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HumanTissueAuthority

Codeofpractice9 Research
September2009

Paragraphs 1-12 13-17

Content
Introduction Scopeofthiscode Structureandnavigation Statusofthiscode Humantissueandresearch Consent Licensing Interfacebetweenresearch,humanapplicationandclinicaltrials HTAstandards AppendixA AppendixB References Glossary

Paragraphs 1-12 13-17 18-20 21 22-32 33-54 55-72 73-81 82-115

Introduction
ThelegislationandtheHumanTissueAuthority
1.TheHumanTissueAct2004(HTAct)www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1coversEngland,WalesandNorthern Ireland.TheHTActestablishedtheHumanTissueAuthority(HTA)toregulateactivitiesconcerningtheremoval,storage,useanddisposalof humantissue.ThereisseparatelegislationinScotlandtheHumanTissue(Scotland)Act2006 www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en_1. 2.TheHumanTissue(QualityandSafetyforHumanApplication)Regulations2007(Q&SRegulations) www.opsi.gov.uk/si/si2007/uksi_20071523_en_1implementtheEuropeanUnionTissueandCellsDirectives(EUTCD).TheHTAisa CompetentAuthorityintheUKundertheQ&SRegulations,whichcoverthewholeoftheUK,includingScotland. 3.TheHTAsremitinScotlandisdescribedintheScottishHealthDepartmentletterissuedon20July2006(Ref:NHSHDL(2006)46) http://www.hta.gov.uk/_db/_documents/Information_about_HT_%28Scotland%29_Act.pdfandtherelevantcodesofpractice.Relevant guidancefromWalesandNorthernIrelandisreferencedthroughoutthecodes.

Aboutthecodesofpractice
4.ThecodesofpracticegivepracticalguidancetoprofessionalscarryingoutactivitieswhichliewithintheHTAsremit.Theymayalsobeof interesttomembersofthepublic.Thefirsteditionsofthecodeshavebeenrevisedtoreflectourexperienceofregulation.Wehavemade thecodesmorerelevanttothesectorsweregulatebyincludingcasestudiesandexamples;andhaverestructuredtheminawaythatmakes themmoreuser-friendly. 5.Thecodesaresupplementedbyothermoredetailedguidance,forexampleonlicensingstandards,whichcanbefoundontheHTAs website. 6.TheHTAhasnowpublishedninecodesofpractice,whicharelistedbelow:www.hta.gov.uk/guidance/codes_of_practice.cfm 1. Consent 2. Donationofsolidorgansfortransplantation 3. Post-mortemexamination 4. Anatomicalexamination 5. Disposalofhumantissue 6. Donationofallogeneicbonemarrowandperipheralbloodstemcellsfortransplantation 7. Publicdisplay 8. Importandexportofhumanbodies,bodypartsandtissue 9. Research 7.AllninecodesofpracticehavebeenbroughtintoforcebyHTADirections www.hta.gov.uk/guidance/licensing_guidance/expected_standards.cfm.

Usingthecodes
8.Inthesecodes,thewordmust referstoanoverridingdutyorprinciple,includingallspecificlegalrequirementsderivedfromprimaryand secondarylegislationforexample,therequirementtoholdalicencetostorehumantissueforascheduledpurpose. 9.Weusethewordshouldwhenexplaininghowtomeetthespecificlegalrequirements.Establishmentsareexpectedtofollowtheguidance inthecodes.ObservanceoftheguidanceinthecodesisoneofthewaysinwhichtheHTAassessesthatestablishmentsarecomplyingwith relevantlegislation.FailuretofollowacodeofpracticeisnotinitselfacriminaloffenceundertheHTActbuttheHTAwillcarefullyconsider anybreachofacodeofpracticeandmaytakeappropriateregulatoryaction. 10.Thecodescomplementeachotherandshouldbereadalongsideotherrelevantadviceandguidance,whichiseitherreferencedinthe textorprovidedontheHTAswebsite.Aglossarywithtermsspecifictoeachcodeisavailableattheendofeachdocument,andafulllistof glossarytermsisontheHTAswebsite. 11.YoucandownloadandprintcopiesofthecodesfromtheHTAswebsitewww.hta.gov.uk/guidance/codes_of_practice.cfm.

Otheradviceandguidance
12.AnumberofotherorganisationshavealsoproducedguidanceonissuesintheHTAsremit.Wherethishasbeenproducedincollaboration

withtheHTA,itwillappearonourwebsite.TheHTAscodesofpracticeandotherguidanceshould,however,beusedasthedefinitivesource ofinformationforissueswithinourremit.Ifyouareinanydoubt,pleasecontacttheHTAorseekyourownlegaladvice.Regulatedsectors shouldalsokeepuptodatewithotherrelevantlegislation.

Scopeofthiscode
13.TheHTActintroducedaregulatoryframeworkfortheremoval,storageanduseofrelevantmaterialforresearchintodisorders,orthe functioningof,thehumanbody.Theframeworkrequiresresearchusingrelevantmaterial(alsoreferredtointhiscodeashumantissue)from eitherthelivingordeceasedtoberegulatedthroughlicensingofthestorageofhumantissue,subjecttocertainexceptions.Inaddition, researchusinghumantissuecanonlybedonewherethereisappropriateconsent,again,subjecttocertainexceptions. 14.Thestorage,asopposedtotheuse,ofhumantissueforresearchislicensedbytheHTA.However,theconsentrequirementsoftheHT Actapplytoitsstorageanduse. 15.TheHTAsremitandlicensingrequirementsinrelationtoresearchdonotextendtoScotland.However,researchersinScotlandmayfind thiscodeausefulreferenceforgoodpractice.(althoughtheoffenceofnon-consensualDNAanalysisappliesacrossthewholeoftheUK). 16.Thiscodeshouldbereadinconjunctionwithguidanceissuedbythefollowingorganisations: GeneralMedicalCouncil(GMC)www.gmc-uk.org/guidance/ethical_guidance/index.aspontheethicalconsiderationsrelatingtoseeking patientsconsent. MedicalResearchCouncil(MRC)www.mrc.ac.uk/Newspublications/News/MRC004137whichprovidespracticalhelpwithlegislativeand goodpracticerequirements. NationalResearchEthicsService(NRES)www.nres.npsa.nhs.uk/ontheuseofhumantissueinresearch. UKClinicalResearchcollaboration(UKCRC)www.ukcrc-rgadvice.org/bestpracticeguidance/Pages/default.aspxwhichprovidesregulatory andgovernanceadvice. NationalInformationGovernanceBoardforHealthandSocialCare(NIGB)www.nigb.nhs.uk/ontheuseofpatientinformation. 17.ForguidanceonhowtocomplywiththeHTAsconsentanddisposalstandards,pleasealsorefertothecodeofpracticeonConsentand codeofpracticeonDisposalofhumantissue.FurtherguidanceaboutlicensingundertheHTActissetoutintheGuidetolicensingfor DesignatedIndividualsandLicenceHolders www.hta.gov.uk/licensing/designated_individuals_and_licence_holders/dls_under_the_ht_act.cfm.

