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January 2019 Research & Development Taighde & Forbairt Research Activity in the HSE and its Funded Organisations AM Terrés, MC O’Hara, P Fleming, N Cole, D O’Hanlon, P Manning A report of staff engaged in research, research studies undertaken, publication output and research networks

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Page 1: Research Activity in the HSE and its Funded Organisations · NUI Galway: National University of Ireland, Galway OLCHC: Our Lady’s Children’s Hospital, Crumlin ... , followed by

January 2019

Research & DevelopmentTaighde & Forbairt

Research Activity in the HSE and its Funded Organisations

AM Terrés, MC O’Hara, P Fleming, N Cole, D O’Hanlon, P Manning

A report of staff engaged in research, research studies undertaken, publication output and research networks

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Executive Summary 4

1. Introduction and Context 12

2. Methodology 14 2.1. Research Activity Indicators and Associated Datasets 15 2.2. Time periods 16 2.3. ClassificationMethodology 17

3. ActivityIndicator1:HealthServiceStaffinvolvedinResearch 18 3.1. SurveyofResearchActiveStaff 19 3.1.1.SurveyAnalysisbyPlaceofWork 19 3.1.2. Survey Analysis by Profession 21 3.1.3. Survey Analysis of EducationalQualifications 22 3.1.4. Survey Analysis of Researcher Competencies 24 3.1.5.SurveyAnalysisofResponsesfromStaffLinkedwithHEIs 27 3.1.6.SurveyAnalysisofTimeAvailabletoConductResearch 27 3.2. MedicalConsultantswithaFormalAcademicAppointment 29 3.2.1.DistributionofMedicalConsultantswithAcademicAppointmentsbyLocation 29 3.2.2.DistributionofConsultantswithaFormalAcademicAppointmentbyDiscipline 31

4. ActivityIndicator2:ResearchStudies 34 4.1. StudiesApprovedbyResearchEthicsCommitteesin2017 35 4.1.1.ResearchCategoriesandGeographicalDistribution 40 4.1.2.ResearchinPrimaryCareandGeneralPractice 43 4.2. HRBfundedStudieswithHealthcareProfessionalsasPIsorCo-PIin2017 44 4.2.1.HRBStudiesAwardedtoHCPsin2017 45 4.2.2.HRBstudiesawardedtoCFAAin2017 47 4.3. EUFundedStudiesinvolvingtheHSEin2017 48 4.4. RegulatedClinicalTrials(medicinalproducts)andInvestigations(medicaldevices) 48 4.4.1.RegulatedClinicalTrialsinIrelandin2017 49 4.4.2.ClinicalInvestigationofMedicalDevices 51 4.5. ResearchRelatedActivityintheThirdLevelSectorFundedbytheHSEin2017 52

5. ActivityIndicator3:ScopusIndexedPublications,2013-2017 56 5.1. AnalysisofPublicationNumberperYearfrom2013-2017 57 5.2. Analysisofoverallpublicationoutputbytopicandresearchactivitytype 59 5.3. AnalysisofPublicationsbyMedicalConsultantswithaFormalAcademicAppointment 63

6. ActivityIndicator4:ClinicalResearchNetworks 64 6.1. ClinicalTrialNetworks(CTNs) 65 6.2. CollaborativeClinicalResearchNetworks 69

7. Conclusions 70

Appendices 74Appendix1:UKHRCScategorydescriptions 75Appendix2:UKHRCSbyHSERegion 77Appendix3:ClinicalResearchFacilities(CRFs)andClinicalResearchCentres(CRCs) 78

Contents

Conte

nts

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CNOH: CappaghNationalOrthopaedicHospital

CT-IMP: ClinicalTrialofInvestigationalMedicinalProduct

CHO: CommunityHealthOrganisation

CFAA: Medicalconsultantwithaformalacademicappointment

CUH: CorkUniversityHospital

CHITIN: Cross-borderHealthcareInterventionTrialsinIrelandNetwork

CÚRAM: CentreforResearchinMedicalDevices

EEA: European Economic Area

EU: European Union

EudraCT: EUClinicalTrialsRegister

GUH: GalwayUniversityHospital

HCP: HealthcareProfessional

HEI: HigherEducationInstitution

HG: HospitalGroup

HPRA: HealthProductsRegulatoryAuthority

HR: HumanResources

HRCS: HealthResearchClassificationSystem

HSCP: HealthandSocialCareProfessional

HSE: HealthServiceExecutive

ICGP: IrishCollegeofGeneralPractitioners

ICHGCP: InternationalConferenceonHarmonisation,GoodClinicalPractice

IDSI: Infectious Diseases Society of Ireland

ISGE: IrishSocietyofGastroenterology

LUH: LetterkennyUniversityHospital

MUH: MayoUniversityHospital

MUH,Cork: MercyUniversityHospital,Cork

NMH: NationalMaternityHospital

NRH: NationalRehabilitationHospital

NSAI: National Standards Authority of Ireland

NUIGalway: NationalUniversityofIreland,Galway

OLCHC: OurLady’sChildren’sHospital,Crumlin

PI: PrincipalInvestigator

Glossary

2 Research Activity in the HSE and its Funded Organisations

Glo

ssary

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QUB: Queen’sUniversity,Belfast

R&D: Research and Development

REC: Research Ethics Committee

RCSI: RoyalCollegeofSurgeonsinIreland

RVEEH: RoyalVictoriaEyeandEarHospital

SJH: StJames’sHospital

SVUH: StVincent’sUniversityHospital

SFI: ScienceFoundationIreland

SUH: SligoUniversityHospital

TCD: TrinityCollegeDublin

TUH: TallaghtUniversityHospital

UCC: UniversityCollegeCork

UCD: UniversityCollegeDublin

UHL: UniversityHospitalLimerick

UL: UniversityofLimerick

ULH: UniversityofLimerickHospitals

AcknowledgementsSincerethankstoalltheinternalandexternalstakeholderswhocontributedwithdataandinformation,withoutwhichthecompilationofthisreportwouldnothavebeenpossible:theResearchOfficesfromthethirdleveleducationinstitutionsinIreland,theHealthResearchBoard,theResearchEthicsCommitteesintheHSEandassociatedorganisations,theHealthProductsRegulatoryAuthority,andallthestaffmemberswhoansweredtheResearchSurvey2018.

InparticularwewouldliketoacknowledgethesupportofDrVirginiaMinogueandourcolleaguesfromtheHSEHealthIntelligenceUnitandtheNationalLibraryandKnowledgeService,NiamhBrennanfromtheTrinityCollegeDublinLibrary,FionnualaKeanefromHRBClinicalResearchCoordinationIreland,andcolleaguesfromtheHealthProductsRegulatoryAuthority.

3Research Activity in the HSE and its Funded Organisations

Glo

ssary

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Executive Summary

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5

1 Numberofresponsesdividedbytotalnumberofstaffinthathospitalgroup.2 Numberofrespondentsdividedbytotalnumberofprofessionalsinthatcategory.

Exe

cutive

Sum

mary

ThisstudywascarriedoutinresponsetotheActionPlanforHealthResearch2009-2013,whichplacedontheHSEtheresponsibilityforestablishingabenchmarkofresearchactivityinthehealthserviceagainstwhichopportunitiescanbeidentified,effortscoordinatedandfutureresearchactivitymonitored.

ThisreportpresentstheresultsofsuchastudyasthefirstattempttobenchmarktheresearchactivitywithinthepublichealthandsocialcareservicesinIreland.Avarietyofdifferentaccessibledatasetswereusedasanindicationofresearchactivityandoutput.Theresultsaredescribedaroundfourmaincategories:staffinvolvedinresearch,researchstudiesundertaken,publicationoutputsandClinicalResearchNetworks.Theseindicatorsshowthatthevolumeofon-goingresearchissignificantandthatbroad experience and capability across a variety of domains currently exists.

Informationrelatedtostaffinvolvedinresearchwasexploredusingtwoapproaches:

1) Anationalsurveyofself-declaredresearchactivestaff

Thenationalresearchsurveyreceived1,904validresponsesfromstaffmemberswhoself-identifiedasbeingresearchactive.Itindicatedthat:

• Staffwereengagedinresearchinallareasoftheservice,includingacuteandcommunitysettings,aswellasnationalservicesandHSEcorporate,andmanywerealsolinkedtoacademia.

• Themajorityofrespondentswerebasedinhospitals(40%)andcommunity-basedhealthcareorganisations(31%).

• TheDublinMidlandsHospitalGroup(HG)wastheonewiththelargestpercentageofrespondentsfollowedbytheSouth/SouthWestHG.However,thelargestproportionalresponserate1wasfromtheNationalChildren’sHG,followedbytheDublinMidlandsHG.

• StafffromtheHealthandSocialCareProfessions(HSCPs)represented32%oftherespondents,followedbyNursingandMidwifery(21%)andMedicalDoctors(15%).Proportionally,theresponserate2fromMedicalDoctorswashighest.

• ThemajorityofHSCPrespondentswerecommunity-based,whilethemajorityofNursingandMidwiferyandMedicalDoctorrespondentswerebasedinacutehospitals.

– Themajorityofcommunity-basedrespondentswerebasedinCommunityHealthcareOrganisation(CHO)7coveringDublinWest,DublinSouthCity,DublinSouthWest,Kildare,andWestWicklow.

Activity Indicator

1Staff Involved in Research

Research Activity in the HSE and its Funded Organisations

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– 48%ofallNursingandMidwiferyrespondentshadamaster’sdegree.MedicalDoctorsandHSCPrespondentshadthehighestproportionofPhDs(23%and22%respectively).

– Themajorityofrespondentsengagedinindependentresearch(abletocarryoutresearchwithoutsupervision)belongedtotheMedicalDoctorcategory.

– NursingandMidwiferyrespondentsindicatedthattheyweremoreprominentlyinvolvedinenablingandassistinginresearchactivity,andasearlystageresearchers.

• 60%ofrespondentshadnoassociationwiththethirdlevelsector.Theremainder40%,indicatedanassociationwiththethirdlevelsector,eithercontractuallyboundornot.

• Themajorityofrespondentsspendbetween1and10hoursconductingresearchperweek.

• Themajorityofthosewhospendbetween11-20+hoursinresearchperweekwerelinkedtoanacademic institution.

2) Assessment of numbersanddistributionofconsultantswithacademicappointments,hence formally linked to the university sector and whose contract generally includes time for research:

• Fromatotalof2,700medicalconsultantsintheHSEandfundedhospitals,189hadaformaljointuniversityacademicappointmentin2018.Thisrepresents7%ofthetotalnumberofconsultantpostsemployed by model 4 and speciality hospitals.

• Thepercentageofclinicalstaffwithanadjunctorhonoraryappointmentsignificantlyoutnumbersthosewithaformalacademicappointment(approximately9:1).

• Atotalof21of50publichospitalsemployconsultantswithanacademicappointment.

• Themajorityofmedicalconsultantswithaformalacademicappointment(CFAA)belongedtotheRoyalCollegeofSurgeonsinIreland(RSCI)HG(n=42,22%),followedbythoseinDublinMidlandsHG(n=34,18%).

• ThehospitalwiththelargestnumberofconsultantswithanacademicappointmentwasGalwayUniversityHospital.

• ThemajorityofCFAAs(69%)arebasedinModel4hospitals.

• TheuniversitywiththelargestnumberofCFAAwasRCSI(25%),followedbyNUIGalway,UniversityCollegeDublin(UCD),TrinityCollegeDublin(TCD)andUniversityCollegeCork(UCC),rangingbetween16-19%.

• ThemajorityofCFAAweregeneralsurgeons(13%),followedbypsychiatrists(11%)andobstetriciansandgynaecologists(10%).ThesethreediscipleshaveadisproportionatelyhigherrepresentationofCFAAcomparedwiththenationalpicture.Theremaining27specialitieswereeachrepresentedbyfewerthan10%ofclinicians.

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Sum

mary

Research Activity in the HSE and its Funded Organisations

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Intheabsenceofanationalregisterforresearchprojectswithinthehealthservice,informationwasgatheredfromalternativesourcesincludingtheResearchEthicsCommittees(RECs),theHealthResearchBoard(HRB),theEUparticipantportal,theEuropeanClinicalTrialsRegister(EudraCT)andtheHealthProductsRegulatoryAuthority(HPRA)amongothers.

1) StudiesApprovedbyRECsin2017

• Atotalof32RECswereidentifiedintheHSEanditsfundedorganisations,allofwhichwereaskedforthetitlesofprojectsapprovedin2017forthepurposeofthisreport.

• Titleinformationwasreceivedfrom30outofthe32RECscontacted.Notitleinformationbuttotalnumberofproposalsapprovedin2017wasreceivedfromtheBeaumontREC.NodatawasreceivedfromtheDaughtersofCharityREC.

• ThemajorityofRECssubmittedinformationfor2017,but3(2ofthemwithverysmallnumbers)submittedinformationforadifferentyear.Inspiteofthisandgiventhesmallnumbers,webelievetheanalysis reasonably represents annual turnover overall.

• Thetotalnumberofstudyproposalapprovedbythe31outofthe30RECswas1,829.AsmanyofthestudiesinvolvedmultiplesitesandmaybereviewedbymorethanoneREC,thisnumberreflectsanundeterminedlevelofduplication,thereforethetotalnumberofprojectsreviewedbyRECsinoneyearwouldbelessthanthat.

• TheregionwiththelargestamountofRECsandofRECapprovalswastheEastRegion,withalmost678RECapprovalsin2017(involving20RECs),andfollowedcloselybytheSouthWestRegionwith525(reviewedbyasingleREC).

• Approximatelyone-quarterofallthe1,772studyproposalsreviewedbytheregionalRECswereofGenericHealthRelevance3,followedbyCancer,MentalHealth,ReproductiveHealthandChildbirth,CardiovascularandNeurologicalHealth.ThestudiesmostcommonlyinvolvedTreatmentEvaluationandHealthServicesResearch.

• Anationaltotalof75researchprojectsapprovedwerespecifictoprimarycare;57receivedbytheIrishCollegeofGeneralPractitioners(ICGP)and18bythePrimaryCareResearchCommittee.ThemajorityofthesewereofGenericHealthRelevanceandmostcommonlyinvolvingHealthServicesResearch.

7

3 GenericHealthrelevancereferstoresearchapplicabletoalldiseasesandconditionsortogeneralhealthandwellbeingofindividuals,publichealthresearch,epidemiologyandhealthservicesresearchthatisnotfocusedonspecificconditionsandunderpinningbiological,psychosocial,economicormethodologicalstudiesthatarenotspecifictoindividualdiseasesorconditions.

Exe

cutive

Sum

mary

Activity Indicator

2Research Studies Undertaken

Research Activity in the HSE and its Funded Organisations

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2) HRBFundedStudies

• Healthcareprofessionalswereinvolvedin45(38%)HRBawardsin2017,worthatotalof€44,610,3694.TheresearchtopicsmostoftenfundedwereGenericHealthRelevance,followedbyCancer,Neurological,MentalHealth,Cardiovascular,andReproductiveHealthandChildbirth.

• 23ofthesegrantswereawardedto18consultantswithajointacademicappointment.Thetotalamountoffundingreceivedbythiscohortamountedto€23,093,127;whichrepresents29%ofallHRBgrants,and52%ofallHRBgrantsawardedtohealthcareprofessionals.ThisincludesfundingforClinicalResearchFacilities.

3) EUResearchGrants

• ThereweresixEUresearchgrantsawardedin2017whichinvolvedtheHSEasapartner.Thetotalvalueofthese(toalltheEUprojectpartners)was€102,317,219,ofwhich€695,245wasawardedtotheHSE.Thenumbersofpartnersrangedfrom13to109andthemajorityofprojectstopicswereofGenericHealthRelevance.

• ThetotalvalueofEUresearchfundingreceivedbytheHSEinthelast10years(from2009to2019)is€2,019,069.56.

4) RegulatedClinicalTrials

• AccordingtotheEudraCTdatabase,atotalof27ClinicalTrialsofInvestigationalMedicinalProducts(CT-IMPs)startedinIrelandin2017,while70wereon-going.TheseareasmallpercentageofallRECapprovedstudies.AlmostallwerecommercialtrialsforthepurposeofTreatmentEvaluation(92%),and33%ofthoserelatedtoCancer.

• ThesefiguresaresignificantlylowerthanEuropeancountrieswithasimilarpopulation;DenmarkandFinland,whichhad365and180clinicaltrialsrespectivelyregisteredonEudraCTduringthesametime period.

• In2017,sevenclinicalinvestigationsofmedicaldeviceswereapprovedbytheHPRA.OnehadanIrishacademicsponsorandtheremainderwereindustrysponsored.Nearlyhalfofthemwereclinicalinvestigationsrelatedtodevicesforcardiovascularconditions.TheSaoltaUniversityHealthCareGroupwasthemostcommonhostfortheseclinicalinvestigations.ThismayberelatedtothefactthatCÚRAM,theScienceFoundationIreland(SFI)CentreforResearchinMedicalDevicesishostedinNUIGalway.

5) ResearchinthethirdlevelsectorfundedbytheHSEin2017

• In2017therewere56researchrelatedprojectscommissionedbytheHSEfromthirdlevelinstitutions.Thisrepresentedatotalspendof€6.5million;32%ofwhichwasawardedtoUCC.ThemajorityofstudieswereofGenericHealthRelevance(68%),andrelatedtoHealthServicesResearch(62%).

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4 Notefundingtoclinicalresearchfacilitiesisincludedinthisfigure.

Exe

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Sum

mary

Research Activity in the HSE and its Funded Organisations

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PublicationoutputwasmeasuredbythenumberofjournalarticlespublishedinScopusindexedjournals.

• ThetotalnumberofpublicationsfromHSEorganisationsandsection38hospitalsnationallyfrom2013to2017was13,466(thisincludestotalHSEHospitals,n=4,050;totalVoluntaryHospitals, n=8,934;andtotalCommunityandNon-Hospital,n=482)

• Publicationoutputhasincreasedslightlyyear-on-year,butcommunityandnon-hospitalresearchonlyaccountforbetween3to4%ofthetotaloutputeachyear.

• Thetotalnumberofjournalarticlespublishednationallyin2017was2,975.Thiswascomparabletothetotalpublicationoutput(alldisciplines)ofuniversitiessuchasTCDorUCDin2017(excludingpublicationoutputofuniversity-associatedinstitutions).

• StJames’sHospital(SJH)wasthehospitalwiththelargestpublicationoutputin2017,followedbyBeaumontHospitalandStVincent’sUniversityHospital(SVUH).

• DublinMidlandsHGandIrelandEastHGhadthehighestnumberofpublicationsbuttheChildren’sHGshowedthehighestpublicationratio(publicationoutputdividedbythetotalnumberofstaffin theHG).

