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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App3Instructions.docx | Thu May 17 00:41:26 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App3Instructions.docx | Tue Jul 17 21:19:31 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 3 – B iosafety | |
3 | (ACORP App . 3 Instru ctions) | |
4 | Version 4 | |
5 | ||
6 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 3 of the ACO RP, and ar e referenc ed to the numbers of the items in the ap pendix. O NLY comple te this ap pendix if it is rele vant to th e protocol being sub mitted for review. T he PI may use the AC ORP Append ix 3 templ ate provid ed in the RAMS appli cation by using the link avail able in qu estion 11 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 | ||
13 | General In structions : | |
14 | 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. | |
15 | To check a n item, ty pe “X” ins ide the ( ) provid ed. | |
16 | Define eac h abbrevia tion the f irst time it is used . | |
17 | ||
18 | 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: | |
19 | PI’s last name: The PI’s name is prepopu lated | |
20 | 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 | |
21 | ||
22 | 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. | |
23 | ||
24 | Summary of All Mater ials Admin istered to Animals o n this Pro tocol. In clude ALL materials administer ed to anim als on thi s protocol , such as, but not l imited to, radioisot opes, chem icals, dru gs (standa rd clinica l agents a s well as test agent s, and all controlle d substanc es listed in Item X. 1 of the m ain body o f the ACOR P), infect ious agent s, biomate rials, pro sthetic de vices, and cells, ti ssues, or body fluid s. For ea ch materia l, enter “ X” in the ( ) for e ach of the descripti ons that a pplies to the nature of the ma terial. S ome materi als may fa ll into mo re than on e category , and will be addres sed in mor e than one correspon ding Item below. | |
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27 | ||
28 | OLAW requi res that o nly pharma ceutical g rade compo unds be ad ministered to animal s unless t he use of non-pharma ceutical g rade compo unds is ju stified by scientifi c necessit y and the lack of av ailability of an acc eptable ve terinary o r human ph armaceutic al grade c ompound (O LAW FAQs, F.4). Com plete list ings of th e compound s approved by the FD A for admi nistration to humans or animal s are avai lable on-l ine: http: //www.fda. gov/Drugs/ Informatio nOnDrugs/u cm129662.h tm for hum ans, and h ttp://www. fda.gov/An imalVeteri nary/Produ cts/Approv edAnimalDr ugProducts /UCM042847 for anima ls. Mark w ith a * ea ch materia l, diluent , or vehic le to be a dministere d to the a nimals on this proto col that i s not phar maceutical grade. F or each of these, pr ovide the justificat ion for us ing a non- pharmaceut ical grade compound, and descr ibe how it will be e nsured tha t the grad e, purity, sterility , pH, pyro genicity, osmolality , stabilit y, formula tion, and pharmacoki netics of the materi al will be suitable for use in the anima ls (Guide, p. 31). Note that OLAW speci fically ad vises that cost-savi ngs alone do not ade quately ju stify the use of non -pharmaceu tical grad e compound s in anima ls. | |
29 | ||
30 | Anesthesia , Sedation , or Tranq uilization . Anesthe sia, sedat ion, or tr anquilizat ion may be important to ensure the safet y of the p ersonnel w hen admini stering ha zardous ma terials. Complete 3 .a. and 3. b. below: | |
31 | ||
32 | For each m aterial to be admini stered wit h the anim als under anesthesia , sedation , or chemi cal tranqu ilization -- identif y the anes thetic, se dative, or chemical tranquiliz er, and de tail the d ose and vo lume, and route of a dministrat ion to be used. Thes e agents s hould also be listed in Item 1 of this a ppendix. | |
33 | ||
34 | For each m aterial to be admini stered wit hout anest hetizing, sedating, or chemica lly tranqu ilizing th e animals, explain w hy these a re not nec essary, or cannot be provided, and descr ibe any al ternate me thods of r estraint t hat will b e used. | |
35 | ||