Structureandnavigation
18.Thefirstsectionofthiscodeexplainswhatismeantbyresearchandcoversthespecificsrelatingtotissuefromthelivingandtissuefrom thedeceased. 19.Thecodethensetsouttheconsentandlicensingrequirementsrelevanttotheresearchcommunityandoffersguidanceonwhattissue fallsundertheremitoftheHTA. 20.AttheendofthiscodethereisasectiononHTAstandardsandhowestablishmentsareexpectedtodemonstratecompliance.

Statusofthiscode
21.ResearchfallswithintheHTAsstatutoryremit.ThiscodeisthefirstHTAcodeonresearch.InaccordancewithSection29oftheHTAct, ithasbeenapprovedbytheSecretaryofStatefollowingconsultationwiththeWelshAssemblyGovernmentandtherelevantNorthernIreland department,andithasreceivedParliamentaryapproval.

Humantissueandresearch
Whatisresearch?
22.TheHTActdoesnotcontainadefinitionofresearchbutforthepurposesofwhatfallswithintheHTAsremit,thefollowingdefinition applies: Astudywhichaddressesclearlydefinedquestions,aimsandobjectivesinordertodiscoverandinterpretnewinformationorreachnew understandingofthestructure,functionanddisordersofthehumanbody.Researchattemptstoderivenewknowledgeandincludes studiesthataimtogeneratehypotheses,aswellasstudiesthataimtotestthemordeveloppracticalapplicationsornewknowledge. TheHTAalsoendorsesthedefinitionprovidedbytheDepartmentofHealthandtheWelshAssemblyGovernment,whichisasfollows: Researchcanbedefinedastheattempttoderivegeneralisablenewknowledgebyaddressingclearlydefinedquestionswithsystematic andrigorousmethods.

Whatishumantissue?
23.Relevantmaterialisthatwhichconsistsof,orcontains,cells.Guidanceonthedefinitionofrelevantmaterialforresearchcanbefoundon theHTAswebsite www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm.

Accesstotissuefromtheliving
24.Tissuefromthelivingmeanstissuetakenwhilethepersonwasalive,andthisdefinitionpersistsaftertheirdeath. 25.DiagnosticarchivesdonotneedtobestoredunderanHTAlicence,providingallthesamplesarefordiagnosis.Ifoneormoresamples arestoredforresearch,thearchivemustbestoredonHTA-licensedpremises. 26.Tissuethatwastakenfromthelivingfordiagnosisandsubsequentlystoredinadiagnosticarchivecanbevaluableforuseinresearchin connectionwiththedisorders,orthefunctioningof,thehumanbody.Diagnostictissuecanonlybereleasedforresearchunderthefollowing circumstances: Whenthepatienthasgivenconsentforuseoftheirtissueinresearch(thepreferablescenario);or Whenthetissuewillbereleasedtotheresearcherinanon-identifiableform;and Whenthetissuewillbeusedinaprojectthathasapprovalbyarecognisedresearchethicscommittee(formoreinformationon recognisedethicscommittees,see paragraph43). Example1Aresearcherwishestouseparaffin-embeddedblocksofsurgicallyremovedthyroidtissuestoredinthearchivesofa pathologydepartmentafteritsusefordiagnosis.Asthepatienthadnotgiventheirconsentfortheuseoftheirtissueforresearch,it canonlybereleasedfromthediagnosticarchiveifitdoesnotidentifythepatientandisusedinaspecificprojectthathasbeen approvedbyaresearchethicscommittee(REC). Example2Aresearcherrequireswholebloodforaresearchproject.Sheisabletoaccessbloodsamplesfromadiagnosticarchiveina hospitalbiochemistrylaboratorywhichhavebeenstoredfortheintendedpurposeofdiagnosisandscreening.Theresearchercanuse thesesampleswithoutthepatientsconsentprovidedthesamplesarenotidentifiabletoherandtheprojecthasbeenapprovedbya (REC). 27.Oncetissueisreleasedfromadiagnosticarchiveforresearch,itmustbestoredonHTA-licensedpremises,unlessitisforaspecific projectapprovedbyaREC,orwhereanyoftheexceptionsdescribedinparagraphs55-72apply.Furtherinformationaboutdiagnostic archivesreleasingtissueforresearchisavailableontheHTAswebsite. 28.Onrareoccasions,tissuemayberemovedfromthelivingfortransplantationandnotused.Suchtissuecanbeusedforresearchwhere consentisinplaceforthatpurposeorthetissuewillnotbeidentifiabletotheresearcherandusedinaspecificprojectapprovedbya recognisedresearchethicscommittee. 29.Ifapersonhasmadeknowntheirobjectiontotheuseoftissueforpurposesotherthanmedicalcare,thisshouldberespected.

Accesstotissuefromthedeceased
30.Humantissueremovedfromthedeceasedmustonlyberetainedforuseinresearchifappropriateconsenthasbeengiven.Youcanfind moreinformationaboutappropriateconsentinthe codeofpracticeonConsent.SeealsothecodeofpracticeonPost-mortemexamination. 31.OncetissuefromthedeceasedisstoredforresearchitmustbeheldonHTA-licensedpremisesunlessitisbeingusedinaspecificproject approvedbyaREC(orwhereapprovalispending),orwhereanyoftheexceptionsdescribedin paragraphs55-72apply.

Fetaltissue

32.Whenundertakingresearchonfetaltissuetherearespecificconsiderationstotakeintoaccount.Formoreinformationrefertothe sectiononfetaltissueinthe codeofpracticeonConsent.

Consent
Obtainingconsent
33.Thegivingofconsentisapositiveact.TheHTActrequiresthatconsentmustbeobtainedfortheremoval,storageanduseofhuman tissueforcertainscheduledpurposes,includingresearchinconnectionwithdisorders,orthefunctioning,ofthehumanbody,subjecttothe exceptionssetoutbelow.

34.AlthoughtheHTActdealswithremovaloftissuefromthedeceased,consenttotreatmentandexaminationiscoveredbythecommon lawandtheMentalCapacityAct(MCAct)2005 www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1whereappropriate.Trustsshould havelocalpoliciesinplaceforobtainingconsenttotreatmentandthelegalpositionissetoutintheDepartmentofHealthsguidancewww.dh.gov.u www.dh.gov.uk/consent.GuidanceforhealthcareprofessionalsinWalesisavailableintheWelshAssemblyGovernmentsReferenceguideto consentforexaminationandtreatmentwww.wales.nhs.uk/consent.TheDepartmentofHealth,SocialServicesandPublicSafety(DHSSPS) (NorthernIreland)haspublisheditsownReferenceguidetoconsentforexamination,treatmentorcare www.dhsspsni.gov.uk/consent-referenceguide.pdf.

35.Notalladultswhosehumantissuemaybeusedinresearchhavethecapacitytoconsentthemselves.However,medicalresearch involvingadultswholackmentalcapacitycanleadtoinnovationsinhealthcarewhichcouldsubstantiallyimprovetheirhealthandqualityof life,andthatofotherswithsimilarconditions.Itisthereforeimportantthattheseadultsaregiventheopportunitytoparticipateinsuch research.However,certainsafeguardsneedtobeinplacetoensurethatthisvulnerablegroupareprotectedwhentheydoparticipatein research.Fordetailedinformationaboutmedicalresearchinvolvingadultswhocannotconsent,refertotheMRCEthicsguide www.mrc.ac.uk/Newspub www.mrc.ac.uk/Newspublications/Publications/Ethicsandguidance/index.htm andtheMCAct2005 www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1.ForinformationaboutthebroadprovisionsoftheMCActanditskeyprinciplessee thecodeofpracticeonConsent. 36.Subjecttotheexceptionsinthesectionbelow,consentmustbeobtainedfromhealthyvolunteers,forexample,employeesorstudents,to usetheirtissueforresearch. ExampleStudentsonasportssciencecoursearebeingaskedtogiveabloodsampleinordertotakepartinresearchintothelink betweenstressandexercise.Fortheconsenttobevalid,thestudentsmustbegivensufficientinformationsotheycangivetheir consentvoluntarily,havingmadeaninformedchoiceaboutwhethertheywanttoparticipateintheresearchornot.

