© NIHS2006

PublishedbyDesignersInk,Limerick

Allorpartofthispublicationmaybereproducedwithoutfurtherpermission,provided

thesourceisacknowledged.

22Charge

Section 1: introduction 01

¢ PurposeoftheGuide 01

¢ ResearchversusAudit 01

Section 2: reSearch concept and hypotheSiS 03

Section 3: Study deSign and protocol development 05

¢ 3.1 CategoriesofResearch 05

¢ 3.2 Randomisation 06

¢ 3.3 Blinding 06

¢ 3.4 Methodology 07

¨ 3.4.1 InformationSource 07

¨ 3.4.2 DataCollection 08

¨ 3.4.3 Sampling 09

¨ 3.4.3(a) Power 09

¨ 3.4.3(b) SampleSizeCalculation 09

¨ 3.4.4 DataManagement 10

¨ 3.4.5 DataAnalysis 11

¨ 3.4.6 DataPresentation 13

¢ 3.5 AssessmentofSubjectComplianceandWithdrawal 14

¢ 3.6 EthicalConsiderations 14

¢ 3.7 InterimReports 14

Section 4: ethicS and health reSearch 16

¢ 4.1 WhentoSeekEthicalApproval(Guideline) 16

¢ 4.2 EthicsCommitteesAuthorisedtoProvideApprovalfor 18

ClinicalTrialsonMedicinalProductsforHumanUse.

¢ 4.3 AdditionalLegalIssuestoConsider 19

Contents

i

Section 5: propoSal development 20

¢ 5.1 TitlePage 20

¢ 5.2 Introduction 20

¢ 5.3 BackgroundandRationale 20

¢ 5.4 Methodology 21

¢ 5.5 BudgetaryRequirements 21

¢ 5.6 Linkages 21

¢ 5.7 Dissemination 22

¢ 5.8 LiteratureReview/Bibliography 22

Section 6: publiShing 24

¢ 6.1 Abstract 24

¢ 6.2 Introduction 24

¢ 6.3 Materials/SubjectsandMethods 24

¢ 6.4 Results 25

¢ 6.5 Discussion 25

¢ 6.6 Bibliography 26

Section 7: reSearch and integrity 27

¢ 7.1 Plagiarism 27

Section 8: referenceS 28

¢ Appendix1 31

¢ Appendix2 35

¢ Appendix3 37

Contents

ii

01

1.1 purpoSe of the guide

Thegoal increatingthisdocument is tosupplyhealthcareworkerswithguidanceon

howtoplanandexecutetheirresearchprojectsinordertoproducegoodqualitydatafor

analysis.Theinformationsuppliedisintendedtoactasaguidethroughthekeystages

in conducting research and to provide some assistance to both the novice andmore

experiencedresearcheralike.

1.2 reSearch verSuS audit 26

Itisimportanttoensurethatyourinvestigationisactualresearchandnotanaudit.An

audit “determineswhetherexistingclinical knowledgeskills and resourcesarebeing

properlyused…andtheprimaryaimofaudit isto improvethedeliveryofhealthcare”.

Incontrast“research isconcernedwithgeneratingnewknowledgewhichwillhavea

generalapplication”and“seekstoinfluenceclinicalpracticeasawhole”.

Introduction 1sectionone

02

Beforeundertakingaresearchprojectitisessentialtodevelopaclearconceptanddefine

thehypothesisyouwanttotest.there are several sources of information available to

achieve this:

¢ Yourownorsupervisor’sknowledgeandexpertise

¢ Review current literature published on the topic. This information can be

accessedvialibraryorinternet:14

¨ Usefulinternetsitesinclude:

• IrishMedicalOrganisation(www.imo.ie)

• HealthDiscovery(www.healthdiscovery.com)

• NationalLibraryofMedicine(www.nlm.nih.gov)

• PubMed(www.PubMed.gov)

• HealthontheNet(www.hon.ch/)

• MedlinePlus(www.medlineplus.gov/)

• Sciseek(www.sciseek.com/)

• Biocrawler(www.biocrawler.com/)

• HSELibrariesOnline(www.hselibrary.ie)

¢ ConsultCochranereviewsonthetopicwww.thecochranelibrary.com

Althoughtheinternetcanbeaveryusefulresource,itisimportanttocriticallyevaluate

thequalityoftheinformationyouretrieve.Keepinmindtheaccuracy,reliability,relevance,

objectivityandauthorityoftheinformationyouaresourcing.

Onceyouhaveanalysedtheinformationrelevanttoyourtopicofresearchitisimportant

torefineyourresearchideaandclarifythespecificgoal(s)andobjective(s)ofthestudy.

consider whether you research is: 9

¢ Descriptive–whatishappening?

¢ Explanatory–howandwhyithappens?

¢ Predictive–whatorhowitwillhappen?

Alsoconsideriftheresearchisappliedorbasicandmakesuretoavoidlargescopethat

isvagueandnotclearlyspelledout.Keepinmind;Who?What?Where?When?Why?and

How?

ResearchConceptandHypothesis 2

03

sectiontwo

Once you have clarified your ideas, determine from whom/what you will get your

information, and if your sources of data will be from subjects directly or from the

recordsofsubjects.Itisimportantatthisstagetoconsidertheresearchtechniquesand

methodologiesyouwilluseandyourgeneralexperimentaldesign.

also consider the following:

¢ Wherewilltheresearchbeconducted?

¢ What resources are available in terms of equipment, people, funding

andfacilities?

04

2sectiontwo

Yourresearchprojectshouldbeconceived,designedandimplementedaccordingtothe

highestpossiblestandards.13, 18, 19Developmentofyourresearchprotocol isakeystep

andnormallyapre-requisiteforethicalapprovalandfundingapplications.Itformsthe

blueprintforhowthestudywillbeconducted.Itshoulddescribethedesign,methodology,

statisticalconsiderationsandorganisationofthestudy.

