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TimeperiodofIRBapproval:   (   򀀀/򀀀/򀀀to򀀀/򀀀/򀀀  l d   c.  LocalIRBreference#:     (     $$N$  Ԉ .r  d 16.0  WillthisprojectrequirethewithdrawalofspecimensJ$$   d   fromthecentralrepository?     ( 0  0p$$0p$p$  򀀀Yes  򀀀No6$$  | d   a.0  If Yes,dateyouwillrequirespecimens(mm/dd/yy):򀀀/򀀀/򀀀T$$ 0 d 17.WillthisprojectrequirethewithdrawalofhostDNAfromtheWIHSDNA_biorepository_?,pd$d$  A$___Yes0 @ ___No \  d   a.If Yes,dateyouwillrequirespecimens(mm/dd/yy):򀀀/򀀀/򀀀 z  0 d   b.If Yes,pleasecompletetheDNA_biorepository_Ԁsamplerequestform.  ! !d$d$  d 18.0  Willthisprojectrequirecollectionofnew:___Dataand/or0$$___Specimens##$$  d 19.0  Sitesinvolvedintheproposedstudy:0($$___AllMACS&WIHSsites%%($($ 0# &b%X Xb7(X$$( d   ___AllMACSsites: &2!' @ d     ___Baltimore/DistrictofColumbia ' "(  d     ___Chicago (#)  d     ___LosAngeles )&$* @m$ d     ___Pittsburgh *4%+ |%@ 4,x&- ___AllWIHSsites: &2!-   ___Bronx '@".   ___Brooklyn  )N#/   ___DistrictofColumbia *\$0   ___LosAngeles &+j%1   ___SanFrancisco 4,x&2 @%  ___Chicago# Xb7X% &b## B-'3   .^(4 5$$X$5 B.0 d STUDYDESIGN (  X Xb7Usethefollowingorganizationtopresentyourstudyplanandtakewhateverspaceisnecessary   tocompletelyrespondtoeachsection.Completein12pointfontonly.PleasesubmitelectroniccopiesinMSWord,  RTF,orWordPerfectformat.)# Xb7X   (#pd$d$  d 1.0  LayLanguageSummary   X Xb7Ԁ(provideaoneparagraphsummaryofthestudyanditsimpactonparticipants)# Xb7X  )# d$$  d   d 2.0  Background   X Xb7(abriefdescriptionoftherationaleforthesubstudyincludingreferences)# Xb7X  *# $$  d   d 3.  SpecificAimsandHypotheses     d 4.0  StudyDesign   X Xb7Ԁ(summarizethetypeofstudy,inclusioncriteria,andsamplesize)# Xb7X  ,#4x$$   d 5.0  LaboratoryMethods   X Xb7Ԁ(ifapplicable,summaryofhownewstudieswillgeneratedata,etc.)# Xb7X  ,#($$  d 6.0  QA/QCProcedures   X Xb7(forstudiesgeneratingnewlaboratorydata:summarizelaboratoryQA/QCprocedures,  participationinrecognizedprogram,pastpublication,etc.,relevanttotheproposedinvestigationsortesting)# Xb7X  -#$$   d 7.0  DataAnalysisandSampleSizeCalculations   X Xb7(Whereappropriateindicatewhichvariablesare  L neededfromtheMACSandWIHSdatabase[MACSquestionnaireswithvariablesareavailableonlineat  8 http://www.statepi.jhsph.edu/macs/forms.html0andforWIHSvariablescontactJohanna_Goderre_Ԁat ! jgoderre@jhsph.edu0],andanticipatedsupportneededfromCAMACSand/orWDMAC.Includehowdatawill |"  bereported:onpaper,whatdatabase,whatfilestructure)# Xb7X  A/#@#!$$   d 8.0  ManuscriptWillBeCompletedby (  X Xb7anticipatedmonthandyearinwhichthemanuscriptwillbeready & !% forsubmissiontotheEC.# Xb7X  92#):'!