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IMPERIALCOLLEGEHEALTHCARETISSUEBANK:PROJECTDESCRIPTION
ImperialCollegeHealthcareTissueBankisanumbrellastructurethatisresponsibleforcollectingandstoringbiologicalsamplesfromavarietyofdifferentsourcesatImperialCollegeLondonanditssisterorganizationImperialCollegeHealthcareNHSTrust,andensuringthattheyareusedforapprovedresearchprojectsinamannerthatisconsistentwiththeconsentobtained.ThegeneralstructureofICHTBanditsgovernanceisgiveninSectionA.ThisisacomplexprojectthatcombinesanumberofdifferentconsentproceduresunderoneResearchEthicsapproval.Itismostlogicaltodividethisintodifferentgroupsofdonors,eachofwhichsharesacommonconsentmechanism.TheseareoutlinedinsectionBbelow.Biologicalsamplesareonlyusefulforresearchiftheyareannotatedwithinformation.SectionCinthisprojectdescriptionprovidesinformationonhowinformationfromtheNHSclinicalrecordislinkedtosamplesstoredunderICHTB’sumbrella,andhowthisdataisanonymisedtoprotectthedonor’sidentity.Inadditiontocollectingbiologicalsamples,ICHTBisalsoresponsibleforapprovingresearchprojectsthatusethesesamples.ThemechanismbywhichthisisdoneisdescribedinSectionD.ICHTBworkscloselywithImperialsJointResearchComplianceOfficetoensurethatallhumanresearchcarriedoutonourcampusesiscarriedoutwithintherelevantregulatoryguidelines.SectionA:StructureofICHTBandGovernance.A.1 OrganisationalStructureofICHTBThemaintissuecollectioncomprisesmaterialfromoperativespecimensthatissurplustodiagnosticrequirement.However,manyofourcliniciansalsowishtocollectfluidsamples(e.g.bloodandurine)fromtheirpatientstoprovidebanksofmaterialforfutureuseinresearchprojects.ICHTBthereforealsoprovidesamechanismwherebylocalPrincipalInvestigatorscancollectandstorebiologicalsamplesfrompatientsundertheircare.InformationonwhoisstoringwhatandinwhichlocationisenteredintoacentralizeddatabasethatprovideslocalPIswithatrackingsystemtorecordthemovementofsamplesinandoutoftheircollectionandtouploadfilesrelevanttotheirsubcollectione.g.SOPsforcollection,annotation,etc(forfurtherinformationseeSectionC).Therearedifferenttypesofsub-collectionsthatareheldundertheHTALicenceatImperial.Withregardtothisapplication,subcollectionsinthefirstgrouparethemostrelevantwithrespecttoconsentofthedonors.Howeverasthereisthepotentialforallthreegroupsofsubcollectiontobeapprovedforresearchuseviatheapplicationforaccessprocedure(seesectionD)forwhichwealsoseekHRAapproval.Broadlythesesubcollectionscanbedividedinto3categories.A2 SubcollectioncategoriesA2.1 DonorsconsentedusingICHTBapprovedconsentmaterial
ThemajorityofoursubcollectionsarethosewhichuseTissueBankconsentmaterial(s)–listedinsectionB-areusedtoconsentdonorsandmaterialsarestoredonICHT/ICLpremises.FurtherinformationisgiveninSectionB.
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Subcollectionregistration(seesectionA2.4below)enablesPIstocollectandstorematerialbutnot tousematerial from their collection. Tousematerial for research theymust, inaddition, register a separate project thatmust be approved by a subgroupof theTissueManagementCommittee(TMC:seesectionA3.2).Multipledifferentprojectscanbeissuedsamplesfromeachsubcollection,buteachprojectmustbeapprovedviathemechanismsetoutinSectionD.
A2.2 DonorsconsentedusingseparatespecificHRAapprovedconsentmaterial(i.e.notpartofthiscurrentRECapproval)These are subcollections where alternative consent materials, not included in thisapplication,areusedtoconsentdonorsandconsentison-goingfromdonorsinourTrustorCollege.ThesemusthaveseparateHRAapprovalandPIsmustprovideacopyoftheconsentform/PISandacopyoftheirHRAapprovalletter.PIsmustalsoprovideamendmentstotheRECapprovalwhenmade.SomeofthesewillhaveagreeduseofsomeoralloftheirsampleswithintheirspecificHRAapproval.InthiscasewedonotneedtohavethespecifieduseofsamplesapprovedbyTMCastheyarecoveredbytheoriginalHRAapproval.IfthesamplesaretobeusedforotherstudiesthathavenotbeenstatedundertheoriginalHRAapproval,thePImustseekanamendmentwhenthesubcollectionremainswithintheHRAapprovaldates.AttheendofaccrualofsamplesandHRAapprovalthePIcaneitherseekrenewalofspecificHRAapprovalfortheirprojector,wherethereisanelementofgenericconsentforfutureunspecifieduse,placethesamplesundertheHTALicenceaspartofICHTB.InthelattercaseanyfurtheruseofsamplesmustgothroughTMCapproval(seesectionD).
A2.3 “Imported”Sub-collectionThese are sub-collections where the material is imported into ICL/ICHT from otherinstitutionsincludingthosefromoutsidetheUK.Thesearesimilarto(A2.2)above,butwillnotnecessarilyhaveUKHRAapproval.IftheydonothaveUKHRAapproval(i.e.theyareimportedfromabroad),thePImustprovideadocumentthatstatesthatthesampleshavebeensourcedinaccordancewiththelocalruleswithregardtoethicsandlaw.Thesecanalsobecollectionsofclinicaltrialmaterials,initiallystoredoutsideImperial,wheretheoriginalHRAapprovalhaslapsed,butgenericconsentforresearchuseofmaterialwassought.AllsubcollectionsmusthaveaMaterialTransferAgreement (MTA) that specifieswhere thesampleshave come from, andwhat they canbe used for. Where thematerialhas beenconsented using HRA approved forms a blank copy of the consent form and patientinformationleafletmustbeprovided.IfthesubcollectionhasbeenestablishedforuseonlywithinwhatisagreedontheMTA,approvalforuseisnotrequiredviatheTMC,providingtheinformationontheMTAisveryspecificandthatanyresidualmaterialistobedestroyedfollowing completion of that specific project. Where future undefined research is to becarriedout,andthishasbeenagreedbythesupplierofthematerial,eachprojectmustgothroughTMCapproval(seesectionD).