36 | Toxic Agen ts. Examp les includ e toxic ch emical and pharmacol ogic agent s, many ca ncer thera peutic age nts with c ytotoxic p roperties, known or suspected mutagens, carcinogen s, teratog ens, and D NA-binding agents. List in th is table e ach agent that is ma rked as a “toxic age nt” in the table in Item 1, ab ove, and e nter “X” i n the ( ) for each property t hat applie s: | |
37 | ||
38 | Mark as “m utagen” ea ch agent t hat is a s uspected o r known mu tagen. | |
39 | ||
40 | Mark as “c arcinogen” each agen t that is a suspecte d or known carcinoge n. | |
41 | ||
42 | Mark as “t eratogen” each agent that is a suspected or known teratogen. | |
43 | ||
44 | For each a gent, indi cate its s tatus as a “select a gent” (www .selectage nts.gov/Re gulations. html): | |
45 | ||
46 | It is not on the CDC -USDA list of “selec t agents” that might have uses in bioter rorism | |
47 | ||
48 | It is a “s elect agen t”, but th e quantiti es to be u sed on thi s protocol fall belo w the thre shold mini ma specifi ed by sele ct agent l egislation , so the u se of this agent is not subjec t to the r equirement s of that legislatio n. | |
49 | ||
50 | It is a “s elect agen t” that re quires reg istration/ approval b efore work with it m ay begin. “Select ag ent” legis lation req uires regi stration w ith CDC an d/or USDA, and VA re quires tha t DNS approval for the us e of this agent be s ecured, be fore studi es with it begin. Ask your r esearch of fice to co ntact the DNS Biosafety Officer f or specifi c instruct ions about registeri ng and sec uring appr oval. Enter the informatio n requeste d below th e table wi th regard to the reg istration and approv al. Copy t he lines s hown for e ach additi onal agent to be doc umented. | |
51 | ||
52 | Mark as “O ther” each agent tha t has toxi c properti es other t han the on es listed (e.g., cor rosive age nts, poiso ns, etc.) and specif y the prop erties | |
53 | ||
54 | Infectious Agents. These incl ude, for e xample, ba cteria (in cluding ri ckettsia), viruses, fungi, pro tozoa, and prions. Copy into the table the name a nd BSL num ber of eac h agent th at is mark ed as an “ infectious agent” in the table in Item 1 , above, a nd provide the infor mation req uested, | |
55 | ||
56 | Specify th e ABSL lev el of the minimum me asures tha t will be applied in handling each agent . The pra ctices, sa fety equip ment, and facilities that corr espond to each ABSL level are described in Biosaf ety in Mic robiologic al and Bio medical La boratories , 5th edit ion (Dece mber 2009) , availabl e at www.c dc.gov/bio safety/pub lications/ bmbl5/. | |
57 | ||
58 | ABSL1 is t he recomme nded minim um for BSL 1 agents. | |
59 | ABSL2 is t he recomme nded minim um for BSL 2 agents. | |
60 | ABSL3 is t he recomme nded minim um for BSL 3 agents. | |
61 | ABSL4 is t he recomme nded minim um for BSL 4 agents. | |
62 | ||
63 | It the han dling of a ny agent i s to be ac cording to an ABSL l evel less than the B SL level o f the agen t, enter t he justifi cation for this as r equested b elow the t able | |
64 | ||
65 | Indicate w hether an antibiogra m, anti-vi ral drug s ensitivity screen, o r other ap propriate drug sensi tivity pan el is avai lable for each of th ese agents , to assis t physicia ns in sele cting prop er therapy if human infection occurs. I f “Yes”, d escribe br iefly. | |
66 | ||
67 | For each a gent, indi cate its s tatus as a “select a gent” (www .selectage nts.gov/Re gulations. html): | |
68 | ||
69 | It is not on the CDC -USDA list of “selec t agents” that might have uses in bioter rorism | |
70 | ||
71 | It is a “s elect agen t”, but th e quantiti es to be u sed on thi s protocol fall belo w the thre shold mini ma specifi ed by sele ct agent l egislation , so the u se of this agent is not subjec t to the r equirement s of that legislatio n. | |
72 | ||
73 | It is a “s elect agen t” that re quires reg istration/ approval b efore work with it m ay begin. “Select ag ent” legis lation req uires regi stration w ith CDC an d/or USDA, and VA re quires tha t DNS approval for the us e of this agent be s ecured, be fore studi es with it begin. Ask your r esearch of fice to co ntact the DNS Biosafety Officer f or specifi c instruct ions about registeri ng and sec uring appr oval. Enter the informatio n requeste d below th e table wi th regard to the reg istration and approv al. Copy t he lines s hown for e ach additi onal agent to be doc umented. | |
74 | ||