• Asthemajorityofpublicationswerefromstaffaffiliatedwithhospitals,thedistributionoftheresearchtopicsatnationalandhospitallevelwereidentical:thetopresearchtopicswereGenericHealthRelevance5(17%),followedbyCancer(15%),Cardiovascular(9%),Neurological(8%)andReproductiveHealthandChildbirth(7%)research.TreatmentEvaluationrepresentednearlyhalfofthetotalresearchactivityofpublicationsin2017(43%),followedbyAetiology(27%),HealthServices(14%),DetectionandDiagnosis(8%)andDiseaseManagement(3%).

• Adifferentprofileofpublicationtopicswasobservedforcommunityandnon-hospitalbasedresearch,wherethemajorityofpublicationsrelatedtoMentalHealth(27.9%),followedbyGenericHealthRelevance(23%),Infection(10%),Cancer(7%)andNeurological(5%).TreatmentEvaluationrepresentedoverhalfofthetotalresearchactivityofpublicationsin2017(54%).

• Ofthetotal13,466articlespublishedbetween2013and2017withintheIrishpublichealthsystem,4,964(37%)werepublishedbyconsultantswithaformalacademicappointment.Thisindicatesthatthepublicationoutputofthiscohortisveryprolificastheyrepresentonly7%ofthetotalnumberofexistingconsultants.Italsoindicatesthat63%ofthepublicationoutputisproducedbystaffwithouta formal university appointment.

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5 GenericHealthrelevancereferstoresearchapplicabletoalldiseasesandconditionsortogeneralhealthandwellbeingofindividuals,publichealthresearch,epidemiologyandhealthservicesresearchthatisnotfocusedonspecificconditionsandunderpinningbiological,psychosocial,economicormethodologicalstudiesthatarenotspecifictoindividualdiseasesorconditions.

Exe

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Sum

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Activity Indicator

3Scopus Indexed Publications, 2013-2017

Research Activity in the HSE and its Funded Organisations

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Forthepurposeofthisreport,ClinicalResearchNetworksaredefinedasnetworksofclinicianswithaninterestinaparticulardiseaseortopicwhoaredevotedtotheimprovedcareofpatientsandhealthservicesthroughresearchinthatparticulartopic.ClinicalResearchNetworksindicatetheexistenceofacriticalmassofresearchactivityaroundaspecificdisease.Someofthesenetworksofteninvolveotheractorssuchasacademics,scientists,patients,professionalbodies,etc.Wedividedclinicalresearchnetworksintotwotypes:ClinicalTrialNetworks(focusedonclinicaltrialsofmedicinalproducts,clinicalinvestigationsofmedicaldevicesandotherclinicalresearchstudies)andCollaborativeClinicalResearchNetworks(focusedonimprovingunderstandingandthesharingofknowledgeandresearchexpertise).

ClinicalTrialNetworks

• WedefinedClinicalTrialNetworksasthosewithafocusonclinicaltrialsofmedicinalproducts,clinicalinvestigationsofmedicaldevicesandotherclinicalresearchstudies.

• Thereare10ClinicalTrialNetworksinIreland,manyofthemfundedbytheHRB,andtheseconductthevastmajorityoftrialactivityinIreland.

• Thereareanumberofnetworksandorganisationsthatsupporttheconductofmulticentreclinicaltrials(bothcommercialandacademic)acrossIreland,includingHRBClinicalResearchCoordinationIreland(HRB-CRCI),HRBTrialsMethodologyResearchNetwork(HRB-TMRN)andCancerTrialsIreland(CTI).

• Cross-borderHealthcareInterventionTrialsinIrelandNetwork(CHITIN)isanewcross-borderinitiativeaimedatpromotinghealthcareinterventiontrialstopreventandcureillness,andtopromoteimprovedhealthandwellbeinginNorthernIreland,IrelandandIrishcross-borderareas.

• Asper2018,therearesevenClinicalResearchFacilities/Centres(CRFs/Cs)jointlyassociatedwithuniversitiesandtheirassociateduniversityhospitals,and14OncologyClinicalTrialsUnitsassociatedwithCTI.

CollaborativeClinicalResearchNetworks

• CollaborativeClinicalResearchNetworksareclinician-ledandfocusonimprovingunderstandingandthesharingofknowledgeandresearchexpertise.Thisreporthighlightsfiveofthem,althoughthisisanon-exhaustivelist.

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Activity Indicator

4Clinical Research Networks

Research Activity in the HSE and its Funded Organisations

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In summary this study showsAsignificantpercentageofstaffintheHSEanditsfundedorganisationsareresearchactive,andtheoutputscannotbeunderestimated.Despitethefactthatresearchisbyandlargenotformallyembeddedwithintheprocessofservicedelivery,itisverymuchapartoftheon-goingactivityinthehealthandsocialcareservice,anditcannotbeignored.Thedatainthisstudyshowsthehugepotentialforimpactthatcouldbeleveragedbyaligningtheresearchactivitytoserviceneeds,inordertoobtainthemaximumbenefitforourhealthserviceandthehealthandwellbeingofourpatientsandthegeneralpopulation.

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Exe

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Sum

mary

1,904 Valid Survey responses

1,829 REC

approvals

51 Grant Awards

45 HRB

6 EU 2,975 Publications

34 HPRA Regulated studies

27 new clinical trials

7 new medical

device trials

Research Activity in the HSE and its Funded Organisations

Research Activity 2017

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1. Introduction and Context

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Healthresearchcontributestotheadvancementofscientificknowledgeandtheevidencebase.Theutilisationofthisevidenceisessentialtoimprovethehealthandwellbeingofpatients,toimprovehealthservicedeliveryandtheequityofhealthcareprovision.Evidencehasshownthatresearch-activeorganisationsdeliverbetterpatientoutcomes,includingreducedmortalityrates6andagrowingbodyofevidenceindicatesthathealthcareorganisationswithastrongresearchculturedeliverbettercare.Suchacultureisassociatedwithbetterorganisationalperformance,reducedstaffturnover,improvedpatientsatisfactionandimprovedorganisationalefficiency,andthesebenefitsgobeyondthoseexperienceddirectly by research participants.7Furthermore,theeconomicbenefitsofhealthresearchcannotbeunderestimated;abriefingdocumentpublishedin2014bytheWellcomeTrust8 in the UK indicates that eachpoundinvestedincancer-relatedresearchbythetaxpayerandcharitiesreturnsaround40pencetothe UK every year thereafter.

ResearchwillthereforebecentraltoachievingthedesiredreformoftheIrishhealthsystemoverthecomingyears,sincetransformationofthewayinwhichhealthcareisdelivered,managedandfinancedwillrequirehighqualityclinical,populationhealth,andhealthservicesresearch.

In2018theHSEestablishedtheHSEResearchandDevelopment(R&D)function.Thisnewfunctionaimstoascertainwhatisrequiredtoembedresearchaspartoftheculturalfabricofhealthservicedeliveryandtotakethestepstoensurethatthisbecomesarealityinthemediumtolong-termfuture.InordertoinformthefutureworkofthisfunctionandtodeliverononeoftheHSEobjectivesarticulatedintheGovernment’sActionPlanforHealthResearch2009-13,anassessmentoftheexistinglevelofresearchactivityintheHSEanditsfundedorganisationswascarriedout.Thiswillrepresentabenchmarkagainstwhichfutureprogresscanbemeasured.

Forthepurposeofthisreport,researchisdefinedinaccordancewiththeUKResearchGovernancePolicyFrameworkas“theattempttoderivegeneralisableortransferablenewknowledgetoanswerorrefinerelevantquestionswithscientificallysoundmethods”. It refers to research that takes place intheHSEanditsfundedorganisations,andthatinvolvestheirpatients,data,stafforinfrastructure.Thisincludes:

• activitiesthatarecarriedoutinpreparationfor,orasaconsequenceof,theinterventionalpartoftheresearch,suchasscreeningpotentialparticipantsforeligibility,obtainingparticipants’consentandpublishingresults,

• non-interventionalhealthandsocialcareresearch(i.e.studiesthatdonotinvolveanychangeinstandardtreatment,careorotherservices),

• studiesthataimtogeneratehypotheses,methodologicalresearch,anddescriptiveresearch,

• studieswhoseprimarypurposeiseducationaltotheresearcher,eitherinobtaininganeducationalqualificationorinotherwiseacquiringresearchskills,whichalsofallintothedefinitionofresearch.

Projectsthatarenotstrictlyresearchaccordingtothedefinition(e.g.standardserviceevaluations)areoftenreviewedandapprovedbyresearchethicscommitteesandpublished.Itwasthereforenotpossibletoexcludetheserelatedactivitiesfromsomeofthedatasetsandconsequentlysomeofthisactivityisincluded in the analysis presented in this report.

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6 OzdemirBA,KarthikesalinghamA,SinhaS,PolonieckiJD,HinchliffeRJ,ThompsonMM,GowerJD,BoazAandHoltPJE.ResearchActivityandtheAssociationwithMortality.PLOS ONE2015,10(2):e0118253.https://doi.org/10.1371/journal.pone.0118253

7 HardingK,LynchL,PorterJ,TaylorNF.Organisationalbenefitsofastrongresearchcultureinahealthservice:asystematicreview.Australian Health Review2016,41(1)45-53.https://doi.org/10.1071/AH15180.

8 The2014MedicalResearch:What’sitworth?StudybyRANDEurope,theHealthEconomicsResearchGroupatBrunelUniversityandKing’sCollegeLondon;andcommissionedbytheAcademyofMedicalSciences,CancerResearchUK,theDepartmentofHealthandtheWellcomeTrust.www.wellcome.ac.uk/economicbenefitscancer

1. Intro

ductio

n a

nd C

onte

xt

Research Activity in the HSE and its Funded Organisations

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2. Methodology

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2.1. Research Activity Indicators and Associated Datasets

InordertoassessresearchactivityintheHSEandassociatedorganisations,fourkeyactivityindicatorswereused:• staffinvolvedinresearch• researchstudiesundertaken• publicationoutputs• ClinicalResearchNetworks

Thelackofcomprehensivedatasetsanddifficultiesaccessingexistingdatasetsweresignificantimpedimentsforthisstudy.However,whiletheinformationavailablewaslimitedandimperfect,ithasenabledustopaintthefirstpictureofthiskindandhashighlightedthegapsininformationmanagementthatneedtobeaddressedtorepeatthisexerciseinthefutureinamoresubstantialway.Theproblemsencountered and alternative approaches used are outlined in Table 1.

Table1:Keyresearchactivityindicators

KeyActivityIndicator

Impediments Approach

Staff involved •Involvementinresearchisoftenapartialoccupation,notformallyrecordedaspartoftheHRprocessforthedifferenthealthservice professions.

•Full-timeresearchersarehiredunderotherHRgrades(i.e.Administration)andarethereforeimpossibletoquantifyusingHRsystems.

•AssociationofclinicalstaffwithuniversitiesviahonoraryoradjunctpositionsisnotformallytrackedbytheHSE.

•Anationalsurveywasusedtocapturedataonself-declaredresearchactivestaff.

•HRdatawasusedtoassessthenumbersofclinicalstaffwithformalacademic appointments.

Research Studies undertaken or commissioned

•Thehealthserviceisdeliveryfocused;researchactivityisnotmeasured,thereforeit is not systematically recorded: there are no national or local research information systems or protocols to record research activity.

•Fundedstudiesarenotregisteredinthefinancialsystemsasthefundingisgenerallymanagedbyexternalorganisations(i.e.universities,foundations,etc.).

•MostResearchEthicsCommitteesinthe health service provided information onresearchstudiesreviewed.

•TheHealthResearchBoardwasapproached for information on funded research studies that involved health servicestaffinaPrincipalor Co-principalInvestigatorcapacity.

•InformationonEUfundedstudiesinwhichtheHSEwasaparticipantwasobtained from the EU participant portal.

•ResearchOfficesinUniversitiesandHEIsprovidedinformationonHSEcommissioned studies.

•InformationonregulatedclinicaltrialsinIrelandwasobtainedfromtheEUClinical Trials Database.

•TheHPRAprovidedinformationonregulatedclinicalinvestigations.

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KeyActivityIndicator

Impediments Approach

Publication Output

•Somehealthprofessionalslinkedtouniversities publish their research outputs usingonlytheiruniversityaffiliation.

•Muchoftheresearchactivitydoesnotgetformallypublishedinpeer-reviewedpublications but rather in the form of reports published at local level. While some of these outputs are published in the LenusOpenAccessrepositoryoftheHSENationalHealthLibraryandKnowledgeService,itwasnotpossibletodetermineiftheseweretheresultofresearchactivityornot,andthereforecouldnotbeincludedinthis study.

•PublicationsindexedinScopuswereanalysedusingtheSciValanalysistool.These included all indexed publications (journalarticles,books,bookchapters,etc.).

•Publicationsofstaffwithaformalacademicappointmentwereavailablevia Scopus.

Clinical Research Networks

•Lackofspecificdefinitions.

•ManynetworksareassociatedwiththeUniversitysectorwithamoreacademicfocusmakingitdifficulttoclassifytheinformation available.

•InformationwasobtainedfromCRDIandtheHRB.Internetaccessibleinformationwasalsoobtainedandvalidated via telephone calls.

A further description of each dataset used is provided in each chapter.

2.2. Time periods

Whiletheoriginalintentionofthisstudywastoascertainresearchactivitywithinthelastfiveyearsthiswasgenerallynotpossibleduetothenatureofthedatasetsandthelimitationsofdataavailability.Thefollowingtime-periodswereanalysedforthedifferentindicators:

a) Staffinvolved:2018

• Surveyofstaffself-identifyingasbeinginvolvedinresearchasperJune2018.

• StaffwithaformalacademicappointmentasperFebruary2018.

b) Researchstudiesundertaken:2017

• Thedataavailablefromthedifferentdatasourceswasoriginallyavailablefordifferenttimeperiods.Inorder to simplify the information for this report and to use a consistent approach across the datasets toenablecomparisons,onlydatafor2017hasbeenincludedinthisstudy.

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c) Publicationoutput:2013-2017

• Publicationoutputwasanalysedforafiveyearperiod,from2013to2017.Thereisgenerallyatime-lapsebetweentheresearchbeingperformedandtheoutputbeingpublished;thereforeitisnotpossible to relate this dataset to any of the above.

• ToenableamorecomprehensiveunderstandingofthetypesofIrishhealthresearchbeingpublishedinScopus-indexedjournals,anin-depthclassificationandanalysisofthe2017publicationswasconducted.

d) ClinicalResearchNetworks:2018

• TheClinicalResearchNetworksidentifiedwereinexistenceasper2018.

2.3. Classification Methodology

Inordertoanalysethedatasetsassociatedwithresearchstudiesandpublicationoutputs,thedata wascategorisedusingtheUKHealthResearchClassificationSystem(HRCS)9 developed in 2005. Twodimensionsoftheframeworkwereusedforthisstudy:

• 21HealthCategories,denotingtheareaofhealthortypeofdiseasebeingstudied(e.g.cancer,mentalhealth,reproductivehealthandchildbirth,etc.).

• Eighttop-levelresearchactivitycodesdenotingthetypeofresearchbeingconducted(e.g.treatmentevaluation,healthservicesresearch,etc.).

ThismethodologyhasalsobeenusedbytheHealthResearchBoard(HRB)inIrelandtoclassifyHRBfunded research.10,11AdetailedbreakdownanddescriptionofthecategoriesisavailableinAppendix1.

17

9 HealthResearchClassificationSystem,February2018.MedicalResearchCouncilonbehalfoftheUKClinicalResearchCollaboration.ISBN978-0-903730-27-3.

10 CurranBandBarettR(2014).Outputs,outcomesandimpactsarisingfromtheHRB’s2000-09grantsportfolio.HealthResearchBoard,Dublin.

11 HineyM(2018).Astudyofactivityfrom2011to2015usingtheHealthResearchClassificationSystem.HealthResearchBoard,Dublin.

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3. Activity Indicator 1: Health Service Staff involved in Research

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Thefollowingsectionfocusesonthestaffconductingresearchwithinthepublichealthandsocialcareservice.ManyofthesewouldbethestaffmembersinvolvedintheresearchstudiesreferredtoinSection4,thoseresponsibleforpublishingtheoutputsreferredtoinSection5,andmembersofthenetworksdescribedinSection6.Thisactivityindicatorwasexploredbywayoftwoapproaches:

1.Analysisofinformationfromself-declaredresearchengagedstaffworkingintheHSEanditsfundedorganisations,whichwascapturedbywayofanationalsurveylaunchedinJune2018.Thesurveywasdistributedviaanumberofchannelsincludingemailbroadcastsandtargetedmailinglistsofprofessionalassociationsandnetworks,viasocialmediaandthroughtheHSEwebsite.

2.Analysisofinformationrelatedtomedicalconsultantswithauniversityacademicappointmentforthepurposeofresearchandteaching.

3.1. Survey of Research Active Staff

Atotalof1,920respondentscompletedthesurvey,but16indicatedthattheyworkedintheprivatehealthcaresector,sotheirresponseswereremovedfromthedataset.Theresultsbelowrepresentananalysis of the information provided by the 1,904respondents. It should be noted that the results must beinterpretedinthecontextofresponsestothesurvey,ratherthanasabsolutenumbers.

3.1.1. SurveyAnalysisbyPlaceofWork

The responses indicated that staffwereengagedinresearchinallareasoftheservice,includingtheacuteandcommunitysectors,aswellasnationalservicesandHSEcorporate,andmanywerealsolinkedtoacademia(Figure1).Respondentswereabletoselectmorethanoneplaceofwork,withsomeselectinguptosix.Intotal,11%indicatedmorethanoneplaceofwork.

Ofthe1,904respondents,40%workedinacutehospitals,31%workedinthecommunity,16%workedinnationalservices,programmesorHSEcorporate,19%workedinacademiaand3%inotherareasoftheservice(Figure1).

.

19

Figure 1: Place of work of respondents (indicated as number and percentage of the total sample)

Hospital Community National Academia Other

800

700

600

500

400

300

200

100

0

No.

of R

espo

nden

ts

HSEHospital

Corporate/NationalServices

CHO

Other

VoluntaryHospital

Academia

PrimaryCare/CommunityServices

4%27%

16%19%

3%

12%

28%

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Fromthesubsetofhospital-basedstaff,31%ofhospitalrespondentsworkedinvoluntaryhospitalsandtheremaining69%werebasedinHSEhospitals.Thismatchesthegeneraldistributionofpublichospitals,whereby32%(16outof50)arevoluntaryhospitals.Allhospitalgroups(HG)wererepresentedintheresponse(Figure2),andtheDublinMidlandsHospitalGroupwastheonewiththelargestpercentageofrespondents(26%).