Onregistration,allsub-collectionsaregivenacodethatlinksthemtotheDepartmentofthePI,andtothePIthemselves.A2.4 RolesandResponsibilitiesofPIsofsubcollectionsEachsubcollectionmusthaveanominatedPIwhoisresponsibleforensuringthatthesubcollectionisappropriatelymanagedandwhoprovidesregularreportstotheDesignatedIndividual(DI)fortheHTALicence,throughthePersonDesignateontheircampuswhohasbeenallocatedtheresponsibilityforoversightoftheirsubcollection.TheseroleandresponsibilitiesaresetoutinAnnex1.ThePI
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mustregisterthesubcollectionontheTissueBankdatabase–isdoneusinganonlinesystemthatallowsthePIstoinputthedatadirectlyintothedatabase.PIsareexpectedtoprovidethefollowingdocumentsortoagreetoabidebytheSOPsprovidedbyTissueBankstaffthatgoverntheseelementswhensamplesarereceivedviaPathologyformaterialleftoverfromoperations:
o procedureforobtaininganddocumentingdonorconsentandreceiptofsampleso procedurefordisposalofsampleso procedurefortransportofsamples(intostorageandfromstorage)o procedureforcleaninganddecontaminationo procedureformanagingabnormalchangesinstoragetemperatureso procedureforrecordingandreportingadverseeventstotheDI
WherethesubcollectiondoesfallintothetypedescribedinA2.2,thePIisalsoobligedtoprovideablankcopyoftheconsentformandpatientinformationleaflet,andacopyoftheEthicsapprovalforthesamplecollectionanduse.Wherematerialhasbeenprovidedfromabroadadocumentwithastatementthatthematerialhasbeenobtainedaccordingtothelocalethicsandlawofthecountryinwhichthesamplesweresourcedmustalsobeprovided.AllexternallysourcedsamplesmusthaveanMTAthatdetailsthesamplesbroughtinandtheusethathasbeenagreedbythesupplier.
TheTissueBankdatabaseprovidesanonlinetrackingfacilitytochecksamplesinandoutofthesubcollection,butinsomecaseswherelargelegacycollectionshavebeenimportedandalreadyhaveatrackingdatabase,PIsmayprefertocontinuetousetheirownsystem.Wherethisisthecase,theremustbeastatementtothiseffectprovidedtotheTissueBanktogetherwithdetailsonwhohasaccesstothedatabaseandcouldbeaskedtoassistwithanyauditsthatmayberequiredfortheHTALicence.PIsareresponsibleforprovidinganannualreportonthenumberofsamplesaccruedandused(seeAnnex1)forbothHRAandHTAreportingpurposes.PIsarepermittedtonominateadeputytocarryoutthesetasks.
AnyapplicationsforaccesstoasubcollectionmustbeapprovedbythePIofthatsubcollection(seesectionDfordetails).
WhenaPIleavesemploymentattheCollegeortheTrusttheymustnominateacurrentemployeetotakeontheirrole,butwheretheyretainanhonorarycontracttheystillretainrightsoveraccesstothematerial.PIsmayseektotaketheircollectionswiththemtotheirnewemployer,butthiscanonlybedonewiththeconsentoftheirHeadofDepartmentatImperialandassurancesmustbeprovidedbythenewInstitutethatthematerialtransferredcanbestoredappropriately.RemovalofsamplesmustbesubjecttoanMTAstatingwhatusecanbemadeofthesamplestoensurethattheconsentprovidedbythepatientisrespected.
A3: GovernanceofICHTBTheGovernancestructureforICHTBisgiveninFigure1.Governancecanbedividedinto2areas–tissuecollectionanduseoftissueinresearch.A3.1 TissueCollectionTheTissueBankstaffcomprisesaSub-collectionManager,whoisresponsibleforgeneralmanagementofsub-collectionsandaudit,aSeniorTechnicianresponsibleforthemanagementoftheTissueBanklaboratory,4othertechnicalstaff,andanadministrativeassistant.ICHTBhas3collectionsitesforhumanmaterialfromImperialCollegeHealthcareNHSTrustpatientsundergoingoperations:Hammersmith,CharingCrossandStMary’sHospital,allofwhichformImperialCollegeNHSTrust.TheTissueBankofficeandlaboratoryisatCharingCrossHospital;thethreetechnical
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positionscoverthethreeImperialCollegeHealthcareNHSTrust(ICHT)sites.TheRecurrentMiscarriageTissueBankisbasedatStMary’sHospitalandisrunbyProfessorLesleyReganaspartofherclinicalpractice.TheTrophoblasticandGermCellTumourBankisrunbyProfessorMichaelSecklaspartofhisclinicalpracticeatCharingCrossHospital.InadditiontopatientsconsentedthroughICHT,ImperialCollegeacademicsholdcontractswithtwootherNHSTrusts–LondonNorthwestUniversityHealthcareNHSTrust(LNUHT)andChelseaandWestminsterHealthcareNHSFoundationTrust(C&WT).Theseacademicsarecloselyassociatedwithtwohospitalsites–StMarksHospital,whichislocatedontheNorthwickParkcampusofLNUHTandthe.ChelseacampusofC&WT.TheHTAhasapprovedthesetwositesassatellitestotheHTAResearchLicence.Onbothofthesesatellites,collectionofpatientsamplesislimitedtoafewspecializedteams.Thesecollectionsareheldassub-collectionsundertheHTALicence,butrequireseparateTrustspecificconsentmaterialstobeprovidedtopatients.ThesecanbefoundinAnnexes12and13tothisapplication.TheconsentmaterialshavebeendesignedtomirrortheICHTconsentmaterialsascloselyaspossible.CharingCrossisthehubfortheHTALicenceandHammersmith,StMarksHospitalontheNorthwickParkCampus,StMary’sHospitalsandChelseaandWestminsterarelistedassatellitesites.AssomehumanmaterialisstoredatImperial’scentralnon-clinicalsite,SouthKensingtonCampusisalsolistedassatellitesiteundertheHTALicence.TheDesignatedIndividualfortheHTALicenceisProfessorGerryThomas,whoisalsothePrincipalInvestigatorforthisapplication.EachofourcollectionsiteshasanumberofPersonsDesignatewhoareresponsiblefordaytodaysupervisionofactivityontheirsite,andprovisionoflocaladvicetoresearchers(seeFigure2).PatientinformationsheetsandconsentformshavebeenNHSTrustapproved,andtheSub-collectionmanagerworkswiththeclinicalteamsoneachsitetoensurethatconsentistakenappropriately.StandardOperatingProceduresfortakingconsentareavailableontheTissueBankwebpages(www.imperial.ac.uk/tissuebank)andareincludedintheAnnexestothisapplication.TheTissueBanktechnicianscheckthatconsentisinplacepriortotakingsamplesforresearch(seesectionB1below).Consentformsaresubjecttoregularrollingaudit.Theclinicalteamsthatcollectmaterialforsubcollectionsareresponsibleforobtainingconsentfromtheirdonors,andthisisalsosubjecttoregularrollingauditbytheSub-collectionmanagerandtheadministrativeassistant.AnnualreportsareprovidedtotheExecutiveCommitteeofImperialCollegeHealthcareNHSTrustandincludeinformationonconsentissues.AnnualreportsarealsoprovidedtotheSeniorManagementCommitteeoftheDepartmentofSurgeryandCancer,thehostDepartmentforthecurrentDesignatedIndividualfortheHTALicence.A3.2 