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Pdrs/shapexml.xmlY_o6@uH?(Eb 70{ kH\'O,h$#X bm`keQwGw'Sb;i]ntI-Lۄ<:y)(eϾv2[yV^Rjeqho{Nj*To 5?én],Qj,Oіxʙ]Q5* yֈʀ-sYOJ-ǽ~`G`ScFhr6>Ƴp6e*`l\NanҳYOp2 \=ȟN'Pb4 ǣ`d$,V¤_ @ {3ʣ}t+9S?kc݇x296GW( ^A \ f8F0E ~ץ -XidD&ܣz [:Oo˒,>}D,+\5plmb $B{\@E+R]fLq@(-a/]{<*0"uF-[ѪW~ɕb%<O:2{*<7y 1x(Y7B!Z*KQ@/FVIkF%$Ljp˸Q@T!KaJAEDn+!61`~uQUy`"/̯y 6R[c+lm8mbõJ%tf(B- !gd?ȟpN ୬1Yz+x~$#i+\J;Ψ<CՖY&oV->xij:$b?Hx O"C' ሁз1З>=hHfbA=a|F9GÓ@/,xIA=~IG78Ͷ.Zx0tиCuKSKgs#[TxXԿ]ǡNŀ޵m ^[ |mۋz:]<go 4Gy!+PK!ؤdrs/downrev.xmlDMO0 @HH\K;ҕeBu׸$Ucqgv6ȇY"Av>"ZB5ڝ힦*%6q, uGd5g  >!   & !!!43e0[___PPT10i.`$B+D=' = @B +}6 8x(  8@ 8  ~6f0e0e?Rectangle 1026  O n(Step 3: Institutional Biosafety Review) ))   !!!43e0[y___PPT10Y+D=' = @B +7  <(  <" <  ~3f0e0e ?Rectangle 1026P  O P IBC REVIEW      <  5f0e0e ?,Content Placeholder 1  O bLocal investigator is responsible for submission to the IBC. Gene transfer protocols will require a full Committee review. All Service Line reviews must be complete prior to submission to the IBC. A site risk assessment must be completed prior to submission to the IBC. This would typically be done by the ̽̽MC Environmental Health and Safety staff, ̽̽ Biosafety, the ̽̽MC Research Pharmacy Manager and the PI for the project. IBC Committee will make the final determination regarding RAC Review for the institution. This determination is separate and distinct from an industry-sponsored determination.c cc   !!!43e0[y___PPT10Y+D=' = @B +M7 XPD8(  D8 D  p4f0e0e ?Title 1XN  O t$Documents Required for IBC Review % $%   D  7f0e0e ?,Content Placeholder 2" PK![Content_Types].xmlJ0*miG]`Hm6 Xwt?. g#Wi3E).+7 >ON ޑ1ˋz "+R RhB.} /<^ITխ%rHK4uK~I0xM e`|X}đ I`߽N4aG2$RKIZ)4(M9`ctB{m:f@`3n|O,ܗr޾jxR0T ,0@}WBLǬ5vPK!߮..drs/shapexml.xmlZn6}/Zd8ňH\]u} hUKJ^'O~ZgHɗzr!93gxUKMdN5Y dT>IrLIGa(XAŠ0LܼSKιEV?4 -[ gVm<]kJE˱t=Hcءq#1SY,tbo̡HEsSZaFT?iuJ4NzѠ :Bnϻyh18`]^JC۽~x=HC_>+D蝵z$A"iȫLV#xd_BL) +ĂϚÛׂiBvuvBFoLk" k""Ovv$'EDdM[uP2d޹U/ˑ)Y#$3vb3Z8t*Ҽص, s=Ș؎Gl IHtK~'[#y wL!\YVCtx3^xggyR8*y-q-Pf->6Wdv%bP@?L,%^Wt1y(#B$6!) .Aj^766jSnxfD6D3oJVb`Oq˩HQ?`=_i~M=p}Ȅ<4!Th;o S',B&)t# BSw "!,)gei.d)-nJ\:N(5fӦcX&n,4B-b ] $DV[qjAݔi7O!'Y"2*"+f0v>h^:D4?h~ӂ4S€rZ2T{e@{q"6?׳Ϡ ¡~$4r'=ڷXPGo0[_y1\G̕+XgvPj\ur9m"mJmbmty{6ˁc4ܦ΅WTS>ɐ<ս~ӎaC&}MC:}vKM8>Mc95A7|3#j|װՈ|VÖ;G-$=K!Jg&_iwR>TOauϡB%Yv `-J>zeO)l ^Gg3Xq*R-us|K#۫l@Aue$MqPK!drs/downrev.xmlDN0H}k+qA)UU KMi{]vd6}{,p\j>r=ꞝYLeUg h֐+yX&7K̕а(1>GmCιZgv YmOpIr -m*R0fa q;7/.-MŖ1{V} ' H~PK!<X^drs/_rels/shapexml.xml.relsMK0!