Figure 2: Number (including percentage) of research active respondents from each hospital group

DublinMid Leinster

South/ South West

Saolta Ireland East ChildrensRCSI University Limerick

250

200

150

100

50

0

No.ofR

espo

nden

ts

26%

19%17%

13%10% 9%

7%

Hospitalgroupsvarygreatlyintheirsize(numberofhospitalspergroup,andnumberofstaffperhospital).Inordertomakeamoremeaningfulcomparison,thenumberofresponsesperhospitalgroupwasdividedbythetotalstaffnumberfromeachhospitalgroup,includingbothclinicalandnon-clinicalstafftocalculateresponserates.Fromthisperspective,thelargestproportionalresponseratewasfromtheNationalChildren’sHospitalGroup,followedbytheDublinMidlandsHospitalGroup.

AnalysisoftheCommunityHealthOrganisation(CHO)distributionofrespondentsindicatedthatthemajorityofrespondents(22%)wereinCHO7(Figure3).Aswithhospitalgroups,thegeographicalareaofCHOsaswellastheirtotalstaffnumber,variesgreatly.Again,inordertomakeamoremeaningfulcomparison,theresponseratewascalculatedasaratiobetweenthetotalnumberofresponsesperCHOandthetotalnumberofstaffineachCHO.ThisstillshowedthatthelargestproportionalresponseratewasinCHO7.

Figure 3: Percentage (including number) of respondents by CHO

CHO7 CHO9 CHO4 CHO2 CHO6 CHO3CHO8 CHO5 CHO1

25%

20%

15%

10%

5%

0%

Percen

tage

ofR

espo

nden

ts

261

176153

137

101 100 9673 71

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3.1.2. SurveyAnalysisbyProfession

Analysisbyprofession(Figure4)indicatedthatthemajorityoftherespondentsbelongtotheHealthandSocialCareprofessions12(32%)closelyfollowedbyNursingandMidwifery(21%)andMedicalDoctors(15%).

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Figure 5: Responce ratio (total number of respondents per category by total number of staff in that category) by profession

MedicalDoctor Nursing&Midwifery

HealthProfessionalCategory

HSCP

0.06

0.05

0.04

0.03

0.02

0.01

0RatioofN

o.ofR

espo

nden

tsto

No.ofS

taff

0.053

0.007 0.005

Figure 4: Percentage (including number) of respondents by profession

0% 5% 10% 15% 25% 35%20%

ResponseRates(%)

30%

Health&SocialCare

Nursing&Midwifery

MedicalDoctor

Researcher

Administration

Management

Other

Academic

Ambulance Service

HealthInformatics

Missing

608

395

277

167

166

99

74

51

25

24

18

Staffnumbersineachofthesecategoriesvarygreatlyatnationallevelhowever,sotheresultswerenormalisedbythetotalnumberofprofessionalspergroupfortheclinicalcategories(medical,nursing/midwiferyandHSCP)andthisindicatedthatmedicaldoctorswereoverwhelminglythemostresearchactive(Figure5).

12 HSCPreferstothe14designatedhealthandsocialcareprofessions:ClinicalBiochemist,Dietitian,DispensingOptician,MedicalScientist,OccupationalTherapist,Optometrist,Orthoptist,Physiotherapist,Podiatrist,Psychologist,Radiographer,SocialCareWorker,SocialWorker,SpeechandLanguageTherapist.

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Themajorityofdoctorsandnurse/midwiferyrespondentswerebasedinacutehospitals,whilethemajorityofHSCPsrespondentswerebasedincommunitysettings(Figure6).

Figure 6: Number (including percentage) of staff in research by profession and health service area (or location)

Health& Social Care

(655)

Nursing&Midwifery (431)

MedicalDoctor (343)

HealthcareProfessionalCategories

Researcher (184)

Management (106)

Administration (168)

300

250

200

150

100

50

0

No.ofR

espo

nden

ts

AcuteHospital National ServiceCommunity Academia Other

33%

51%

11%

13%26%

57%

43%

7%

23%

38%13%

30%

8%

18%

42%

33%10%19%

6%

13%

57%

13%3%

9%

3% 7% 8%1%

1%

3%

3.1.3. SurveyAnalysisofEducationalQualifications

Surveyrespondentswereaskedabouttheirhighestacademicqualification.Clinicalstaffcategories(medicaldoctor,HSCP,nursing/midwifery)hadhigherqualificationsthannon-clinicalstaff(Figure7).Thehighestmostcommonlyoccurringqualificationlevel,acrossthethreemainclinicalprofessionalgroupswasamaster’sdegree(Figure8),withthepercentageslistedrepresentingtheproportionofeachqualificationwithineachprofessionalgroup:48%ofallnursingandmidwiferyrespondentshadamaster’sdegree, and medicaldoctorsandHSCPsrespondentshadthehighestproportionofPhDs(23%and22%respectively).

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Figure 7: Number (including percentage which represents the proportion within the Clinical and Non-Clinical grouping) of respondents by highest qualification level

Masters Degree PhD Higher Diploma

MD Diploma Other Advanced /Higher

Cert

Leaving Cert

600

500

400

300

200

100

0

No.ofR

espo

nden

ts

29.1%

13.2%

11.7%

7.2%

3% 1.5%

1.3%

0.7%

0.3%

8.7%

4.3%

10%

1.7% 0%

2.4% 0.8%

1.6%

2.4%

HealthcareQualificationLevel

Clinical Non-Clinical

Figure 8: Percentage (including number) of clinical staff by highest qualification level

ResponseRates(%)

Highe

stQua

lifica

tionLe

velb

yHea

lthca

re

Professiona

lCateg

ory

4

17

0

56

51

50

20

1

8

1

1

0

99

20

190

73

24

64

Nursing&Midwifery

(396)

Medical Doctor (280)

6

0

14712

66

18281

134

Health& Social Care

(611)

Other

Degree Diploma

MD

LeavingCert

PhD

Advanced/HigherCert

Masters HigherDiploma

0% 5% 10% 15% 25% 40%35%20% 30% 45% 50%

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3.1.4. SurveyAnalysisofResearcherCompetencies

Respondentswereaskedtopickthedescriptionthatbestdescribedtheirresearchcompetenciesortheirinvolvement in research as indicated in Table 2.

Table2:Self-reportedresearchcompetencies

ResearcherCategory

ResearchCompetencies

Research Enabler

•Idonotactivelyparticipateinthecollection,analysisorreportingofdata

•Igenerateresearchideas,identifyresearchneedsandappropriatepeopletoundertakethisbodyofwork

•Ihavecontributedtodesignandresearchgrantapplicationswhenrequested

•Icommissionresearch

Research Assistant

•Icontributetoawiderresearchteambycarryingoutdatacollection

•Iorganiseaccesstodata

•Icleanandpreparedataforuseinanalysis

•Iconductliteraturesearches

Early stage researcher

•Icarryoutresearchundersupervision,demonstratingtheabilitytocollect,analyseand interpret data

•Icancriticallyevaluateandsynthesisenewinformation

•Ihaveexcellentcommunicationskillsandamabletocommunicatetheoutcomesofmy research

Experienced Research team member

•Idesignandimplementresearchstudies

•Ipresentmyresearchatconferenceseitherorallyorbyposter

•Imanagearesearchprojectandcontributetograntapplications

•Ihaveproducedasubstantialbodyofworkthatmeritspublicationinpeer-reviewedjournals

Independent researcher13

•Idesignandimplementresearchaspartofawiderresearchprogramme

•Iapplyforresearchgrants

•Imanageandsuperviseateamofresearchstaff

•Imentorresearchstaffandcontributetoarticlesinhigh-qualitypeer-reviewedjournals

•Ipresentresearchnationally/internationally

13 Independentresearchers,researchleadersorinternationalresearchleadersmaybecarryingontheirresearchactivityundertheauspicesoftheHSEorassociatedorganisationsuchasauniversity.

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ResearcherCategory

ResearchCompetencies

Research Leader

•Idesignandimplementasubstantialprogrammeofresearch,includingmanagementofaresearchteam,grantapplicationsandfinancialmanagement

•Ihaveatrackrecordofpublishinginhigh-qualitypeer-reviewedjournalsasfirstauthor and present research internationally

•Ihaveteachingexperiencebasedonmyownresearchwithatrackrecordofmentoringresearchstaff

•Ihaveathoroughunderstandingoftheresearchenvironmentnationallyandinternationally

International Research Leader

•Ihaveaninternationalreputationbasedonresearchexcellence

•Imakeasubstantialcontributiontomyfieldormultipleareas

•Iidentifyandexecuteresearchactivitiesandleadaresearchteam

•Irecognisethebroaderimplicationsofmyresearchandcontributetothestrategicvisionforfutureresearchinmyfield

•Ipublishandpresentinfluentialpapersandbooks,serveonconferenceorganisingcommittees and deliver invited talks

Thecategoriesofindependentresearcher,researchleaderandinternationalresearchleaderdescribestaffcapableofcarryingonresearchactivitywithoutsupervision(i.e.independentresearchactivity)and these three representedatotalof15%oftherespondents(Figure9).

Figure 9: Number (including percentage) of respondents by research competencies

Research Enabler

Research Assistant

EarlyStageResearcher

Experienced Research Team

Member

Research Leader

Independent Researcher

International Research Leader

400

350

300

250

200

150

100

50

0

No.ofR

espo

nden

ts

14%

12%

18%17%

6%

4%5%

TypeofResearchers

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RespondentsfromtheHSCPgrouparerepresentedacrossallcategories(Figure10),butarepredominantlyintheearlystageandexperiencedresearchteammembercategories,whilea total of11%ofHSCPrespondentsdescribethemselvesasbeingengagedinindependentresearchactivity (independentresearcher,researchleaderandinternationalresearchleader).Medicaldoctorswerealsorepresentedacrossallcategories,butwithmorerespondentsclassifyingthemselvesashavingthecompetenciesofaninternationalresearchleadercomparedwithHSCPsornurses.Intotal,42%ofmedicaldoctorrespondentsdescribedthemselvesasbeingengagedinindependentresearch. The response of nursesandmidwiferyprofessionalsindicatedthattheyweremorepredominantlyinvolved in enablingandassistingresearchactivity,andasearlystageresearchers.HSCPrespondentsweremorecommonlyintheearlystageresearcherandexperiencedresearchteammembercategories.

Figure 10: Number (including percentage which represents a proportion within the HSCP, Medical and Nursing groups) of respondents by type of researcher and profession (clinical types)

300

250

200

150

100

50

0

No.ofR

espo

nden

ts

Health&SocialCareProfessionals Nursing&MidwiferyMedicalDoctor

TypeofResearchersbyProfession

Research Enabler(176)

24%

15%

14%

Research Assistant (153)

24%

7%

14%

EarlyStageResearcher

(261)

32%

12%

28%

Experienced Research Team

Member (254)

13%

24%

32%

Independent Researcher

(71)

3%

15%

5%

Research Leader (43)

1%7%

4%

International Research Leader (68)

1%

20%

2%

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3.1.5. SurveyAnalysisofResponsesfromStafflinkedwithHEIs

Respondentswereaskediftheyheldapositionwithacademicinstitutions:60%indicatedthattheywerenotassociatedwithathirdlevelacademicinstitution,while40%indicatedanassociationwiththethirdlevelsector,eithercontractuallyboundornot. The types of activities carried out in the HigherEducationInstitutions(HEIs)aredescribedinFigure11.

3.1.6. SurveyAnalysisofTimeAvailabletoConductResearch

Thesurveysoughttodeterminehowmanyhours(inatypicalweek)respondentsspendonresearch(Figure12),andtheresultsshowedthatthevastmajorityofrespondentsspentbetweenoneand tenhoursperweekconductingresearchduringworkinghours(clinical14n=728,62%,non-clinical n=292,51%).

Figure 11: Percentage (including numbers) of respondents by their academic activities in HEIs

0% 5% 10% 15% 25% 35% 40% 45% 50%20%

Percentage

Acad

emicActivity

of

Respo

nden

tsin

Universities

30%

Tutor

Advisory

Board/Committee

Adjunct

Research

Teaching

16

53

83

164

359

376

Figure 12: Hours spent on research during the working week by the number of respondents (percentages represent proportion within the clinical or non-clinical grouping)

Zero 1 to 10 11to20+

800

700

600

500

400

300

200

100

0

No.ofR

espo

nden

ts

HoursSpentConductingResearchinWork(perweek)

Clinical Non-Clinical

27%

25%

62%

11% 24%

51%

14 ClinicalreferstoHSCP,medicaldoctorsandnursingandmidwiferyprofessionals.Non-clinicalreferstoallotherprofessions.

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Manyindicatedtheirinvolvementinresearchactivityoutsideofworkinghours.Ofthese,71%ofclinicalstaff(n=763)and63%ofnon-clinicalstaff(n=287)spentonetotenhours,while10%ofclinicalstaffreportedspendingbetween11andover20hoursconductingresearchafterformalworkinghours(Figure13).27%ofclinicalstaffand25%ofnon-clinicalstaffcarryoutresearchexclusivelyoutsideworkinghours.

Onlystaffmembersengagedinresearchwereaskedtoparticipateinthesurvey.Thereforeitisassumedthatthoseindicating“zero”duringworkinghourswereengagedinresearchoutsideworkinghours.

Furtheranalysisindicatedthatthemajorityofthosewhospendbetween11-20+hoursinresearchhadanacademiclink(Figure14).

Figure 13: Hours spent on research outside of working hours by the number of respondents (percentages represent proportion within the clinical or non-clinical grouping)

Figure 14: Hours spent on research inside and outside of working hours (percentages represent the proportion of respondents with and without an academic post)

Zero 1 to 10 11to20+

900

800

700

600

500

400

300

200

100

0

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

No.ofR

espo

nden

tsRespo

nseRate(%

)

HoursSpentConductingResearchOutsideWork(perweek)

Hours(perweek)

Clinical Non-Clinical

Hourswithinworkingday Hoursoutsideworkingday

Academic Post No Academic Post

19%32%

Zero

92

369

1 to 10

464559

11to20+

194

70

Zero

63

292

1 to 10

555

498

11to20+

7948

71%

10% 5%

63%

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3.2. Medical Consultants with a Formal Academic Appointment

Healthprofessionalsinvolvedinresearchoftenhavecloselinkswiththeuniversitysector.Someofthoselinkagesinvolveaformalcontractualacademicappointmentgenerallyforthepurposeofeducationand/orresearch(Section3.1.5).Ingeneral,staffmemberswithformalacademicappointmentshaveprotectedacademictime,fullaccesstosupportandresourcesofferedbythethirdlevelinstitution,andfurtheropportunities to establish academic collaborations.

Ontheotherhand,therearemanyotherhealthcarestaffwhoarenon-contractuallyengagedwithacademicinstitutions,butwhohaveadjunctorhonoraryconnections.Theseprovideformaluniversityacknowledgementoftheircontributionstoacademicactivities,recognisingthatmanycontributestronglydespitehavingnoprotectedacademictime,althoughtherangeofuniversitysupportsofferedtothiscohortvariesgreatly.

Theacademicaffiliation/sandkeydisciplineofmedicalconsultantswithacademicappointments(CFAA)asper2018wereanalysedinordertodeterminehowthesestaffaredistributedacrossclinicalsitesandhowthisvariesbyspeciality.Manymedicalconsultantswithaformalacademicappointmenthadappointmentswithmorethanonehospital.Forthepurposeofthereport,theanalysiswasbasedonthe principal clinical site and does not include vacant posts.

Unfortunately,dataonmedicalconsultantswithhonorary/adjunctacademicappointmentswasnotavailableornotprovidedtousbysomeoftheuniversities.However,informationreceivedfromtwouniversities[TrinityCollegeDublin(TCD)andUniversityofLimerick(UL)]seemstoindicatethat thepercentageofclinicalstaffwithanadjunctorhonoraryappointmentsignificantlyoutnumbersthosewithaformalacademicappointment(approximately9:1).

3.2.1. DistributionofMedicalConsultantswithAcademicAppointmentsby Location

In2018therewere189CFAAs.Atotalof21outof50publichospitals(42%)inIrelandemployconsultantswithanacademicappointment.ThebreakdownofCFAApostsbyhospitalgroup(basedonprincipalclinicalsite)isshowninFigure15(‘Other’indicatesanon-hospitalappointment).ThemajorityofCFAAsbelongedtotheRCSIhospitalgroup(n=42,22%),followedbytheDublinMidlandshospitalgroup(n=34,18%).Table3showsthebreakdownofdualappointmentsaccordingtohospitalwithinthevarioushospitalgroups.

FurtheranalysisindicatedthatthemajorityofCFAAs(69%)arebasedinModel4hospitals(hospitalsproviding24/7acutesurgery,acutemedicine,criticalcare,tertiarycareand,incertainlocations,supra-regionalcare).OftheUniversities,RoyalCollegeofSurgeonsIreland(RCSI)hadthelargernumberofCFAAposts(n=47,25%),withGalway(NUIG),UCD,TCDandUCChavingbetween16%and19% (n=30to34).

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Figure 15: Number (including %) of CFAA posts by Hospital Group (based on principle clinical site)

0 5 10 15 25 35 40 4520

No.ofCFAAposts

Hos

pitalG

roup

s

30

UL

Children’s

Other

Ireland East

South/SouthWest

Saolta

DublinMidlands

RCSI

11%

4%

4%

13%

14%

14%

18%

22%

Table3:DistributionofCFAApostsperHospitalGroupandHospitals(onlyhospitalswithCFAApostsareshown)

HospitalGroup Hospital No.ofCFAAposts

NationalChildren’s

OurLady'sChildren'sHospital,Crumlin 5

TempleStreetChildren'sUniversityHospital 3

IrelandEast MaterMisericordiaeUniversityHospitalDublin 11

StVincent'sUniversityHospital 9

RoyalVictoriaEye&EarHospital 2

CappaghNationalOrthopaedicHospital 1

Saolta GalwayUniversityHospital 27

PortiunculaUniversityHospital 1

DublinMidlands StJames'sHospital 21

TallaghtUniversityHospital 7

CoombeWomen&InfantsUniversityHospital 6

StLuke'sHospital,Rathgar 1

South/SouthWest CorkUniversityHospital 24

MercyUniversityHospital,Cork 2

RCSI BeaumontHospital 25

ConnollyHospital 11

RotundaHospital 6

UL UniversityHospitalLimerick 7

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ThenumberofCFAAswassubsequentlycomparedtothetotalnumberofconsultantpostsinthosehospitalswherejointpostsexist(i.e.HospitalsinTable3,excludinghospitalswherenodualappointmentsexists),anditwasnotedthatclinicianswithaformalacademicappointmentrepresentaverysmallproportion(7%)ofthetotalnumberofconsultantpostsinthehospitals.