UseofTissueinResearchTheTissueManagementCommittee(TMC)overseesissuesconcerningthedaytodayrunningofthetissuebank,andtheuseofmaterialreleasedfromit.TheTMCmeetsaminimumoftwiceayear.TermsofReferencefor,andmembershipof,theCommittee.MinutesoftheTMCmeetingsareincludedintheannualreportstotheTrust’sExecutiveCommitteeandSeniorManagementBoardoftheDepartmentofSurgeryandCancer.AnApplicationReviewPanelconsidersapplicationsforuseofmaterialtakenprospectivelywithexplicitconsent(sectionBbelow)andmaterialthathasbeentakenexclusivelywithdiagnosticintent,butthatmaybeusedforresearchoncethediagnosticprocessiscompleted(seesectionDbelow).RepresentativesoftheApplicationReviewPanelsitontheTMCandareportofapplicationsandtheresultsoftheirreviewisprovidedtothebiannualmeetingsoftheTMC.TheHTAhasindicatedthatitiscontentforstoredsamplesthathavebeentakenfordiagnosisandremainafterthediagnosticprocedurehasbeencompletedtobeusedinresearch,providingthatallsamplesareanonymisedtoresearchersandthatthereisHRAapprovalinplace,eitherseparately
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foraspecificresearchproject,orthatthesesamplesareeffectivelyheldwithinaResearchTissueBankthathasHRAapprovalforamechanismofaccessand“deemedethicsapproval”isprovidedbytheResearchTissueBankmechanism.
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Figure1ICHTBGovernance
SectionB-ConsentAnumberofdifferentconsentmechanismsareincludedinthisapplicationforapproval,andthesecanbebroadlydividedinto5groups,listedbelow.B1 DonorswhoarepatientstreatedunderImperialCollegeNHSTrust(ICHT)Diseasedtissueisremovedfrompatientsduringoperationsaspartoftheircarepathway.SamplesfromthistissuearetakenfordiagnosticpurposesinthePathologyDepartment,butinmanycases,somematerialisleftoverfromtheoriginaloperativespecimen.Thismaterialisnormallydisposedofbyincineration.This“material”canbeextrablocksoffixedtissuetakenfromtheoperativespecimen,orcanbefreshtissuethatissubsequentlyfrozenorusedforprimarycultureetc.Patientsarealsoapproachedtogivefluidsamplesfordiagnosis(e.g.blood,urine,pleuralorasciticfluid).Aswithmaterialfromsurgery,sometimessomeofthesampleremainsafterthediagnosticprocedure,andwouldnormallybedisposedofbyincineration.Withthepatient’spermissionthisleftovermaterialcanbeusedforresearchpurposes.Allaspectsofthecollection,documentation,furtherprocessingandstorageofmaterialsarecarried
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Figure2:TheHTAResearchLicenceatImperial
outtospecificStandardOperatingProcedures.AlldocumentationismanagedwithinaSharepointdocumentmanagementsystem,andtheICHTBdatabaseprovidesaLaboratoryInformationManagementSystemusingbarcodestotrackmovementofsamplesinandoutofthetissuebank,and,whereappropriate,throughdifferentprocessingsteps.ICHTisimplementingaTrustwidepolicytoconsentallpatientsforresearchuseofbiologicalsamplesanddata.Eventuallyitishopedthatthiswilloperateasa“consentatdoor”programme,butfortheinitialphasepatientsintheICHTBprogrammewillbeconsentedeitherelectronicallybytrainedConsentersapproachingpatientsinoutpatientsandclinicwaitingroomsorviapaperorelectronicallybyNHScliniciansatthepointofconsentingpatientsforclinicalprocedures(e.g.biopsyorsurgery).InbothcasesImperialCollegeHealthcareNHSTrustwillensurethatthepatientisprovidedwiththeICHTBPatientInformationSheettoensurethatconsentisinformed.Stepswillbetakentoensurethatpatient’sidentitiesare
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adequatelyverified;thesedifferdependingontheconsentmethodused.B1.1 FacetoFaceconsentintheclinicwaitingareaImperialCollegeHealthcareNHSTrustwillbeemployinganumberofstafftoconsentpatientsdirectlyforICHTB.ThesestaffwillattendoutpatientclinicstoconsentpatientsforICHTB.TheywillbeequippedwithTabletcomputers;thesewilldisplayaTrustAppthatwillallowconsenterstoaccesstheconsentengineandrecordchangestotheresearchconsentintheapp.FullpermissiontoattendtheclinicswillbegrantedbytheTrustDivisionalDirectorresponsiblefortheclinic.
ConsenterswillfollowtheICHTBconsentSOPwhichisoutlinedbelow.
1. ConsenterswillintroducethemselvesandaskifthepatientwouldliketoknowabouthowtheycanhelphealthresearchatImperial.Ifthepatientishappytoproceedtheywillbetoldabouttheprogrammeandaskedtoreadthepatientinformationleaflet.
2. ConsenterswillhaveprintedcopiesofthePatientinformationleafletthattheywillprovideacopytothepatient.
3. OncethepatientisfinishedtheconsenterswillaskthemiftheyhaveanyquestionsandiftheywouldliketoconsenttodonatetotheICHTB,explainingthatitisvoluntaryandtheircarewillnotbeaffectedbytheirdecision.
4. IfapatientagreesandwantstoconsenttheywillbeaskedshowphotoIDtoverifytheiridentity
5. Theconsentingstaffwillopentheappandusethepatientsnameanddateofbirth(orNHSnumberiftheyhaveaclinicletter)toidentifythemonthesystem.Thesystemwillreturnanymatchingpatientsandtheconsenterwillaskthemtoconfirmtheiraddress.Thispartoftheprocessiscompletedbytheconsenterandthepatientwillnotbeshownthedetailsonthescreenwhenmultiplepatientsmaybeshown.