&$$ j(R"(" d      P    <      (   __________________________ (R"'  :X Xb7 d      P    <     0 ( 0($($0p$$Month0p$p$0\$$Year# Xb7X :3#(>#(\$\$   d 9.0  PotentialFundingSource   X Xb7(pendingapplication,plannedapplicationorfundedeffort)# Xb7X  ]5# &b%X Xb7+%+$$ # Xb7X% &b5#  ^-'-  C.0 d SAMPLESPECIFICATIONS d$d$  &b%X Xb7 d 1.  EpidemiologicSpecifications   d   a.  Subgroup: 0 HIV(+)  HIV() ( 0 $ $HighRiskHIV() \ SeroconverterD $$  7 d     No./Subgroup ______  ______ ( 0  ______  0\$$______ \$\$  d   b.  DiseaseProgression: <   0  Rapid   p Intermediate  Slow8 |$$  d     Immunologicallydefined  0  ______   p 0$$______ \ 0$$0$$______|  $$ 8 d     Clinicallydefined <   0  ______   p 0$$______ \ 0$$0$$______ $$  d   c.  Serialspecimenswithexplicitlystatedcomparisons: p   d 0  d.  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SampleQuantity: Minimum:  $$N$  Ԉ   d      P   Optimum:  $$N$  Ԉ d   d 4.0  ExpectedPersonVisits:0<$$______ X"<$<$  d 5.0  Expectednumberofuniqueparticipants:0($$_____!$($($ # Xb7X% &bsB#33 &b%X Xb7 d 6.0  InvestigatorSignature# Xb7X% &bE#Ԁ0<$$  $$N$<$<$33Dӈ t$'  d 0  0$$0P $$0 P $P $0 $ $0< $ $ :X Xb7Yoursignatureindicatesthatyouagreewithalltheaboveinformationandthatyouhave `%( receivedlocalIRBapprovalorwillattainapprovalbeforedataorspecimensarereleased. &T )  NOTE: AfteryourCollaborationConceptSheethasbeensubmittedelectronically,please &!* signandFAXthispageandthecoverpagetoJudyKonig(4109557587).t'!+<$<$ # Xb7X :_F# NOTE: 󀀀 )@$.   X Xb7"0 d Ifyouarerequestinglymphoblasticcelllines,theNIHAIDSResearchandReferenceReagentProgramrequiresall d+%0 investigatorstoberegisteredpriortoreceivingsamples.Registrationmaterialsandinstructionscanbefoundonthe (,l&1 ReagentProgramwebsitelocatedat 4G O  5  www.aidsreagent.org 6IO J  78J,0'2d$d$ "0 d AdatafilecontaininglabresultsandacodebookofspecimensreceivedmustbesubmittedtotheappropriateData .Y(4 Center(CAMACSorWDMAC)priortothereleaseofvisitdataforanalysis.# Xb7X  H# ZH .)5d$d$  D.0 d INTERNALCOLLABORATIONSONLY d$d$  d 1.0  NEW_SUBSTUDIES_   X Xb7(detailanyanticipatedadditionalparticipantandMACS/WIHSstaffburden(interms  ofamountoftimerequired,additionalvisits,specimenstobecollected,etc.))# Xb7X  L#$$  d 2.0  RELEVANCE   X Xb7(tooverallMACSand/orWIHSaimsandjustificationforuseofMACS/WIHSspecimens)# Xb7X  M# d$$  d 3.0  COREGOALS   X Xb7(DiscussionofconsistencywithMACS/WIHScoregoalsandscope.Proponentsof  ,  ConceptsareencouragedtolinkwithMACS/WIHSinvestigatorstoavoidoverlapwithongoinginitiatives.   Pleasereviewthefileslistedathttp://statepiaps.jhsph.edu/wihs/admin/reswritgrps.htmPtoseeactiveconcept   sheetsbyresearchtopicintheWIHS.)