3.2.2. DistributionofConsultantswithaFormalAcademicAppointmentby Discipline

ThedistributionofCFAAswasanalysedbyprimarydisciplineandasaproportionofnationaldistribution(seeTable4).Themajorityweregeneralsurgeons(13%),followedbythoseinpsychiatry(11%)andobstetricsandgynaecology(10%).ThetopthreedisciplinesweredisproportionatelyrepresentedbyCFAAscomparedwiththenationalpicture.Theremaining27specialitieswereeachrepresentedbyfewerthan10%ofclinicians.

Table4:DistributionofCFAAbydiscipline

Discipline CFAA %oftotalCFAA National%bydiscipline

General Surgeon 25 13% 6%

Psychiatry 20 11% 9%

Obstetrics and Gynaecology 18 10% 5%

Paediatrics 13 7% 4%

General Physician 11 6% 0%

Histopathology 11 6% 4%

Endocrinology and Diabetes Mellitus 10 5% 2%

Geriatrics 7 4% 4%

Microbiology 7 4% 2%

Anaesthesia 7 4% 13%

Respiratory 7 4% 2%

Gastroenterology 6 3% 2%

Infectious Diseases 5 3% 1%

Radiology 5 3% 9%

Haematology 4 2% 2%

Oral & Maxillofacial 4 2% 0.4%

Pharmacology & Therapeutics 4 2% 0.2%

Nephrology 4 2% 1%

Cardiology 3 2% 2%

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Discipline CFAA %oftotalCFAA National%bydiscipline

Otolaryngologist 3 2% 2%

Rheumatology 3 2% 1%

Ophthalmology 3 2% 1%

Emergency 2 1% 3%

Neonatology 2 1% 1%

Orthopaedic 1 1% 4%

Urology 1 1% 2%

Immunity 1 1% 0.3%

Genetics 1 1% 0.1%

Neurology 1 1% 2%

Radiation Oncologist 1 1% 1%

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7% of medical consultants have a joint

university academic appointment.

The majority of independent

researchers were doctors.

Doctors 15%Nursing 21% HSCPs 32%

Doctors & HSCPs have the highest

proportion of PhDs (23% & 22%).

1,904 valid survey responses.Majority of respondents

were hospital based (40%).

1 - 10 hours conducting researchper week.

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Research Activity in the HSE and its Funded Organisations

Survey Responses

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4. Activity Indicator 2: Research Studies

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Thefollowingsectionexploresthetypesandvolumeofresearchstudiesthattheresearchactivestaffreferredtoaboveareengagedin.DatawerereceivedfromavarietyofsourcesincludingResearchEthicsCommittees,theHealthResearchBoard,theEUparticipantportal,theEUclinicaltrialsdatabase,theHPRAandtheresearchofficesofthirdlevelinstitutions:

4.1 Studies Approved by Research Ethics Committees in 201715

Researchinvolvingpatients,eitherdirectlyorindirectly(e.g.concerningtheirbiologicalsamplesortheirdata),requiresethicalapproval.Muchoftheresearchtakingplaceinthehealthservice,therefore,requiresResearchEthicsCommittee(REC)approval.Intheabsenceofformalresearchprojectregistersinmosthospitals,communityhealthcareorganisationsandotherpartsofthehealthservice,theRECsrepresentauniquerepositoryofinformationaboutresearchactivity.

SomeRECsreviewproposalsforbothhospitalandCHObasedresearch,whileothers(mainlyintheDublinandsurroundingregion)reviewexclusivelyhospital-basedresearch.ThereisamisalignmentbetweentheregionalRECcatchmentareas(whicharebasedontheoldhealthboardregions),andtheHospitalGroupsandCHOs,soanalysisbyHospitalGrouporCHOareawasnotpossiblewiththedatareceived.Withtheexceptionofstudiesongeneralpractice(whichareapprovednationallybytheIrishCollegeofGeneralPractitionersREC),aregionalapproachtotheanalysiswasdeemedthemostadequategiventhenatureofthedatasets.Figure16indicatestheregionaldivisionusedfortheanalysis.Table5indicatestheRECsassociatedwitheachregionandthedatasettime-periodinquestion.Table6indicatesthecounties,hospitalsandCHOsectionscoveredbyeachRECregion.

Atotalof32committeesservingthehealthservicenationallywereidentified.TheseincludehospitalandHSEregionalRECsinadditiontoRECsinsection38/39organisations.All32RECswerecontactedtorequestinformationrelatedtotheprojecttitlesofresearchstudiesapprovedbythecommitteesduring2017.Thevastmajorityofcommitteesrespondedwithinformation(n=30,94%),althoughthreereportedinformationfrom2016(orearlier)ratherthan2017(Table5).BeaumontHospitalandDaughtersofCharityRECsdidnotsubmittitleinformation(Table5andTable6),thereforetheEastRegiondatasetisslightlyincomplete. The time period of the datasets used for the analysis is indicated in Table 5.

Notethateleven(outofatotalof12)oftheRECsthatsharedtheirinformationareapprovedbytheDepartmentofHealthtoreviewClinicalTrialsofInvestigationalMedicinalProducts(CT-IMP)atnationallevel.Astheoriginofthesestudiescouldnotbeidentifiedbythetitlealone,theanalysisindicatesregionalisationofRECapprovalratherthanregionalisationoftheactualresearchactivity.Furthermore,nonCT-IMPstudiesthatinvolvemultiplesitesrequiremultipleRECapprovals,thereforethenumbersincludeanundeterminedlevelofduplicationandhenceindicateapprovalsratherthanabsoluteprojectnumbers.

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15 See caveats in text related to dates of some datasets

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Figure 16: REC regions used for the analysis

Research Activity in the HSE and its Funded Organisations

Donegal

Sligo

Mayo

Galway

Roscommon

LeitrimCavan

Monaghan

Louth

MeathDublinNorth

DublinSouthKildare

Wicklow

Wexford

Carlow

Kilkenny

Waterford

Laois

Offaly

Westmeath

ClareTipperary

North

TipperarySouth

Limerick

CorkKerry

South/SouthWest

East

West/NorthWest

South East

MidWestern

Midlands

North East

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Table5:RECsapproachedforinformationperregionandtimeperiodofdatasetsupplied

Region AssociatedRECs Yearofdataincluded in Analysis16

Totalnumberofapprovalsper region

Midlands Region HSEMidlandsAreaREC17 2017 32Mid-Western Region #HSEMid-WesternArea&Universityof

LimerickHospitalGroupREC172017 157

South East Region #HSESouth-EasternAreaREC17 2017 72North East Region #HSENorthEastAreaREC17 2017 21South/South West Region

#ClinicalRECoftheCorkTeachingHospitals(CREC)atUCC18

2017 526

West/North West Region

SligoUniversityHospitalREC19 2017(n=43) 367MayoUniversityHospitalREC20 2017(n=31)LetterkennyUniversityHospitalREC20 2017(n=17)#GalwayUniversityHospitalREC19 June‘16–

Feb’17(n=276)East Region CappaghNationalOrthopaedicHospitalREC21 2017(n=9) 597

ConnollyHospitalREC21 2017(n=14)CoombeHospitalREC21 2017(n=30)Enable Ireland21 2016(n=2)#MaterMisericordiaeREC21 2017(n=34)NaasGeneralHospital21 2017(n=9)#NationalMaternityHospitalREC21 2017(n=36)NationalRehabilitationHospitalREC21 2013(n=4)#OurLady’sChildren’sHospital,CrumlinREC21 2017(n=83)RotundaHospitalREC21 2017(n=13)RoyalVictoriaEye&EarHospitalREC21 2017(n=11)StJohnofGod21 2017(n=24)StLuke’sHospital,RathgarREC21 2017(n=5)StMichael’sHouse21 2017(n=14)#St.Vincent’sHospitalREC21 2017(n=93)StewartsHospital21 2017(n=1)TempleStreetChildren’sHospitalREC21 2017(n=78)TUH/SJHJointREC21 2017(n=135)LauraLynn21 2017(n=2)^#BeaumontHospitalREC21 2017(n=78)*DaughtersofCharity21 *No data supplied.

#National REC for approvalofIMPclinical trials.

National #IrishCollegeofGeneralPractitionersREC 2017 57TOTALnumberofRECreviews(Note:someproposalsarereviewedbymorethanoneREC,hencethetotalnumberofprojectsis,therefore,lessthanthetotalnumberofreviews)

1,829

^Submittedtotalnumberofstudiesbutnofurtherdata,hencetheseprojectsarenotincludedinfurtheranalysis.* No data supplied. #NationalRECforapprovalofIMPclinicaltrials.16 SomeRECssubmitteddataindifferentyearperiodduetoadministrativecapacityconstraints.17 RegionalResearchEthicsCommittees:ReviewsHospitalandCHObasedresearch.18 UniversitybasedRECwhichreviewsHospitalsandCHObasedresearch.19 HospitalbasedRECswhichalsoreviewCHObasedresearch.20 HospitalbasedRECwhichreviewsHospitalbasedresearchonly(somereviewcommunityresearchoccasionally.21 CommunityServices(Section39)OrganisationREC.

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Table6:RECregionalcoverage(counties,hospitals,CHOorCHOsection)

RECs Counties Hospitals CHO

HSEMidlandsREC Longford,Westmeath,Offaly,Laois.

IrelandEastHGHospitals:

•MidlandRegionalHospitalMullingar

DublinMidlandsHGHospitals:

•MidlandRegionalHospitalPortlaoise

•MidlandRegionalHospitalTullamore

•NaasGeneralHospital

CHO8 (Laois,Offaly,Westmeath)

HSEMid-WesternAreaREC

Limerick,Clare,NorthTipperary.

UniversityLimerickHGHospitals:

•Mid-WesternRegionalHospital

•LimerickEnnisGeneralHospital

•NenaghGeneralHospital

•StJohn’sHospital

•LimerickMid-WesternRegionalMaternityHospital

•Mid-WesternRegionalOrthopaedic

CHO3

HSESouth-EasternAreaREC

Kilkenny,Wexford,Carlow,Waterford,South Tipperary.

IrelandEastHGHospitals:

•StLuke’sGeneralHospitalCarlowKilkenny

•WexfordGeneralHospital

South/SouthWestHGHospitals

•UniversityHospitalWaterford

•SouthTipperaryGeneralHospital

•LourdesOrthopaedicHospital,Kilcreene

CHO5

HSENorthEastAreaREC Monahan,Cavan,Louth,Meath

IrelandEastHGHospitals:

•OurLady’sHospital,Navan

RCSIHGHospitals:

•CavanandMonaghanHospital

•OurLadyofLourdesHospital,Drogheda

•LouthCountyHospitalDundalk

CHO1(CavanandMonahan)

CHO8(LouthandMeath)

Clinical REC of the Cork TeachingHospitals(CREC)atUCC

Cork,Kerry South/SouthWestHGhospitals:

•CorkUniversityHospital/CorkUniversityMaternityHospital

•UniversityHospitalKerry

•MercyUniversityHospital

•SouthInfirmaryVictoriaUniversityHospital

•BantryGeneralHospital

•MallowGeneralHospital

CHO4

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RECs Counties Hospitals CHO

SUHREC

MUHREC

LUHREC

GUHREC

Galway,Sligo,Mayo,Roscommon,Leitrim,Donegal

SaoltaHospitalGroup:

•GalwayUniversityHospital

•SligoUniversityHospital

•LetterkennyUniversityHospital

•MayoUniversityHospital

•MerlinParkUniversityHospital

•PortiunculaUniversityHospital

CHO1 (Donegal,Sligo,Leitrim)

CHO2 (Mayo,Roscommon,Galway)

RotundaHospitalREC

StLuke’sHospitalREC

RVEEHREC

NRHREC

TempleSt.Children’sHospitalREC

NMHREC

MaterMisericordiaeREC

TUH/SJHJointREC

CNOHREC

StewartsHospital

StMichaelsHouse

Enable Ireland

ConnollyHospitalREC

CoombeHospitalREC

BeaumontHosp.REC

OLCHCREC

SVUHREC

NaasGeneralHospitalREC

StJohnofGodREC

LauraLynnREC

DaughtersofCharityREC

Dublin,Wicklow&Kildare

RCSIHGHospitals:

•RotundaHospitalDublin

•ConnollyHospitalDublin

•BeaumontHospital

IrelandEastHGHospitals:

•MaterMisericordiaeUniversityHospitalDublin

•StMichael’sHospital,DunLaoghaire

•CappaghNationalOrthopaedicHospitalDublin

•RoyalVictoriaEyeandEarHospitalDublin

•NationalMaternityHospitalDublin

•StVincent’sUniversityHospitalDublin

•StColumcille’sHospitalLoughlinstown

DublinMidlandsHGhospitals:

•StJames’HospitalDublin

•StLuke’sRadiationOncologyNetwork

•TallaghtUniversityHospital

•TheCoombeWomen&InfantsUniversityHospital

•NaasGeneralHospital

Children’sHospitalGroup:

•OurLady’sChildren’sHospital,Crumlin

•TempleStreetChildren’sUniversityHospital

CHO6

CHO7

CHO9

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4.1.1. ResearchCategoriesandGeographicalDistribution

Thetitlesof1,772researchproposalsreviewedbytheRECsineachregion(projectsreviewedbyICGPRECnotincludedhereasithasnationalremit,seesection4.1.2)werecategorisedaccordingtotheUKHealthResearchClassificationsystem(UKHRCS)aspertheMethodologysection.ThisdatasetrepresentstotalstudiesreviewedbytheseRECsin2017(withsomeexceptions,seeTable5).TheEastregion,whichhas20outofthe32RECs,approved34%ofthetotalnumberofstudiesfollowedbytheSouth/SouthWestregion(1REC)andtheWest/NorthWestregion(4RECs)(Figure17).

GenericHealthRelevance accounted for almostaquarterofallstudiesapproved(Figure18).Thisreferstoresearchapplicabletoalldiseasesandconditionsortothegeneralhealthandwellbeingofindividuals,publichealthresearch,epidemiologyandhealthservicesresearchthatisnotfocusedonspecificconditionsorunderpinningbiological,psychosocial,economicormethodologicalelementsspecifictoindividualdiseases.

Cancer,MentalHealth,ReproductiveHealthandChildbirth,CardiovascularandNeurologicalwerethenextmostprevalentresearchactivitycategories(Figure18).AnalysisbyregionshowsasimilaremphasisonGenericHealthRelevancealthoughtheSouthEastshowedhigherratesofMental Health research,closelyfollowedbyMidlandsandNorthEastregions(Figure19,andAppendix2).

Figure 17: Number of proposals approved per region in 2017 or nearest year as indicated in Table 5

*ThedataforEastregionisslightlyincompleteasindicatedinTable5andTable6

0 100 200 300 500 700400

No.ofStudiesApproved

HSE

Reg

ion

600

EastRegion*

South/SouthWest

West/North-West

Mid-Western

South East

Midlands

North East

30%

34%

21%

9%

4%

2%

1%

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Figure 18: Percentage and numbers of REC approved studies for the six top health categories nationally

*DataforEastregionisslightlyincompleteasindicatedinTable5andTable6

0 5 10 2015

Percentage

UKHRCSTop6Hea

lthCateg

ories

25

Neurological

Cardiovascular

ReproductiveHealth& Childbirth

MentalHealth

Cancer

GenericHealthRelevance

119

126

147

180

180

394

Figure 19: Percentage and number of REC approved studies for the six top health categories per region Percentage and numbers

HSERegion

120

100

80

60

40

20

0

No.ofS

tudies

GenericHealthRelevance

Cancer Reproductive Health&Childbirth

MentalHealth Cardiovascular Neurological

18%

East

8%10%

8%6%

8%

24%

W/NW

9%5%

9%14%

4% 31%

Midlands

9%

28%3%

21%

S/SW

13%11%

9%4%

9%

19%

South East

17%7%

24% 3%6%

37%

Mid-Western

8%4%11% 8% 3%

29%

North East

10%14%

29%

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Furtheranalysisbyresearchactivitytype,indicatedthatTreatmentEvaluationwasthemostfrequenttypeofresearchactivity(36%).ThiswascloselyfollowedbystudiesrelatedtoHealthServicesResearch(25%)andAetiology(20%)(Figure20).

Researchactivityanalysisbyregionindicatesthatnationaldistributionisalignedwithregionaldistributionin the South/South-West,West/North-WestandEast,withtreatmentevaluation,healthservicesresearchandaetiologyaccountingforthelargestproportionofresearchactivity(Figure21).In the remainingregions(Figure22),healthservicesresearchaccountsforthemajorityofapprovedstudies,i.e.Mid-Western(50%),South-East(37%),Midlands(31%)andNorth-East(38%).

42

Figure 20: Percentage and number of studies classified by research activity in the overall sample

0% 5% 10% 15% 25% 40%35%20% 30%

Percentage

UKHRCSResea

rchAc

tivity

Cod

es Other

Detection and Diagnosis

Aetiology

HealthServices

Treatment Evaluation

179

163

356

438

636

Figure 21: Percentage and number of studies classified by type of research activity for the regions with more annual project throughput

HSERegion

300

250

200

150

100

50

0

No.ofS

tudies

42%

East

22%17%

9% 4% 2% 1%3% 1%

35%

S/SW

22%25%

8%5%

1%

2%1% 1%

37%

W/NW

18%26%

8%2%4% 1%2% 1%

Treatment Evaluation

Treatment Development Underpinning

Aetiology

Prevention

HealthServices

NA

DetectionandDiagnosis DiseaseManagement

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Figure 22: Percentage and number of studies classified by type of research activity for the regions with less annual project throughput

Figure 23: Percentage and number of studies by health categories from the ICGP and PCRC at national level

HSERegion

80

70

60

50

40

30

20

10

0

40

35

30

25

20

15

10

5

0

No.ofS

tudies

No.ofS

tudies

19%

Mid-West

50%7%

11%1% 6%

2%3% 1%

61%

ICGP

14%

7% 5% 4% 4% 2%2% 2%

56%

PCRC

6% 6% 6%22% 6%

19%

Midlands

31%9%

19%19%

3%

38%

SE

40%10%11% 11% 5%

NE

38% 29% 19% 10%

4.1.2. ResearchinPrimaryCareandGeneralPractice

NationaldatawerealsoreceivedforresearchstudiesinprimarycarefromthePrimaryCareResearchCommittee*(PCRC,n=18studiesin2017),andforresearchstudiesingeneralpracticefromtheIrishCollegeofGeneralPractitioners(ICGP)REC(n=57studiesin2017).ThevastmajorityofstudieswereofGenericHealthRelevancewith61%and56%forICGPandPCRCrespectively(Figure23).