6. TheconsenterwillconfirmthepatientselectionandtheappwilldisplaythepatientdetailsontheApp.• Name• Dateofbirth• NHSNumber• Address• Email• Contactnumber
a. Ifdetailsareinthesystemthepatientwillbeaskedtoconfirmthattheyarecorrectb. Ifdetailsarenotinthesystemthepatientwillbeaskedtoprovidetheiremail,address
and/orcontactphonenumber.c. Intheunlikelycasethatthepatientdetailsarenotfoundbythesystemtheconsent
formwillberecordedonpaperconsentformsusedtoconsentforextrasampleswhenapproachedbyaclinician(seesectionB2).
• Consentstatus(ifthepatienthasalreadyconsented)7. TheappwillthenaskifthepatienthasbeenverifiedandtheConsentingstaffwillselecteither
yesorno.Ifyesisselectedtheappwilldisplaytheconsentquestion:
IagreetojointheICHTBresearchproject,aimedatenablingapprovedresearchtoenhancethedeliveryandimprovementofhealthcare.InjoiningIagreethat:
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• IconsentthatforbiologicalsamplesleftoverfromroutineoperationsandprocedurescarriedoutatImperialCollegeHealthcareNHSTrustcanberetainedforuseinapprovedresearch.
• IconsentthatifIhaveabiopsyprocedure,twoorthreeextrasamplescanbetakenforuseinapprovedresearch.
• IconsentthatIifattendtohaveabloodtestitmayincludetakingupto45ml(3tablespoons)ofadditionalbloodforuseinapprovedresearch.
• IconsenttoallowNHSclinicianstocontactmeaboutopportunitiesformetoparticipateinresearchstudiesrelevanttomyhealthconditions.
• IconsenttoallowNHSclinicianstocontactmeiffindingsfrommyresearchsamplesarefoundthatmayaffectmyormyfamily’shealth.
• IamawarethatIcanwithdrawatanytimewithoutitaffectingthedeliveryofanyfuturehealthcare,andthatanysamplesstillheldwillbedestroyed.
8. Twobuttonswillbedisplayeda. IhavereadthepatientinformationleafletandgivemyconsenttojoinICHTBb. IDONOTwanttoConsenttoICHTB
9. Ifthepatientdoesnotconsentthefollowingmessagewillbeshown
YouhavenotconsentedtoJoinICHTBThankyouforyourtime.PleasecontacttheTrustifyouchangeyourmind.Youdonothavetoprovideareasonfornotconsenting,butitwouldhelpusifyoulettheconsentingstaffknowwhyyoudidnotjoin.Youron-goingcarewillnotbeaffectedbyyourdecisionnottojoin
10. Ifthepatientconsentsthefollowingmessagewillbeshown
ThankyouforconsentingtoJoinICHTBIfyouhaveprovideduswithacontactemail,ImperialCollegeHealthcareNHSTrustwillemailyouwiththepatientinformationsheetanddetailsofyourdecisiontojoin.Thiswillcontaincontactnumbersandemailaddressthatyoucanuseifyouhaveanyfurtherquestionsorwishtochangeyourmind.TheconfirmationemailtemplateisprovidedinAppendixone.
Oncethepatienthasclickedonthelinktheconsentupdateprocesswillbetriggered.TheprocedureissummarizedinFigure3below.Figure3:ICHTBElectronicconsentpathwayandICHTBconsenters
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B1.2 Consentviaclinician/nursepriortoclinicalprocedureConsentingforresearchisalreadyembeddedintheTrustprocessforconsentingapatienttoperformaclinicalprocedure.ThecurrentsystemhasbeenusedsuccessfullyforanumberofyearsandwasapprovedpreviouslybyWalesRECin2012andauditedbytheHTAin2014.SOPsdetailingtheprocedure,whichreflecttheproposeduseoftheICHTBPatientInformationSheet,areattachedareavailablefromtheTissueBankwebpages(www.imperial.ac.uk)ImperialCollegeHealthcareNHSTrustwillmovetoadapttheconsentbyclinicianorresearchnurseprocesstoanelectronicbasedsystem,butthiswilltaketimeandcannotbereplacedinonesinglestepastheprocessforpatientconsenttoclinicalprocedureswillneedtobechangedandagreedwiththeTrustatthesametime.Untilsuchtimethatallconsentsareregisteredpriortoproceduresthatwouldresultinbiologicalspecimensbeingtaken,thesurgicalteamswillbenotifiedwhenapatientisbookedforanoperationwhenthepatienthasnotalreadybeenapproachedforconsenttoICHTB.EachweektheresearchdatawarehousewillprovidePathologywithalistofpatientsbookedforoperationsthefollowingweekwhohaveconsentedtoICHTB.ThiswillalertPathologytotakeafrozensampleoftissuewherethisdoesnot,intheopinionofthereportingPathologist,prejudicediagnosis.ThesesampleswillthenbepassedtoTissueBankstaffforfurtherprocessingandstorage.SimultaneouslyalistofpatientswhohavenotyetbeenapproachedforICHTBwillbeprovidedtoTissueBankwhowillliaisewithsurgicalstafftoapproachpatientsforconsenttoICHTBatthetimeoftheirprocedure,usingthepaperbasedconsentprocedureoutlinedinFigure4below.
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Figure4:ICHTBconsent–paperpathwayusingTrustconsentforms
Whentheconsentisrecordedonapaperform,itwillbepassedtotheTissueBankatImperialCollegeLondon.NHSstaffwillthenusetheTrustconsentApptorecordtheconsentelectronically.Figure5showshowthetwoproceduresabovewillinteract.B1.2.1Consentforbothinvasiveandnon-invasivesamplesImperialresearchersareofteninvolvedinprojectsthatseektodevelopteststhatcanbeusedtodiagnosepatientsusingalternativesamplingmethods–forexample,samplesofsaliva,breathorurineorvaginal,aural,oralorrectalswabs.Thisusuallyinvolvescomparisonsbetweensamplesobtainednon-invasivelypriortoaprocedure,duringaproceduresuchasinsertionofarectalorvaginalprobe,andanextratissuesampleobtainedspecificallyforresearchpurposesatthetimeofabiopsyproceduree.g.endoscopy.Patientswhoarescheduledtoundergoabiopsyprocedureandwhowouldbecandidatesforprojectsusingtheapproachoutlinedabovewillbeaskedforconsentusingthe“extrasamplesconsentform”whentheyattendapre-operativeclinicappointment.Thepersontakingconsentwillseekpermissiontotakenon-invasivesamples(definedassaliva,sweat,breath,faecesand/orurine)aswellasextrabiopsymaterialanddocumentwhichsamplesareexpectedtobeprovidedontheextrasampleconsentform.DetailsofthisprocedurecanbefoundintheSOPforextrasampleconsentinAnnex4.