3.1 categorieS of reSearch:

Choosethetypeof researchyouwillbeconducting. the options include but are not

limited to: 1, 2

¢ obServational: analytic and deScriptive

Examplesinclude:

¨ caSe-control StudieS

• Investigational samples are chosen on the basis of their

diseaseoroutcomeofinterest

• Controls should be sourced from a similar population but not

havetheoutcomeofinterest

¨ cohort-StudieS

• The exposure of interest should be clearly described and

usedtoclassifytheexposedgroup

• Internal comparison group without exposure of interest will

beused

¨ croSS-Sectional StudieS

• Exposure status and disease status are assessed at a single

pointintime

• Provides useful data on the health status of the population at

agiventime

¨ caSe reportS

StudyDesignandProtocolDevelopment 3

05

sectionthree

sectionthree

¢ eXperimental (see Appendix 2)

examples include:

¨ ClinicalTrials

¨ Non-interventional trials (including randomised controlled trials)

asdefinedbyEUdirectiveMay20047

¨ Non-clinical trials (may involve physiological studies, development

of health and disability services and use of secondary data for

epidemiologystudies)

¨ Experimental studies can be designed in parallel, crossover and

factorialfashion

3.2 randomiSation 24

Inordertominimizebiassubjectsaregenerallyrandomisedtothevarioustreatmentor

testgroups.the randomisation can be:

¢ Stratified

¢ Blocked

¢ Systematic

¢ Clustered

3.3 blinding 20, 21

Blindingcanalsobe introducedtoreducebias.Theblindingapproachusedwillneed

EthicsCommittee(EC)approval.there are two types of blinding;

¢ Single blind:Eitherthepatient/subjectorinvestigatorisnotawareofthe

treatmentbeenadministered.

¢ double blind:boththepatient/subjectandinvestigatorarenotawareofthe

treatmentbeingadministered.

Doubleblinddesignmaynotalwaysbepossiblee.g.insurgicaltreatments

3

06

sectionthree

ItisadvisabletoinvolveaqualifiedBiostatisticianinordertoensurethattheappropriate

study design approach is used. the expertise of a biostatistician will facilitate the

following:

¢ Selectingasuitablesamplefromyourpopulationofinterest

¢ Ensuringthatthesamplesizewillgiveyouenoughpower

¢ Choosingthecorrectstatisticalapproachtodataanalysis

StatisticalsupportisfreelyavailabletoHSEemployeesintheMid-WestRegionthrough

theStatisticalConsultingUnitattheUniversityofLimerick.

¢ Statistical consulting unit

UniversityofLimerick

tel: +35361213471

mob: +353863866353

fax: +35361334927

email jean.saunders@ul.ie

3.4 methodology

3.4.1 information Source 20

The protocolmust detail the source of your data/information. in the case of healthy

volunteers or patients, provide specific details on:

¢ Howindividualsaresourced

¨ Thepublicdomain

¨ Aclinic

¨ Aregister

¢ Whatinclusion/exclusioncriteriawereapplied

¢ Therecruitment/enrolmentprocess

¢ Iftherewaspayment/compensationinvolved

¢ Howpatientconsentwasobtainedanddetailsofinformationsheetssupplied

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07

sectionthree

3.4.2 data collection

Datacollectionmethodsinclude:9

¢ Surveysandquestionnaires(usingscales,measuresandindices)

¢ Experimentaltests,proceduresandscreens

¢ Interviewsandfocusgroups

Ensurethatyouhaveconsideredwhatyourreferencepointorcontrolwillbe,i.e.thatwith

whichyoucancompareyourdata.Thedatayouneedtocollecttotestyourhypothesis

maybequantitative,qualitativeorboth.Qualitativedatacanbeobtainedfromstructured

or semi-structured interviews, focus groups, surveys, questionnaires, photographs,

videosandsoundrecordings.this type of data is useful for: 6, 15

¢ Describingcomplexsituations

¢ Providinganinsightintohowpeoplemakesenseofexperiences

¢ Intheinitialexploratoryphaseofathemeofinvestigation

¢ Tofurtherenhanceorexplainquantitativedata

Quantitativedataistypicallynumericalandcanbesourcedfromsurveys,questionnaires,

andarangeoflaboratoryandclinicalprocedures.2

group Sub-group examples

Categorical(Qualitative) Nominal Gender,bloodgroup

Ordinal Indicesassociatedwith

diseasegradese.g.

cancertumours

Numerical(Quantitative) Continuous Resultsfrommeasuring

thingse.g.weight,time

spentwaiting

Discrete Wholenumbersandarise

fromcountingthings

3

08

sectionthree

3.4.3 Sampling 9, 21, 24

Appropriate sampling is a critical part in the data collection process.representative

samples can be obtained from a target population in several ways:

¢ Systematicsampling-may be atypical

¢ Randomsampling-best option when trying to avoid bias

¢ Conveniencesampling-bias may be hidden

Itiscriticaltotheoutcomeoftheresearchthatasufficientsamplesizeisanalysedto

detectadifferencebetweencontrolandtestgroups.Ifastudyistoosmallitmaylack

powertopickupdifferences.Thesamplemustbe largeenoughtoavoidproducinga

falsenegativeresult.

3.4.3(a) power

Theprobabilityofdetectingatruedifferenceiscalledpower(1-β).

the power of a study is low when:

¢ Largevariabilityexistsbetweenthedataandthestandarddeviationislarge

¢ Smallsamplesize

¢ Tryingtodetectsubtledifferences

Themajority of studies seek to have a power of 80-90%. This can then be used to

calculatethenumberofsubjectsthatarerequiredtodetectaminimumclinicallyrelevant

difference

3.4.3(b) Sample size calculation(whenyouhavecontinuousdata–parametersknown)

Quantify the following:

¢ Power:(1-β);β=0.2to0.3

¢ SignificanceLevel(α):Thelevelbelowwhichthenullhypothesisisrejected

(seepage12)

¢ StandardDeviation(σ)

3

09

sectionthree

¢ Smallesteffectofinterest/clinicallyrelevant(δ)

¢ Standardiseddifference=(δ/σ)=Ds

RefertotheAltmanPowerPlotforf(α,β)

n*ineachgroup=f(α,β)x2σ2/(μ1–μ2)2=f(α,β)x2/Ds

2

Assumesequalnumbersineachgroup

Forsamplingandsamplesizecalculations(includingpowercalculations)aBiostatistician

shouldbeconsultedunlessyouhaveexperienceinthisarea.Samplesizingmethodology

dependsontheprimaryoutcomevariabletypeandisnotalwaysasstraightforwardas

examplegivenabove.

3.4.4 data management 20

Informationmustbeprovidedontheapproachusedtoobtainresearchdataintermsof

experiments,testsandprocedures.efficient and accurate data management in research

is key, and the following information should be stated:

¢ Thesourceofdata

¢ Whowillcollectthedata?