Treatment Evaluation

Treatment Development Underpinning

Aetiology

Prevention

HealthServices

NA

DetectionandDiagnosis DiseaseManagement

GenericHealthRelevance

Nurological Ear

Cardiovascular

Skin Other Oral&Gastrointestinal Stroke

Infection

InflammatoryandImmuneSystem

MentalHealth

ReproductiveHealthandChildbirth

*NotethatthePCRCisnotaREC,butagovernancebodythatapprovesresearchprojectsforPrimaryCareintheCHOswhichhavepriorRECapproval.HencethestudiesinthePCRCsample(n=18)arealsoincludedintheanalysis of section 4.1.1.

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Analysisbyresearchactivityindicatedthatthemajorityofresearchactivityrelatedtohealthservicesresearch,accountingfor65%ofapprovedstudiesbyICGPand61%bythePCRC(Figure24).

Figure 24: Percentage and number of studies by research activity from the ICGP and PCRC at national level

UKHRCSResearchActivityCodes

40

35

30

25

20

15

10

5

0

No.ofS

tudies

65%

ICGP

26%

2% 2%

5%

61%

PCRC

17% 11% 6% 6%

HealthServices Treatment EvaluationUnderpinning DetectionandDiagnosis

AetiologyDiseaseManagement

4.2 HRB funded Studies with Healthcare Professionals as PIs or Co-PI in 2017

TheHealthResearchBoard(HRB)isastateagencyandthefundingarmoftheDepartmentofHealth.TheHRBfundshealthresearchtoprovideevidencetopreventillness,toimprovehealthandtocontributetowardsthetransformationofpatientcare.TheHRBhasanannualbudgetofover€45million,andmanagearesearchinvestmentportfolioofapproximately€200milliononanannualbasis.Tobeeligibleforfunding,arecipientmustbeaffiliatedwithapre-approvedorganisationthathasbeenawarded‘researchhostinstitution’status,withthecapacitytorobustlymanagetheassociatedfinancialreportingrequirements,andthemanagementofintellectualproperty.HospitalsandHSEfundedhealthcaredeliveryorganisationsdonotholdthestatusof“researchhostorganisation”andthereforecannotreceivedirectfundingfromtheHRB.HencefundingreceivedfromtheHRBforstudiesinvolvinghealthcarestaffisgenerallyawardedtotheuniversitysector.

TheHRBkindlyprovidedinformationaboutstudiesawardedoverthelastfiveyears.Inordertomaintainaconsistentapproachacrossthedifferentproject-relateddatasets,only2017dataarepresentedforthepurposeofthisreport.ThedatasetwasgeneratedthroughtheHRBgrantsapplicationsystem(GrantE-ManagementSystemknownasGEMS).ItidentifiedindividualslistedasgrantrecipientPrincipalInvestigators(PIs),Co-PIsorCo-Applicantswhohadindicatedthattheywerea‘healthprofessional’.WithinGEMS,ahealthprofessionalisanyonewitharecognisedqualificationchosenfromthefollowinglist(andincludesthosewithadualappointmentwithathirdlevelinstitute):

• Dentistry

• Dietetics/Nutrition

• Medical/SurgicalDoctor

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• NurseorMidwife

• ClinicalResearchNurse

• OccupationalTherapy

• Ophthalmology/VisualSciences

• PharmacyorPharmacology

• Physiotherapy

• Podiatrist/Chiropodist

• PsychologyorBehaviouralScience

• Radiography

• SocialCareorSocialServices

• SpeechandLanguageTherapy

Thedatasetincludesallawards,whicharemainlyprojecttypeawards,butalsoincludesfundingforHRBfundedClinicalResearchFacilities.

4.2.1. HRBStudiesAwardedtoHCPsin2017

During2017theHRBissuedatotalof118awardsworth€79,690,355(Figure25&Figure26).Ofthe 118awards,38%involvedhealthcareprofessionals(HCP)(n=45)inthecapacityofPI,Co-PIor Co-Applicant(Figure25),whichrepresented56%ofthefundingawarded(Figure26).

Figure 25: Number of HRB awards issued in 2017 for Healthcare Staff and Non-Healthcare Staff

Non-HealthcareStaff HealthcareStaff

80

70

60

50

40

30

20

10

0

No.ofH

RB-Fu

nded

Awards

StaffType

62%

38%

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Figure 26: Annual value of HRB awards issued in 2017, for Healthcare Staff and Non-Healthcare Staff

Non-HealthcareStaff HealthcareStaff

50,000,000

45,000,000

40,000,000

35,000,000

30,000,000

25,000,000

20,000,000

15,000,000

10,000,000

5,000,000

0

Annu

alValue

ofH

RB-Fu

nded

Awards

(€)

StaffType

€44,610,36956%

€35,079,98644%

AnalysisbyHRCSHealthCategoriescodes(Figure27)showedthatthetopfundedfocusareaswereGenericHealthRelevance(28%),Cancer(19%),Neurological(10%),andMentalhealth(9%).

Figure 27: Percentage and number of HRCS top 6 health categories for HRB funded research studies in 2017

0% 5% 10% 15% 25%20% 30%

Percentage

UKHRCSTop6Hea

lthCateg

ories Reproduction

Health&Childbirth

Cardiovascular

Mental

Neurological

Cancer

Generic

5

8

4

9

18

26

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Figure 28: Percentage and number of HRB-funded studies by health categories by CFAAs

0 1 2 3 54 6

No.ofStudies

UKHRCSHea

lthCateg

ories

Stroke

Respiratory

Eye

CongenitalDisorders

Cardiovascular

Cancer

Metabolic&Endocrine

Reproduction Health&Childbirth

GenericHealthRelevance

MentalHealth

Neurological

9%

13%

4%

13%

17%

22%

4%

4%

4%

4%

4%

4.2.2. HRBstudiesawardedtoCFAAsin2017

ThenumberofHRBawardsmadetomedicalconsultantswithaformalacademicappointment(CFAA)wassubsequentlyanalysed.Fromthe45HRBgrantsinvolvingHCPsin2017;23grantswereawardedto18CFAAs(fiveofthemreceivedtwoawards).

AsindicatedinSection3.2,therewereatotalof189CFAAsin2018.Ifweassumenomajorchangesinthenumberofthesepositionsbetween2017and2018,thisindicatesthatonly9.5%ofCFAAsareinreceiptofHRBfunding.Thetotalamountoffundingreceivedbythiscohortamountedto€23,093,127;whichrepresents29%ofallHRBgrants,and52%ofallHRBgrantsawardedtohealthcarestaff.

Thehealthcategoriesofthesestudiesawardedtothiscohortwerefurtheranalysed.GenericHealthRelevanceandMentalHealth(Figure28)werethetopcategories.ThisisconsistentwiththefactthatPsychiatryisoneofthetopdisciplinesforCFAAs(Section3.2.2,Table4).

Analysis by research activity area indicated that themajorityofstudiesrelatedtoAetiology(22%),TreatmentEvaluation(17%)andPrevention(17%).

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4.3. EU Funded Studies involving the HSE in 2017

ThemainresearchfundingvehicleoftheEuropeanCommissionistheHorizon2020programme.Thisprogramme(2014to2020)isthelargestEUresearchandinnovationprogrammetodate,withfundingofalmost€80billionbeingmadeavailable.TheprogrammeisbasedaroundpartnershipswithotherEuropeaninstitutionalcollaboratorsandindustry.Horizon2020fundshealthresearchundermanyoftheirdifferentprogrammes,inparticular,thecallsunderSocietalChallenges.

TheECalsofundshealthresearchviatheThirdHealthProgramme,whichisthemaininstrumentthattheCommissionusestoimplementtheEUHealthStrategy.Ittargetsinitiativestopromotehealth,topreventdiseases,andtofacilitateaccesstobetterandsaferhealthcare,amongothers.

InformationrelatedtoEUfundedstudiesinvolvingtheHSEwasobtainedfromtheEUparticipantportal.In2017thereweresixEUfundedstudiesinwhichtheHSEwasaprojectpartner.TheseincludedthreeHorizon2020awardsandthreefromtheThirdHealthProgramme.TheHSEparticipatedasapartner rather than as the coordinator in all studies.

EUfundedstudiesusuallyinvolveparticipantsfromseveralEUcountries,withthenumberofpartnersperstudyinthisdatasetrangingfrom13to109.Thetotalawardvalueofthesestudies(forallpartners)in2017was€102,317,219.Ofthis,€695,245wasawardedtotheHSEin2017.The total value of EU researchfundingreceivedbytheHSEinthelast10years(from2009to2019)is€2,019,069.56.

ClassificationusingtheUKHealthResearchclassificationsystemshowedthatthemajorityofstudieswereofGenericHealthRelevance(n=4,67%),andtheremainderrelatedtoEnvironmentalHealth(n=2,33%).

4.4. Regulated Clinical Trials (medicinal products) and Clinical Investigations (medical devices)

HealthProductsRegulatoryAuthority(HPRA)regulatedclinicalresearchfallsintotwocategories:clinicaltrialsofinvestigationalmedicinalproducts(CT-IMP)andclinicalinvestigationsofmedicaldevices.22 In Ireland,theHPRAisdesignatedastheCompetentAuthorityfortheirregulationandensurescompliancewiththeEUlegislation[EuropeanCommunities(ClinicalTrialsonMedicinalProductsforHumanUse)Regulations,2004,transposedintoIrishlawthroughSINo190of2004].23

Forthepurposeofthisreport,thetermClinicalTrialisusedasdefinedinthelegislation(SINo190of2004);anyinvestigationinhumansubjects,otherthananon-interventionaltrial,intendedto:

a) Discoverorverifytheclinical,pharmacologicalorotherpharmacodynamiceffectsofoneormoreinvestigationalmedicinalproducts,or

b) Identifyanyadversereactionstooneormoresuchinvestigationalmedicinalproducts,or

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22 https://www.hpra.ie/23 S.I.No.190/2004-EuropeanCommunities(ClinicalTrialsonMedicinalProductsForHumanUse)Regulations,2004.Available

onhttp://www.irishstatutebook.ie/eli/2004/si/190/made/en/print.AccessedonDecember06,2018.

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c) Studyabsorption,distribution,metabolismandexcretionofoneormoresuchinvestigationalmedicinalproducts,or

d) Discover,verify,identifyorstudyanycombinationofthemattersreferredtoatsubparagraphs(a),(b),and(c),withtheobjectofascertainingthesafetyorefficacyofsuchproducts,orboth.

RegulatedclinicaltrialsarealsosubjecttotheguidanceofICHGCP(InternationalConferenceonHarmonisation-GoodClinicalPractice)andtheDeclarationofHelsinki.InadditiontoHPRAapproval,clinicaltrialsmustalsobeapprovedbyadesignatedResearchEthicsCommittee(REC).Therearecurrently12ResearchEthicsCommittees(REC)inIrelandrecognisedandauthorisedbytheDepartmentofHealthtoconsideranapplicationforIMPclinicaltrials.24

TheothermaintypeofregulatedstudyisaClinicalInvestigationofaMedicalDevice. These are alsoregulatedbyEUlawwhichwasenactedinApril2017.25TheseareregulatedbytheHPRAandtheNationalStandardsAuthorityofIreland(NSAI)Regulations,andalsorequireethicalapproval.Themedicaldevicesregulationoverlapsinmanyareaswiththeclinicaltrialsregulations,butunlikethose,thereisnoprovisionforasinglenationalethicsopinionformulti-siteregulatedClinicalInvestigations.

Regulatedstudiesrequireasponsor,whichisapersonorentitythattakesresponsibilityfortheinitiation,managementand/orfinancingofthestudy.ThesponsordoesnotneedtobelocatedinanEUMemberStatebutmusthavealegalrepresentativeintheEEA.Theinvestigatorandthesponsormaybethesameperson,andthesponsormaydelegateanyorallofhistrial-relateddutiesandfunctionstoanotherpersonororganisation.Thesponsorremainsresponsibleforensuringthattheconductofthetrialandthedatageneratedcomplywithallrelevantregulations.

4.4.1. RegulatedClinicalTrialsinIrelandin2017

InformationaboutIrishRegulatedClinicalTrialsisavailableintheEUClinicalTrialsRegister(EudraCT).ThisregistercontainsinformationonauthorisedinterventionalclinicaltrialsofmedicinesconductedintheEuropeanUnion(EU),ortheEuropeanEconomicArea(EEA),afterMay01,2004.TheRegistercontainsPhaseII-IVclinicaltrialsonadultsandpaediatricpopulationsconductedintheEU/EEA,andregistrationonthisregisteriscompulsoryforallsuchregulatedtrials.

Studiesareregisteredbythestudysponsor,andthedatabaseisusedbytheHPRAfordatarelatedtoclinicaltrialprotocols.TheHPRAaddstheauthorisationonlywhenafavourableethicscommitteeopinionis provided by the sponsor. Whilethesponsorsare,inmanycases,pharmaceuticalcompanies,organisationssuchasCancerTrialsIreland(CTI),HRBClinicalResearchCoordinatorIreland(HRB-CRCI)haveakeyroleincoordinatingandsupportingthesetrials.Inaddition,someuniversitiescanalsotaketheroleofsponsor.

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24 ResearchEthicsCommitteesinIrelandrecognisedtoconsiderapplicationsforclinicaltrials.DepartmentofHealth2012.25 Regulation(EU)2017/745oftheEuropeanParliamentandoftheCouncilof5April2017onmedicaldevices,amending

Directive2001/83/EC,Regulation(EC)No178/2002andRegulation(EC)No1223/2009andrepealingCouncilDirectives90/385/EECand93/42/EEC.

Regulation(EU)2017/746oftheEuropeanParliamentandoftheCouncilof5April2017oninvitrodiagnosticmedicaldevicesandrepealingDirective98/79/ECandCommissionDecision2010/227/EU.

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Forthepurposeofthisstudy,theEUclinicaltrialsdatabasewassearchedforclinicaltrialsthatwereconductedinIrelandin2017(thosewhichhadbeenauthorisedbytheHPRAandforwhichtheHPRAhavereceivedconfirmationofRECapproval).

AccordingtotheinformationinEudraCT,27clinicaltrialswithanIrishsitelocationwererecordedashavingastartdate(thedatethestudywasauthorisedtoproceed)in2017.Therewereanadditional70clinicaltrialsidentifiedas‘on-going’withanIrishsitelocation.All97clinicaltrialshavebeenapprovedbytheHPRA.Thesefiguresaresignificantlylowerthancountrieswithasimilarpopulation;DenmarkandFinland,whichhad365and180clinicaltrialsrespectivelyregisteredonEudraCTduringthesametimeperiod.

ThemajorityoftheseIrishclinicaltrialsweresponsoredbyindustry(n=24,89%).AbbVieDeutschlandGmbH&Co.KGandAimmuneTherapeutics,Inc.,werethemostcommonsponsor,withthree trials each. Theremainingthreenon-industrysponsoredtrialsweresponsoredbyaforeignuniversity,anIrishhospitalandaHSEcommunityarea.

AccordingtotheUKHRCScategories,themajority(n=9,33%)oftheseclinicaltrialswererelatedtoCancerand15%(n=4)wererelatedtoInflammatoryandImmunediseases(Figure29).

TreatmentEvaluationrepresented92.6%(n=25),whileDiseaseManagement(n=1,3.7%)andTreatmentDevelopment(n=1,3.7%)accountedfortheremainder.

Figure 29: Percentage and number of Irish clinical trials by the six most frequent HRCS health categories on the EudraCT

0% 5% 10% 15% 25%20% 35%30%

Percentage

UKHRCSTop6Hea

lthCateg

ories Neurology

Infection

CongenitalDisorders

Cardiovascular

Inflammatory&Immune

Cancer

2

2

2

2

4

9

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4.4.2. ClinicalInvestigationofMedicalDevices

InformationrelatedtoapprovedclinicalinvestigationsofmedicaldevicesduringthesametimeperiodwasprovidedbytheHPRA.In2017thereweresevenclinicalinvestigationsofmedicaldevicesapprovedbytheHPRA.

Thestudiesweresponsoredbysevendifferententities,ofwhichonlyonewasanIrishacademicsponsor,withtheremainingfivestudiessponsoredbyindustry.SaoltaUniversityHealthCareGrouphostedthehighestnumberofapprovedclinicalinvestigations;n=4,57%(Figure30).

Figure 30: Percentage and number of HPRA approved clinical investigations by Hospital Group

0 1 2 3 54

No.ofHPRAApprovedClinicalInvestigations

Hos

pitalG

roup

s

DublinMidlands

RCSI

NationalChildren’s

Saolta University

14%

14%

14%

57%

AccordingtotheUKHRCScategories,themajority(n=3,43%)oftheseclinicalinvestigationsrelatedtodevicesforCardiovascularconditions(Figure31).TreatmentEvaluationrepresented71%(n=5),whileDetectionandDiagnosisaccountedfortheremainder.

Figure 31: Percentage and number of HPRA approved clinical investigations by health categories

0 1 2 3 4

No.ofHPRAApprovedClinicalInvestigations

UKHRCSHea

lthCateg

ories Cancer

Neurology

Renal&Urogenital

Metabolic&Endocrine

Cardiovascular

14%

14%

14%

14%

43%

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4.5. Research Related Activity in the Third Level Sector Funded by the HSE in 2017

TheHSEengagestheIrishuniversitysectortocommissionhealthservicesresearchandtoevaluaterelatedstudies.TheresearchsupportofficesintheUniversitiesandInstitutesofTechnologykindlyprovidedinformationaboutstudiesfundedbytheHSEoverthelastfiveyears.Forthepurposeofthisreport,only2017datahasbeenincludedtoensureconsistencywiththeotherdatasets.

In2017theHSE-funded56studieswithin10differentHEIs(Table7),whichtotalledalmost€6.5million.

Table7:Studies/collaborationsbyHEI

HigherEducationInstitution NumberofStudies/Collaborations

PercentageofTotalStudies/Collaborations

UniversityCollegeCork 17 30

UniversityCollegeDublin 9 16

RoyalCollegeofSurgeonsinIreland 8 14

TrinityCollegeDublin 8 14

Dublin City University 5 9

WaterfordInstituteofTechnology 3 5

UniversityofLimerick 3 5

NUIGalway 1 2

DundalkInstituteofTechnology 1 2

MaynoothUniversity/NUIMaynooth 1 2

UniversityCollegeCorksecuredthelargestnumberofstudies(30%)(Table7),andthehighestproportionofHSEfundingovertheperiod,representing32%(€2,112,996)ofthetotalspend (Figure32).

DundalkITreceivedthesecondlargestamountoffundingfromtheHSEdespitehavingjustoneproject(€1,804,580,28%ofthetotalfunding),followedbyRCSI(€1,036,751,16%ofthetotalfunding).Theproportionoffundingvariesbetween6%and0.2%fortheremainingsevenHEIs.