# Xb7X  N#` $$  E.0 d MACS/WIHSINFORMATION ,d$d$  d 1.0  MACSand/orWIHSLiaison:  $$  d 2.0  Institution: "f$$  d 3.0  FAXNumber: 0 $$0< $ $0<$<$0$$$$  d 4.0  EmailAddress: *$$ AQ d 5.0  MailingAddress: H$$  d 6.0  CAMACS/WDMACPointPerson: d$$  d 0  TelephoneNumber: 0<$$0<$<$0$$0($$(410)9554320or6141340 P($($  d 0  FAXNumber:  0<$$0<$<$0$$0($$(410)9557587or6147125<($($  d 0  MailingAddress:  < 0$$0$$0($$JohnsHopkinsUniversity(($($  d      P 0 0 $ $0< $ $0<$<$0$$0($$BloombergSchoolofPublicHealth  ($($  d      P 0 0 $ $0< $ $0<$<$0$$0($$DepartmentofEpidemiology!!($($  d      P 0 0 $ $0< $ $0<$<$0$$0($$615NorthWolfeStreet,RoomE7644""($($  d      P 0 0 $ $0< $ $0<$<$0$$0($$Baltimore,MD212051999##($($ XTXX Xb7 NOTE# Xb7XXXTaY#: 0  EmailcompletedConceptSheetinaWord,WordPerfect,PDForRTFfiletoJoanaRoeat 0(t"( NIH(jroe@niaid.nih.gov-Z)forMACSandtoWDMAC(wdmac@jhsph.eduZ)forWIHS.Ifa  )d#) jointcollaborationtheConceptSheetmustbesenttoboth. *P$*$$ $PleasereadtheGuidelinesonthefollowingpages  .(/ @&( :X Xb7 Guidelines # Xb7X :[#Ԉ X  &b%X Xb7  A.0 d GeneralInstructions Dd$d$  TheMACS/WIHSCollaborationConceptSheetisintendedforuseforallcollaborations,whethertheinitiativeis  tocombinedatafrombothstudiesorforjustoneofthestudies.SectionsBandCarestudyspecificprotocolsfor t theconceptsubmissionandprocessing. L  \*Udddd dd xdd xU$$, dd , dd +  / /IntendedStudy A,!L   AReadSections -#!L  " -MACS   `  BandD ! ` " !WIHS 0&$  0CandD 0&!$ " 0MACSand/orWIHS 0& 8  0B,C,andD1'% 8 "   1  B.0 d ForresearchtobeperformedwiththeMACS: p d$d$  `  d 1.0  InvestigatorswishingtoaccessMACSdataorbiologicsamplesareencouragedtoreviewtheirproposed \ researchwiththeMACS.IfnotMACSliaison,contactNIHProjectOfficer,Robin_Huebner_Ԁat301 4 402-4239orrhuebner@niaid.nih.govbforpossiblerecommendations.d $$  d 2.0  Internalinvestigator:reviewconceptsheetwithsitePI.Externalinvestigator:reviewconceptsheetwith P MACSliaisonandenterliaisonscontactinformationofpage2.($$  d 3.0  ProposalisassignedtoappropriateMACSWorkingGroupforreviewwithin2weeks.WorkingGroup l maycontactinvestigatorforfurtherclarificationorsuggestions.D$$  d 4.0  IfapprovedbyWorkingGroup,submitconcepttoJoanaRoe(seeSectionD)forpostingtotheweband  reviewbytheMACSExecutiveCommittee(EC).WorkingGroupchairnotifiesECthatitreceived ` preliminaryapproval.8$$  d 5.0  MACSECreviewswithin2weeksofposting,atwhichtimetheinvestigatormaybeaskedtoparticipate |! inaconferencecallforfurtherclarification.T"$$  d 6.0  TheinvestigatorwillbecontactedbytheECChairthattheconceptwasapproved,approvedwith $ comments,tabledforfurtherclarification,needstoberevisedandreviewedagain,orrejected.p%$$  \a d 7.0  PleasereviewtheMACSpublicationpolicyindepthafteryourCShasbeenapprovedlocatedat  '  http://www.statepi.jhsph.edu/macs/MACSpubpolicy.pdfh. ($$   &  C.0 d ForresearchtobeperformedwiththeWIHS: !@*d$d$  ni  d 1.0  ALLabstractsMUSTbesubmittedtotheWIHSECforreviewandapprovalbeforetheyaresubmitted " , toaconference.Also,ALLmanuscriptsMUSTbesubmittedtotheWIHSECforreviewandapproval #\!