¢ Isthedataaccuratecompleteandunbiased?

¢ Thetimepointsforcollections

¢ Whythedataisbeingcollected(e.g.baselinecomparison,primary

outcomeetc)?

¢ Mentionuseofstandardisedtools

¢ Theforminwhichthedatawillbepresented.

¢ Methodofdatahandling,recoding(paper/electronicandback-ups)security

andretention

¢ Methodsused for data transfer, protection and storage–must adhere to the

DataProtectionAct5

¢ Patient/healthyvolunteerconfidentialitymustbemaintainedatallstages

oftheresearch

3

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sectionthree

3.4.5 data analysis

analysis of Qualitative data 6, 9, 15

¢ Collect

¢ Reduce

¨ Usingnumberssuchaspercentages

¨ Identifyrecurringconcepts,themesandgroupings

¢ Drawconclusionsandverify

Thereareanumberofcomputerprogrammesavailableforqualitativeanalysisofdata

includingNUD*IST,ATLAS,QUALRUSandNVIVO.

analysis of Quantitative data 2, 12, 21, 23

basic characteristics of Quantitative data

As previously stated a Biostatistician should be consulted during the study design

andmethodologystage.Atthispointsuitableapproachestostatisticalanalysiscanbe

identifiedtosuitthetypeofdatacollected.

Summaries include:

¢ MeasuresofCentralTendency

¨ Mean;average

¨ Median;middlevalue

¨ Mode;mostcommonvalue

¢ MeasuresofVariability

¨ StandardDeviation;variationaboutthemean

¨ Inter-quartilerange

¨ Range

3

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sectionthree

InferencescanbemadeaboutdatathroughconstructionofConfidenceintervalsand/or

Hypothesistesting.Theprotocolshouldprovideasummaryonthestatisticalanalysis

thatwillbeperformedandtheformatinwhichthedatawillbepresented.

Statistical inference:

ConfidenceIntervalEstimation(CI)

¢ Involvesusinganintervaltoestimatethepopulationparameter.Usuallysetat

95%andindicatesthataresearcheris95%confidentthatthedatarepresents

aplausiblerangeofvaluesforthetruepopulationvalue.ThenarrowertheCI

thebetter.

HypothesisTesting

¢ Theresearchobjectiveisoftenexpressedintheformofanullhypothesis.The

nullhypothesisstatesthatnodifferenceexistsbetweencontrolandtestgroups.

ThePvalueistheprobabilityofaresultoccurringbychance.

Ifthepvalue<0.05–thenullhypothesisisrejected,thisimpliessignificance

Ifthepvalue>0.05-donotrejectthenullhypothesis

Sufficientpowerisrequiredtoavoiderrors.

errors in hypothesis testing:

type i error

A difference is detected yet no difference exists - false positive. This probability is

denotedαisequaltothesignificancelevel(usually5%).Thistypeoferrorcanoccurif

thesampleisbiasedand/ortoosmall.

3

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sectionthree

type ii error

No difference is detected but a difference exists - false negative. This probability is

denotedβand20%isusuallyanacceptablelevel.

Thetypesofhypothesistestsusedtocalculatethep-valueincludethechi-squaredtest

ofassociationandthet-testdependingonthetypeofvariabletobetestedandthenull

hypothesisstated.

3.4.6 data presentation

Datacanbepresentedasfractions,proportions,ratesandwholenumbers.Thedatacan

beformattedinseveralways. examples include:

¢ Tables–synopsisofrawdata,usuallyintheformofmeansandstandard

deviations

¢ Graphs–x-axisindependentvariable(treatment),y-axisdependentvariable

(totalsormeans)

¨ Histograms

¨ Boxplots

¨ Linegraphs

• Usefulinshowingdatapointsovertime

Thejuxtapositionoftwodifferentsetsofdatacancreategoodvisualeffect.

Inadditionerrorbarscanbeusedtoshowthelevelofvariabilityaboutthemean.

¢ Pie Charts – can be used to display the contribution of each treatment to

thewhole

for further information on graphing data visit:

www.bettycjung.net/Graphing.htm

www.scene.asu.edu/habitat/data_present.html

3

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sectionthree

3.5 aSSeSSment of Subject compliance and WithdraWal 20

¢ Whatsystemswillbeusedtomonitorpatient/volunteercompliance?

¨ Howwillalapseincomplianceberecorded/andfollowed-up?

¢ Asubjectcanwithdrawfromastudyatanytimeandforanyreason

¨ Howwillawithdrawalbedocumented?

¨ Willthesubjectbefollowed-up?

3.6 ethical conSiderationS

TheresearcherneedstodetermineifapprovalfromanECisnecessarytoconductthe

research(seeSection4).IfECapprovalisdeemednecessarythenpatientconsentforms

andinformationsheetsmustbepreparedandthensuppliedtotheappropriateEC.

3.7 interim reportS

WhereappropriatethePrincipalResearchershouldcoordinatethegenerationofinterim

reportssummarisingtheprogressoftheresearch.

the production of interim reports would generally be necessary when conducting:

¢ Clinicaltrials(includingtrialsonmedicinalproductsasdefinedbyEUDirective,

May2004)7

¢ Non-interventionalandnon-clinicaltrials

¢ Longitudinalinvestigations

interim reports are generally not necessary for:

¢ Short-terminvestigationsusingsmallsamplesizes

¢ Cross-sectionalstudies

3

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sectionthree

Interim reportsmaybe requestedby theECthatprovidedapproval for thestudy, the

instituteorhospitalhostingtheresearchorthefundingbodythatprovidedthefinancial

supporttoconducttheinvestigation.Theformatofthereportwillvarydependingonthe

bodythathasrequestedtheinformation.it may be in the form of:

¢ Anabstractorsummary

¢ Scientific/MedicalPaper

Details may be required on resource personnel, expenditure as well as significant

scientific andmedical output. In general, dissemination in science, health and public

domainsisalsorecommendedwhereappropriate.

3

15

Healthresearchersneedtoconsiderifethicalapprovalisarequirementtoconducttheir

specificinvestigation.ThedeclarationofHelsinkifromtheWorldMedicalAssociationin

June1963outlinedtheguidelinesthatmedicalpractitionersandresearchersmustfollow

when engaging in trials that involve human subjects. This declaration also provides

ethicscommitteeswithguidanceanddirectionwhenreviewingresearchorclinicaltrial

applicationsinvolvinghumansubjects.