ݤAD {Dֳdi6%Iۋ xaxa<;a..E èqqVFQŠ}E*uSaDEuzhA&tRҚG1)}T#ۦ7 & yg6D08ۤ瀱Q!,wHPG?eY| ,>A4%M_ŻCVy~NsTD׊tPK-![Content_Types].xmlPK-!1_a ._rels/.relsPK-!߮..)drs/shapexml.xmlPK-!drs/downrev.xmlPK-!<X^drs/_rels/shapexml.xml.relsPK>  O___PPT9tl +IBC Protocol Form including Standard Operating Procedures for Drug Preparation, Transport, and Handling as approved by the Service Lines Complete Human Subjects IRB Cover Form Draft of Human Subjects IRB Consent Form Clinical Protocol Investigational Drug Brochure *Review of these materials satisfies the requirement to meet the Points to Consider Section, M-I-A, of the NIH Guidelines.  m  {  m')5          5                B2O !!!43e0[___PPT10i.`R+D=' = @B +r7 }uH](  HZ H  ~0/f0e0e ?Rectangle 2050@-  O 8Step 4: Recombinant DNA Advisory Committee (RAC) Review9 89   H  ,f0e0e ?Rectangle 2051"K E PK![Content_Types].xmlJ0*miG]`Hm6 Xwt?. g#Wi3E).+7 >ON ޑ1ˋz "+R RhB.} /<^ITխ%rHK4uK~I0xM e`|X}đ I`߽N4aG2$RKIZ)4(M9`ctB{m:f@`3n|O,ܗr޾jxR0T ,0@}WBLǬ5vPK!kM5drs/shapexml.xml[[o6~ uH-+N68EZb-T;$[[tm"s'}IwϕN29o2V/OF +&2ɧ_yOtԓ|ꯍ'. pD t b/1 ܁P-lр0r%"Y$@dTL$[]2EBǶUŶJթaE2Lp3x@f:dbP1˵)Vw[*O)].k5Dz!V̻E%"$pS>}J ]x݁ښc&Yxh(؂EbyJjVN"Ve+h'ާAOp?0@~|o_1r&U?llvfV[?zdY&H4JuVU,-랔9 #8;5Wann&zb`'܊ޥY+tj ]V}7-uTϟaC& ̯>xS=:F$%N8P3fe=[^.ogQ8[@ڻٹ9q7lOvwcWW8_=f} %Gzvs 2:Rӏ*ۖ+@_$q҇l1~6ƾxxS`gܞ|eKmog{l21ڪ(F#{]y'Z?~}QIS|YPz Ts|I88k?h? -8 oOo,8;zAQgPK!tHdrs/downrev.xmlDn0EJURCUEVC=Gۑ:^X e=8+`2΀jl-k Yps.VR_ƚ% 9 1v9d0]G6u' }͕KOllzZSu.tEFNcTȏ])x|9HC[9~M M'3`%1D^MPK-![Content_Types].xmlPK-!1_a ._rels/.relsPK-!kM5)drs/shapexml.xmlPK-!tH3drs/downrev.xmlPK: yI O___PPT9h` The Recombinant DNA Advisory Committee is a federal advisory committee that provides recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules. RAC review is not required for all gene transfer protocols. Effective April 27, 2016, a protocol will be selected for RAC review if (1) a local oversight body (IBC or IRB) determines that the protocol would significantly benefit from RAC review and (2) the protocol satisfies one or more of the following criteria: (i) new vectors/new gene delivery systems, (ii) new diseases, (iii) unique applications of gene transfer, and (iv) other issues considered to require further public discussion. P " PP " P  rB:      !!!43e0[___PPT10i.] 3+D=' = @B +7 L(  LJ L  ~1f0e0e ?Rectangle 2050@-  O x(Who Decides if RAC Review Is Required? ) ()  A L  /f0e0e ?Rectangle 2051"  PK![Content_Types].xmlJ0*miG]`Hm6 Xwt?. g#Wi3E).+7 >ON ޑ1ˋz "+R RhB.} /<^ITխ%rHK4uK~I0xM e`|X}đ I`߽N4aG2$RKIZ)4(M9`ctB{m:f@`3n|O,ܗr޾jxR0T ,0@}WBLǬ5vPK!