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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App7Instructions.docx | Thu May 17 00:41:18 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App7Instructions.docx | Tue Jul 17 21:21:41 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 7 -- Use of Pat ient Care Equipment and/or Are as | |
3 | for Animal Studies | |
4 | (ACORP App . 7 Instru ctions) | |
5 | Version 4 | |
6 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 7 of the ACO RP, and ar e referenc ed to the numbers of the items in Append ix 7. 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 7 template provided in the RAM S applicat ion by usi ng the lin k availabl e in quest ion 15 of section M. | |
7 | ||
8 | General In structions : | |
9 | 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. | |
10 | To check a n item, ty pe “X” ins ide the ( ) provid ed. | |
11 | Define eac h abbrevia tion the f irst time it is used . | |
12 | ||
13 | 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: | |
14 | PI’s last name: The PI’s name is prepopu lated | |
15 | 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 | |
16 | ||
17 | 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. | |
18 | ||
19 | Full Name( s) of Prin cipal Inve stigator(s ). Give t he full na me(s) of t he Princip al Investi gator(s), who are re sponsible for the us e of anima ls on this protocol. | |
20 | ||
21 | Equipment to be used . | |
22 | ||
23 | Identify t he equipme nt – Descr ibe the hu man patien t care equ ipment and provide w hatever ad ditional i dentifying informati on is nece ssary to m ake it cle ar which p iece(s) of equipment will be u sed on thi s animal p rotocol. | |
24 | ||
25 | Procedures to be per formed – S pecify the procedure s that are to be per formed on the animal s, using t his human patient ca re equipme nt. | |
26 | ||
27 | Describe t he specifi c protocol to be fol lowed to p revent con tamination of the hu man patien t care equ ipment by animal fec es, urine, saliva, b lood, or o ther body fluids, an d to clean /sanitize the equipm ent before its subse quent use for human patients. The proc edures use d should b e at least as thorou gh as the procedures establish ed by the clinical f acility fo r cleaning and sanit izing the equipment between hu man patien ts. | |
28 | ||
29 | Human Pati ent Care P rocedural Areas to b e used. | |
30 | ||
31 | Location(s ) -- Ident ify the lo cation(s) of the hum an patient care area (s) in whi ch animals will be u sed, speci fying the building(s ) and room number(s) . | |
32 | ||
33 | Animal spe cies to be studied o r treated – Enter th e species covered by this ACOR P, so that this Appe ndix can b e reviewed by offici als respon sible for the human patient ca re areas, without re ferring to other por tions of t he ACORP. | |
34 | ||
35 | Number of individual animals t o be studi ed or trea ted – Ente r the tota l number o f animals to be stud ied or tre ated in hu man patien t care are as on this protocol. | |
36 | ||
37 | Date(s) – Enter spec ific dates , or indic ate the da ys of the week and t he period of weeks o ver which animals wi ll be stud ied or tre ated in th e human pa tient care area(s). | |
38 | ||
39 | Time(s) of day – Spe cify the t ime(s) of day at whi ch the ani mals will be studied or treate d in the h uman patie nt care ar ea(s), and address h ow these r elate to t he times o f day at w hich human patients receive ca re in thes e areas. | |
40 | ||
41 | Procedures to be per formed in these area s – Specif y the proc edures tha t are to b e performe d on the a nimals, in these hum an patient care area s. | |
42 | ||
43 | Protection and clean ing of pat ient care room surfa ces – Desc ribe the s pecific pr otocol to be followe d to preve nt contami nation of the human patient ca re room su rfaces by animal fec es, urine, saliva, b lood, or o ther body fluids, an d for any cleaning/s anitizing necessary before sub sequent us e of the r oom for hu man patien ts. The p rocedures used shoul d be at le ast as tho rough as t he procedu res establ ished by t he clinica l facility for clean ing and sa nitizing t he room be tween huma n patients . | |
44 | ||
45 | Benefits t o VA patie nts – Addr ess the po tential va lue of thi s research to VA pat ients, whi ch justifi es the use of areas dedicated to care of human pat ients for research o n animal s ubjects. | |
46 | ||
47 | Necessity for use of human pat ient care areas – Ex plain why the animal facility and resear ch laborat ory areas cannot be used for t his work o n research animal su bjects, an d the anim als must b e studied or treated in the hu man patien t care are as. | |
48 | ||
49 | Animal tra nsport – T ransportat ion of ani mals throu gh human c linical ca re areas m ust be dis crete and secure. C orridors a nd elevato rs used by human pat ients must be avoide d. Include descripti ons of the transport enclosure s (cages, carriers, etc.) and how they w ill be sec ured to pr event esca pe, any ve hicles to be used, t he planned route(s) for the tr ansport, a nd any oth er precaut ions to be taken to minimize t he likelih ood that p atients, v isitors, o r other no n-research personnel will beco me aware o f the anim als. | |
50 | ||
51 | Preventing human pat ients and patient ca re personn el from be ing affect ed by the presence o f the anim als. Prov ide detail ed descrip tions of t he measure s to be ta ken to pre vent patie nts and pa tient care personnel from beco ming aware of the an imals beca use of noi ses or odo rs, and th e cleaning and disin fection pr otocols to be follow ed to prot ect them f rom exposu re to alle rgens and transmissi on of zoon otic patho gens from the animal s. | |
52 | ||
53 | Signatures . Provide the signa tures requ ired on th e signatur e pages (I tem Z.7) o f the main body of t his ACORP. Note tha t the sign atures req uired for use of hum an patient care equi pment in t he VMU or animal res earch area s are diff erent from the signa tures requ ired for t reatment o r study of research animals in human pat ient care areas. |
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