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Figure5:Combinedconsentpathwaysshowinginteraction
B1.3 RecordingconsentforICHTBImperialhavedevelopedasecureconsentenginethatsitswithintheclinicalsystemsintegrationenginewithintheTrustfirewall.Theconsentengineismaintainedwithinasecureenvironmentwithbothtechnicalandorganisationalsecuritymeasures,onlythosewithalegitimaterelationshipandsubjecttotheappropriatecontractualclauseswillhaveaccesstotheconfidentialinformationmaintainedtherein.TheconsentengineisdesignedtomanagethemultipleconsentsthatarecapturedinvariousareaswithImperialandfromsystemsexternaltoImperialthatcaptureconsentsthatwouldaffectpatients’care.TheengineisconnectedtotheelectronicpatientrecordandhassecureinterfacetoImperial’swebinterfaceapplicationtoreceiveconsentinformationfromwebapplicationsandexternalsystems.Theconsentengineallowsconsentstobeactionedappropriately,byinteractingautomaticallywithclinicalsystemstoplaceordersandtoinformusersoftheconsentstatusofpatientstheyaretreating.ThisconsentenginewillbeusedtostoreandactionallICHTBconsents.AstheconsentengineisembeddedintheTrustelectronicpatientrecordssystemitmonitorsallphlebotomyorders.WhenordersforbloodsamplesaresentviaNHSclinicalstaff,theorderischeckedagainsttheconsentengine.IfapatienthasconsentedtoICHTBandhasnotprovideda
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researchbloodsample,theconsentenginewillautomaticallyaddtwobloodsamples(12.5ml)totheorderbeforeitispassedtophlebotomy.Oncethepatienthasprovidedaninitialsamplethisisloggedintheconsentengineandnofurtherbloodordersareroutinelyrequestedforresearch,unlessaspecificrequestismadebyanNHSclinicianatalatertimepointinthepatients’treatmentpathway(e.g.toobtainabloodsamplefromacancerpatientforanalysisofbiomarkersthatcouldbeusedfordiseaseprocessmonitoring).TheconsentenginewillalsobeusedtoprovideauniqueIDthatcanbeusedtolinkfurtherclinicalinformationontreatmentandoutcometobiologicalsamplesrecordedontheICHTBdatabase(seesectionC)B1.4 Re-contactingpatientsVeryoccasionallyresearchstudiescanidentifypatientsthatmayrequireachangetothetreatmentthattheyarereceivingorbesuitableforotherresearchstudies(e.g.aclinicaltrial)thatmaybebeneficialtotheirhealth. Itisimportantthatthepatientismadeawareofthisatthetimeofconsent. AspecificparagraphintheintroductionofthePISstatesthefollowing“Wealsowanttogiveyoutheoptiontotakepartinfurtherresearchstudiesrelatedtoyourconditionsorthatarerelevanttoyou.Todothisweneedtobeabletocontactyoutoprovidefurtherdetailsofthesestudiessoyoucandecideifyouwanttotakepart,,contactwillonlybemadebyNHSclinicalstaffwhowillexplainthestudyandaskforyourpermissiontoshareyourcontactdetailswiththeresearcherrunningthestudy.Youhavenoobligationtosayyes.”ThefollowingisalsostatedexplicitlyinthePIS
“Whatifyoufindsomethingnewaboutmyhealth?Resultsforindividualpatientsfromparticularresearchstudieswillnotnormallyberelayedbacktoyouoryourdoctor.Inveryraresituations,someresearchprojectscouldidentifychangestoyourdiagnosisortreatmentorthatmayindicateaninheriteddiseasethatcouldaffectyouoryourfamilymembers.Yourhospitaldoctorwillbenotifiedifanyinformationthatisdiscovered,asaresultoftheresearch,mayaffectyouoryourfamily’scare.”
WhenandhowwillIbecontactedaboutresearchstudiesthatImaywishtoparticipatein?Approvedresearcherswillbeablesearchyourde-identifiedhealthdataanddataobtainedfromyourbiologicalsamples to identify people whomay be suitable to take part in research studies that assist researchers inimprovinghealthcareandtreatments.Forexample,asearchmightbeconductedtofindpeoplewhoareovertheageof40andhavediabetes
Ifyourdatamatchestherequirementsforaresearchstudythatmaybebeneficialtoyou,wewillallowanNHSclinicianatImperialCollegeNHSTrusttoaccessyourcontactdetailstoprovideyouwithdetailsoftheresearchstudy. If you are interested in finding outmore, the NHS clinician will pass your contact details on to theresearcherwhowillgetintouchwithyoutodiscussitfurther.Youdecideifyouwanttotakepart.It isyourchoiceandyoucansayno.Yourfullidentifiablemedicalrecordwillneverbeseen.
Youdonothavetotakepartinanystudiesifyoudonotwishto,andyourmedicaltreatmentwillbeunaffectedbyyourdecision.”
ParticipationinsuchfutureresearchprojectswillrequireseparateprojectspecificHRAapprovalandthepatientwillbegivenfurtherinformationrelevanttotheprojectandaskedtosignaspecificconsentformfortheproject.ICHTBhasaspecificpolicyonreturnofresearchresultstopatients–thisisincludedasAnnex5.Intheeventofarequestfromaresearcherforrecontact,theICHTBteamwillbenotifiedofthepatientsuniquetissuebankID,aNHSclinicianwillthenre-identifythepatientviatheTrust’sconsentengine.IfthepatientisreceivingactivetreatmentintheTrustthecareteamwillbecontactedandconsultedastowhetherthepatientissuitablefortheresearchstudy.IfthepatientisnotreceivingactivetreatmentthenNHCclinicianwillmakeanassessmentofwhetherthepatientissuitableandcontactthemwithdetailsiftheyare.