PrinciplesofEthicalReview(AsoutlinedbytheIrishCouncilforBioethics,

websitewww.bioethics.ie):17

¢ Respectforpersons

¢ Privacyandconfidentiality

¢ Validityofresearchproposals

¢ Minimalrisktoparticipants

¢ Toneitherdiscriminateorneglectindividuals

Researchinvolvinghumanparticipantsincludesbutisnotlimitedtoclinicaltrials.EC’s

are located throughout Ireland in hospitals, universities and research institutions to

reviewapplicationstoconductresearchinvolvinghumanparticipation.

4.1 When to Seek ethical approval (guideline)

Researchproposalsthatinvolvehumanparticipationorthecollectionanduseofprimary

andsecondarydatamayrequirereviewbyanEC.the text below summarises when a

researcher may require ethical approval from and ec:

mayRequireECApproval:17

¢ Clinicaltrialsonmedicinalproducts/medicaldevicesinvolvinghumans

¢ Newtreatmentorinterventions

¢ Research involvinghumanremains,cadavers, tissues,discardedtissuesand

biologicalfluids

¢ PhysiologicalStudies

4 EthicsandHealthResearch

16

sectionfour

¢ Comparinganestablishedprocedure(therapeuticordiagnostic)withprocedures

notestablished

¢ Innovativepracticesinhealthanddisabilityservices

¢ Observationalclinicalresearch

¢ Researchconductedbystudentsthatinvolveshumanparticipants

¢ Surveysorquestionnairesusedtocollectpersonalinformationonindividuals

¢ Useofdataderivedfromindividualrecordswherepeoplemaybeidentified

¢ Casestudieswithaseriesofsubjectobservationstoextrapolategeneralisations

withtheintenttopublish/disseminatedata

may notRequireECApproval:

¢ Researchusingexistingpubliclyavailabledataordocuments

¢ QualityAssuranceStudies*

¢ Audit*

¢ Casestudyof1patientwheninformedconsenthasbeenobtained

¢ Observationalstudiesinpublicplaceswhentheidentityofthepersonsremains

anonymous

* This statement does NOT imply that all quality assurance studies and audits are exempt

from ethical approval. That will depend on the source on the information and whether

confidentiality of patients or participants may be compromised.

Whenindoubtastowhetheryourresearchproposalorprojectrequiresethicalapproval

thenanECshouldbeconsultedfortheiropinion.

the documentation required by the ec to consider an application for ethics approval

generally includes but is not limited to:

¢ Signedanddatedapplicationform

¢ Protocol

¢ If a product (e.g. Pharmaceutical) is being assessed then a summary of all

pharmacological, toxicological and clinical experience data on a product or

deviceunderinvestigation.

¢ Casereportforms,patientinformationsheet,diarycards,questionnairesand

consentforms.

4

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sectionfour

¢ CurriculumVitaeofallinvestigators

¢ Processusedtoobtainconsent

¢ Arrangementsmadetoindemnifyvolunteersandinvestigators

¢ All otherECdecisionsmade in relation to theproposal andanysubsequent

amendmentsthatweremade

¢ Descriptionoftheethicalconsiderationsinvolvedintheproposal

4.2 ethicS committeeS authoriSed to provide approval for clinical trialS on medicinal productS for human uSe

Therearecurrently13ECsinIrelandthathavebeenauthorisedtoprovideapprovalforof

clinicaltrialsonmedicinalproductsasdefinedintheEuropeanDirectiveonClinicaltrials

onMedicinalProductsforHumanUse(May2004).7Whenconductingclinicaltrialson

medicinalproductsforhumanuseguidanceonapplicationsforrecognisedECopinion

maybefoundat:www.dohc.ie/issues/clinical_trials_2004/

TheECsalsofunctiontoprovideapprovalforthemanyotherformsofhealthresearch

includingnon-clinicaltrialsandobservationalstudies.

See Appendix 1 for details on each committee.

See Appendix 3 for additional information on ECs operating in the Mid-West Region.

4

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sectionfour

4.3 additional legal iSSueS to conSider

¢ AllClinicalTrialsonMedicinalProductsmustbeapprovedbytheIrishMedicines

Board7

¢ WhenconductingClinicalTrialsonMedicinalProductstherecommendations

detailed in the EU Directive, May 2004 must be adhered to.7 In addition

investigatorsmustfollowtherecommendationsoutlinedintheEUDirectiveon

GoodClinicalPractice(GCPDirective2005/28/EC)8

¢ Incaseswhereuseandstorageofbiological tissue isnecessaryaspartof

a research protocol the principle investigator should insure that the

recommendations outlined by The Irish Council for Bioethics are followed

(HumanBiologicalMaterial:RecommendationsforCollectionUseandStorage

inResearch2005).16

¢ AwarenessofDataProtectionLaws(seeDataProtectionAct1988)5

¢ That appropriate insurance is in place at the study site and that individuals

conductingthestudyareindemnified

¢ TheControlofClinicalTrialsActs1987and1990shallapplytoclinicaltrialsnot

subjecttotheRegulationsoutlinedintheEUDirective,May2004

(www.dohc.ie)

¢ Inthecaseofresearchandtrialsinvolvingthedevelopmentofmedicaldevices

researchersshouldadheretoGoodManufacturingPractice(GMP),andcomply

with the EU Medical Device Directives (see www.ec.europa.eu/enterprise/

medical_devices/index_enhtml).Ifthedevicewillbetestedanddevelopedwith

aview tomarketing in theUnitedStates theFood andDrugAdministration

(FDA)hassetoutarangeofguidelinesthatmustbefollowed(seewww.fda.

gov/cdrh/devadvice/)

4

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sectionfour

5.1 title page 20

both a full title and short title are required:

¢ Thefulltitleshoulddetailasummaryofstudydesign,exposureandoutcomes

ofinterest,patientpopulationandsetting.

¢ Theshorttitleissummaryoftheabove.

also include details of:

¢ Authors,investigatorsexpertsandadvisorsinthestudy(includingCurriculum

Vitae)

¢ Studysite:Clinical laboratory,technicaldepartments,clinicsand institutions

involvedinthestudy

¢ Acontentspage

¢ Listanddefinitionofabbreviations

5.2 introduction

Stateclearlytheaimoftheproposedresearch.Thisisgenerallyabroadstatementof

intent. Subsequentlyelaborateonhowthegoal(s)willbeachieved.The introduction

shouldalsocontaindetailsonthestrategy(ies)youwillemploytoachieveyourgoals

andobjectives.