Consentexceptions
37.TheconsentrequirementsoftheHTActarenotretrospective.ThismeansthatlegallyitisnotnecessarytoobtainconsentundertheHT Acttostoreoruseanexistingholdingforascheduledpurpose.Anexistingholdingismaterialfromthelivingordeceasedthatwasalready heldatthetimetheHTActcameintoforceon1September2006 www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_2. 38.Althoughthereisnostatutoryrequirementtoobtainconsentforstorageoruseoftissuethatisanexistingholding,itdoesnotmeanthat allsuchhumantissuecanbeusedfreelyandwithoutregardtoissuesofconsentorotherethicalconsiderations.Ifpractical,theconsentof theparticipantshouldbesoughtandtheviewsofthedeceasedpersonoroftheirfamily(ifknown)mustberespected.Inaddition,the potentialbenefitsoftheresearchshouldoutweighanypotentialharmtodonorsofthesamples. 39.Whateverthedatethetissuewasdonatedforresearch,ifmorethan100yearshaveelapsedsinceapersonsdeath,consentto undertakeresearchontheirtissueisnotrequiredundertheHTAct. 40.Intermsofresearch,theconsentprovisionsoftheHTActdonotapplytoimportedmaterial.However,theHTAconsidersitgoodpractice fortheretobemechanismsinplacetoprovideassurancethatthetissuehasbeenobtainedwithvalidconsent.Guidanceforthosewishingto importhumanbodies,bodypartsandtissuefromabroadintoEngland,WalesandNorthernIreland,issetoutinanotherHTAcodeof practice. 41.Thereisafurtherstatutoryconsentexceptionfortheuseandstorageofhumantissueforresearchwhereallofthefollowingcriteria apply: tissueisfromalivingperson;and theresearcherisnotinpossession,andnotlikelytocomeintopossessionofinformationthatidentifiesthepersonfromwhomithas come;and wherethematerialisusedforaspecificresearchprojectapprovedbyarecognisedresearchethicscommittee. 42.Theremaybeoccasionswhenaclinicianinvolvedinresearchmayalsohaveaccesstoasecuredatabasethatwouldpermitidentification ofasampleusedinresearchandtheidentityofthepatientwhosematerialisbeingused.Providingtheresearchmaterialisnotidentifiableto theresearcher(e.g.codedbyalaboratoryaccessionnumber)andtheresearcherdoesnotseektolinkthesampletothepatient,itwillstill beregardedasnon-identifiableandtheresearchwillbepermissiblewithoutconsentifapprovedbyarecognisedresearchethicscommittee. 43. TheHTAsremitdoesnotincludeethicalapprovalofresearchonhumantissue,whichmustbeappliedforusingtheguidanceprovided bytheNationalResearchEthicsService(NRES)www.nres.npsa.nhs.uk/rec-community/guidance/andtheGMC

bytheNationalResearchEthicsService(NRES)www.nres.npsa.nhs.uk/rec-community/guidance/andtheGMC www.gmc-uk.org/guidance/ethical_guidance/index.asp.Ethicalapprovalcanonlybegivenbyarecognisedresearchethicscommitteewhich iseither: aResearchEthicsCommittee(REC)establishedunderandoperatingtothestandardssetoutinthegovernancearrangementsissuedby theUKHealthDepartments www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727;or anethicscommitteerecognisedbyUnitedKingdomEthicsCommitteeAuthority(UKECA),toreviewclinicaltrialsofinvestigational medicinalproductsundertheMedicinesforHumanUse(ClinicalTrials)Regulations2004 www.opsi.gov.uk/si/si2004/20041031.htm. FurtherinformationaboutthelinkbetweenethicalapprovalandthelicensingandconsentexceptionsisprovidedinAppendixB.

44.ForthepurposesoftheHTAct,recognisedethicscommitteesincludeallRECswithintheResearchEthicsServicesofthefourUK countries(althoughtheHTAdoesnotlicensestorageoftissueforresearchinScotland)aswellastheethicscommitteesestablishedoutside theNHStoreviewPhase1clinicaltrialsinhealthyvolunteers.WithintheUKResearchEthicsServices,thetermfavourableopinionisusedto meanethicalapproval.DetailsofallrecognisedcommitteesandgeneralinformationaboutethicalapprovalcanbefoundontheNRESwebsite http://ww http://www.nres.npsa.nhs.uk/ . 45.Auniversityethicscommitteeisnot,forthepurposeoftheconsentexceptionconsideredtobearecognisedresearchethicscommittee. Therefore,consentisstillrequiredfortissuetobeusedinaresearchprojectapprovedbyauniversityethicscommittee,evenifitusestissue fromthelivingandtheresearcherisnotinpossession,andnotlikelytocomeintopossession,ofinformationidentifyingtheparticipant. 46.RecognisedRECswillacceptallapplicationsrelatingtoresearchinvolvingtheuseofhumantissueevenwherethisisconductedoutside theNHS. 47.Tofacilitatetheuseofvaluablehumantissueinresearch,theHTAadvises,inlinewiththeMRCandNRESthatconsentshouldbe genericbecausethisavoidstheneedtoobtainfurtherconsents.Itisstillimportanthoweverthatconsentisvalid.Iftheintentionistostore thetissueforanasyetunknownresearchpurposeoraspartofatissuebankforresearchthenthisshouldbeexplained,settingoutthe typesofresearchthatmaybeinvolved,anywiderimplicationsandthecircumstancesunderwhichthetissuewillbedisposedof. 48.ItisimportantforthoseinvolvedinresearchtobeawarethatinadditiontotheconsentprovisionsoftheHTActtheywillneedtoadhere tootherlegalrequirementssuchastheDataProtectionAct1998 www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1andthecommon lawdutyofconfidentiality.FormoreinformationrefertotheNationalInformationGovernanceBoardforHealthandSocialCare(NIGB) www.nigb.nhs.uk/.

