TB-DOC-M2 version 5 14/9/2018 1 IMPERIAL COLLEGE HEALTHCARE TISSUE BANK: PROJECT DESCRIPTION Imperial College Healthcare Tissue Bank is an umbrella structure that is responsible for collecting and storing biological samples from a variety of different sources at Imperial College London and its sister organization Imperial College Healthcare NHS Trust, and ensuring that they are used for approved research projects in a manner that is consistent with the consent obtained. The general structure of ICHTB and its governance is given in Section A. This is a complex project that combines a number of different consent procedures under one Research Ethics approval. It is most logical to divide this into different groups of donors, each of which shares a common consent mechanism. These are outlined in section B below. Biological samples are only useful for research if they are annotated with information. Section C in this project description provides information on how information from the NHS clinical record is linked to samples stored under ICHTB’s umbrella, and how this data is anonymised to protect the donor’s identity. In addition to collecting biological samples, ICHTB is also responsible for approving research projects that use these samples. The mechanism by which this is done is described in Section D. ICHTB works closely with Imperials Joint Research Compliance Office to ensure that all human research carried out on our campuses is carried out within the relevant regulatory guidelines. Section A: Structure of ICHTB and Governance. A.1 Organisational Structure of ICHTB The main tissue collection comprises material from operative specimens that is surplus to diagnostic requirement. However, many of our clinicians also wish to collect fluid samples (e.g. blood and urine) from their patients to provide banks of material for future use in research projects. ICHTB therefore also provides a mechanism whereby local Principal Investigators can collect and store biological samples from patients under their care. Information on who is storing what and in which location is entered into a centralized database that provides local PIs with a tracking system to record the movement of samples in and out of their collection and to upload files relevant to their subcollection e.g. SOPs for collection, annotation, etc (for further information see Section C). There are different types of sub-collections that are held under the HTA Licence at Imperial. With regard to this application, subcollections in the first group are the most relevant with respect to consent of the donors. However as there is the potential for all three groups of subcollection to be approved for research use via the application for access procedure (see section D) for which we also seek HRA approval. Broadly these subcollections can be divided into 3 categories. A2 Subcollection categories A2.1 Donors consented using ICHTB approved consent material The majority of our subcollections are those which use Tissue Bank consent material(s) – listed in section B - are used to consent donors and materials are stored on ICHT/ICL premises. Further information is given in Section B.
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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.
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