-,C drs/shapexml.xmlYn6?YۊFE mcaY%*VC*I{[i!EI{h6Z'<Ùy9{eVZelr]T.coNYbWZ=ޟY3MNkWnԦ5FXwX?ռRS͢j6sTE&`kz#rp'EGka%3O) =>$QG ZaAqaԍu{hdKی pr2N'4k->?S] `a{Xz|dKrOp09 ^0o-LR4z'E9EG|6N,?+v2ap4N!}r_>PI d,w& W2mY w3hrEku_ijfQb|3" Y}v\"iQsk {cTp-n`#573h< x_ 2VYrKU8_xoyK6L.>G\9젘C\.b vd_$ yz:NǞшj,׋]zQׅ8p-~ڿx!W׼$y|ōMc,ߝ?2)",7sf,K|>u]GIDn/[5=.}ÐuzPz[,ANnD5Blz?yrAV&Ѻ2;Gݕ=(}]IvzUA>`m8}(KI3uZ4m^~ՑtYʟ)>S8L;O>u?Nh[Ap) m>+t@/}|p;B (Ij(4^jeP¡Ph˼.Ҁl? t 9\ 5_ uBw{SHPx) --h' NmJsn8/T/l7X/vAn?$_C{ B$1)G6PK!7/drs/downrev.xmlDMO0DHkTiU@\-6^8hFovb[r׭k|n@DFabJ*nDRڐŸ=ԝ|)FcNVZl]z0Ӄ >,2:â(_߫R뫩4y,z 60Vd(/PK-![Content_Types].xmlPK-!1_a ._rels/.relsPK-!-,C )drs/shapexml.xmlPK-!7/drs/downrev.xmlPK0 O BInvestigator-Initiated Single-Site UVM s IBC will determine if a protocol requires RAC review based on the criteria presented in previous slide. Industry-Sponsored Multiple Sites Often times, sponsors will make a study level decision and approach RAC if they feel it meets criteria. The local site, however still makes its own determination of the need for RAC review. The various sites determinations are provided back to NIH for consideration. # Zn Z" Z Z Z#n"   !!!43e0[___PPT10i.!+D=' = @B +w6 zPb(  P* P  ~05f0e0e?Rectangle 1026~  O XStep 5: IRB REVIEW    !!!43e0[___PPT10i.S`=+D=' = @B +7  T(  T" T  ~.f0e0e ?Rectangle 1026?  O P IRB Review     P T  /f0e0e ?,Content Placeholder 1?r O j$Local investigator is responsible for submission to the IRB. Gene transfer protocols will require a full Committee review. Initial IBC review has to be completed with an approved-type status. 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In addition to submitting a serious adverse event (SAE) to the OSP, researcher must submit SAEs to theIBC and the IRB. @W [AF\      @    L2O\jM2O#c !!!43e0[y___PPT10Y+D=' = @B +N7  iaI(     x>f0e0e ?Rectangle 2 k`  O R CONCLUSION  $      ~p:f0e0e ?Rectangle 3~t b O>6___PPT9  This presentation was designed to inform the audience on the local and national requirements for review of gene therapy experiments.  "    !!!43e0[y___PPT10Y+D=' = @B +,O og@O(  @Y @ c 1fh}h}1??Rectangle 3079 z  v*C   #Fi @  rh}h}?Rectangle 2qg   O @  ~4fh}h}?Rectangle 3 H_  O 6    ̙3380___PPT10.b`|O og0XO(  XY X c P0fh}h}1??Rectangle 3079 z  v*C   #Fi X  rh}h}?Rectangle 2qg   O X  ~-fh}h}?Rectangle 3 H_  O 6    ̙3380___PPT10. `RKdO ogP`O(  `Y ` c 0,fh}h}1??Rectangle 3079 z  v*C   #Fi `  rh}h}?Rectangle 2qg   O `  ~,fh}h}?Rectangle 3 H_  O 6    ̙3380___PPT10. p@%O oglO(  lY l c p7fh}h}1??Rectangle 3079 z  v*C   #Fi l  rh}h}?Rectangle 2qg   O l  ~p1fh}h}?Rectangle 3 H_  O 6    ̙3380___PPT10. V.r]*]9 .z!M!dsz0Kޥcb1g 0&+-<N$Xz\q`hd_hVl! Y Oh+'0` hp  ( 4 @ LX0Human Gene Therapy Clinical Trial ProceduresbobhashTM03457496[[fn=Parallax]]Nicholas Thompson121Microsoft Office PowerPoint@P14E@@2z"@@J0 @pIH (N ՜.