5.3 background and rationale

Summariseswhyyouareconductingtheresearch,referencingwhathasbeenpublished

thus far in the area, how you plan to add to the knowledge base, who will benefit

frompotential outcomes,will benefits includepotential discoveryof newprocedures,

treatmentsorhaveapositivefinancialoutcome?

5 ProposalDevelopment

20

sectionfive

5.4 methodology

include details of the following:

¢ Studydesignchosenandwhy

¨ RandomisedControlledTrials,observationalstudyetc.

¢ Datasource,collection,storageandprocessing

¢ Subjectsandsamplesize(astatementshowinghowsamplesizewascalculated

whenappropriate)

¢ Patientinformationsheetsandconsentforms

¢ Ethicalapproval(ifnecessaryforthestudy)

¢ Methodofstatisticalanalysis

5.5 budgetary reQuirementS

Supplyconcisedetailsofpredictedongoingrunningcostsincludingstaffandnon-staff

costs(equipment,transportetc).Ifrelevanttothefundingcallcapitalcostsshouldalso

beaddressed.

5.6 linkageS

describe linkages to other national and international research cohorts:

¢ Highlightanyrelevantcollaboratorsyouproposetoengagewithfortheduration

ofthestudy

¢ Highlight their specific areaof expertise andsuccessful outcomes fromany

previousworkthatyouhaveconductedwiththisgroup

¢ Mentiontheresources,techniquesandequipmenttheywillbringtothestudy

5

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sectionfive

5.7 diSSemination

Describeyourplanstodisseminateinformation/resultsduringandattheconclusionof

yourresearchincludingmilestonesanddeliverables.consider the following:

¢ Howoftenandthroughwhatmediumdoyouplantopubliciseyour

researchdata?

¢ Considerusingseminars,conferences,researchpublications

¢ Whatisyourexpectedpublishingoutput?

¨ Willyoutargetlocal,regionalnationalandinternationalpeer

reviewjournals?

¢ Howwillyoumonitorthescientificandclinicalvalueofyourresearch?

5.8 literature revieW/bibliography

It is usual practice to use the Vancouver method when referencing journals and

texts. (International Committee of Medical Journal Editors Uniform Requirements

for Manuscripts Submitted to Biomedical Journals: www.nlm.nih.gov/bsd/uniform_

requirements.html)

¢ Standard journal article:e.g.

HalpernSD,UbelPA,CaplanAL.Solid-organtransplantation inHIV-infected

patients.NEnglJMed.2002Jul25;347(4):284-7.

¢ book or monograph: e.g.

MurrayPR,RosenthalKS,KobayashiGS,PfallerMA.Medicalmicrobiology.4th

ed.St.Louis:Mosby;2002.

¢ newspaper article:e.g.

TynanT.Medicalimprovementslowerhomiciderate:studyseesdropinassault

rate.TheWashingtonPost.2002Aug12;Sect.A:2(col.4).

5

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sectionfive

¢ World Wide Web page (no author):e.g.

Cancer-Pain.org[homepageontheInternet].NewYork:AssociationofCancer

OnlineResources, Inc.; c2000-01 [updated 2002May 16; cited 2002 Jul 9].

Availablefrom:www.cancer-pain.org

Pleasenotethateachfundinginstituteorbodywillusuallyhaveitsownspecifictemplate

intermsofdocumentlayoutandinformationrequested.Ingeneral,thedetailsrequired

willcoverthetopicsoutlinedabove.

national and international research funding bodies include:

HealthResearchBoard;www.hrb.ie

ScienceFoundationIreland;www.sfi.ie

EnterpriseIreland;www.enterprise-ireland.com

IrishResearchCouncilforScience,Engineering&Technology;www.ircset.ie

IrishCancerSociety;www.cancer.ie

IrishHeartFoundation;www.irishheart.ie

EuropeanUnion;www.welcomeeurope.com

WellcomeTrustFoundation;www.wellcome.ac.uk

5

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sectionfive

the editorial committee of each journal has its own standards and guidelines that must

be adhered to for publication:

¢ Checkeachjournalspecificrequirementsbeforesubmission

¢ RefertotheGuidelinesonGoodPublicationPractice3

in general the basic sections of any journal will include most if not all of the following

topics;

6.1 abStract

This is a very short summary ofwhatwas investigated by the researcher andwhy.

It should summarise key results. In addition the key-words in the paper should be

highlightedundertheabstracttext.

6.2 introduction 4

This section should define the condition or problem being investigated and provide

background information and concept. These should then be linked to the hypothesis

beingtested.Theaimsandobjectivesoftheresearchmustbeclearlystatedatthispoint.

In addition, summarisewhat youhave foundandhow,describe the limitationsof the

studyandtheimportanceofyourfindings.

6.3 materialS/SubjectS and methodS

Provide details on the source of you data, ie patients, healthy volunteers, bio-banks,

records etc and detail your inclusion/exclusion criteria. State the study design, is it

experimentalorobservational?Supplyinformationonwhatwillbemeasuredandhow.

Will you be using gold standard approaches, if so, what are they? Also discuss the

6 Publishing22

24

sectionsix

statisticalmethods used to analyse your data, i.e. confidence intervals or hypothesis

tests.

6.4 reSultS

Datamaybepresentedintheform,oftables,chartshistograms,imagesetc.Eachfigure

detailing resultsmust have a legend underneath summarising the content. The body

oftext intheresultssectionshoulddescribeinamatteroffactwaythedataandnot

explainoraccountforthefindings.Thetextshoulddealwiththeeachfigureofdatain

chronologicalorder.

figures, tables and legends – critical for the paper’s success 4

¢ Mostimportantpartofpaper

¢ Mostneglectedpartofthepaper

¢ Shouldbethefirstparttobedesignedandwritten

¢ Partofthepaperthatdeterminessuccessorfailure

6.5 diScuSSion 4

Thissectionofthepaperallowstheauthortopresenthis/herinterpretationofthedata

anddiscussthelikelyimpactofthefindingsoncurrentbestpracticeinthespecificfield.

Italsoprovidestheauthorwiththeopportunitytonotethelimitationsofthestudyand

describefutureresearchthatmaybeconductedinthearea.