Theoffenceofnon-consensualDNAanalysis
49.AlthoughtheHTAdoesnotlicenseestablishmentsinScotlandundertheHTAct,theoffenceofnon-consensualanalysisofDNAappliesto thewholeoftheUKincludingScotland. 50.DNA(asopposedtothebodilymaterialfromwhichitoriginates)isnotconsideredtoberelevantmaterialundertheHTAct. 51.Bodilymaterialdiffersfromrelevantmaterialasitincludeshairandnailsfromthelivingaswellasthedeceased.Italsoincludesgametes. 52.TheresultsofDNAanalysiscanbeusedforresearchwithoutconsent,providingthebodilymaterialfromwhichtheDNAisextracted: isfromalivingperson;and theresearcherisnotinpossession,andnotlikelytocomeintopossessionofinformationthatidentifiesthepersonfromwhomithas come;and thematerialisusedforaspecificresearchprojectwithrecognisedethicalapproval. 53.Althoughnooffencewillbecommittedinthissituation,theHTArecommendsthat,wherepractical,consentisobtained.Information aboutrecognisedresearchethicscommitteesisprovidedinparagraph43. 54.AnoffencewillbecommittedwheresomebodyhasbodilymaterialintendingtoanalyseitsDNAandusetheresultsforresearchwithout consentfornon-exceptedpurposes.Formoreinformationonexceptedpurposes,seethesectiononconsentanduseofDNAinthe codeof practiceonConsent. ExamplearesearcherisusingtheresultsofDNAanalysisextractedfromtissuebiopsiesfromlivingpeopleaspartofaresearch projectthathasbeenapprovedbyaREC.Theresearcherwillnotcomeintopossessionofanypatientidentifiableinformation.No offencewillbecommittedifconsentisnotobtained.

Licensing
55.Thissectionexplainswhere,inthecontextofresearch,alicencefromtheHTAisneededandwhereexceptionstolicensingrequirements apply. 56.ImportedtissuestoredforresearchshouldbetreatedinthesamewayastissueoriginatingfromparticipantsinEngland,Walesor NorthernIreland.Thismeansthatthesameexceptionstolicensingapply.(Seeparagraph40forinformationaboutimportedmaterialand consent.) 57.TheHTActdoesnotdefinethetermstorage.Neitherdoesitgiveanyminimumormaximumtermforstorageofhumantissuefor research.Therefore,theHTAconsidersstoragetobewhentissueiskeptforanyperiodoftimeforthepurposeofresearch,subjecttothe exceptionssetoutintheparagraphsbelow.TheHTAexpectsrelevantmaterialforresearchtobeheldunderthegovernanceofethical approvaloranHTAlicence.Wheretheethicalapprovalisnotbyarecognisedresearchethicscommittee,relevantmaterialshouldbeheld underthegovernanceofboth.Formoreinformationaboutrecognisedresearchethicscommitteesseeparagraph43. 58.Alicenceisnotrequiredtostorehumantissueforresearchifitisfromapersonwhodiedover100yearsago. 59.UndertheHTAct,wherehumantissueisinstoragependingtransferelsewhere,providingitisheldforamatterofhoursordaysand certainlynolongerthanaweek,theHTAtakestheviewthatthestorageisincidentaltotransportationandanHTAlicenceisnotrequired. ExampleSkinbiopsiesforuseinresearcharecollectedacrossanumberofsitesandbatchedbeforebeingsenttoanestablishment licensedbyHTAforstorageforresearch.Themultiplesitescollectingthebiopsiesdonotneedtobelicensedasthestorageispending transportationtoalicensedestablishment. 60.WherehumantissueisbeingheldwhilstitisprocessedwiththeintentiontoextractDNAorRNA,orothersubcellularcomponentsthat arenotrelevantmaterial(i.e.renderingthetissueacellular),theHTAviewsthisasanalogoustotheincidentaltotransportationexception.A licenceisnotthereforerequired,providingtheprocessingtakesamatterofhoursordaysandcertainlynolongerthanaweek. Example-Aresearcherwantstoundertakeastudylookingintoimmunologicalresponsestobreastcancer.Todothisclottedblood sampleswillbespundowntocollecttheserum.Asthebloodwillbespundownwithinamatterofdaysandanyresidualcellsdisposed oftoleaveserumthatisnotrelevantmaterial,theblooddoesnotneedtobestoredunderanHTAlicence. 61.Forthepurposeofresearchthatdoesnotinvolveanyapplicationoftissuesorcellsintohumans,materialthatiscreatedoutsidethe humanbodydoesnotfallundertheremitoftheHTA.Formoreinformationabouttheinterfacebetweenresearchandhumanapplication,see paragraphs7381. 62.Cellculturesarerelevantmaterialiftheycontaincellsthatwerecreatedinsidethehumanbodye.g.iftheculturecontainsoriginalcells fromabiopsyorbloodsample.Individualresearcherswillneedtomakeajudgmentastowhencellsinculturenolongercontainoriginalcells. 63.Inadditiontotheexceptionsabove,thereisabroaderexceptionsetoutintheHTAct2004(EthicalApproval,ExceptionsfromLicensing andSupplyofInformationaboutTransplants)Regulations2006(theRegulations)www.opsi.gov.uk/si/si2006/20061260.htm. 64.TheRegulationsallowhumantissueheldforaspecificresearchprojectapprovedbyarecognisedresearchethicscommittee(orwhere approvalispending)tobestoredonpremiseswithoutanHTAlicence.Formoreinformationaboutethicalapprovalbyrecognisedresearch ethicscommittees,see paragraph43. 65.Anapplicationforethicalapprovalispendingfromthepointithasbeensubmitteduntilthedecisionofthecommitteehasbeen communicatedtotheapplicant. 66.TheHTAadvisesresearcherstogainethicalapprovalbeforeembarkingonanyresearch.AnHTAlicenceshouldnotbeviewedasan alternativetoethicalapprovalbyarecognisedresearchethicscommittee. 67.Oncehumantissueisnolongerbeingusedforaprojectapprovedbyarecognisedresearchethicscommitteeoronewheresuchapproval ispending,itmustbestoredonHTA-licensedpremisesifitisintendedforascheduledpurpose.Whereitistobeusedforfurtherresearch thatdoesnothaveresearchethicscommitteeapproval,theresearchmustbeinaccordancewiththeinitialconsentobtainedor,if appropriate,furtherconsentshouldbeobtained. 68.SomespecificRECshavebeenauthorisedtogivebroadethicsapprovalforresearchtissuebankswhichwillthenberequiredtowork underNRESstandardoperatingprocedures(SOPs).Thismeansthataspecifiedremitofworkispermittedwithouttheneedforfurther individualprojectspecificapprovals.ThetissueintheseresearchtissuebanksmustbestoredonHTA-licensedpremises.

69.REC-approvedbankscanprovidehumantissuetoresearchers;therecipientsofthetissuedonotneedtostoreitunderanHTAlicence duringtheperiodoftheresearchproject,subjecttocertainrequirements.Iftheresearchisnotcarriedoutinaccordancewiththese requirements,specificprojectapprovalbyarecognisedresearchethicscommitteewillberequiredor,alternatively,thesampleswillneedto bestoredunderanHTAlicence.InformationabouttherequirementsgoverningthereleaseoftissuecanbefoundontheNRESwebsite www.nres.npsa www.nres.npsa.nhs.uk/ . 70.IftissueintheresearchtissuebankisstoredonHTA-licensedpremisesbutdoesnothavebroaderethicsapproval,eachresearcher acquiringhumantissuefromthebankmustapplytotheHTAforalicencetostorehumantissue,orapplyfortheirownspecificproject