ThelownumberamongsomeoftheotherinstitutionsmaybeduetostudiesbeingconductedbetweenagivenHEIandvoluntaryhospitals(ratherthanaHSEinstitution).Also,itisnotclearifstudiesrecordedas“fundedbyHSE”intheHEIsinformationmanagementsystemsreferredtofundingfromHSECorporate/NationalDepartmentsortoHSEfundedorganisations(i.e.someuniversitiesmayhaverecordedfundingfromaHSEhospitalbythehospitalnamewhichwillthenexcludeitfromthesearchcriteria).

Research Activity in the HSE and its Funded Organisations

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Figure 32: Percentage proportion of funding by HEI in 2017

UCC

TCD

WIT

RCSI

MaynoothUniversity

NUIGalway

Dundalk IT

UL

DCU

UCD

32%

28%

16%

6%

6%

6%

3%3% 1%1%

Whencategorisedbyhealthcategory,themajorityofHSEfundedstudieswereofGenericHealthRelevance;68%(Figure33).Thisisnotunexpectedsinceuniversitieswouldgenerallybecontractedtoconductevaluativeresearch,forexample,basedonchangesinservicedelivery.Withregardtoresearchactivitytype,HealthServicesresearchwasthemostprominentat65%(Figure34).

Figure 33: Percentage and number of studies by top six HRCS health categories

0% 10% 20% 30% 50%40% 80%70%60%

Percentage

UKHRCSTop6Hea

lthCateg

ories Metabolic&

Endocrine

Other

ReproductiveHealth& Childbirth

Cancer

MentalHealth

GenericHealthRelevance

2

3

1

4

8

38

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Figure 34: Percentage and number of studies by HRCS research activity codes

0% 10% 20% 30% 50%40% 70%60%

Percentage

UKHRCSResea

rchAc

tivity

Cod

es

Treatment Evaluation

Detection & Diagnosis

Prevention

Unknown

NA

Disease Management

Aetiology

HealthServices

3

1

3

2

1

5

5

63

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56 research projects commissioned

by the HSE from third level

institutions

51 Grant Awards45 HRB 6 EU

1,829 REC approvals

34 HPRA Regulated studies

27 new clinical trials

7 new medical device trials

32 Research Ethics

Committees

The majority (1/4) of REC approved studies were of ‘Generic Health

Relevance’

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Research Studies undertaken

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5. Activity Indicator 3: Scopus Indexed Publications, 2013-2017

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One important measure of research activity is publication output. Research outputs can bedisseminatedinmanydifferentways,butforthepurposeofthisreport,wefocusedtheanalysisonresearcharticlespublishedinjournalsindexedinScopus.Thistypeofpublicationoutputwaschosenbecause:

• Indexationisconsideredtobeavalidationofthequalityofagivenjournal,indicatingthatitpublisheshigh-qualityresearcharticles.

• ScopusistheElsevierabstractandcitationdatabaseandindexesjournalsfromthefieldsofscience,technology,medicine,socialsciences,artsandhumanities.Italsoprovidesresearchanalysisandtrackingtools.Thisdatabaseincludesover36,000titlesandover11,000publishers,ofwhichover34,000arepeer-reviewedjournalsintop-levelfields,includinglifesciencesandhealthsciences.

Trendsovertimewereanalysedforjournalarticlespublishedbetween2013and2017.TheanalysisofScopusindexedpublicationswascarriedoutusingSciVal,abibliometrictoolthatusesScopusdatatoanalysetheresearchperformanceofindividuals,groupsorinstitutions.AsthereisnoHSEpublicationpolicy,hospitalpublicationsweregenerallynotaffiliatedwiththeHSEbuttoindividualhospitalsorCHOs.InordertousetheSciValtool,thehospitaldatasetswereextractedfromScopusindividually,curatedand

then imported into SciVal for analysis.

5.1. Analysis of Publication Number per year from 2013-2017

ThetotalnumberofpublicationsfromHSEorganisationsandsection38hospitalsnationally indexed in Scopus inthefiveyearperiodfrom2013to2017was13,466(thisincludestotalHSEHospitals,n=4,050;totalVoluntaryHospitals,n=8,934;andtotalCommunityandNon-Hospital,n=482,whereatleastoneoftheauthorshasknownHSEaffiliation).Thefiguresincludethepublicationoutputofmedicalconsultantswithanacademicappointment.Therehasbeenaslightsteadyincreasesince2013inthetotalnumberofpublicationsfromthehealthservice(Figure35),althoughcommunity andnon-hospitalresearchonlyaccountforbetween3to4%ofthetotaloutputeachyear. This may indicatethatmuchresearchisnotpublishedorispublishedinother(non-peerreviewed)outlets.

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Figure 35: Total number of publications between 2013 and 2017 by HSE Hospitals, Voluntary Hospitals, Community & Non-Hospital and Total

2013

Total Total Voluntary Hospitals

TotalHSEHospitals

Community and Non-Hospital

2014 2015 2016 2017PublicationYear

Num

bero

fSco

pus-Inde

xedPu

blications

(2013-2017)

3,500

3,000

2,500

2,000

1,500

1,000

500

080 87 102 102 111

727 815 764 855 889

1,742 1,758 1,698 1,7611,975

2,549 2,660 2,5642,718

2,975

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Figure 36: Comparison of 2017 Scopus indexed publications between the health services nationally and the university sector.

3,500

3,000

2,500

2,000

1,500

1,000

500

0No.ofS

copu

sInde

xedPu

blications

in2017

UCD

3,106

2,975

UL

1,169

2,975

UCC1,943

2,975

RCSI

655

2,975

TCD

3,007

2,975

DCU

1,022

2,975

UCG

1,594

2,975

MU

506

2,975

Institutions

UniversityOutput,2017* HealthServiceNationalOutput,2017

Fromanannualperspective,thetotalnumberofjournalarticlespublishednationallyin2017was2,975.Thisiscomparabletothetotaloutput(alldisciplines)ofsomeIrishuniversitieslikeTCD*orUCD*inonesingleyear(Figure36).

Thetotalnumberofpublicationsbyhospitalsin2017was2,864.Nineoutofthe50publichospitalsaccountedforthree-quartersoftheoverallhospitalpublicationoutput;73%(n=2,103)(Figure37),whichmayindicatethecloseassociationwiththeacademicsectorastheyareallteachinghospitals.

*Notethatonlypublicationswithauniversityaffiliationarecapturedhere,itexcludesassociatedaffiliations (i.e.hospitals,institutes)

Figure 37: Hospitals with a publication output of 100 or more journal articles in 2017

0 50 100 150 250200 350 400300

No.ofScopusIndexedPublicationsin2017

University

Hos

pitals

St.James’s

Beaumont

St.Vincent’s

MaterMisericordiae

Cork

Galway

OLCH,Crumlin

Tallaght

Limerick

8%

10%

8%

8%

11%

12%

6%

6%

3%

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ThepublicationswereanalysedbyHospitalGroup(Figure38),andthepatternwasconsistentacrossallfiveyears,withDublinMidlandsHospitalGroupandIrelandEastHospitalGrouphavingthehighestnumberofpublications.

Figure 38: Scopus indexed publication output per hospital group per year from 2013-2017

PublicationYear

700

600

500

400

300

200

100

0

No.ofS

copu

sInde

xedPu

blications

by

Hos

pitalG

roup

s

20%

2013

20%19%18%

20% 17%19%

20%

2015

19%18%18%

19%19%

18%

21%

2014

19%20%20%

18%19%

21%

19%

2016

21%19%

22%20%21%

21%

21%

2017

22%23%22%

23%24%

21%

Ireland East

Saolta UL

RCSIDublinMidlands South/SouthWest NationalChildren’s

Publicationratiosforeachhospitalgroupwerealsocalculatedbydividingthetotalnumberofpublicationsofahospitalgroupbythenumberofstaffperhospitalgroup.Whencomparingthepublicationratios,theChildren’sHospitalGroupshowedthehighestrelativeoutput.

5.2. Analysis of overall publication output by topic and research activity type

ToenableamorecompleteanalysisofthetypesofhealthresearchbeingconductedintheHSEandfundedorganisations,asubsetoftheScopus-indexedpublications,relatedto2017only,werecodedusingtheUKHealthResearchClassificationSystem.In2017,therewere2,975publicationsintotal.

Thetopresearchtopics(Figure39)wereGenericHealthRelevance26(17%),followedbyCancer(15%),Cardiovascular(9%),Neurological(8%)andReproductiveHealthandChildbirth(7%)research.

TreatmentEvaluation(Figure40)representednearlyhalfofthetotalresearchactivitytypeofpublicationsin2017(43%),followedbyAetiology(27%),HealthServices(14%),DetectionandDiagnosis(8%)andDiseaseManagement(3%).

26 GenericHealthrelevancereferstoresearchapplicabletoalldiseasesandconditionsortogeneralhealthandwellbeingofindividuals,publichealthresearch,epidemiologyandhealthservicesresearchthatisnotfocusedonspecificconditions.

Research Activity in the HSE and its Funded Organisations

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Figure 39: Percentage and number of Scopus indexed publications in 2017 by top six health categories nationally

Figure 40: Percentage and number of Scopus indexed publications in 2017 classified using the UK HRCS research activity codes nationally

%ofScopus-IndexedPublications

0 2 4 6 10 168 1412 18

Infection

Reproductive and Childbirth

Neurological

Cardiovascular

Cancer

GenericHealthRelevance

187

209

230

254

434

505

UKHRCSTop6Hea

lthCateg

ories

%ofScopus-IndexedPublications

0 5 10 15 25 4035 5020 30 45

Underpinning

Prevention

NA

Treatment Development

DiseaseManagement

Detection&Diagnosis

HealthServices

Aetiology

Treatment Evaluation

11

22

50

73

98

249

402

788

1,282

UKHRCSResea

rchAc

tivity

Cod

es

Research Activity in the HSE and its Funded Organisations

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Figure 41: Percentage and number of Scopus indexed publications in 2017 by the top six health categories for community and non-hospital areas

5.2.1 TopicsandresearchactivitytypeofCommunityandNon-Hospital Researchpublications

Communityandnon-hospitalresearchonlyrepresent4%ofthetotalpublicationsidentifiedin2017.ThemajorityofpublicationsrelatedtoMentalHealth(27.9%),followedbyGenericHealthRelevance(23%),Infection(10%),Cancer(7%)andNeurological(5%)(Figure41).TreatmentEvaluation(Figure42)representedoverhalfofthetotalresearchactivityofpublicationsin2017(54%),followedbyAetiology(20%),HealthServices(12%),notapplicable/relevant(6%)andDetectionandDiagnosis(5%).

%ofScopus-IndexedPublications

0 5 10 15 2520 30

CongenitalDisorders

Neurological

Cancer

Infection

GenericHealthRelevance

MentalHealth

5

6

8

11

26

31

UKHRCSTop6

Hea

lthCateg

ories

Figure 42: Percentage and number of Scopus indexed publications in 2017 classified using the UK HRCS research activity codes for community and non-hospital areas

%ofScopus-IndexedPublications

0 10 20 30 5040 60

Treatment Development

Detection&Diagnosis

NA

HealthServices

Aetiology

Treatment Evaluation

4

5

7

13

22

60

UKHRCSResea

rchAc

tivity

Cod

es

Research Activity in the HSE and its Funded Organisations

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Figure 44: Percentage and number of Scopus indexed publications in 2017 by research activity codes for total hospitals

Figure 43: Percentage and number of Scopus indexed publications in 2017 classified by the top six health categories for total hospitals

5.2.2 Hospitalresearchpublications–topicsandresearchactivitytype

Hospitalresearchrepresentedthevastmajorityofthetotalpublicationsidentifiedin2017(96%),hencetheresultsoftheanalysisofhospital-basedresearchareverysimilartothenationaltotal.ThemajorityoftheresearchwasofGenericHealthRelevance(17%),followedbyCancer(15%),Cardiovascular(9%),Neurological(8%)andReproductiveHealthandChildbirth(7%)research (Figure43).TreatmentEvaluation(Figure44)representednearlyhalfofthetotalresearchactivityofpublicationsin2017(43%),followedbyAetiology(27%),HealthServices(14%),DetectionandDiagnosis(9%)andDiseaseManagement(3%).

%ofScopus-IndexedPublication

0 2 4 6 10 16148 12 18

Infection

ReproductionHealth and Childbirth

Neurological

Cardiovascular

Cancer

GenericHealthRelevance

176

205

224

251

426

479

UKHRCSTop6Hea

lthCateg

ories

%ofScopusIndexedPublications

0 5 10 15 25 4035 5020 30 45

Underpinning

Prevention

NA

Treatment Development

DiseaseManagement

Detection&Diagnosis

HealthServices

Aetiology

Treatment Evaluation

11

22

43

69

98

244

389

766

1,222

UKHRCSResea

rchAc

tivity

Cod

es

Research Activity in the HSE and its Funded Organisations

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5. A

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tor 3Figure 45: Scopus indexed CFAA publications indexed in the Scopus database from 2013 to 2017

5.3. Analysis of Publications by Medical Consultants with a Formal Academic Appointment

Ofthetotal13,466articlespublishedbetween2013and2017withintheIrishpublichealthsystem,4,964(37%)werepublishedbyCFAAs(Figure45),whichindicatesthatthepublicationoutputofthiscohortisveryprolificastheyrepresentonlyaverysmallpercentageofthetotalnumberofexistingconsultants.

2013 2014 2015 2016 2017

3,500

3,000

2,500

2,000

1,500

1,000

500

0

No.ofS

copu

sInde

xedPu

blications

1,028 39%

1,632 1,561

990 36%

1,7282,046

929 31%

1,535

1,003 39%

1,014 40%

PublicationYear

CFAA NoFormalUniversityAppointment

2,975 Publications

(in 2017).

13,466 publications between 2013 and

2017. Slight increase year-on-year.

37% were published by consultants with a formal academic

appointment.

The majority of publications were by Hospital-based staff

(primarily in Voluntary Hospitals).

The majority of publications

were on topics of ‘Generic Health

Relevance’.

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Publications

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6. Activity Indicator 4: Clinical Research Networks

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Forthepurposeofthisreport,ClinicalResearchNetworksaredefinedasnetworksofcliniciansinterestedinaparticulardiseaseortopicwhicharedevotedtotheimprovedcareofpatientsandhealthservicesthroughresearchinthatparticulartopic.Theexistenceofthesenetworksindicatesacriticalmassofresearchactivityinagiventhematicarea.Someofthenetworksinvolveotheractorssuchasacademics,scientists,patients,professionalbodies,etc.

Thesenetworkscanbefundedinavarietyofways:

• HealthResearchBoard,statefundingorotherresearchfundingagencies,e.g.WellcomeTrust

• Membershipfees

• Fundraisingorviaanassociatedcharity

• Philanthropicorotherfunding

Thisreportfocusesonnetworkswithaclinicalresearchfocus.Otherhealthresearchnetworksorcentreswithamorebasicresearch,translationaloracademicfocus,patient-lednetworks,professionalbodynetworksoracademicresearchcentresareoutsidethescopeofthisreport.

WehaveclassifiedtheClinicalResearchNetworkintotwodistincttypes:ClinicalTrialNetworks(withafocusonclinicaltrialsandstudies)andCollaborativeClinicalResearchNetworks(withafocusonknowledgesharing,disseminationandcollaboration).

6.1. Clinical Trial Networks (CTNs)

Thesenetworkshaveastrongfocusonclinicaltrialsofmedicinalproductsbutmayalsobeinvolvedinclinicalinvestigationsofmedicaldevicesandotherclinicalstudies.Thoseinvolvedinregulatedclinicaltrialsrequiresignificantfundingandinfrastructuretomanagetheirregulatory,financialandoversightrequirementsandareoftenfundedbytheHRB.

Thisgroupincludesthefollowingnetworks:

• CancerTrialsIreland(CTI)

• BloodCancerNetworkIreland(BCNI)

• HRBCriticalCareClinicalTrialsNetworkIreland(HRBCCTNI)

• HRBMother&BabyClinicalTrialsNetworkIreland(CTNI)

• HRBPrimaryCareClinicalTrialNetworkIreland(PrimaryCareCTNI)

• InvestigatorNetworkforInflammatoryBowelDiseaseTherapyinIreland(INITIative)

• IrishHepatitisCOutcomesResearchNetwork(ICORN)

• TheVasculitisIrishNetwork(VINE)

• RespiratoryandAsthmaResearchNetwork(INCA)

• NeurologyResearchGroupinSt.Vincent’sUniversityHospital/SVUH

FurtherdetailonthesenetworksisincludedinTable8.

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Table8:ClinicaltrialNetworksinIreland

PrimaryTopic NetworkName/Acronym/Start Date

Membership Core funding

Aim

Cancer Cancer Trials Ireland/CTI

1996

17CancerTrialResearch Units in Cork,Limerick,Offaly,Galway,Sligo,Donegal,Waterford and Dublin.

Members:Almostallcancertreatingspecialists in Ireland areMembersofCTI(98%).

HRB,IrishCancer Society,grantincome,monitoringincome.

CTIs vision is to be able to provide everypatientwithcancer,accesstopotentiallyhigh-qualityandlife-alteringcancertrialsandmakeIrelandahighlyattractivelocationto open cancer trials.

CTI’smissionistodiscovernewdiagnosticsandtreatmentsthatwillextendandenhancethelivesofthemillionsofpeoplewhoarediagnosedwithcancereachyear.

BloodCancer BloodCancerNetworkIreland/BCNI

2015

NUIGalway/UHG,UCC/CUH,TCD/SJH,The National Cancer RegistryIreland,BeaumontHospitalandTheMaterHospital

SFIandICS TheaimofBCNIistoprovideIrishbloodcancerpatientswithaccessto novel and innovative cancer treatmentsthroughtheprovisionofearlyphaseclinicaltrials,offeringtheopportunitytotestnew,potentiallylife-savingtreatmentsanddrugs.Thenetworkalsocollects information and samples from blood cancer patients in Ireland in order to improve their understandingandtouncovernewwaystocombatthisdisease.

Critical Care HRBCriticalCare Clinical TrialsNetworkIreland(HRBCCTNI)

2015

Thenetworkencompasses more than75%ofalltheICUcapacity in Ireland.

HRB TheHRBCCTNIbringstogetherdoctors,nursesandresearcherstotestnewtreatmentsthatcanimprove outcomes for critically ill patients in intensive care units.

Perinatal health HRBMother&BabyClinicalTrialsNetworkIreland(CTNI)

2015

The members includeresearchers,consultants,obstetricians,neonatologists,midwivesandrelatedprofessionals from sevenofthelargestmaternity hospitals in Ireland.