6

25

sectionsix

6.6 bibliography

Eachjournalwillspecifytheformatinwhichtopresentthebibliographythiswillusually

betheVancouvermethod(seesection5.8).

note:

in cases where the author plans to release the findings to the mass media all participants

in the study should be made aware of the findings in advance.

6

26

sectionsix

Aresearchermust conduct scientific/medical researchandpublish thefindings in an

ethicalmanner.Thefollowingactionsareconsideredunethicalpracticesinthescientific

andmedicalcommunities:3,10,11

¢ Piracy-exploitationofideasfromotherswithoutacknowledgement

¢ Plagiarism-copyingofideas,dataandtextwithoutacknowledgement

¢ Fraud-fabrication,falsification/inventionofdata

Beawarethatmultipleauthorshipdisputesarealsoverycommon.Thepracticeofgift

orguestauthorshipshouldbeavoided.Althoughthereisnouniversallyagreeddefinition

ofauthorshipitisessentialthatrolesinmatterofauthorshipandpublicationbeagreed

whenthestudyisbeingdesigned.Atthispointthelevelofcontributionandinputtothe

studydesignandexecutionthatisrequiredtowarrantauthorshipshouldbestated.

7.1 plagiariSm 25

ArecentarticleintheIrishExaminerhighlightstheproblemofplagiarismandthatthis

issueisnotconfinedtothosetryingtoestablishthemselvesearlyonintheircareers.The

authorcorrectlydescribesplagiarismastheblatant “disregard for the reputationand

hardworkofothers”

common unacceptable excuses include:

¢ Cutandpasteerrorononespersonalcomputerresultinginreferencesbeing

“inadvertentlyomitted”.

¢ Topleadignoranceasitisthefirstsubstantialworkonehaswritten.

Inordertoavoidtheinadvertentplagiarismpitfallandgeneralmisconductinscientific

andmedicalresearch,theCommitteeofPublicationEthics(COPE)hasproducedasetof

guidelinesprovidingadviceanddirection.3

7ResearchandIntegrity

27

sectionseven

1. Bland JM, Butland BK, Peackock JL, Poloniecki J, Reid F, Sedgewick P.

StatisticsGuide forResearchGrantApplicants [monographon the Internet].

No date [cited 2005Dec12]. Available from:www.sgul.ac.uk/depts/chs/chs_

research/stat_guide/guide.cfm#top

2. BowersD,HouseA,OwensD.UnderstandingClinicalPapers.JohnWiley&

Sons;2003.

3. Committee on Publication Ethics (COPE). Guidelines on Good Publication

Practice[monographonthe Internet].Nodate [cited2005Dec21].Available

from:www.publicationethics.org.uk/guidelines/reports/2003/2003pdf15.pdf

4. CostelloR.Gettingon:Asseenbysomeonewhoisgettingon[homepageonthe

Internet].c2000[cited2006Jan16].Availablefrom:www.nihs.ie

5. DataProtectionCommissioner.DataProtection(Amendment)Act2003[statute

ontheInternet].c2003[cited2006Oct17].Availablefrom:

www.dataprotection.ie/documents/guidance/New_Act_Summary_website_

version.pdf

6. Denzin,Lincoln.HandbookofQualitativeResearch.3rded.Sage;2005

7. DepartmentofHealth&Children. EuropeanCommunities (ClinicalTrialson

MedicinalProductsforHumanUse)Regulations,2004[statueontheInternet].

c2004[cited2005Nov25].Availablefrom:

www.dohc.ie/legislation/statutory_instruments/pdf/si20040190.pdf?direct=1

8. Department of Health & Children. European Communities (Clinical Trials on

Medicinal Products for Human Use) (Amendment no. 2) Regulations 2006

[statuteontheInternet].c2006[cited2006Sept3].Availablefrom:

www.dohc.ie/issues/consultation_good_clinical_practice_2006/Draft_

Regulations.pdf?direct=1

8

28

Referencessectioneight

9. Kane E. De- Bruin-O’ Reilly M. Doing Your Own Research. London: Marion

Boyars;2001

10. Fenton J. Integrity in Medical Research & Publication [homepage on the

Internet].c2005[cited2005Dec21].Availablefrom:www.nihs.ie

11. FentonJE,JonesAS. Integrity inMedicalResearchandPublication.Clinical

Otolaryngology.2002;27,436-439.

12. Gardner MJ, Altman Douglas G. Statistics with Confidence – Confidence

intervalsandstatisticalguidelines.London:BritishMedicalJournal,1994.

13. Wellcome Trust. Guidelines on Good Research Practice [monograph on the

Internet].c2002.[updated2005Nov;cited2005Dec6]Availablefrom:

www.wellcome.ac.uk/doc%5Fwtd002753.html

14. GuptaR.ConceptandIdea[homepageontheInternet].c2005[cited2005Dec

21].Availablefrom:www.nihs.ie

15. Houghton F. Qualitative Methodologies [homepage on the internet]. c2005

[cited2005Dec21].Availablefromwww.nihs.ie

16. IrishCouncil forBioethics.HumanBiologicalMaterial:Recommendationsfor

Collection,UseandStorageinResearch.Dublin: IrishCouncilforBioethics,

2005.

17. Irish Council for Bioethics. Operational Procedures for Research Ethics

Committees:Guidance2004.Dublin:IrishCouncilforBioethics,2004.

18. MedicalResearchCouncil;EthicsSeries.GoodResearchPractice[monograph

on the Internet]. c2000. [updated 2005Sept; cited 2006Nov 20]. Available

from:www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002415

8

29

sectioneight

19. International Conference on Harmonisation of Technical Requirement for

Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised

Tripartite Guidelines; Guideline for Good Clinical Practice (GCP(E6.R1))

[monographontheInternet]c2002[cited2006Nov20]Availablefromwww.

emea.eu.int/pdfs/human/ich/013595.en.pdf

20. Medical Statistics Unit, UCLH R&D Directorate. Guidelines for Completing

aResearchProtocol forObservational Studies [monograph on the Internet].

c2006 [cited 2006 Sept 6]: Available from: www.uclh.nhs.uk/NR/rdonlyres/

066EBB58-BB0F-462A-908A-86DB5FB9216A/0/obs_protocol_guidelines_

2006.pdf

21. PetrieA,SabinC.MedicalStatisticsataGlance.BlackwellPublishing;2003.

22. BrownerW.Publishing andPresentingClinical Research. 2nd ed. Lippincott

Williams&Wilkins;2006.