acquiringhumantissuefromthebankmustapplytotheHTAforalicencetostorehumantissue,orapplyfortheirownspecificproject approvalbyaREC. 71.OncompletionofresearchusingtissuefromaREC-approvedresearchtissuebank,theindividualresearchermusttransferthetissueback tothebankortoanalternativeHTA-licensedestablishment;applyfortheirownHTAlicence;applyforspecificprojectapprovalbyaREC;or disposeofthehumantissue. Example---ADentalTeachingHospitalestablishesabankofhumanteethtocarryoutresearchintotootherosion,wearand hypersensitivity;andcontrolofdentalplaqueandstaining.Theteethwillbedonatedwithconsentfromthedonorafterroutinedental extraction.ThehospitalobtainsastoragelicencefromtheHTAaswellasethicalapprovalasaresearchtissuebank.Anindividual researcherreceivingteethfromthebankdoesnotneedtomakefurtherapplicationsforprojectspecificethicalapprovalorforanHTA licence,providedtheresearchprojectfallswithintheresearchaims,materialdisposalterms,andtermsofdonorconsentspecifiedinthe hospital'sresearchtissuebankethicsapproval.Inthisway,valuablehumantissueforresearchiscontrolledandmademoreaccessible toanumberofresearchprojects. 72.Tissuemayneedtobedisposedofbecause,forexampletheconsentdoesnotpermititsbroaduseforresearch,or(inrareinstances) consenthasbeenwithdrawn.SuchdisposalmustbeinaccordancewiththeguidancesetoutinthecodeofpracticeonDisposalofhuman tissue.Formoreinformationaboutthewithdrawalofconsentseethe codeofpracticeonConsent.

Interfacebetweenresearch,humanapplicationandclinicaltrials
Tissueandcells,includingstemcellsandcelllines
73.Theuseoftissuesandcellsinhumanapplicationandclinicaltrialsisarapidlydevelopingfield.Astheboundariesbetweenresearchand humanapplicationarecontinuallyshiftingthepotentialforcross-overbetweenthesectorsissignificant.Toensurethatyouareuptodate withtheregulatoryrequirements,youareadvisedtokeepabreastofinformationprovidedbytheHTAviathee-newsletterandwebsite. 74.Humantissueforresearchinvitroi.e.willnotbetransplantedintohumans(referredtoashumanapplication)mustbestoredunder anHTAlicence,subjecttotheexceptionssetoutinthelicensingsectionofthiscode.

75.Tissueorcells,includingcelllines,whichmaybetransplantedintohumans,evenwhereitisforresearch,mustbelicensedbytheHTA undertheHumanTissue(QualityandSafetyforHumanApplication)Regulations2007(Q&SRegulations)www.opsi.gov.uk/si/si2007/uksi_20071523 www.opsi.gov.uk/si/si2007/uksi_20071523_en_1.FordetailedinformationaboutthelicensingrequirementsseetheHTAswebsiteorcontacta memberofHTAstaff. 76.Tissuesandcellsfortransplantationintopatients,includingstemcellsandcelllines,areregulatedbythreeregulatorybodiesforhuman application: TheHumanFertilisationandEmbryologyAuthority(HFEA)www.hfea.gov.uk/regulatesthecreationanduseofembryosinthe derivationofembryonicstemcelllines.TheHFEAsremitceasesatthepointtheembryoisdissociated,atwhichpointtheHTAsremit begins. TheHTAregulatestheprocurement,testing,processing,storage,distributionandimport/exportoftissuesandcells,includingcell lines,intendedforhumanapplication. TheMedicinesandHealthcareProductsRegulatoryAgency(MHRA)www.mhra.gov.uk/index.htmregulateswhenacelltherapyis deemedtobeaMedicinalProduct(MP)orInvestigationalMedicinalProduct(IMP). 77.Researchersplanningtoworkwithtissueandcellswithareasonableexpectationthatthosecellswillbeusedinpatients,shouldcontact theMHRAforadecisionastowhethertheproductcouldbeaMPoranIMP. 78.TreatmentsclassedasMPsorIMPsareregulatedbytheHTAonlyforprocurementandtestingoftissue.Thesubsequentstepsare regulatedbytheMHRA.IfatreatmentcontaininghumantissueorcellsisnotconsideredanMPorIMPbytheMHRA,itwillberegulated entirelybytheHTAundertheQ&SRegulations. 79.TheHTAhasproducedstatementsinconjunctionwiththeMHRAandHFEAwhichexplaintheirregulatoryremitsinregulatingstemcells andAdvancedTherapyMedicinalProducts www.hta.gov.uk/guidance/licensing_guidance/atmp_regulation_and_quality_and_safety_regulations.cfm www.hta.gov.uk/guidance/licensing_guidance/atmp_regulation_and_quality_and_safety_regulations.cfm.Aregulatoryroutemapisalso availableontheHTAswebsite.

Clinicaltrials
80.Thestorageofhumantissueaspartofaclinicaltrial(wherethematerialitselfwillnotbeusedinhumanapplication)musttakeplaceon HTA-licensedpremises,subjecttotheexceptionssetoutinthelicensingsectionofthiscode. 81.EstablishmentsusingtissuesorcellsforhumanapplicationaspartofaclinicaltrialmustbelicensedundertheQ&SRegulations.Itis importanttonotethatwheretissueorcellsareusedforhumanapplicationaspartofaclinicaltrialapprovedbyaUKECA-recognisedethics committee,licensingundertheQ&SRegulationsstillapplies.

HTAstandards
82.InordertoobtainanHTAlicence,anestablishmentmustdemonstratethatitmeetsanumberofcorestandards.Theserelatetothe consentprovisionsoftheHTActandtheregulatoryrequirementsforgovernanceandqualitysystems,suitablepremisesandappropriate arrangementsfordisposal. 83.TheHTAundertakesinspectionofHTA-licensedestablishmentsandwillassessthesuitabilityoftheLicenceHolder(LH),theDI,the practicesandthepremisesduringtheseinspections. 84.ThecodesofpracticeonConsentandDisposalofhumantissueprovideadviceandguidanceonhowtomeettherequirementsofthe HTActandlicensingstandardsintheseparticularareas.GuidanceonunderstandingtherequirementsrelatingtotheHTAstandardson governanceandqualitysystemsandpremises,facilitiesandequipmentisprovidedbelow.

85.StorageofhumantissueforresearchmustbecarriedoutonpremiseslicensedbytheHTA(subjecttotheexceptionssetoutthe licensingsectionofthiscode).Thestoragemustalsobecarriedoutinaccordancewiththeconditionsofthelicence.Thepersonwith statutoryresponsibilityundertheHTActtheDIhasadutytoensurethatpeopleworkingunderthelicencearesuitableandthatthey followsuitablepractices.TheDImustalsoensurethattheconditionsofthelicencearebeingcompliedwith www.hta.gov.uk/licensing/designated_indiv www.hta.gov.uk/licensing/designated_individuals_and_licence_holders/dls_under_the_ht_act.cfm . 86.Tissuestoredforaspecificresearchprojectapprovedbyarecognisedresearchethicscommittee(seeparagraph43)doesnotneedtobe storedunderanHTAlicence.However,wheretheapprovalexpires,ornofurtherapprovalispending,legallythetissuemustbestoredunder anHTAlicence.