+,D՜.+,0    ( Letter Paper (8.5x11 in)Stanford University u  CorbelArialTimes New RomanCalibri Wingdings 3 Wingdings Parallax 1_Parallax 2_Parallax 3_Parallax 4_Parallax7 Human Gene Therapy Institutional Review Procedures Introduction-Investigator-Initiated vs Industry SponsoredStep 1: Obtain FDA ApprovalAStep 2: Obtain Approval from the Following Hospital Services ,Materials Required for Each Service Review)Step 3: Institutional Biosafety Review IBC REVIEW%Documents Required for IBC Review 9Step 4: Recombinant DNA Advisory Committee (RAC) Review)Who Decides if RAC Review Is Required? Step 5: IRB REVIEW IRB ReviewDocuments for IRB ReviewCStep 6: Register Protocol with NIH Office of Science Policy (OSP) ^Documentation of Registration with NIH OSP must occur prior to release of Committee Approvals/Step 7: AFTER NIH OSP REGISTRATION IS RECEIVED8Once Registration is Received the Following will Occur&Post Approval Reporting RequirementsMSerious Adverse Event Reporting Requirements for Human Gene Therapy Research CONCLUSION  Fonts UsedTheme Slide Titles  8@ _PID_HLINKSAt ~https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm351744.htm#mailto:Wes.McMillian@uvmhealth.org"mailto:Maria.Marra2@uvmhealth.org"mailto:Maria.Marra2@uvmhealth.org&mailto:christopher.huston@med.uvm.edu%mailto:Carolyn.Terhune@uvmhealth.org4http://www.uvm.edu/~ibc/?Page=ibc_formslibrary.html!mailto:HGTprotocols@mail.nih.gov!mailto:HGTprotocols@mail.nih.govOhttp://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelinesAhttps://osp.od.nih.gov/biotechnology/faqs-on-incident-reporting/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm351744.htm#mailto:Wes.McMillian@uvmhealth.org"mailto:Maria.Marra2@uvmhealth.org&mailto:christopher.huston@med.uvm.edu%mailto:Carolyn.Terhune@uvmhealth.org4http://www.uvm.edu/~ibc/?Page=ibc_formslibrary.html!mailto:HGTprotocols@mail.nih.gov!mailto:HGTprotocols@mail.nih.govOhttp://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelinesAhttps://osp.od.nih.gov/biotechnology/faqs-on-incident-reporting/)_lNicholas ThompsonNicholas Thompson  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PicturesvCurrent UserSummaryInformation(PowerPoint Document(M mDocumentSummaryInformation8