23. SaundersJ,SCU,UniversityofLimerick.MedicalStatistics[homepageonthe

internet].2005[cited21December2005].Availablefrom:www.nihs.ie.

24. Saunders J, SCU, University of Limerick. Study Design & Methodology

[homepageonthe internet].2005 [cited18December2005].Available from:

www.nihs.ie

25. ProneT.CopyrightandCopyWrongs.IrishExaminer.2005Nov11.

26. CooperM,TurpinG,BucksR,KentG.GoodResearchPracticeGuidelinesforthe

ConductofPsychologicalResearchwithintheNHS.[monographontheInternet].

c2005 [cited 2006 Jan 17] Available from: www.bps.org.uk/downloadfile.

cfm?file_uuid=E615A15A-1143-DFD0-7E9F-60808ED2875D&ext=pdf

8

30

sectioneight

name of ethics address for date of area for description or class

committee correspondence recognition which of clinical trials

committee for which

may act committee may act

SJH/AMNCH TallaghtHospital, 13July Thewhole Clinicaltrialsof

ResearchEthics Dublin24 2004 State alldescriptions

Committee andclasses.

StVincent’s Administrator, 13Sep Thewhole Clinicaltrialsof

HealthcareGroup StVincent’s 2004 State alldescriptions

Ethicsand HealthcareGroup andclasses.

MedicalResearch Ethicsand

Committee MedicalResearch

Committee,

Educationand

ResearchCentre,

ElmPark,Dublin4.

ClinicalResearch Secretariat, 27Sep Thewhole Clinicaltrialsof

EthicsCommittee ClinicalResearch 2004 State alldescriptions

oftheCork EthicsCommittee andclasses.

Teaching ofTheCork

Hospitals TeachingHospitals,

2200CorkAirport

BusinessPark,

KinsaleRoad,Cork

HSENorthEast Secretary,HSE 26Jan Thewhole Clinicaltrialsof

AreaResearch NorthEastArea 2005 State alldescriptions

EthicsCommittee ResearchEthics andclasses.

Committee,Dublin

Rd,Kells,Co.Meath

Appendix1 8

31

sectioneight

name of ethics address for date of area for description or class

committee correspondence recognition which of clinical trials

committee for which

may act committee may act

ResearchEthics Administrator, 22Feb Thewhole Clinicaltrialsof

Committee,Mater ResearchEthics 2005 State alldescriptions

Misericordiae Committee,Mater andclasses.

UniversityHospitalMisericordiae

andMaterPrivate UniversityHospital,

Hospital EcclesStreet,

Dublin7

BeaumontHospitalGillianVale, 9March Thewhole Clinicaltrialsof

EthicsCommittee Administrator, 2005 State alldescriptions

EthicsCommittee, andclasses.

BeaumontHospital,

BeaumontRoad,

Dublin9

GalwayRegional SecretaryResearch 21April Thewhole Clinicaltrialsof

HospitalsResearchEthicsCommittee, 2005 State alldescriptions

EthicsCommittee Services andclasses.

Department,Block

2C,MainHospital,

UniversityCollege

Hospital,

NewcastleRoad,

Galway

8

32

sectioneight

name of ethics address for date of area for description or class

committee correspondence recognition which of clinical trials

committee for which

may act committee may act

ResearchEthics Secretary, 17May Thewhole Clinicaltrialsof

Committee, ResearchEthics 2005 State alldescriptions

OurLady’s Committee, andclasses.

HospitalforSick OurLady’s

Children HospitalforSick

Children,Crumlin,

Dublin12

IrishCollegeof Administrator, 17May Thewhole Clinicaltrialsof

General ICGPResearch 2005 State alldescriptions

Practitioners Committee,4/5 andclasses.

ResearchEthics LincolnPlace,

Committee Dublin2

EthicsResearch MsDeniseO’Brien, 20July Thewhole Clinicaltrialsof

Committee, Secretary, 2005 State alldescriptions

NationalMaternity EthicsResearch andclasses.

Hospital Committee,Masters

/CEOOffice,

NationalMaternity

Hospital,Holles

Street,Dublin2

8

33

sectioneight

name of ethics address for date of area for description or class

committee correspondence recognition which of clinical trials

committee for which

may act committee may act

HSESouth- Secretary, 30Aug Thewhole Clinicaltrialsof

EasternArea ResearchEthics 2005 State alldescriptions

ResearchEthics CommitteeOffice, andclasses.

Committee OldSchoolOf

Nursing,Waterford

RegionalHospital,

DunmoreRoad,

Waterford

ResearchEthics Administrator, 20Sep Thewhole TheCommitteeshall

CommitteeSligo ResearchEthics 2005 State actinrelationto

GeneralHospital Committee, clinicaltrialsofall

SligoGeneral descriptionsand

Hospital,TheMall, classesotherthan

Sligo thosetowhich

Regulation13(4)

refers(i.e.gene

therapy,somaticcell

therapyetc.).

EthicsResearch Secretary, 22March Thewhole Clinicaltrialsof

CommitteeHSE EthicsCommittee, 2006 State alldescriptions

Mid-WesternArea Mid-Western andclasses.

RegionalHospital,

Dooradoyle,

Limerick

8

34

sectioneight

a clinical trial

Any investigation in human subjects intended to discover or verify the clinical,

pharmacologicaland/orotherpharmacodynamiceffectsofaninvestigationalproducts(s)

and/or to identify anyadverse reactions to an investigational product and/or to study

absorption,distribution,metabolismandexcretionofaninvestigationalproduct(s)with

theobjectofascertainingsafetyandorefficacy.(ICHHarmonisedTripartiteGuidelines

forGoodClinicalPractice.19

also see:PocockSJ.ClinicalTrials:APracticalApproach.JohnWiley&Sons;1990.

a clinical trial (clinical trialS on medicinal productS for human uSe regulationS, may 2004) 7

any investigation in human subjects, other that a non-interventional trial intended:

A. Todiscoverorverifytheclinical,pharmacologicalorotherpharmacodynamic

effectsofoneormoreinvestigationalmedicinalproducts,or

B. Toidentifyanyadversereactionstooneormoresuchinvestigationalmedicinal

products,or

C. To study absorption, distribution,metabolism and excretion of one ormore

suchinvestigationalmedicinalproducts,or

D. Todiscover,verify,identifyorstudyanycombinationorthemattersreferredto

inA,B,orCwiththeobjectofascertainingsafetyorefficacyofsuchproducts

orboth.

non-interventional trial: (clinical trialS on medicinal productS for human uSe regulationS, may 2004) 7

is a trial involving the study of one or more medicinal products which have a marketing

authorisation where the following conditions are met:

Appendix2 8

35

sectioneight

A. Theproductsareprescribedintheusualmannerinaccordancewiththeterms

ofthatauthorisation.