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Whenpatientsarecontactedbyphone,theywillbeaskedinformedofthedetailsofthestudyandaskedifthewanttoreceivefurtherdetails.Iftheywanttotakepart,permissionwillbesoughtfortheresearchertocontactthemaboutenrollinginthestudy.B2: Donorswhoarehealthyvolunteers–studentsorstaffemployedbyImperialCollege LondonorImperialCollegeNHSTrustResearchersoftenneedsamplesfromacontrolpopulation.Insomecasesthesesamplescanbeobtainedfrompatientswithadifferenttypeofdiseasefromtheonetheresearcherisstudying,butsometimesafluidsample(usuallyblood)ornon-invasivesample(e.g.,sweat,saliva,breath,stoolorurine)fromahealthypersonisrequired.WheretheindividualisnotcurrentlyapatienttreatedbytheNHSTrust,consentforacquisitionofthesamplemustberecordedinanappropriatemanner.UnlikethesituationwithpatientsenrolledintheICHTB,noinformationonindividualresearchresultswillbeprovidedtohealthyvolunteersandtheirmedicalrecordswillnotbeaccessed.Whereacquisitionofabloodsampleisrequired,venepunctureiscarriedoutbyatrainedphlebotomist.Wherethetargetvolunteerpopulationand/orPIarestafforstudentsofImperialCollegeLondonorofitsNHSTrust,approvalfortheprojectmustbesoughtviaImperialCollegeResearchEthicsCommitteeICREC).FurtherinformationonthisprocedurecanbefoundontheTissueBankwebpages(http://www.imperial.ac.uk/imperial-college-healthcare-tissue-bank/types-of-samples/).ThisapprovalisaroundmanagementoftheprojectandtoprotecttheCollegefromallegationsofcoercionetc.Whereappropriate,ICRECmayseekapprovaloftheHeadofDepartmentofthePIandregardthisasequivalentto“Chairman’saction”forREC.B2.1 RecordingconsentforobtainingfluidsamplesfromahealthyvolunteerDetailsoftheconsentprocedureandtherelevantformsareavailablefromtheTissueBankwebpages(http://www.imperial.ac.uk/imperial-college-healthcare-tissue-bank/types-of-samples/).Researcherswillbeprovidedwiththeconsentform,thepatientinformationsheetandbarcodelabelsfortheirsamplesbytheTissueBankSecretariat.CopiesofthesignedconsentformsarekeptinlockedcabinetsbythePIsofthestudiesandsamplesarelabeledwithauniquealphanumericIDrelatedtothesubcollectionregistrationnumber.B2.2 RecordingandtrackingofsamplestakenforresearchfromhealthyvolunteersResearcherswishingtocollectfluidsamplesforresearchpurposesfromhealthyvolunteersmustfirstlyregistertheirsub-collectiononTissueBankDatabase.Forinformationonhowtoregisterasub-collectionseehttp://www.imperial.ac.uk/imperial-college-healthcare-tissue-bank/collection-of-tissue/.AllsamplesaregivenauniqueIDthatlinkthesampletothePIandtothePI’sdepartmente.g.ONC-GT-01-0001B1wouldrepresentthefirstbloodsamplefromthefirstpatientinthefirstregisteredsubcollectionforPIGTwhoisbasedintheOncologyDepartment.B3: SpecificResearchTissueBanksthatusetheirownconsentformsandpatientinformationleaflets
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Thissectionrelatestoonlythosestudiesthatarestillactivelyconsentingpatientsandaccruingsamples.OurpreviousRECapprovalincludedtheQueenCharlotte’sMilkBank,whichisnownolongerconsentingpatients.SamplesfromthisbankarenowheldundertheHTALicenceasan“imported”sub-collection–seesectionA2.3above.B.3.1:TheRecurrentMiscarriageTissueBankTherecurrentmiscarriageunit,basedatStMary’sHospitalandisnowrecognisedinternationally,receivingsome800newreferralsperyearandcontinuingtoprovideantenatalcareformanythousandsmorecouplesduringtheirsubsequenthighriskpregnancies.Thetissuebankcollectsbloodsamplesfromtheparents,andasamplefromthebaby’scord,orfromtheproductsofmiscarriage,dependingonthepregnancyoutcome.DNAisextractedfromthesamplesforresearchintothegeneticsofrecurrentmiscarriage.Patientsaregivenaleafletonreferraltotheclinicandareaskedtosignagenericconsentformforfutureresearchonrecurrentmiscarriage.Allsamplesareanonymisedandstoredasasub-collectionundertheImperialHTAResearchLicence(seesectionA2above).ApplicationstousematerialfromtheTissueBankaremadethroughtheRECapprovedprocedureoutlinedinsectionDbelow.B3.2 TrophoblasticandGermCellTumourResearchBankGestationaltrophoblastictumoursandovariangermcelltumoursareraretumoursthataffectyoungwomenof reproductiveage. In theUKmanagementofwomenwith trophoblasticdiseasehasbeencentralisedwithCharingCrossHospitalbeingthelargestoftwocentresintheUKthattreatwomenwithtrophoblastictumours.Thishasenabledtheunittogainaninternationalreputationforresearchandgoodpatientoutcomesinthisfield.ManagementofovariangermcelltumoursisnowalsobeingcentralisedwithCharingCrossHospitalthemajorcentrefortreatmentofthiscondition.TheobjectiveoftheTrophoblasticandGermCellTumourResearchBankistocollecttissuefrommolarpregnancies,trophoblastic tumoursandgermcell tumourstogetherwithbloodandsalivasamples frompatientswiththeseconditionsandifappropriatebloodandsalivasamplesfromtheirrelatives.Theresourcewillenableus,andothers,toapplymoderntechnologiestoinvestigatethebiologyofthesediseaseswith the aim of improving diagnosis, developing new and more effective treatments and furtherimprovingpatientoutcomes.Patientsprovidingsampleswillbegivenapatientinformationsheetandaskedtosignagenericconsentformtoprovidesamplesforfutureresearchandallowustocontactrelatives.Relativeswhoparticipatewill be providedwith a participant information sheet and asked to sign a generic consent form toprovidesamplesforfutureresearch.Allsamplesareanonymisedandstoredasasub-collectionunderthe ImperialHTAresearch licence. Applications to usematerialwill bemade through the ImperialCollegeHealthcareTissueBank(seesectionDbelow).B3.3 StMarksHospitalNHSTrustColorectalTissueBankStMarksHospital is located inHarrowand is theonlyhospital in theUK to specialize in colorectaldisease.Althoughco-locatedgeographicallywithNorthwickParkNHSTrust,ithasstronglinkswithImperialCollegeLondon,withmanycliniciansholdingsubstantiveorhonoraryImperialcontracts.TheStMarkscampusislistedasaspokefortheImperialCollegeHTAResearchLicence,andhistoricallyhadbeenincludedintheICHTBTissueBankRECapproval,butcollectionoftissuehadbeeninabeyanceforawhile. It isnowwished to restart collectionand to integrateas faraspossiblewith the ImperialsystemsforTissueBanking. Patientswillbeofferedthechancetoconsenttodonateeithersamplesleftover fromdiagnosisorextra samplesofbloodandbiopsymaterial, as is the casewith ImperialCollegeHealthcareNHSTrustpatients.SampleswillbeheldatStMarksinaspecificsub-collectionandcoveredundertheImperialHTAResearchLicence. TheconsentmaterialsusemirrorthoseusedatImperialonlyvaryingwithrespecttothedifferentTrustspecificdetailsthatarerequired.Applications