- beforetheyaresubmittedtoajournal.'!i$4".$$  d 2.0  PleasereviewtheWIHSpublicationpolicyindepthafteryourCShasbeenapprovedlocatedat %x#0  http://statepiaps.jhsph.edu/wihs/pubpolicy.html l. &P$1$$  j d 3.0  UponConceptSheetapproval,aWIHSRepositoryRequestChecklist(availableon '%3  http://_statepiaps.jhsph.edu_/wihs/WIHS.Repository.Request.Checklist.doc&m )mustbefaxedtoChristine (r&4 Aldenat410-6147125.)L'5$$   D.0 d ForresearchtobeperformedwiththeMACSand/orWIHS: T+(7d$d$  n  d 1.0  ForjointMACS/WIHSpublications,withthefirstauthorbeingacoinvestigatorofeitherstudy,the ,@*9 numberofcoauthorsshouldbe:1to3fromthe1stauthor'scenterandtheanalytical p-+: (CAMACS/WDMAC)centercombined;andatotalof2to3fromstudyspecificsitescombined(e.g., H.+; ColeSR,LiR,AnastosK,DetelsR,YoungM,ChmielJS,MuozA.StatMed2003). /,<$$  n d 2.0  Allpublicationsandpresentationsofstudiesutilizingsamplesand/ordatasuppliedbytheMACSand/or X WIHSshouldacknowledgeboththecontributionsofsamplesandtheMACSand/orWIHScollaboration 0 itself.Thesuggestedformforacknowledgmentis:$$ eH  % &bDatainthismanuscriptwerecollectedbytheMulticenterAIDSCohortStudy(MACS)andtheWomen'sInteragency ` HIVStudy(WIHS)CollaborativeStudyGroupwithcenters(PrincipalInvestigators)locatedat: |$ MACScenters:TheJohnsHopkinsBloombergSchoolofPublicHealth(JosephMargolick);HowardBrownHealth @ CenterandNorthwesternUniversityMedicalSchool(JohnPhair);UniversityofCalifornia,LosAngeles(Roger  Detels);UniversityofPittsburgh(CharlesRinaldo);andDataAnalysisCenter(LisaJacobson).TheMACSisfunded p bytheNationalInstituteofAllergyandInfectiousDiseases,withadditionalsupplementalfundingfromtheNational  4  CancerInstitute;andtheNationalHeart,Lung,andBloodInstitute:UO1AI35042,5M01RR00052(_GCRC_), P   UO1AI35043,UO1AI37984,UO1AI35039,UO1AI35040,UO1AI37613,andUO1AI35041.    WIHScenters:NewYorkCity/BronxConsortium(KathrynAnastos);Brooklyn,NY(Howard_Minkoff_);Washington  D  DCMetropolitanConsortium(MaryYoung);TheConnie_Wofsy_ԀStudyConsortiumofNorthernCalifornia(Ruth `   _Greenblatt_);LosAngelesCounty/SouthernCaliforniaConsortium(AlexandraLevine);ChicagoConsortium(_Mardge_ $  Cohen);DataAnalysisCenter(Stephen_Gange_).TheWIHSisfundedbytheNationalInstituteofAllergyand   InfectiousDiseaseswithsupplementalfundingfromtheNationalCancerInstitute,andtheNationalInstituteonDrug T  Abuse(U01AI35004,UO1AI31834,UO1AI34994,UO1AI34989,UO1AI34993,andUO1AI42590). p FundingisalsoprovidedbytheNationalInstituteofChildHealthandHumanDevelopment(UO1HD32632)and 4 theNationalCenterforResearchResources(MO1RR00071,MO1RR00079,MO1RR00083).  # &b%  >r#"r  d 3.0  ManuscriptsresultingfromcollaborativestudiesmustbereviewedbyMACSand/orWIHS < investigatorswhoarecoauthors.Sufficienttimeforrevisionshouldbeallowedbeforesubmission l toajournal.Finalrevisionsalsomustbeavailabletocoauthorsforreviewbefore_resubmission_.Ds#s#  *{ d 4.0  TwocopiesofallpublishedmanuscriptsshouldbesenttoJudyKonigtoprovideanarchivalrecord 0 ofworkresultingfromthestudy.AnadditionalcopyshouldbesenttoJoanaRoefortheMACSand ` theWIHSat_NIAID_.8s#s# S(  Ss#Ss#(e  % &bJoanaRoe  DivisionofAIDS T NationalInstitutesofHealth,_NIAID_ p  Room4218,_MSC_Ԁ7626 4! 6700B_Rockledge_ԀDrive " Bethesda,MD208927626 d# (301)4353759 ($ JudyKonig $ CAMACS/WDMAC T% JohnsHopkinsUniversity p& BloombergSchoolofPublicHealth 4' 615N.WolfeStreet,RoomE7644 ( Baltimore,MD21205 d) (410)9554320# &b%  ~#  % &b (* e~5Ss#Ss#  S^~5# &b%  c#  * S  d 5.0  IfdataanalysisforthemanuscripthasnotbeencarriedoutatCAMACSand/orWDMAC,thefirst  t+ authorisresponsibleforsendingthecomputerprograms,finaldatasetsandcodebooksthatdirectly !L, relatetotablesandfiguresinthemanuscripttoCAMACS/WDMAC.Theprogramsanddatashould |"$ - belabeledtable1.dat,table1._sas_Ԁ(ifSASwasused),etc.andshouldbesentalongwiththereprintsto T# . JudyKonigatCAMACS/WDMAC.DatareceivedfromCAMACSandWDMACshouldbekept ,$!/ confinedtothespecificaimsoftheanalysisproposed.Additionalinitiativesshouldbesubmittedto %"0 theExecutiveCommittee(EC)viacompletionofanewCollaborationConceptSheetSubmission %#1 Form.&\$2s#s#  d 6.0  SpecimensordataprovidedbytheMACSandWIHSareintendedfortheexpresspurposeof '%4 performingECapprovedresearch.Thesespecimensanddatamust not beprovidedtoother (x&5 investigatorsorusedforadditionalprojectswithoutthewrittenconsentoftheMACSand/orWIHS )T'6 ExecutiveCommittees.*,(7s#s#  d 7.0  LeadauthorsshouldnotifyCAMACS/WDMACofanyandallmanuscriptsacceptedforpublication.+p)9s#s#  %  d 8.0  InternalInvestigatorsonly: Uponapprovalofaconceptsheet,authorsareexpectedtoupholdthe  -*; followingtimeframe:-+<s#s#  d   "0  Assemblyofanalyticaldatasetshouldfollow0.5to1monthafterreceiptofrequest.Awriting ,/,> groupwillbeassembledduringthistimeandyouwillbenotifiedofthemembership.Oneof 0-? _thecoauthorswillbethedesignatedcoauthorwhoshouldreceivecopiesofalldraftsand X analyticdatasets.Thatauthorshouldbepreparedtostandinifyouareunabletocompletethe 0 workinatimelyfashion.s#s#  d   "0  Preliminarystatistics,datavisualization,descriptions,explorationshouldbecomplete1to2 L monthsafterCSapproval.$s#s#  d 0  "0s#s#Afocusedstatisticalanalysisaimedataddressingresearchquestions,includingdraftoffigures h andtablestobeincludedinthepaper,wouldfollowwithinamonth.Atthispoint,coauthors @ shouldbesolicitedforinput.  