HRB The aim of the CTNI is to addressproblemsinwomenandchildren’shealththatwillhaveaglobalimpact.CTNIhasawell-established record in collaborative researchandinconductinglarge-scale,multicentre,randomisedcontrolled trials.

Primary Care HRBPrimaryCare Clinical TrialNetworkIreland (PrimaryCareCTNI)

2015

NUIGalway,RCSI&QUBandICGPwithmanyGPsandotherprimary care health professionals.

HRB Itsaimsarethedesign,conductanddisseminationofhighquality,internationallyrecognised,randomised trials in Irish primary care,whichaddressimportantandcommon problems.

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PrimaryTopic NetworkName/Acronym/Start Date

Membership Core funding

Aim

InflammatoryBowelDisease

InvestigatorNetworkforInflammatoryBowelDiseaseTherapy inIreland/INITIative

ClinicalandscientificinvestigatorswithaninterestinCrohn’sDisease and Ulcerative Colitisthroughouttheisland of Ireland

Not available It aims to foster collaboration andencouragemulti-centreinvestigator-initiatedstudiesinCrohn'sDiseaseandUlcerativeColitis in Ireland.

HepatitisC IrishHepatitisC Outcomes Research Network/ICORN

2012

CollaborationbetweenClinicians from BeaumontHospital,CUH,GUH,theMaterHospital,St.Luke’sHospital,Kilkenny,SJHandSVUH,patientadvocacygroupsandhealthcare service providersincludingISGE,IDSI,andtheNCPE.

AbbVie Ireland and BristolMyersSquibb

TheinitialgoalofthiscollaborationwastooptimisethequalityofcareofpatientswithHepatitisC(HCV)undergoingtreatmentwithdirect-actingantiviraltherapy(DAAs).Othernetworkresearchthemesdeveloped since 2012 include innovative research studies on modelsofcareandscreeningforHCVinfection.

Vasculitis VINE/TheVasculitis Irish Network

2012

SJH/TUH,SVUH,OLCHC,CUH,GUH,SouthernHealth&SocialCareTrust,UKand Vasculitis Ireland Awareness.

HRB,Vasculitis Ireland,

Thenetworkiscomprisedofdedicatedmulti-disciplinarycentresthatprovideacoordinatedcare-pathforpatientswithprimarysystemic small vessel vasculitis (PSV),fromdiagnosistorelapseandontolongtermremission.Itprovides access to clinical trials for patientswithPSV.

Respiratory Respiratory and Asthma Research Network/INCA Studies

2011

A collaborative researchprogrammedelivered from the RCSI Research Centre and TCD Bioengineering.

SFI The focus is on clinical investigationsforrespiratorydevices,particularlydevelopinganoveltechnologywhichcanbe used in clinical practice as an objectiveassessmentofpatientadherence to inhaled therapy.

Neurology NeurologyResearch GroupinSVUH

2003

UCDandSVUH SFI,HRBand industry

Their areas of excellence are in neuroinflammatorydisorders,inparticular,multiplesclerosis,movementdisordersandcognitiveneurology.Thefocusisonrunningnumerous clinical pharmaceutical trials,academicresearchstudies–bothclinicalandbasicscience,andinterventionalstudieswithallied health professionals. Several nationalneurologyregistriesandresearch databases are also coordinatedfromtheSVUHsite.

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Theperformanceofaclinicaltrialrequiresagreatdealofsupportandinfrastructure.Anumberoforganisations,manygenerallyfundedbytheHealthResearchBoard,providesignificantsupportforthisactivity:

HRBClinicalResearchCoordinationIreland(CRCI)27 HRB-CRCIprovidessupportforclinicaltrialsundertakenintheuniversityassociatedClinicalResearchFacilities/Centres(CRF/Cs).CharacteristicsandinformationoneachCRF/CcanbefoundinTable4ofAppendix 3.

TheHRB-CRCIservicesandactivitiesincludebeingthecentralpointofcontactforsponsorslookingtostartatrial,streamliningnationalprocessesforfeasibilitystudies,improvingstudystart-uptimelinesforstudysetup,recruitmenttrackingandcollationofmetrics,provisionofadviceinrelationtoregulatorypathwaysandresearchethicalapproval,andauditandmonitoring,amongothers.

HRB-CRCIishostedbyClinicalResearchDevelopmentIreland(CRDI)28,whichisanot-for-profitresearchpartnershipcomprisingNUIGalway,RCSI,TCD,UCC,UCD,andUL,theirmedicalschools,associatedacademichospitalsandCRFs,withtheobjectiveofacceleratingthetranslationofbiomedicalresearchintoimproveddiagnostics,therapiesanddevicesforpatients.ItwasformallylaunchedbytheMinisterforHealthonOctober2nd,2017.CRDIbuildsontheachievementsofMolecularMedicineIrelandwhichwasestablishedin02October,2017.

HRBTrialsMethodologyResearchNetwork(TMRN)29

TheHRB-TRMNisanew,collaborativeinitiativebetweenanumberofIrishandinternationalhighereducationinstitutesandmethodologycentres.ItisfundedbytheHRBandwillprovidedirectsupportintwoways,firstlythroughthedevelopmentofaClinicalTrialExpertiseDatabase(C-TED)andalsothroughtheTrialMethodologyandReportingAdvisoryService(TMRAS).

CancerTrialsIreland(CTI)30 CTIprovidessupportsforoncologyclinicaltrialswithintheOncologyClinicalTrialunitsacross14publicandthreeprivatehospitalsitesinCork,Limerick,Offaly,Galway,Sligo,Donegal,WaterfordandDublin.Itisanot-for-profitorganisationwithcharitablestatus.Servicesprovidedincludeplanning,opening,co-coordinating,supporting,monitoringandauditingcancertrialsinIreland.Inaddition,theorganisationprovidestrainingfacilitates,co-operationbetweenallprofessionalsworkinginthearea,andsupportsthedevelopment of cancer trials research units around the country.

Cross-borderHealthcareInterventionTrialsinIrelandNetwork(CHITIN)TheCHITINinitiativewaslaunchedinSeptember2018andisauniquecross-borderpartnershipbetweenthePublicHealthAgencyinNorthernIrelandandtheHealthResearchBoardintheRepublicofIreland,todevelopinfrastructureanddeliverhealthcareinterventiontrialsinhealthandsocialcare.Theinitiativewillhelppreventandcureillness,andpromoteimprovedhealthandwellbeinginNorthernIreland,IrelandandIrishcross-borderareas.Itwillalsoenhanceall-Irelandpartnershipsforresearchersandhealthprofessionals.

27https://www.hrb-crci.ie/28https://www.crdi.ie/29https://www.hrb-tmrn.ie/30http://www.cancertrials.ie/

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6.2. Collaborative Clinical Research Networks

Thefocusoftheseclinicalnetworksismainlyonattractingcliniciansandotherprofessionalsinterestedinaparticulardiseaseortopicforthepurposeofimprovingunderstanding,andthesharingofknowledgeandresearchexpertise.Theycanalsobefocusedonthedevelopmentofdiseaseregistriesorbiobanks.Table9includesfurtherdetailonthesenetworks*.

Table9:CollaborativeClinicalResearchNetworks

PrimaryTopic

NetworkName/Acronym/Start Date

Membership Core funding

Aim

Neurology/Pain

Irish Pain Research Network(IPRN)

2015

Healthcareprofessionals and scientists,withexpertise in pain management.

Irish Pain Society and other funders.

Thisnetworkaimstobringtogetherallactive pain researchers on the island of Ireland(NorthandSouth)forthepurposesofsharingresearchresultsandideasandfacilitatingcross-institutionalcollaborationin the area of pain research.

MentalHealth

Irish Psychosis Research Network(IPRN)

RCSI,TCD,StPatrick’sHospital,UCC,NUIGalway,QUBandUCD.

RCSI,SFIandHRB.

Thenetworkaimstosharecurrentknowledgeandnewdiscoveriesaboutthecausesof,andtreatmentfor,psychoticdisorders. Research areas include disordersthataffectperception,cognitionandmoodinwaysthatarechallengingand,attimes,disablingforthoseaffected.

Diabetes GalwayDiabetes Research Centre (GDRC)

2012

NUIGalwayandSaolta University HealthCareGroup.

SFIandHRBs.

The centre is a hub for collaborative effortofresearchersandclinicians,withapassionforthiswork,toprovideagreaterunderstandingofhowdiabetesdevelopsandtheunderlyingmechanisms,thedevelopmentofnewandbettertherapiesforpatients,andassessinghealthcareinterventions and delivery for patients.

Arthritis Arthritis Research Coalition

2016

SVUH,GUH,LUH,OLCHC,MaterHospital,CUHandBeaumontHospital.

Arthritis Ireland and theHRB–CRCI.

The primary aim of the biobank is to recruitpatientswithcommonrheumaticdiseases,andtoobtainbio-samplesthatwillunderpinclinicalresearch.Asecondary aim is to increase national involvement in clinical trials of novel therapeuticagents.

Research Activity in the HSE and its Funded Organisations

*Healthresearchnetworksorcentreswithamorebasicresearch,translationaloracademicfocus,patient-lednetworks,professionalbodynetworksoracademicresearchcentresareoutsidethescopeofthisreport.

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7. Conclusions

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ThisreportisthefirstbenchmarkofresearchactivityinpubliclyfundedhealthandsocialcareservicesinIreland.Theprocessofinformationgatheringwaslaboriousandhighlightedthelackofinformationsystemsandinfrastructuretosupportthecollectionofmeaningfulresearchrelatedmetrics.Hence,alargeportionoftheanalysishasbeenpossibleonlythankstothegenerosityofalltheentitiesthatcontributedinformation,suchastheRECs,theHRB,theHPRA,thevariousClinicalTrialNetworks,UniversitiesandofcoursetheHealthServicestaffwhorespondedtothesurvey.

Despitethediversityofdatasets,sometimesincompleteorimperfect,andtheimpossibilityoflinkingthemtoobtainaclearerpicture,thisanalysisprovidesareasonablesnapshotofresearchactivityinthehealthserviceinrecenttimesagainstwhichfutureprogresscanbemeasured.Theinformationhasbeenpresentedaroundfourresearchactivityindicators;people,projects,publicationsandnetworks.Moresophisticatedkeyperformanceindicatorstraditionallyusedforresearchinothersettings(i.e.researchfunding,etc.)couldnotbeusedduetothelackofavailableinformation.

ThisstudyshowsthattheHSEanditsfundedorganisationsareresearchactive.Staffmembersengagedinresearcharedistributedacrosstheserviceinhospitals,thecommunityandcorporateservices,andalthoughthemajorityofresearchactivestaffbelongtotheclinicalprofessions(medicaldoctors,nursesandmidwives,andhealthandsocialcareprofessionals),therearealsoresearchactivestaffamongtheadministrationandmanagementcategories.

Whileresearchactivestaffexistinbothhospitalandcommunitybasedservices(i.e.40%ofstaffsurveyrespondentswerehospitalbasedand31%werecommunitybased),thepeerreviewedpublicationoutput(indexedinScopus)wasmainlyauthoredbyhospitalbasedstaff.Thismayindicatethatcommunity-basedstaffengagedinresearchmaydisseminatetheirresultsviadifferentoutletsratherthanviapeer-reviewpublicationsindexedinScopus(i.e.presentationatconferences,non-peerreviewedpublications,internalreports,etc.),maynotpublishtheirresearchoutputsormaydosobyco-authoringwithhospital-basedstaff.

Thesurveyalsoindicatedthatalargeproportionofrespondents(37%)werefromtheHealthandSocialCareprofessions.However,whenthenumberofrespondentswascomparedtothetotalnumberofprofessionalsineachcategory,theproportionalresponsefrommedicaldoctorswasthehighest.ThismayindicatethatitismorecommonformedicaldoctorstoberesearchactivethanitwouldbeforstaffintheHealthandSocialCareortheNursingandmidwiferyprofessions.

Interestingly,overaquarterofsurveyrespondentswerebasedintheDublinMidlandsHospitalGroup(230)andCHO7(261).DublinMidlandsHospitalGroupwasalsooneoftheHospitalGroupswiththelargestpublicationoutput(withSt.JamesHospitalbeingthetopperformer),togetherwiththeIrelandEastHospitalGroup(withSt.Vincent’sandtheMaterHospitalbeingthetopperformersofthegroup).Understandably,thepublicationoutputofteachinghospitalscloselyassociatedwithuniversitypartnerswasthegreatest.Interestingly,nearlythree-quarterofallpublicationsin2017wereproducedbyninehospitals,andforthemostpart,althoughnotalways,thehospitalswithlargerpublicationoutputalsohadthelargernumberofconsultantswithjointacademicappointments.ThiswasnotthecaseforOurLady’sChildren’sHospitalsCrumlinhowever,whichonlyhadfivejointappointmentsbuthadasignificantpublicationoutput.Ontheotherhand,ConnollyHospitalhad11jointappointmentsbutwasnotoneofthetopninepublicationperformers(i.e.withover100publicationsperyear).

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Medicalconsultantswithanacademicappointmentrepresent7%ofallconsultants,butareresponsiblefor37%ofthepublicationofjournalarticlesindexedintheScopusdatabase,andwereinreceiptof30%ofthetotalHRBfundingin2017.Thesejointpoststhereforeappeartobeakeydriverofresearchactivity.Howeverthevastmajorityofhealthservicestaffdonothaveanacademicaffiliation,andhavethereforenoaccesstosupportsofferedbytheacademicsector.Inspiteofthelackofothersupportmechanismsandtimeavailablility,theirinvolvementinresearchandresearchoutputareadmirable;60%ofsurveyrespondentshadnolinkage(formalorotherwise)withtheacademicsector,and63%ofpublicationswereauthoredbystaffwithoutformalacademicappointments.Thesurveyalsoindicatesthatmanystaffcarryoutresearchafterworkinghoursontopoftheirnormalclinicalduties,whichshowsthecommitmentofresearchactivestafftothisactivity.

Themostprevalentresearchtopicnationally,bothforresearchprojectsandforpublicationswas“generichealthrelevance”.Thisisresearchthatisapplicabletoalldiseasesandconditions.CancerwasthesecondmostcommonresearchtopicasdeterminedbyanalysisoftheRECapprovedstudies,regulatedclinicaltrials,HRBawardsandpublications;withmoststudiesrelatingtotheevaluationofcancertreatment.ThismayrelatetotheexistenceofCancerTrialsIreland,whichovertheyearshashadakeyroleinsupportingcancerclinicaltrialsandstudiesinIreland.Cancerwasthesecondmostprevalenttopicofpublicationsfromhospitalbasedstaff,whilementalhealthwastheprioritytopicofpublicationsfromcommunitybasedstaff.

Theanalysisofthedataprovidedbytheresearchethicscommitteesprovidesinterestinginsightsintothevolumeofprojectapprovalsonanannualbasisandthetopicsofinterest.Thisanalysishastobeconsideredinthecontextthatnon-regulatedclinicalstudiesinvolvingmultiplesitesrequiremultipleapprovalsforasingleproject.Halfofallapprovalswererelatedtotheevaluationoftreatmentsandhealthservicesresearch.RegionalanalysisofprojectapprovalsshowedlargedifferencesintheregionalRECserviceprovision:theSouth/South-WestregionreviewedoveraquarterofthetotalnumberofprojectswithonlyoneREC,whiletheEastregionreviewedasimilarnumberofproposalsbuthad20hospitalbasedRECs,andlacksaRECtoreviewCHObasedresearchinthearea.

Duetothefactthatmulti-sitestudiesmustbeapprovedbymultipleRECs,thetotalnumberofprojectapprovalsatnationallevelis,therefore,largerthanthetotalnumberofprojects,whichunfortunatelycouldnotbespecificallydetermined.Asthetotalnumberofapprovalswasover1,800,wecanonlyconcludethatthetotalnumberofprojectsstartingin2017waslessthanthat.Asonly27regulatedclinicaltrialsandnineregulatedclinicalinvestigationscommencedinthatyear,thedataimpliesthatthemajorityoftheprojectsapprovedinvolvednon-HPRAregulatedresearch.

AsimplecomparisonofthenumberofclinicaltrialsinothercountriesofsimilarsizetoIreland,suchasDenmarkandFinland,indicatesthatthereissignificantroomforimprovementinIreland.Overthelast10yearsasignificantamountofinvestmentinthedevelopmentofclinicalresearchnetworksandclinicalresearchinfrastructurehastakenplace,andmuchofthisinvestmenthastakenplaceviatheacademicsector.Asshowninchapter6,asignificantamountofnetworksandinfrastructurecurrentlyexisttosupportclinicalresearch,butyetthehealthserviceisunderperforminginthisregardwhencomparedtoother EU countries.

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TheanalysisofEUgrantsinvolvingtheHSEasaparticipantshowsthatthisisamissedopportunity.OnlysixprojectswereawardedtotheHSEin2017,whichreceivedamarginalpartoftheoveralltotalawardedprojectfunding.Also,whiletheHSEisalsoactivelyinvolvedincommissioningresearchrelatedservicesfromthethirdlevelsectorinIreland,only€6millionwasinvestedinthisactivityin2017,whichseemsverysmallconsideringtheevidencerequirementofsuchalargehealthserviceandthelinksthatalreadyexistwiththeuniversitysector.

Overall,thisstudyshowsthatasignificantpercentageofstaffintheHSEanditsfundedorganisationsareresearchactive,andtheoutputscannotbeunderestimated.Despitethefactthatresearchis,byanlarge,notformallyembeddedwithintheprocessofservicedelivery,itisverymuchpartoftheon-goingactivityinthehealthservice,anditcannotbeignored.Thedatainthisstudyshowsthehugepotentialforimpactthatcouldbeleveragedbyaligningresearchactivitytoserviceneeds,inordertoobtainthemaximumbenefitforourhealthservice,andthehealthandwellbeingofourpatientsandthegeneralpopulation.

