 | ||
6 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 6 of the ACO RP, and ar e referenc ed to the numbers of the items in Append ix 6. 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 6 template provided in the RAM S applicat ion by usi ng the lin k availabl e in quest ion 14 of section M. | |
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8 | ||
9 | Regulatory documents mentioned in the in structions are abbre viated as follows: | |
10 | ||
11 | Guide – Gu ide for th e Care and Use of La boratory A nimals, 8t h ed., 201 1 | |
12 | 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 | |
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. | |
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25 | Descriptio n of Proce dures. Th e details of each sp ecial proc edure to b e included in this p rotocol, r egardless of whether it will b e carried out by the animal ca re staff o r research staff, mu st be docu mented in a formal S OP, elsewh ere in thi s ACORP, o r in this Appendix, as indicat ed in Item V of the main body of the ACO RP. | |
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27 | Examples o f special husbandry include ho using unde r temperat ure extrem es, food o r water re striction, dietary m anipulatio ns, specia l housing/ caging, mo dified lig ht cycle, special he alth monit oring, wou nd managem ent measur es to be t aken to mi nimize the chances o f chronic infections where imp lanted dev ices penet rate the s kin, and u nusual mea ns of iden tification . | |
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29 | Special pr ocedures m ay also in clude non- husbandry procedures involving features such as pr olonged ph ysical res traint, no xious stim uli, force d exercise , behavior al manipul ations, to tal body o r local ir radiation, and radio graphy or other imag ing. | |
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31 | The detail s of speci al procedu res that a re documen ted in the local SOP manual or elsewhere in this A CORP need not be cop ied again here, as l ong as the level of detail and the speci fic inform ation prov ided in th e SOP or e lsewhere i n this ACO RP are at least as m uch as req uested her e. | |
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33 | Include in the descr iption of each speci al procedu re not onl y what wil l be done, but also the durati on of each procedure , how freq uently it will be re peated in any one an imal, what potential effects o n the anim al are exp ected (inc luding bot h the inte nded effec ts and pot ential sid e effects such as sk in lesions related t o the use of restrai nt devices ), how sid e effects will be ad dressed, a nd why the special p rocedure i s necessar y. | |
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35 | Be sure to document in Appendi x 9 any of these pro cedures th at represe nt “depart ures” from the stand ards in th e Guide. Consult th e IACUC or the Atten ding Veter inarian fo r help in determinin g whether any “depar tures” are involved. | |
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37 | Personnel. Identify the indiv iduals who will carr y out the special pr ocedures, and the in dividuals who will b e responsi ble for mo nitoring t he animals specifica lly with r egard to t heir condi tion durin g the proc edures and during an y post-pro cedural re covery per iod. Indi viduals re sponsible for routin e monitori ng unrelat ed to the special pr ocedures n eed not be included here. Not e that the experienc e of each of the ind ividuals l isted in t he table s hould be d escribed i n Item E o f the main body of t he ACORP. | |
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39 | Potential Pain or Di stress. I n consider ing the po tential fo r pain and /or distre ss that th e animals may experi ence as a result of the specia l procedur e(s) descr ibed in It em 1, abov e, it is i mportant t o keep in mind that the US Gov ernment Pr inciples ( IV) specif ically sta te that “i nvestigato rs should consider t hat proced ures that cause pain or distre ss in huma n beings m ay cause p ain or dis tress in o ther anima ls”. | |
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41 | If potenti al pain an d/or distr ess is exp ected unle ss measure s are take n to preve nt or alle viate it, provide a descriptio n of the p otential p ain and/or distress (the table will expa nd as need ed), and i ndicate wh ether meas ures will be taken t o relieve the pain a nd/or dist ress. | |
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43 | If measure s will be taken to p revent or alleviate the expect ed potenti al pain an d/or distr ess, compl ete the ta ble to des cribe the administra tion of an algesic(s) and/or st ress-relie ving agent s (Each of these sho uld be inc luded in I tem 1 of A ppendix 3) , and desc ribe any o ther measu res to be taken to a ddress the potential pain and/ or distres s (e.g., t raining wi th positiv e reinforc ement to p romote ada ptation to restraint devices, padding to prevent s kin lesion s). | |
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45 | If no anal gesic(s) o r stress-r elieving a gents will be admini stered or other meas ures taken to preven t or allev iate the e xpected po tential pa in and/or distress, explain wh y this is necessary. | |
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47 | Monitoring . Describ e the meth ods to be used in mo nitoring t he animals specifica lly for ef fects of t he special procedure s, both wh ile they a re undergo ing each o f the proc edures and afterward s. Inclu de the fre quency of monitoring , the vari ables to b e monitore d, and a d escription of the wr itten reco rds to be maintained . Then de fine the c riteria fo r removal of individ ual animal s from par ticipation in any of these pro cedures be cause of p ain or dis tress (e.g ., if an i ndividual animal fai ls to adap t to a res traint dev ice). The table wil l expand a s needed. |
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