B. Theassignmentofanypatientinvolvedinthestudytoaparticulartherapeutic

strategy isnotdecided inadvancebyaclinicaltrialprotocolbut fallswithin

currentpractice.

C. Thedecisiontoprescribeaparticularmedicinalproduct isclearlyseparated

fromthedecisiontoincludethepatientinthestudy.

D. Nodiagnosticormonitoringproceduresareappliedtothepatientsincludedin

thestudy,otherthanthosewhichareordinarilyapplied inthecourseofthe

particulartherapeuticstrategyinquestion

E. Epidemiologicalmethodsaretobeusedfortheanalysisofthedataarisingfrom

thestudy.

non-clinical trial

Canbedefinedasaninvestigationtoobtaininformation,advanceknowledgeandimprove

humanwell-being.Suchstudiesmayinvolvebutnotbelimitedtophysiologicalstudies,

developmentofhealthanddisabilityservicesanduseofsecondarydataforepidemiology

studies.

8

36

sectioneight

ethicS committeeS in the mid-WeSt region

university of limerick research ethics committee

applications to conduct research must be sought from the university rec by ul staff

and students in the following circumstances:

¢ Directexperimentationonindividuals

¢ Surveysorquestionnairesposedtoindividuals

¢ Useofdataderivedfromindividualrecordswherepeoplemaybeidentified

PleasenotethattheECattheUniversitydealswithinvestigationsinvolvingpublicand

communityparticipantsonlyandnotpatientsthatarereceivingtreatmentortherapyfor

an illness. Ifpatientsare involvedapprovalmustbesought fromtheEthicsResearch

CommitteeHSEMid-WesternArea

the operational procedures of this ec are as follows:

¢ FormalmeetingsareheldmonthlyduringtheAcademicYear(onepermonth

exceptAugust),andthedeadlineforreceiptofprotocolsisthelastworkingday

oftheprecedingmonth(allowancemustbemadeforbankholidaysetc.)

¢ Thereare15membersonthecommittee

¢ GuidelinesandapplicationformsforresearchbasedinScience&Technologies

orBusinessHumanities andEducationcanbedownloaded fromtheULREC

website www.ul.ie/researchethics. Receipt of the application form will be

acknowledgedandallocatedaULRECNumber.

¢ Themain REC approves doctorate and staff directed proposals that involve

membersofthecommunityasparticipants.Approvalmaybegivenimmediately

orpendingminorchanges.Approvalcanbegivenforupto3yearsandifthe

projecthasnotstartedwithinayearapprovalmayberescinded.

Appendix3 8

37

sectioneight

university of limerick research ethics committeeTheSecretary,

UniversityofLimerickResearchEthicsCommittee

C/oVicePresidentAcademicandRegistrar’sOffice,

UniversityofLimerick.

ethics research committee hSe mid-Western area

ApplicationforethicsapprovalmustbesenttothisECwhentheresearchinvolvesaccess

topatientsorclientsanddata/recordswithinthehealthservice.Thisethicscommittee

canprovideapprovalforClinicalTrialsonMedicinalProductsforHumanUseasdefined

bytheEUDirective.7ApplicationsmaybesenttothisoroneoftheothertwelveEthics

Committees which have been recognised under Regulation 7 of the EU Directive on

ClinicalTrialsonMedicinalProductsforHumanUse.

http://www.dohc.ie/issues/clinical_trials/ethics_committees.html

(seeAppendix1)

the operational procedures of this ec are as follows:

¢ MeetingstakeplaceonceamonthexceptinJuly,AugustandDecember.

¢ Applications and submissions to the ethics committee shall be received

nolessthanthreeweeksinadvanceofthemeetingatwhichtheapplicationis

tobeconsidered.

¢ MsBernadetteRyancanbecontactedforinformationonmeetingschedulesPh:

061-482482ore-mailbernadettef.ryan@mailh.hse.ie

¢ One of the researchers involved in the proposed research must attend the

ECmeetingtopresenttheresearchandexplainanyethicalissues.

¢ The application form to apply for ethical approval can be obtained fromMs

BernadetteRyan(Ph:061-482482ore-mailbernadettef.ryan@mailh.hse.ie)

8

38

sectioneight

8

¢ The committeemembers receive proposals in advance of eachmeeting. At

this meeting the research proposal will then be; a) accepted, b) rejected

outright,orc)acceptedpendingamendments.Followingthemeetinga letter

will be sent to the applicant stating what changes must be made before

approvalcanbegiven.Initialapprovalisgrantedfora12monthperiod.Ifthe

study/project continues after 12months then the primary investigatormust

reapplyinwriting(letter).

¢ Allapplicationssubmittedmusthavetheproposedresearchprojectsupervised

byamedicalconsultantfromtheHSEintheMid-WestRegion.

ethics research committee hSe mid-Western areaSecretary,

EthicsCommittee

Mid-WesternRegionalHospital,

Dooradoyle,

Limerick

39

sectioneight

40

ethicS approval in the mid-WeSt region

use of:• healthy volunteers from the public and community by ul staff or students• data from the public or community by ul staff or students

use of:• patients• clients of hSe• patient data

apply to the university of limerick rec

apply to the ethics research committee hSe mid-Western area

complete the application form and Supply all relevant documentation

• approval• approval pending protocol amendments• rejection

8

health reSearch

sectioneight

if the reSearch comeS under:

clinical trials on medicinal products for human use

(AsdefinedbyEUDirective,May2004andauthorisedbytheIrishMedicinesBoard)

ThentheprincipalresearchermustapplytotheEthicsResearchCommitteeHSE

Mid-WesternAreaoroneoftheother12approvedEthicsCommitteesthathavebeen

recognisedbytheEthicsSupervisoryBodyunderregulation7oftheEUDirectiveto

approvesuchstudies(SeeAppendix1)

41

8sectioneight

42

Notes

National Institute of Health ScienceSt. Camillus Hospital

Shelbourne RoadLimerick, Ireland

T: 061 483929 F: 061 326670 E: info@nihs.ie W: www.nihs.ie