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tousematerialwillbemadethroughImperialCollegeHealthcareTissueBank(seesectionDbelowfordetails).B3.4ChelseaandWestminsterHealthcareNHSFoundationTrust(C&WT)TissueBankChlesea and Westminster Healthcare NHS Foundation Trust operates two hospitals, the Chelsea and Westminster Hospital in Fulham and the West Middlesex University Hospital in Isleworth. The Chelsea and Westminster Hospital has close ties with Imperial College London, and many of the hospital's employees hold research contracts with Imperial College London. The HTA Research Licence has recently been extended to include the Chelsea campus, to enable collection of human samples from patients treated by C&WT to be used in research by Imperial College academics based at the Chelsea site. Patientswillbeofferedthechancetoconsenttodonateeithersamplesleftoverfromdiagnosisorextrasamples of blood and biopsy material, as is the case with Imperial College Healthcare NHS Trustpatients.SampleswillbeheldontheChelseacampusinspecificsub-collectionsandcoveredundertheImperialHTAResearchLicence.TheconsentmaterialsusemirrorthoseusedatImperialonlyvaryingwithrespecttothedifferentTrustspecificdetailsthatarerequired.ApplicationstousematerialwillbemadethroughImperialCollegeHealthcareTissueBank(seesectionDbelowfordetails).B4: SpecificconsentforxenograftstudiesTheHTAhasproducedguidancethatspecificconsentneedstobesoughtwhentissuesfromapatientaretobeusedinxenograftmodels.Ifmaterialisbeingcollectedwiththisintent,patientswillbeaskedtosignboththeappropriateconsentformforICHTB(seesectionB1)andanadditionalconsentform.Patientswillalsobeprovidedwithanextrapatientinformationsheetthatprovidesexplicitinformationonwhataxenograftis,anditsuseinresearch.Informationontheconsentmaterialsforxenograftstudiescanbefoundherehttp://www.imperial.ac.uk/imperial-college-healthcare-tissue-bank/types-of-samples/.
B5: MaterialobtainedPostmortemB5.1 MaterialobtainedfromstandardpostmortemsImperialNHSTrustalreadyhasestablishedproceduresforconsentingfamilymembersforpostmortemstobecarriedoutformedico-legalreasons.TheTrusthasembeddedconsentforresearchstudiesintothisprocedure.B5.2 MaterialobtainedfollowingdonationofabodyforanatomicalexaminationImperialCollegeobtainsbodiesdonatedthroughtheLondonAnatomyOfficeforanatomicalexaminationforteachingpurposes.Donorsconsentantemortemandconsentistakenforbothteachingandresearch.Donationforresearchthroughthismechanismisparticularlyvaluableforprojectsinbioengineeringasaccesscanbegainedtowholebonesorjoints.Aresearcherusingsamplesfromsuchdonorsmustregisterasubcollection(seeSectionA)sothatsamplescanbetrackedfromtheAnatomyDepartmentthroughtoreleaseforindividualresearchprojects.Allsamplesarede-identifiedusingthesamecodingmechanismasforsamplestakenfromlivingpatientsorvolunteers.
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SectionC:DatalinkageSectionC.1 SamplemetadataToensuredonorconfidentiality,biologicalsamplesandtheirclinicalinformationarelinkedbyauniqueID.ThisIDisissuedbytheTissueBankandislinkedtotheconsentIDrecordedontheTrust’sconsentengineinthecaseofNHSpatientsconsentedforICHTB(seeFigure4).Wherethedonorisahealthyvolunteer,theIDisallocatedbytheTissueBankdatabase,onregistrationofasub-collection.ThecurrentdatabasesystemisshowninFigure5.TissuebankstaffholdinghonoraryclinicalcontractsareprovidedwithausernameandpasswordbytheNHSTrusttologintoTrustITsystems,andareabletoaccessmetadataonthesamplee.g.thepathologicaldiagnosisforthesample,SNOMEDcodeetc.TheTissueBankdatabaseissimilarlyprotectedbyusernamesandpasswordsandisinsideImperialCollege’sFirewalls.TheTissueBankdatabaseprovidesnotonlyamethodforholdinganonymisedinformation,butalsoprovideatrackingsystemforsamples.Individualsamplescanbetrackedthroughprocessingtodifferentanalytes(e.g.DNA,RNA,serum,plasmaetc)throughtoreleasetoresearchers.Thesedataaremaintainedbytissuebankstaffforthesubcollectionthatcomprisesmaterialleftoverfromoperation.PrincipalInvestigatorswhoholdregisteredsub-collectionssignanagreementwiththeTissueBankthattheywillupdateaccrualofsamplesintotheirsub-collectionandreleaseofsamplestoresearchersfollowingappropriateapproval(seesectionD).Allcollectionsaresubjecttorollingaudittoensurethatthedataheldonthedatabaseisaccurate.TheTissueBankdatabaseismaintainedonImperialCollegeserversatSouthKensingtonwithregularback-upsbeingmadeandheldoffsite.EachmemberofImperialCollegehasauniquenumericalIDlinkedtoausernameandpasswordheldwithintheCollege’sLDAPsystem.TheTissueBankutilizesthissystemtoprovideaccesstotheTissueBankdatabaseforsubcollectionusers,ensuringthataccesscanbetrackedbytheCollege’sICTsystem.Withinthetissuebankdatabase,usersareprovidedwithdifferentlevelsofaccessdependingontheirroles.ForexamplesubcollectionPIsandtheirnomineescanaccesstheirownsubcollections,researcherscanaccesstheirownresearchprojects.OnlyTissueBankseniorstaffhaveaccesstotheentiredatabaseassuperusers.TheTissueBankinfrastructureismanagedbytheBioinformaticsDataScienceGroup(http://www.imperial.ac.uk/bioinformatics-data-science-group)withintheDepartmentofSurgeryandCancer.SectionC.2 LinkageofconsentedpatientstohealthcaredatastoredinICHTWhenpatientsareconsentedforICHTB,theirdataheldinthehospitalmedicalrecordcanbelinkedtothepatient.AflagwillbeplacedinthesedatasetstoindicatethatthepatienthasconsentedtoICHTB.ThedatasetsarepseudonymisedintheTrustdatawarehousebeforebeingpassedtoanyoneoutsidethecareteamofthepatient.DatawillonlybetransferredfollowingappropriateapprovalsfromtheTrustInformationGovernanceTeamorviaanHRAapprovedmechanism(projectspecificHRAapprovalorviathemechanismoutlinedinSectionD).SectionC.3 