87.InordertoassessthesuitabilityoftheDIaswellasthepracticestakingplaceatanestablishmentandthepremisesonwhichtheytake place,theHTAhasdevelopedanumberofstandardswithwhichtheestablishmentmustcomply www.hta.gov.uk/guidance/licensing_guidance/expec www.hta.gov.uk/guidance/licensing_guidance/expected_standards.cfm .Thestandardsweredevelopedinconsultationwithrepresentatives fromtheresearchsector. 88.TheHTAstandardsaregroupedundertheheadings:Consent(C);Governanceandqualitysystems(GQS);Premises,facilitiesand equipment(PFE);andDisposal(D).

Governanceandqualitysystems
89.TheHTAstandardsongovernanceandqualityfocusontheestablishmentsinternalsystemsandprocessesthatareinplacetosupport staffinthedeliveryofhighqualityoutput. 90.Someestablishmentswillhavereviewedtheirworkingpracticesmorefrequentlythanothers.TheHTAregulatoryprocessencourages thoseinvolvedinresearchtoregularlyreviewtheirproceduresandmakeimprovementswhereareasofdeficiencyareidentified. 91.Theworkofthestaffattheestablishmentundertakingresearchmustbesubjecttoasystemofgovernance.Thismeansthatthere shouldbeclearreportinglinesandaccountability(particularlywithregardtotheindividualresearchersandtheDI),documentedrolesand responsibilities,asystemofstaffappraisal,andtraininganddevelopment. 92.AllstaffworkingundertheHTAlicenceshouldbeawareofthegovernancearrangementsinplace,andtheyshouldberepresentedat governancemeetings.EvidenceforHTAinspectionpurposescouldincludeteammeetingminutes. 93.Theremustbedocumentedpoliciesandprocedurescoveringallaspectsofactivityrelatingtothestorageofhumantissueforresearch; forexample,howtoobtainconsent.Theseshouldbeuptodate,subjecttoregularreviewandreflectiveofgoodpractice. 94.Allestablishmentsshouldidentifytherisksinherentinthekeyactivities,andproceduresshouldbedevelopedinconsiderationofandto mitigatethesepotentialriskswhereappropriate. 95.Riskassessmentsshouldbeundertakenbyasuitablytrainedpersonwhoisabletotakeanobjectiveview.Inanyevent,theresultsof riskassessmentsshouldbesharedwithstaffsothattheyhaveanunderstandingoftheissuesidentified. 96.TheHTAexpectsDIstobecommittedtoimprovingquality.Thiscouldbedemonstratedby,forexample,aprogrammetoaudithuman tissuestoredunderthelicence,andstaffbeinggiventraininganddevelopmentopportunitiestoupdatetheirskills. 97.AccesstoadviceandguidancefromorganisationssuchastheHTAwww.hta.gov.uk/,GMC www.gmc-uk.org/guidance/ethical_guidance/index.aspandNRESwww.nres.npsa.nhs.uk/rec-community/guidance/#useofhumantissue shouldbefreelyavailabletostaffworkingundertheHTAlicence,andthereshouldbeacommitmentfrommanagementtoprovidethemeans bywhichimprovementscanbemade. 98.Recordsmustbekeptthatdocumentconsentandallowtraceabilitytothetissuestoredforresearch.Theproceduresrelatingto record-keepingshouldreferencetheestablishmentssystemoflabellinghumantissueforresearch. 99.TheHTAstandardsrequireallhumantissuetobeuniquelyidentifiableinordertoensuretraceability. 100. Thesystemofrecord-keepingmustincludethelocationofhumantissuestoredunderthelicence(i.e.whichcupboard/fridge/freezer

itisstoredin)andthenameoftheresearcher.Therecordsmayincludeadescriptionofthetissue,theprojectitiscurrentlybeingusedfor andwhotheleadresearcheris,andwhetherconsentisspecificfortheprojectorforwideruseinresearch. 101. TheDImustbeawareoftheneedtoensurethesafetyofstaffundertakingresearch.Thisshouldbecoveredbyadocumentedrisk assessment. 102. AllestablishmentslicensedbytheHTAarerequiredtohaveaninternalsystemforreportingadverseeventsand,wherenecessary, instigatinganinvestigationorrootcauseanalysis.Inaresearchenvironment,thefocusmaybeonnon-compliancewiththeHTActandcodes ofpracticeordamagetothetissueintegrity;forexample,throughinappropriatestorage. 103. StaffworkingundertheHTAlicencemustunderstandwhatismeantbyanadverseeventandtheproceduretofollowwhensuchan eventoccurs.

Premises,facilitiesandequipment
104. TheHTAseekstoworkwithestablishmentsthroughitsinspectionprocess,tohelpthemmakeimprovementswheretheycanbemade, andtakesaproportionateandrisk-basedapproachwherescopeforimprovementhasbeenexhausted. 105. Premisesmustbefitforpurpose.Thismeansthatareasusedforstorageofhumantissueforuseinresearchmustprovidean environmentthatissafeforthoseworkingunderthelicenceandpreservestheintegrityofthetissue. 106. Humantissuemustbestoredinsuchawaythatitminimisestheriskofcontaminationtothoseworkingunderthelicence.Ifnecessary, theDIshouldworkwithhealthandsafetypersonneltoimplementenvironmentalcontrolsandappropriateequipmenttoreducetheriskof contamination. 107. TheDI,withtheadviceofhealthandsafetypersonnelwhereapplicable,mustalsoconsiderriskstothehumantissuesuchastheftor damage.Securitymeasuresshouldincludetheuseoflockablestoragefacilities,alarmsystemsandindelibleidentificationmarkingofhuman tissueifappropriate.Considerationshouldalsobegiventomitigatingdamagecausedbythehumantissuebeinghandledbythoseworking underthelicence.Forexample,storageenvironmentsmayrequirecontinuoustemperaturemonitoringandheatingandcoolingsystems. 108. Wherechemicalsareusedforpreservationofhumantissue,theareamustbeadequatelyventilatedtocontrolexposure.Controlof SubstancesHazardoustoHealth(COSHH) www.hse.gov.uk/coshh/requirestheexposureofformaldehydetobeminimisedandbelowthe maximumexposurelimit(2ppm).Thismayincludemonitoringoflevelsandcontinuousoperatingextractventilation. 109. Theestablishmentmustbeclean,wellmaintainedandsubjecttoaprogrammeofplannedpreventativemaintenance. 110. Ifapplicable,staffmusthaveaccesstotheprotectiveclothing,materialsandequipmenttheyneed.Equipmentmustberegularly maintainedtoensurethatitissuitableforuse.Equipmentshouldbemadeofmaterialthatiseasytoclean,impervious,non-rusting, non-decayingandnon-staining.Thereshouldbeasystemforrenewingitemsthatarenolongersuitablethroughwearandtear. 111. Ifapplicable,staffworkingunderthelicenceshouldbeawareofandhaveaccesstoguidancefromtheHealthandSafetyExecutive (HSE) www.hse.gov.uk/pubns/index.htmonsafeworkingandthepreventionofinfection. 112. Ifhumantissueistransferredbetweenestablishmentsconsiderationmustbegiventominimisingthelikelihoodoftheft,damageorloss duringtransport.Someformofformalarrangement,forexample,aspartofaMaterialTransferAgreements(MTA)shoulddefinehowthe humantissueispreserved,anypotentialcontaminationrisksassociatedwithitandwhoisresponsiblefordisposalifapplicable. 113. Theestablishmentmusthavecontingencyarrangementsinplaceshouldtherebeanemergencysituationthatrendersthepremises unusableforthestorageofhumantissueforresearch. 114. TheHTAexpectscompliancewithallitsstandards,evenifhumantissueistobeheldonlyforashortperiodoftimeorifonlyafew itemsareheldundertheauthorityofalicence.