Research Activity in the HSE and its Funded Organisations

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Appendices

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Appendix 1: UK HRCS category descriptions

TableA1:UKHealthResearchClassificationSystemHealthCategories

Category Description

1 Blood Haematologicaldiseases,anaemia,clotting(includingthrombosisandvenousembolisms)andnormaldevelopmentandfunctionofplateletsanderythrocytes

2 Cancer Alltypesofneoplasms,includingbenign-malignantcancers(includesleukaemia)

3 Cardiovascular Coronaryheartdisease,diseasesofthevasculatureandcirculationincludingthelymphaticsystem,andnormaldevelopmentandfunctionofthecardiovascular system

4 CongenitalDisorders PhysicalabnormalitiesandsyndromesthatarenotassociatedwithasingletypeofdiseaseorconditionincludingDown’ssyndromeandcysticfibrosis

5 Ear Deafness and normal ear development and function

6 Eye Diseases of the eye and normal eye development and function

7 Infection Diseasescausedbypathogens,acquiredimmunedeficiencysyndrome,sexuallytransmittedinfectionsandstudiesofinfectionandinfectiousagents

8 InflammatoryandImmune System

Rheumatoidarthritis,connectivetissuediseases,autoimmunediseases,allergiesandnormaldevelopmentandfunctionoftheimmunesystem

9 InjuriesandAccidents Fractures,poisoningandburns

10 MentalHealth Depression,schizophrenia,psychosisandpersonalitydisorders,addiction,suicide,anxiety,eatingdisorders,learningdisabilities,autisticspectrumdisordersandstudiesofnormalpsychology,cognitivefunctionandbehaviour

11 MetabolicandEndocrine

Metabolicdisorders(includingDiabetes)andnormaldevelopmentandfunction.Includesallresearchonpineal,thyroid,parathyroid,pituitaryandadrenalglands.

12 Musculoskeletal Osteoporosis,osteoarthritis,muscularandskeletaldisordersandnormalmusculoskeletalandcartilagedevelopmentandfunction

13 Neurological Dementias,transmissiblespongiformencephalopathies,Parkinson’sdisease,neurodegenerativediseases,Alzheimer’sdisease,epilepsy,multiplesclerosisand studies of the normal brain and nervous system

14 Oral and Gastrointestinal

Inflammatoryboweldisease,Crohn’sdisease,diseasesofthemouth,teeth,oesophagus,digestivesystemincludingliverandcolon,andnormaloralandgastrointestinaldevelopmentandfunction

15 RenalandUrogenital Kidneydisease,pelvicinflammatorydisease,renalandgenitaldisorders,andnormaldevelopmentandfunctionofmaleandfemalerenalandurogenitalsystem

16 ReproductiveHealthand Childbirth

Fertility,contraception,abortion,invitrofertilisation,pregnancy,mammaryglanddevelopment,menstruationandmenopause,breastfeeding,antenatalcare,childbirthandcomplicationsofnew-borns

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Category Description

17 Respiratory Asthma,chronicobstructivepulmonarydisease,respiratorydiseasesandnormal development and function of the respiratory system

18 Skin Dermatologicalconditionsandnormalskindevelopmentandfunction

19 Stroke Includesbothischaemic(bloodclots)andhaemorrhagic(cerebralhaemorrhage)strokes

20 GenericHealthRelevance

Researchapplicabletoalldiseasesandconditionsortogeneralhealthandwellbeingofindividuals.Publichealthresearch,epidemiologyandhealthservicesresearchthatisnotfocusedonspecificconditions.Underpinningbiological,psychosocial,economicormethodologicalstudiesthatarenotspecifictoindividualdiseasesorconditions

21 DisputedAetiologyand Other

Conditionsofunknownordisputedaetiology(suchaschronicfatiguesyndrome/myalgicencephalomyelitis),orresearchthatisnotofgenerichealthrelevanceandnotapplicabletothetop19specifichealthcategorieslisted above

TableA2:UKHealthResearchClassificationSystemResearchActivityCodes

Category Description

1 UnderpinningResearch

Researchthatunderpinsinvestigationsintothecause,development,detection,treatmentandmanagementofdiseases,conditionsandillhealth

2 Aetiology Identificationofdeterminantsthatareinvolvedinthecause,riskordevelopmentofdisease,conditionsandillhealth

3 Prevention of Disease andConditions,andPromotionofWell-Being

Researchaimedattheprimarypreventionofdisease,conditionsorillhealth,orpromotionofwell-being

4 Detection,ScreeningandDiagnosis

Discovery,developmentandevaluationofdiagnostic,prognosticandpredictivemarkersandtechnologies

5 Development of Treatments and Therapeutic Interventions

Discoveryanddevelopmentoftherapeuticinterventionsandtestinginmodelsystemsandpreclinicalsettings

6 Evaluation of Treatments and Therapeutic Interventions

Testingandevaluationoftherapeuticinterventionsinclinical,communityorappliedsettings

7 ManagementofDiseases and Conditions

Researchintoindividualcareneedsandmanagementofdisease,conditionsor ill health

8 HealthandSocialCareServices Research

Research into the provision and delivery of health and social care services,healthpolicyandstudiesofresearchdesign,measurementsandmethodologies

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Appendix 2

Appendix 2: UK HRCS by HSE Region

TableA3:UKHealthResearchClassificationSystem–ResearchCategoriesofRECapprovedstudiesperregion.

HRCSHealthCategories

East* South/South West

West/North-West

Mid-Western

South East

Midlands NorthEast

TOTAL

GenericHealthRelevance

106 111 89 58 14 10 6 393

Cancer 46 70 34 13 12 3 2 180

Reproductive HealthandChildbirth

57 58 17 7 5 3 147

MentalHealth 49 48 34 17 17 9 6 179

Cardiovascular 36 21 53 13 2 1 126

Neurological 48 49 13 5 4 119

MetabolicandEndocrine

30 22 21 12 1 86

Musculoskeletal 29 21 22 3 3 78

Oral and Gastrointestinal

22 23 8 2 55

Infection 25 16 15 5 4 1 66

InflammatoryandImmune System

31 23 10 3 1 1 1 70

Other 12 13 4 2 4 35

Respiratory 12 10 10 3 35

Eye 16 5 5 1 5 32

Blood 14 10 2 2 2 2 32

Renal and Urogenital

9 2 8 4 2 25

Stroke 8 6 7 1 1 23

CongenitalDisorders

16 9 2 5 32

Skin 17 5 7 2 1 32

InjuriesandAccidents

7 4 2 1 14

Ear 7 0 7

NA 4 0 4

597 526 367 157 72 32 21 1772

*StudiesapprovedbyBeaumontHospitalandDaughtersofCharityRECsnotincluded.

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Appendix 3: Clinical Research Facilities (CRFs) and Clinical Research Centres (CRCs)n

TheCRFandCRCprovide“infrastructure,physicalspaceandfacilities,experiencedresearchandspecialistsupportstaffandthenecessaryqualityandoversightprogrammesthatarecriticalforthesuccessfulconductofworld-classpatient-focusedresearch”.ResearchinCRFsandCRCsissupportedbyClinicalResearchCoordinationIreland(TableA4):

Asper2018,thefollowingCRFs/CRCsexist:

• HRBCRFCorkatUniversityCollegeCorkandMercyUniversityHospital

• HRBCRFGalwayatUniversityHospitalGalway

• RoyalCollegeofSurgeonsIrelandCRCatBeaumontHospital

• UniversityCollegeDublinCRCatMaterMisericordiaeUniversityHospitalandSt.Vincent’sUniversityHospital

• WellcomeTrust–HRBCRFatSt.James’sHospital

• NationalChildren’sResearchCentreatOurLady’sChildren’sHospitalCrumlin

• HealthResearchInstitute(HRI)ClinicalResearchSupportUnit(CRSU)attheUniversityofLimerickandUniversityLimerickHospitals

TheCRF/Csarecommittedtoprovidingstate-of-the-artfacilitiesandequipmenttofacilitateresearchinpartnershipwithacademiaandthecommercialsector,inordertogainabetterunderstandingofhowdrugsworkonhumans,andtodeveloplife-enhancingtherapiesthroughclinicaltrialsandbasicresearch.Researchcarriedoutattheselocationsaimstofindbreakthroughsindrugtreatments,foodtherapies,foodsupplementationsandmedicaldevices,whichwillbeconvertedintobetterandsafertreatmentsforpatients.Patient-focusedresearchistopoftheagenda.Theunitsfacilitateawiderangeofresearchersinconductingclinicaltrials,observationalstudiesandthecollectionofbiologicalmaterialsinareassuchasexperimentalmedicine,earlyandlatephaseclinicaltrials,and,studiesbyalliedhealthprofessionals.

Thestructuresandset-upoftheCRFs/Csvaryfrominstitutiontoinstitutionandareoftenco-locatedonahospitalsiteratherthanthemainuniversitycampus.CRFs/Cssupportinstitutionalsponsoredtrials,industry-sponsoredtrials,investigator-ledtrials,regulatedandnon-regulatedtrials.Theysupportavarietyofpersonnelincludinginvestigators,researchers(includingtrialnurses),clinicians,honoraryappointees,projectmanagers,biomedicalengineers,translationalscientists,industrysponsorsandotherresearchsupportstaff.

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Appendix 3

TableA4:AsummaryofClinicalResearchFacilities/CentresacrossIrelandandNorthernIreland

No. Facility/Centre Funder

Institution(s) Established Director Coverage Core Team

Studies

1 HRBClinicalResearch FacilityCork(HRBCRF-C)

HRB/UCC

UCC and MUH,Cork

2011 Professor Joseph Eustace

SouthandSouth-WesternregionsofIrelandwithapopulation of over 1million(greaterMunsterregion)

69 108ActiveStudies

2 HRBClinicalResearch Facility,Galway(HRBCRFG)

HRB

NUIGalway,GUHSaoltaUniversity HealthCareGroup

2008 Professor MartinO’Donnell

West and North regionofIrelandwithapopulationofjustunder1million

58inCRFG

9inCancer Clinical Trials Unit (CCTU)

Non-Oncology:48active studies

CRFGDataManagementand Statistics: 16 active studies

CCTU: Unknown

3 Wellcome TrustHRBClinical Research FacilityatSJH(WellcomeTrustHRBCRFSJH)

Wellcome Trust and the HRB

TCDandSJH 2013 Professor MartinaHennessy

GreaterDublinMidlandsareagenerally.Forsome specialist areasSt.James’sis the National Centre for many specialist services (e.g.Haemophilia,Burns,BoneMarrowTransplant,OesophagealCancer)

23 41 studies currently open to patient recruitment.

53 studies completed and closed since 2013

4 RCSI Clinical Research Centre(RCSICRC)

RCSI

RCSI and BeaumontHospital

2000 Professor Dermot Kenny

GreaterDublin/North East area

30 MajorSupport=40

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No. Facility/Centre Funder

Institution(s) Established Director Coverage Core Team

Studies

5 UCD Clinical Research Centre(UCDCRC)

HEAinvestment for the initial three years,NowUCD School ofMedicine&LeveragedFunding

UCD,MaterMisericordiaeandSVUH,

National MaternityHospital&Ireland East HospitalGroup

2006 Professor Peter Doran

Dublin/Leinsterand other national tertiary referrals

18Core

22ProjectSpecific

225

6 Children’sClinical Research Unit,NationalChildren’sResearch Centre(NCRC)

Children’sMedicalResearch Foundation(CMRF)

OLCHC(Children’sHealthIrelandfrom January 2019)

NCRC is over 50 years but theChildren’sClinical Research Unit (CCRU)wasestablished in 2010

Professor Colm O'Donnell

OurLady’sChildren’sHospital,Crumlin,withspecificstudies also supported by NCRCstaffatTemple Street Children’sUniversity Hospital,TallaghtUniversity Hospital,UniversityHospitalLimerickandUniversityCollegeHospitalGalway.Centralised clinical research support service is available to all paediatric centres. Per the national paediatric modelofcare,themajorityofquaternaryandtertiary paediatric healthcare services are delivered by OLCHCandTSCUH(Children’sHospitalGroup).

26 131

OLCHC:110(46Haematology/OncologyTrialsUnit)

TSCUH:6

TUH:6

UCHG:1

UHL:8

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No. Facility/Centre Funder

Institution(s) Established Director Coverage Core Team

Studies

7 HealthResearch Institute Clinical Research Support Unit Limerick(HRICRSU)

UHLandUL

ULHandUL 2014 Professor Rachel Msetfi

Mid-WestregionofIrelandwithapopulationofjustunder400,000

8 Majorsupport=5

Minorsupport=3

8 Wellcome Trust-WolfsonClinical Research Facility(NICRF)

Wellcome Trust and Wolfson Foundation

QUB,TheBelfastHealthandSocial Care Trust,UlsterUniversity and The Northern Ireland HealthandSocial Care Research and Development division

2013 Professor Judy Bradley

Northern Ireland 9F.T.E.

(10Staff)

25 studies inset-up/approved and 47studiesActive/Completed

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s

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TableofTables

Table 1: Key research activity indicators 15

Table2: Self-reportedresearchcompetencies 24

Table3: DistributionofCFAApostsperHospitalGroupandHospitals(onlyhospitalswith CFAApostsareshown) 30

Table4: DistributionofCFAAbydiscipline 31

Table5: RECsapproachedforinformationperregionandtimeperiodofdatasetsupplied 37

Table6: RECregionalcoverage(counties,hospitals,CHOorCHOsection) 38

Table7: Studies/collaborationsbyHEI 52

Table8: ClinicaltrialNetworksinIreland 66

Table9: CollaborativeClinicalResearchNetworks 69

TableA1:UKHealthResearchClassificationSystemHealthCategories 75

TableA2:UKHealthResearchClassificationSystemResearchActivityCodes 76

TableA3:UKHealthResearchClassificationSystem–ResearchCategoriesofREC approvedstudiesperregion. 77

TableA4:AsummaryofClinicalResearchFacilities/CentresacrossIrelandandNorthernIreland 79

TableofFigures

Figure1: Placeofworkofrespondents(indicatedasnumberandpercentageofthetotalsample) 19

Figure2: Number(includingpercentage)ofresearchactiverespondentsfromeachhospitalgroup 20

Figure3: Percentage(includingnumber)ofrespondentsbyCHO. 20

Figure4: Percentage(includingnumber)ofrespondentsbyprofession 21

Figure5: Responseratio(totalnumberofrespondentspercategorybytotalnumberofstaff inthatcategory)byprofession 21

Figure6: Number(includingpercentage)ofstaffengagedinresearchbyprofessionand healthservicearea(orlocation) 22

Figure7: Number(includingpercentagewhichrepresentstheproportionwithintheClinical andNon-clinicalgrouping)ofrespondentsbyhighestqualificationlevel 23

Figure8: Percentage(includingnumber)ofclinicalstaffbyhighestqualificationlevel 23

Figure9: Number(includingpercentage)ofrespondentsbyresearchcompetencies 25

Figure10: Number(includingpercentagewhichrepresentsaproportionwithintheHSC,Medical andNursinggroups)ofrespondentsbytypeofresearcherandprofession(clinicaltypes) 26

Figure11: Percentage(includingnumbers)ofrespondentsbytheiracademicactivitiesinHEIs 27

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Table

s

Figure12: Hoursspentonresearchduringtheworkingweekbythenumberofrespondents (percentagesrepresentproportionwithintheclinicalornon-clinicalgrouping) 27

Figure13: Hoursspentonresearchoutsideofworkinghoursbythenumberofrespondents (percentagesrepresentproportionwithintheclinicalornon-clinicalgrouping) 28

Figure14: Hoursspentonresearchinsideandoutsideofworkinghours(percentagesrepresent theproportionofrespondentswithandwithoutanacademicpost) 28

Figure15: Number(including%)ofCFAApostsbyHospitalGroup(basedonprincipleclinicalsite) 30

Figure16: RECregionsusedfortheanalysis 36

Figure17: Numberofproposalsapprovedperregionin2017ornearestyearasindicatedin Table 5 40

Figure18: PercentageandnumbersofRECapprovedstudiesforthesixtophealthcategories nationally 41

Figure19: PercentageandnumberofRECapprovedstudiesforthesixtophealthcategories perregionPercentageandnumbers 41

Figure20: Percentageandnumberofstudiesclassifiedbyresearchactivityintheoverall sample 42

Figure21: Percentageandnumberofstudiesclassifiedbytypeofresearchactivityforthe regionswithmoreannualprojectthroughput 42

Figure22: Percentageandnumberofstudiesclassifiedbytypeofresearchactivityforthe regionswithlessannualprojectthroughput 43

Figure23: PercentageandnumberofstudiesbyhealthcategoriesfromtheICGPandPCRC at national level 43

Figure24: PercentageandnumberofstudiesbyresearchactivityfromtheICGPandPCRC at national level 44

Figure25: NumberofHRBawardsissuedin2017forHealthcareStaffandNon-HealthcareStaff 45

Figure26: AnnualvalueofHRBawardsissuedin2017,forHealthcareStaffand Non-HealthcareStaff 46

Figure27: PercentageandnumberofHRCStop6healthcategoriesforHRBfundedresearch studiesin2017 46

Figure28: PercentageandnumberofHRB-fundedstudiesbyhealthcategoriesbyCFAAs 47

Figure29: PercentageandnumberofIrishclinicaltrialsbythesixmostfrequentHRCShealth categoriesontheEudraCT 50

Figure30: PercentageandnumberofHPRAapprovedclinicalinvestigationsbyHospitalGroup 51

Figure31: PercentageandnumberofHPRAapprovedclinicalinvestigationsbyhealthcategories 51

Figure32: PercentageproportionoffundingbyHEIin2017 53

Figure33: PercentageandnumberofstudiesbytopsixHRCShealthcategories 53

Figure34: PercentageandnumberofstudiesbyHRCSresearchactivitycodes 54

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Figure35: Totalnumberofpublicationsbetween2013and2017byHSEHospitals, VoluntaryHospitals,Community&Non-HospitalandTotal 57

Figure36: Comparisonof2017Scopusindexedpublicationsbetweenthehealthservices nationallyandtheuniversitysector. 58

Figure37: Hospitalswithapublicationoutputof100ormorejournalarticlesin2017 58

Figure38: Scopusindexedpublicationoutputperhospitalgroupperyearfrom2013-2017 59

Figure39: PercentageandnumberofScopusindexedpublicationsin2017bytopsix healthcategoriesnationally 60

Figure40: PercentageandnumberofScopusindexedpublicationsin2017classifiedusingthe UKHRCSresearchactivitycodesnationally 60

Figure41: PercentageandnumberofScopusindexedpublicationsin2017bythetopsixhealth categoriesforcommunityandnon-hospitalareas 61

Figure42: PercentageandnumberofScopusindexedpublicationsin2017classifiedusingthe UKHRCSresearchactivitycodesforcommunityandnon-hospitalareas 61

Figure43: PercentageandnumberofScopusindexedpublicationsin2017classifiedbythe topsixhealthcategoriesfortotalhospitals 62

Figure44: PercentageandnumberofScopusindexedpublicationsin2017byresearchactivity codes for total hospitals 62

Figure45: ScopusindexedCFAApublicationsindexedintheScopusdatabasefrom2013to2017 63

Research Activity in the HSE and its Funded Organisations

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January 2019

Research & DevelopmentTaighde & Forbairt

Research Activity in the HSE and its Funded Organisations

AM Terrés, MC O’Hara, P Fleming, N Cole, D O’Hanlon, P Manning

A report of staff engaged in research, research studies undertaken, publication output and research networks