LinkageofconsentedcancerpatientstotheNationalCancerRegistryServiceCollectionsofhumantissuesamplesfromcancerpatientsheldbybiobanksorresearchstudiesaremostusefulwhenaccompaniedbyhighquality informationabout theirdonors’diagnosis, treatmentandoutcomes. Although this information is important, biobanks are not normally funded to collectlongitudinaldataandrelyontheNHStoprovidethese.Thisworkswell fordetailsofdiagnosisandinitialtreatmentbutinformationonvitalstatusandrecurrence/diseaseprogressioncanbehardertoobtain,especiallywhenthepatientisnolongerinthecareoftheoriginalTrustinwhichtreatmentwascarriedout.ThisisaparticularprobleminLondonwherepatientsoftenmoveawayonretirement–thismakesobtainingverylongtermdataparticularlychallenging.Thesamesituationoftenappliestoresearchstudieswherelongitudinalpatientinformationcanalsobedifficulttoobtain.Cancerregistriesproviderepositoriesofdetailedclinicaldataaboutcancerpatients.InEngland,asinglenational cancer registration system (ENCORE, the English National Cancer Online RegistrationEnvironment)was out inplace by July 2013.Managed by theNational CancerRegistrationService
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(NCRS),ENCOREprovidesacentralsourceofinformationthatcancomplementthedataalreadyheldbybiobanksorotherhumantissuecollections.OpportunitiestoexchangeinformationbetweencancerregistriesandbiobankswerediscussedatameetingbetweenbiobanksandtheNCRSinJanuary2013.Theconclusionofthismeetingwasthatamechanismshouldbeestablishedforcollectionsto‘register’theirdonorsandsampleswiththeNCRS.ThiswouldallowtheownerofthecollectiontorequestinformationaboutdonorsfromtheNCRSandtheNCRStoprovideabasiccatalogueofsamplesheldbydifferentcollections.ICHTBtookpartinthepilotofthisprojectin2013,approvedbyICHT’sCaldicottGuardian,DrSanjayGautama,andremainsoneofthefewResearchTissueBanksthathaveusedthisexcitingopportunitytoenrichlongtermoutcomedata.InitiallinkagetoNCRSrequirestheuseofpatientidentifierssothisiscarriedoutviatheTrust’ssecureN3system.OnlypatientswhoareenrolledinICHTBwillbeeligibleforthislinkageprocedure.ThisprocedurelinksthepatientidentifiableinformationandtheTissueBankIDtoauniqueIDstoredontheNCRSdatasystems.ThislinkageenablestheTissueBankdatabasetorequestupdatesonoutcomedirectlyusingthelinkagebetweentheTissueBankIDandtheNCRSIDonly,thusavoidinganyfurthertransmissionofidentifiabledata.
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Figure6.Databaseschema
SectionD AccesstosamplesforresearchWeareseekingcontinuationofapprovalnotonlytoaccessmaterialforresearchthathasbeentakenwithconsentasoutlinedaboveinsectionC,butalsomaterialthathasbeentakenwithdiagnosticintentandremainswithinthediagnosticarchivestoredatour3hospitalcampuses,andsubsequentlyinNHSTrustapprovedstorageoffsiteviaCellnass.Archivedmaterialisapotentialgoldmineforresearchersasinsomecasesitcanbelinkedtoadetailedlongitudinaldatasetthatcontainsinformationonultimatepatientoutcome.However,priortotheadventoftheHTA,prospectiveconsentfrompatientswasnotsought,andalthoughregardedasgoodpracticebytheHTA,theHTAhasacceptedthatmaterialfromthediagnosticarchivecanbeaccessedwithoutconsentprovidingthematerialisanonymisedandthatthereisaRECapprovedmechanismforaccess.TheHTAdoinsistthatconsentisapre-requisiteforaccesstosamplesobtainedpostmortem.OurprocedureforconsenttomaterialobtainedpostmortemisoutlinedinSectionB5.SectionD1 DiagnosticPathologyArchiveImperialCollegeHealthcareNHSTrusthasanextensivearchiveofsamplesoffluid,andformalinfixed,paraffinembedded(FFPE)materialthatwastakenfordiagnosticpurposes.Oncediagnosisiscomplete,thismaterialisarchived.FFPEmaterialandarchivedfluidssuchasserumarevery
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valuableresourcesforresearch,astheycanbelinkedtoextensiveinformationonhowthepatienthasbeentreated,andhowthepatienthasrespondedtotreatment.Datacanbecollatedeitherbytissuebankstafforthespecializedclinicalteam,whoareboundbytheirclinicalcontractstorespectpatientconfidentiality,andassociatedviaananonymisedlinktothepathologicalbiologicalsamplesontheTissueBankdatabase.FFPEblocksthemselvesarerarelyissuedtoresearchers.Sectionsfromthem,withappropriateapprovalbyapathologisttoensuresufficientresidualmaterialremainsforunforeseendiagnosticpurposes,arecutbytissuebanktechniciansandissuedtoresearchersusinganidentificationcodeprovidedbythetissuebank.ThepathologynumberonlyisrecordedandtrackedontheTissueBankdatabase.Thisensuresthatpatientconfidentialityisprotected–accesstothepatientidentifiers(hospitalnumber,NHSnumber,name,addressetc)remainontheNHSTrustITsystem,butcanbelinkedtothepatientviathePathologynumbershouldthisbenecessarybystaffwithapprovedaccesstotheTrustITsystem.Datafromresearchstudieswouldnotbefedbacktopatientswhohadnotbeenapproachedforconsenttousetheirsamples.D2 ProcedureforaccessingmaterialsforresearchTheprocedureforseekingaccesstotissueforresearch,whetherthematerialistakenspecificallyforresearchandcomesthroughtheconsentproceduresasoutlinedinsectionB,orwhetherthesampleshavebeentakenoriginallywithdiagnosticintent(seeD1above)isavailableontheTissueBankwebpages(http://www.imperial.ac.uk/imperial-college-healthcare-tissue-bank/using-human-samples/).Eachresearchprojectisassignedauniquereferencenumber.ProjectsthathaveseparatespecificRECapprovalareassignedanNnumberandthosethatareapprovedviatheApplicationReviewPanelwith“deemed”ethicsapprovalareassignedanRnumber.Theprojectsareprovidedwithanidentifierfortheyearandasequentialnumbere.g.R17001wouldbethefirstprojectapprovedthroughthedeemedethicsroutein2017.EachsamplewithitsuniqueIDisassignedtoeachindividualproject.Allsamplesarebarcoded.Alistofthesamplesprovidedtoeachprojectissuppliedwiththesamplesandtheresearchersareaskedtoconfirmreceipt.AllofthisinformationisstoredontheTissueBankdatabase.