115. TheHTAhaspublishedaguidetolicensingforDesignatedIndividualsandLicenceHolderswww.hta.gov.uk/licensing/designated_individuals_a www.hta.gov.uk/licensing/designated_individuals_and_licence_holders/dls_under_the_ht_act.cfmwhichsetsoutindetailthelicensing arrangementsundertheHTAct.IncludedisadescriptionoftheroleoftheDI,whichisoffundamentalimportancetotheHTActsschemeof regulatorycontrolandtheHTAslicensingframework.

AppendixA

AppendixB

References
Referencesarelistedintheorderinwhichtheyappearinthecode.Supplementaryreferencesareincludedattheend. HumanTissueAct2004 HumanTissue(Scotland)Act2006 HumanTissue(QualityandSafetyforHumanApplication)Regulations2007 HumanTissue(Scotland)Act2006:AguidetoitsimplicationsforNHSScotlandissuedon20July2006(Ref:NHSHDL(2006)46)) HTAcodesofpractice HTADirections GeneralMedicalCouncil(GMC)guidance MedicalResearchCouncil(MRC)publications NationalResearchEthicsService(NRES)guidance UKClinicalResearchcollaboration(UKCRC)guidance NationalInformationGovernanceBoardforHealthandSocialCare(NIGB) HTAguidetolicensingforDIsandLHs HTAdefinitionofrelevantmaterial MentalCapacityAct(MCAct)2005 DepartmentofHealthConsentguidance WelshAssemblyGovernmentReferenceguidetoConsentforexaminationortreatment DepartmentofHealth,SocialServicesandPublicSafety(DHSSPS)(NorthernIreland)ReferenceguidetoConsentforexamination,treatment orcare MedicalResearchCouncil(MRC)Ethicsguide DepartmentofHealthGovernancearrangementsforNHSResearchEthicsCommittees MedicinesforHumanUse(ClinicalTrials)Regulations2004 NationalResearchEthicsService(NRES) DataProtectionAct1988 TheHumanTissueAct2004(EthicalApproval,ExceptionsfromLicensingandSupplyofInformationaboutTransplants)Regulations2006 HumanFertilisationandEmbryologyAuthority(HFEA)website MedicinesandHealthcareproductsRegulatoryAgency(MHRA)website HTAinformationonATMPRegulationandQualityandSafetyRegulations HTAlicensingguidance HealthandSafetyExecutive(HSE)ControlofSubstancesHazardoustoHealth(COSHH)regulations HealthandSafetyExecutive(HSE)publications

Supplementaryreferences
WelshAssemblyGovernmentguidanceontheMentalCapacityAct2005

WelshAssemblyGovernmentConsentdocuments WelshLanguageAct E-learningcourseforDIs HTAsummaryinspectionreports HTAguidetoourkeymessages-whichexplainstheHTAsrolesandresponsibilities HTAe-newsletterwhichprovidesregularnewsandupdatesabouttheHTA'swork

Glossary
Altruisticnon-directeddonation:Aformoflivingdonationwherebyanorgan(usuallyakidney)orpartorgan(forexampleliverorlung lobe)isdonatedbyahealthypersonwhodoesnothavearelationshiptotherecipient. Appropriateconsent:DefinedintheHTActbyreferencetothepersonwhomaygiveconsent.Thisisbroadlyeithertheconsentofthe personconcerned,theirnominatedrepresentativeor(intheabsenceofeitherofthese)thatofapersoninaqualifyingrelationshiptothem immediatelybeforetheydied. Autologous:Cells,tissueororgansremovedfromandappliedortransplantedintothesameperson. Bestinterests: Atestofaperson'sbestintereststakesintoaccountnotonlythemedicalbutalsothewideremotional,psychologicaland socialaspectsofthepotentialprocedure,aswellastherisks. Bonemarrow:Thesoft,spongytissuefoundinthecentreofmostlargebonesthatproducesthecellularcomponentsofblood:whitecells, redcellsandplatelets. Cells: Individualhumancellsoracollectionofhumancellswhennotboundbyanyformofconnectivetissue.Forestablishmentslicensedfor humanapplicationthisincludescelllinesgrownoutsidethehumanbodybutnotgametes,embryosoutsidethehumanbody,orbloodand bloodcomponents. Directeddonation:Aformofdonationwhereahealthypersondonatesanorgan(usuallyakidney)orpartofanorgan(e.g.liverorlung lobe)toaspecificrecipient.Therecipientcouldbeknowntothedonor(inthecaseofgeneticallyoremotionallyrelateddonation)orunknown tothedonor(inthecaseofpaired/pooleddonation). Dominodonation:Aformoflivingdonationwhereanorganorpartorganisremovedfortheprimarypurposeofapersonsmedical treatment.Theorgan(s)removedmayprovesuitablefortransplantintoanotherperson(e.g.aheartoriginallyremovedfromtherecipientof aheartorlungtransplant). Donation: Theactofdonatinghumantissue,cells,organsorpartorgansforascheduledpurposeeitherduringlifeorafterdeath. Donor:Everyhumansource,whetherlivingordeceased,oftissue,cells,organsorpartorgans. Emotionallyrelateddonation:Wherethepotentialdonorhasarelationshipwiththepotentialrecipient,forexample,spouse,partneror closefriend. Geneticallyrelateddonation:Wherethepotentialdonorisgeneticallyrelatedtothepotentialrecipient. Heartbeatingdonors: Patientsdiagnosedwithbrainstemdeaththatcontinuetobeventilated.Thiskeepstheheartbeatingandblood circulatingafterdeath,untildonationtakesplace. Humanapplication:Inrelationtotissueorcells,meansuseonorinahumanrecipient,includinguseinapplicationssituatedoroccurring outsidethebody,butnotincludingusewhentissueandcellsareremovedfromandappliedinthesamepersonwithinthesamesurgical procedure. IndependentAssessor: ApersontrainedandaccreditedbytheHTAtoactasarepresentativeofboththedonorandtheHTAtoensure therelevantrequirementsoftheHTActandHTAct(PersonswhoLackCapacitytoConsentandTransplants)Regulations2006aremet,for certaintypesoflivingorgantransplantations. Intraperitonealcooling:Amethodofsurfacecoolingoforgansbyinfusingcoldfluidintotheabdominalcavitytoaidpreservationafter deathofthedonorforthepurposesoftransplantation. Licensing: AnumberofactivitiescanonlybecarriedoutwheretheestablishmentislicensedundertheHTActbytheHTA.Organisations whoseactivitiesinvolvetheremoval,storageoruseofrelevantmaterialmayneedtoworkunderanHTAlicence.Allestablishmentsworking underanHTAlicencemustworktospecifiedstandardssetbytheHTA. Licensedpremises:Wherethelicensedactivitytakesplace.Ifthelicensedactivitywilltakeplaceatmorethanoneplace,aseparatelicence willbeissuedforeachplace.Premisesindifferentstreetsorwithdifferentpostalcodesareconsideredasbeingindifferentplaces.In contrast,differentbuildingsonahospitalsitecouldberegardedasthesameplace. Livingdonor: Thepersondonatingtissue,cellsororgansfortransplantation.Themostcommonformsarelivekidneydonation(whereone kidneyisremoved),orlivebonemarrowdonation. Lymphocytes:Whitebloodcellsthatfightinfectionanddisease. Nominatedrepresentative: Apersonappointedtorepresentsomeoneaftertheirdeathwhoisempoweredtoconsenttotheremoval, storageanduseofthebodyortissueforanyofthescheduledpurposes,otherthananatomicalexaminationorpublicdisplay. Non-heartbeatingdonation: Aformofdonationincircumstanceswherethedeceaseddonorwasnotventilatedatthetimeofdeath.

