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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App9Instructions.docx | Thu May 17 00:40:26 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App9Instructions.docx | Tue Jul 17 21:22:39 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 9 -- Departures from “Mus t” and “Sh ould” Stan dards in t he Guide | |
3 | (ACORP App . 9 Instru ctions) | |
4 | Version 4 | |
5 | ||
6 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 9 of the ACO RP, and ar e referenc ed to the numbers of the items in Append ix 9. 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 9 template provided in the RAM S applicat ion by usi ng the lin k availabl e in quest ion 17 of section M. | |
7 | ||
8 | ||
9 | Regulatory documents mentioned in the in structions are abbre viated as follows: | |
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 | PHS Policy – Public Health Ser vice Polic y on Human e Care and Use of La boratory A nimals | |
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 | PHS Policy (IV.B.3) requires t hat IACUC- approved d epartures from PHS P olicy, inc luding the provision s of the G uide, be r eported to the Insti tutional O fficial in the repor t of each semiannual evaluatio n of the i nstitution al animal care and u se program . This ap pendix is to documen t the depa rtures tha t have bee n approved by the IA CUC for th is protoco l. The co mpleted ap pendix may be copied for inclu sion in se miannual r eports. | |
26 | ||
27 | Consider e ach instan ce in this protocol that requi res care o r use of a nimals in a way that does not meet the g eneral sta ndards des cribed in the Guide. These ar e all cons idered “de viations”, and most commonly a ppear in I tems C.2.c , M, T, U, and V, an d Appendic es 2, 4, 5 , 6, and 7 of the AC ORP (proce dures, hus bandry, en dpoint cri teria, eut hanasia, a ntibody pr oduction, antemortem specimen collection , surgery, transport ation). A pply the s eries of t est questi ons below to determi ne whether any of th e “deviati ons” are c onsidered “departure s” and the refore mus t be docum ented in A ppendix 9 (see also OLAW FAQs C.7): | |
28 | ||
29 | 1. Does th e Guide de scribe the general s tandard as a “May” s tandard? If so, thi s is NOT a “departur e”, and ne ed not be documented in Append ix 9. Oth erwise, fo r any “Sho uld” or “M ust” stand ard, proce ed to the next quest ion. | |
30 | ||
31 | 2. Does th e Guide in clude an e xplicitly stated exc eption tha t allows f or the “de viation”? If so, th is is NOT a “departu re”, and n eed not be documente d in Appen dix 9. Ot herwise, p roceed to the next q uestion. | |
32 | ||
33 | 3. Does th e “deviati on” meet a well-esta blished pe rformance standard f or a “Shou ld” standa rd, accord ing to loc ally-defin ed and con tinuously monitored performanc e measures ? If so, this is NO T a “depar ture”, and need not be documen ted in App endix 9. O therwise, this IS a “departure ”, and may be approv ed by the IACUC only if justif ied on sci entific, v eterinary medical, o r animal w elfare gro unds. | |
34 | ||
35 | The test q uestions a bove are s ummarized in the fol lowing flo w chart: | |
36 | For each I ACUC-appro ved depart ure includ ed in this protocol, provide t he followi ng informa tion: | |
37 | ||
38 | Briefly su mmarize th e standard that is d escribed i n the Guid e and refe rence the page numbe rs on whic h it appea rs. | |
39 | ||
40 | Describe t he specifi c alternat e standard (s) that w ill be met on this p rotocol, a nd how the y will be monitored. | |
41 | ||
42 | Provide th e specific scientifi c, veterin ary medica l, or anim al welfare considera tions that justify t his depart ure. |
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