s#s#  d   "0  TwotothreemonthsafterCSapprovalreworkingofanalysesandwritingshouldbeinprocess. \   Theanalystwillberesponsibleforhelpingtodraftmethodsandresults.Theleadauthorand 4   coauthorsareresponsiblefordraftingothercomponents.Bytheendofmonththree,afairly   completedraftshouldbecirculating. s#s#  d   "0  Threeto4monthsafterCSapprovalthedraftshouldberevisedwithinputfromcoauthorsin (  preparationofthefinaldraft. s#s#  d 0  "0s#s#Byendofmonth4thereshouldbeamanuscriptreadytosubmitforMACS/WIHSECapproval D  andpublication.s#s#    d 0  Thistimeframeisdependentonmanyvariablesbutitisareasonabletarget.Theclearertheconcept ` sheetisthefastertheprocess.Investigatorsshouldbewillingtobecontinuallyengagedwiththe 8 analyst.LeadauthorsareexpectedtokeeptheCAMACS/WDMACPointPersonapprisedofany  delaysintesting,analysis,writing,andmanuscriptsubmission.s#s#  d 9.0  Pleasereadthefollowing: InternalinvestigatorsshouldhavetheirConceptSheets(CS)reviewed , bythesitePI.ExternalinvestigatorsshouldhavetheirCSreviewedbytheircoinvestigatorliaison  (asindicatedonpage2ofthisform)fromoneofthestudiestodeterminethatthisconceptsheetis  appropriate.Ifnoliaisonexists,MACSCSshouldbesenttoJoanaRoeatNIH,DivisionofAIDS ` andWIHSCSshouldbeemailedtowdmac@jhsph.edu.8s#s#  d 10.0  Yoursubmissionindicatesthatyouagreewithalltheinformationonthepreviouspages(Internal |! Investigatorsonly)andthatyouhavereceivedlocalIRBapprovalfortestingtobeperformedatthe T" timesamplesarerequestedfromtherepository.BoththeMACSandWIHSECwillreviewyourCS ,# forMACS/WIHScollaborativestudies.Studyspecificcollaborationswillbereviewedbythatstudy \$ EC.YouwillbenotifiedofthestatusofyourCSviaemail.AfteryourCShasbeenreviewedbythe 4% MACSand/orWIHSEC,youwillbesentanemailindicatingifithasbeenapproved,approvedwith  & comment,revisionrequestedorrejected.Additionally,approvedCSwillbeassignedaproject ' number:rYY##(MACS)and/orwYY###(WIHS),whereYY=year.Youshouldusetheseproject  d( #sinallcorrespondenceuptoandincludingpublication.!<)s#s#  d 11.0  ExternallyfundedinvestigatorsutilizingMACSand/orWIHSdataarerequestedtosendacopyof " + theirannualProgressReport(minusbudgetinformation)totherespectivestudy.#X!,s#s#  d   0  ForMACSrelatedprojectspleaseemailProgressReportstocamacsms@jhsph.eduÚormailto $". addresslistedbelowandidentifytheleadinvestigatorandtitleaspresentedontheoriginal %t#/ ConceptSheetinyouremail/coverletter.&L$0s#s#  א d 0  0s#s#0P s#s#0 P s#P s#  % &bCAMACSJudyKonig'%2 s# s#  d 0  0s#s#0P s#s#0 P s#P s#JohnsHopkinsUniversity(T&3 s# s#  d 0  0s#s#0P s#s#0 P s#P s#BloombergSchoolofPublicHealthp)'4 s# s#  d 0  0s#s#0P s#s#0 P s#P s#615N.WolfeStreet,RoomE76444*'5 s# s#  d 0  0s#s#0P s#s#0 P s#P s#Baltimore,MD21205# &b%  E#*(6 s# s# G d   0  InvestigatorswhouseWIHSspecimensordatainR01projectsarerequestedtosendacopyof ,)8 theirannualprogressreporttotheWDMACemailaccount:wdmac@jhsph.edu.