75 | Biological Agents. These incl ude, for e xample, an tigens, se rum, cell lines, tis sue, and n ucleic aci d. List i n the tabl e each age nt that is marked as a “biolog ical agent ” in the t able in It em 1, abov e, and des cribe how the materi al will be screened to make su re that it does not harbor oth er agents that could infect ot her labora tory anima ls or pers onnel. | |
76 | ||
77 | Radioactiv e Agents. List in t he table e ach agent that is ma rked as a “radioacti ve agent” in the tab le in Item 1, above, and speci fy the rad ioactive i sotope inv olved. Id entify the individua l who has been given permissio n to utili ze the iso tope(s) in dicated, a nd identif y the comm ittee that has appro ved the us e (e.g., R adiation S afety Comm ittee or o ther equiv alent comm ittee). | |
78 | ||
79 | Recombinan t nucleic acid and r ecombinant infectiou s agents. These inc lude both isolated r ecombinant nucleic a cid and re combinant infectious agents. List in th e table ea ch agent t hat is mar ked as “co ntains rec ombinant n ucleic aci d” in the table in I tem 1 (Rec ombinant i nfectious agents sho uld also b e marked a s “infecti ous agents ” in the t able in It em 1, and addressed in Item 5, above.), and indica te which o f the foll owing cond itions app lies: | |
80 | ||
81 | This work is subject to, and w ill be con ducted acc ording to, the anima l research guideline s included in the la test versi on of the publicatio n, NIH Gui delines fo r Research Involving Recombina nt DNA Mol ecules (NI H Guidelin es), and t he Biosafe ty Committ ee and vet erinarian will be co nsulted to ensure co mpliance. | |
82 | The recomb inant cons tructs are exempt fr om the ani mal resear ch guideli nes includ ed in the latest ver sion of th e publicat ion, NIH G uidelines. | |
83 | ||
84 | Potential for Pain o r Distress . Include any of th e agents l isted in I tem 1 that is expect ed to have effects t hat are po tentially painful or distressi ng to the animals (i nclude eve n if measu res will b e taken to prevent a nimals on this proto col from a ctually ex periencing the pain or distres s). Focus on the ef fects of t he agents, and not o n the pote ntial pain or distre ss associa ted with t he procedu res involv ed in admi nistering them, whic h are addr essed else where in t he protoco l. Descri be the nat ure of the potential pain and/ or distres s expected , and desc ribe the m easures th at will be taken to alleviate that poten tial pain and/or dis tress. Th ese measur es may inc lude not o nly admini stration o f pharmaco logical an esthetics, analgesic s, tranqui lizers, or sedatives , but also appropria te special husbandry procedure s (describ e in Appen dix 6). A ny agents that will be adminis tered to a lleviate p otential p ain and/or distress should als o be liste d in the t able in It em 1 of th is appendi x. | |
85 | ||
86 | Protection of Animal Facility Staff from Hazardous Materials . This ta ble addres ses specif ically the protectio n of membe rs of the staff of t he Animal Facility f rom the ha zardous ag ents to be used on t his protoc ol. (Make sure that protectio n of the r esearch pe rsonnel fr om the ris ks associa ted with e ach of the se agents is address ed in Item G of the main body of the ACO RP.) | |
87 | ||
88 | Complete t he table. | |
89 | ||
90 | “Hazardous Agents” – include e ach agent listed in Item 4, 5, 6, 7, of this Appen dix. | |
91 | ||
92 | “Approving Committee or Offici al” – iden tify the s pecific co mmittee or official (e.g., Saf ety, Biosa fety, or R adiation S afety) tha t has appr oved the u se of the hazardous agent on t his protoc ol. | |
93 | ||
94 | “Instituti on (VA or affiliate) ” – indica te “VA” or give the name of th e affiliat e institut ion that i s represen ted by the approving committee . | |
95 | ||
96 | “Animal Fa cility Sta ff Members at Risk” – identify by name e ach indivi dual membe r of the a nimal faci lity staff who is at risk of e xposure to the hazar dous agent (e.g., vi a contact with treat ed animals , or with contaminat ed bedding ). | |
97 | ||
98 | Include wh at informa tion will be posted, and where , and summ arize any specific t raining to be provid ed. | |
99 | ||
100 | Signatures . Provide the appli cable sign atures on the signat ure pages (Item Z.3) of the ma in body of this ACOR P. |
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