Non-heartbeatingdonation: Aformofdonationincircumstanceswherethedeceaseddonorwasnotventilatedatthetimeofdeath. Donationthereforeoccursoncedeathiscertifiedfollowingcardiorespiratoryarrest(i.e.thedonorshearthasstoppedbeating).Thisis describedascontrolledwhentreatmenthasbeenactivelywithdrawnwithinahospitalsetting;oruncontrolledwhereapatienthas experiencedanunexpectedcardiacarrestfromwhichtheycannotberesuscitated. Organ:DefinedbytheHTAct(PersonswhoLackCapacitytoConsentandTransplants)Regulations2006.Adifferentiatedandvitalpartof thehumanbody,formedbydifferenttissues,thatmaintainsitsstructure,vascularisationandcapacitytodevelopphysiologicalfunctionswith animportantlevelofautonomy. OrganDonorRegister: Aconfidential,computeriseddatabasemanagedbyNHSBloodandTransplant(NHSBT),whichholdsdetailsof peoplewhohavesigneduptobecomeorgandonorsintheeventoftheirdeath.Theregisterisusedafterapersonhasdiedtohelpestablish whethertheywantedtodonateandifso,whichorgans. Paireddonation:Wherearelative,friendorpartnerisfitandabletodonateanorganbutisincompatiblewiththepotentialrecipient,and theyarematchedwithanotherdonorandrecipientinasimilarsituation,sothatbothpeopleinneedofatransplantreceiveacompatible organ. Parentalresponsibility:Apersonwhohasparentalresponsibilitywillusually,butnotalways,bethechildsparent.Thecategoryofpersons withparentalresponsibilityisassetoutintheChildrenAct1989. Partorgan:ForthepurposesoftheHTActandtheHTAct(PersonswhoLackCapacitytoConsentandTransplants)Regulations2006, materialispartofanorganifitistobeusedforthesamepurposeastheentireorganinthehumanbody. Perfusion:Amethodoftreatingorganstopreservethembeforetransplantation.Inthedeceaseddonorthiswilltakeplaceafterdeath,and inthelivingdonoraftertheorganhasbeenremoved. Pooleddonation:Aformofpaireddonationwherebythedonorandrecipientareincompatibleandsoarematchedwithotherdonorsand recipientsfromapoolofpairsinsimilarsituations.Morethantwodonorsandtworecipientsareinvolvedintheexchange,sothatmorethan twopeopleinneedofatransplantreceiveacompatibleorgan. Post-mortemexamination: Dissectionandexaminationofabodyafterdeath,principallyinordertodeterminethecauseofdeathorthe presenceofdiseaseprocesses.Ahospitalpost-mortemexaminationiscarriedoutwithappropriateconsenttogainafullerunderstandingof thedeceasedpersonsillnessorthecauseofdeath,andtoenhancefuturemedicalcare.Coronerspost-mortemexaminationsarecarriedout undertheauthorityofthecoronerandwithoutconsenttoassistcoronersincarryingouttheirfunctions. Processing: Alloperationsinvolvedinthepreparation,manipulation,preservationandpackagingoftissuesorcellsintendedforhuman application. Procurement:Theprocessesbywhichtissuesandcellsaremadeavailable,includingthephysicalactofremovingtissueandthedonor selectionandevaluation. Qualifyingrelationship:Person/swhocangiveconsentforthedeceasedpersonifthedeceasedpersonhasnotindicatedtheirconsentnor appointedanominatedrepresentative. Relevantmaterial: DefinedbytheHTActasmaterialotherthangametes,whichconsistsof,orincludes,humancells.IntheHTAct, referencestorelevantmaterialfromahumanbodydonotinclude:(a)embryosoutsidethehumanbody,or(b)hairandnailfromthebodyof alivingperson.SeepolicyguidanceonhowtoapplythisdefinitionontheHTAswebsite www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm. Research:Astudywhichaddressesclearlydefinedquestions,aimsandobjectivesinordertodiscoverandinterpretnewinformationorreach newunderstandingofthestructure,functionanddisordersofthehumanbody.Researchattemptstoderivenewknowledgeandincludes studiesthataimtogeneratehypotheses,aswellasstudiesthataimtotestthemordeveloppracticalapplicationsofnewknowledge. RecognisedResearchEthicsCommittee: aResearchEthicsCommittee(REC)establishedunderandoperatingtothestandardssetoutinthegovernancearrangementsissuedby theUKHealthDepartments www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727;or anethicscommitteerecognisedbyUnitedKingdomEthicsCommitteeAuthority(UKECA),toreviewclinicaltrialsofinvestigational medicinalproductsundertheMedicinesforHumanUse(ClinicalTrials)Regulations2004 www.opsi.gov.uk/si/si2004/20041031.htm. Scheduledpurposes:UndertheprovisionoftheHTActconsentmustbeobtainedtoremove,storeorusebodiesorrelevantmaterialfor scheduledpurposes.Thepurposesaredividedinto2parts: Part1:Purposesrequiringconsent:Generalanatomicalexamination;determiningthecauseofdeath;establishingafterapersonsdeaththe efficacyofanydrugorothertreatmentadministeredtohim;obtainingscientificormedicalinformationaboutalivingordeceasedperson whichmayberelevanttoanyotherperson(includingafutureperson);publicdisplay;researchinconnectionwithdisorders;orthe functioning;ofthehumanbody,transplantation. Part2:Purposesrequiringconsent:Deceasedpersonsclinicalaudit,educationortrainingrelatingtohumanhealth,performance

assessment,publichealthmonitoring,qualityassurance. Stemcell:Aprecursorcellthatcandevelopintomorethanonekindofcell.Forexample,earlybonemarrowcellscandevelopintoredblood cells,whitebloodcellsorplatelets. Tissue:Anyandallconstituentpart/softhehumanbodyformedbycells. Transplantation:Animplantofanorganorpartorgan,tissueorcellseitherfromandintothesamebodyorfromonepersontoanother. Transplantcoordinator:Apersonwhohelpsapotentialtransplantrecipienttounderstandthetransplantprocessandalsocoordinatesthe transplantevaluationbetweenthedialysisunit,transplantsurgeon,andtissuetypinglaboratory.Afteratransplantoperation,thetransplant coordinatorprovidesacommunicationlinkbetweentherecipientandthetransplantdoctorsforpost-transplantcare. Validconsent: Consentwhichhasbeengivenvoluntarily,byanappropriatelyinformedpersonwhohasthecapacitytoagreetotheactivity inquestion.