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Ethicalresearchguidelinesforwastewater-basedepidemiologyand
relatedfields
Version1.0
2015
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DevelopedjointlybytheUniversityofTasmania,theUniversityofQueensland,MarioNegri,theUniversityofAmsterdam,UniversidadJaume,SaarlandUniversity,UniversiteitAntwerpen,ImperialCollegeLondon,LeuphanaUniversität,theUniversityofAppliedSciences,theNorwegianInstituteforWaterResearch,andtheUniversityofBath.EndorsedMarch2016ContributingauthorsJeremyPrichard,WayneHall,EttoreZuccato,PimDeVoogt,NickVoulvoulis,KlausKummerer,BarbaraKasprzyk-Hordern,AngeloBarbato,AlbertoParabiaghi,BarbaraKasprzyk-Hordern,FelixHernandez,JanellevanWel,KevinVThomas,KarlFent,MarieMardal&SaraCastiglioni.
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TableofContents1.0Purposeandscopeofthisdocument..................................................................................42.0Governance..................................................................................................................................5
2.1Responsibilitiesofresearchersandinstitutions......................................................................................52.2Referencetotheseguidelinesinpublications,correspondencewithjournals&inethicsapplications.....................................................................................................................................................................62.3Revisionoftheseguidelines..............................................................................................................................62.4Promulgationoftheseguidelines...................................................................................................................7
3.0Ethicalcontext............................................................................................................................73.1.Risksarisingfromgeneralpopulationstudies........................................................................................83.2.Risksarisingfromsitespecificstudies(e.g.prisons,schools,hospitals&workplaces).......8
4.0Mitigationstrategies.................................................................................................................94.1Researchplanning.................................................................................................................................................94.2Identifyingandmanagingstakeholders...................................................................................................104.3Adoptingmediacommunicationprotocols.............................................................................................124.4Protectinganonymitythroughthescientificpublicationprocess................................................12
5.0Usefulsourcesandothermaterials...................................................................................13
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1.0PurposeandscopeofthisdocumentThisdocumentprovidesguidelinesforresearchersinanewfieldthatappliesanalyticalchemistrytechniquestoanalysesamplesofsewagewater.Thefieldisvariouslycalled‘wastewater-basedepidemiology’(WBE)*,‘wastewateranalysis’,‘sewage-basedepidemiology’,and‘sewageepidemiology’.WBEisusedforawidevarietyofpurposesthatincludeestimating:
• Ratesofconsumptionofillicitdrugs,alcohol,tobacco,licitpharmaceuticalsandfoodstuffs;
• Humanexposuretopollutants.Whereillicitsubstancesareconcerned,studieshavebeenconductedonmajordrugtypes,includingcannabis,cocaine,heroinandotheropioids,andamphetamine-typestimulants.Whilemoststudieshaveconcentratedonmappingpopulationdrugconsumption,severalstudieshaveappliedWBEinspecificsettingswithsmallcatchmentareas,suchasprisons,hospitals,schoolsandworkplaces.ThisemergingfieldhasattractedmultipleresearchteamsinEurope,NorthAmericaandAustraliaanditsbroad,interdisciplinaryfocusmeansthatdisciplinescontributingtothisresearchincludechemistry,biology,mathematics,economics,engineering,epidemiology,forensicsciences,socialscience,lawandcriminology.TodatetherehasbeenlittleoversightbyresearchethicscommitteesbecauseWBEdataarenotcollectedonindividuals.OnlyonehumanresearchethicscommitteehasrequiredreviewofaWBEdrugstudyanditapprovedthestudyaslow-risk.OtherhumanresearchethicscommitteeshavedeclinedtoreviewWBEstudiesonthegroundsthattheyraisenoethicalissues.ItisreassuringthathumanresearchethicscommitteeshaveconcludedthatWBEstudiesinvolveverylowethicalrisks.Butsomelevelofcautionisrequiredintheabsenceofsupervisionbyethicscommittees.TheseethicalguidelinesweredevelopedbyresearchersinEuropeandAustraliaandtheyabidebyinternationallyrecognisedethicalprinciples.1GuidelineswillassisttopromoteanethicalresearchcultureamongWBEteamsandscholarsinvolvedinthepublicationprocess.Anethicalresearchculturewillmaximiseethicalpractice,minimiserisksforvulnerablepeopleandothergroups,andhelptomaintainthegoodreputationofthefield.Theseguidelinesaredesignedtobeinterdisciplinaryandreflectasmuchaspossibletheinternationalcharacteristicsofthis
1E.g.asexpressedinAustralia’sNationalStatementforEthicalConductinHumanResearch;https://www.nhmrc.gov.au/guidelines-publications/e72*WBEisnowtheagreedtermforthefield.
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fieldofresearch.Theguidelinesalsoaimtopromoteethicalresearch(includinginpublicationprocesses)withminimaldetailandrestrictions.2
TheobjectiveoftheseguidelinesistooutlinethemainpotentialethicalrisksforWBEresearchandtoproposestrategiestomitigatethoserisks.Mitigatingrisksmeansreducingthelikelihoodofnegativeeventsand/orminimisingtheconsequencesofnegativeevents.Likeotherethicaldocuments,theseWBEguidelinesprovideprinciplesandapproachesthatshouldbeadaptabletomostsituationsencounteredbyresearchers.Itisbeyondthescopeoftheseguidelinestoprovideanexhaustivelistofallpotentialrisks,coveringallpossiblescenariosindifferentcountries.Seefurther2.1,below.
TheWBEethicalguidelineswillbe‘living’,meaningtheycanbeupdatedperiodically.Thisisaveryimportantpoint.ItenablestheWBEfieldtoadapttheguidelines–forinstancebecausethefielddevelopsinnewways,orbecauseWBEresearchersidentifynewethicalrisksorbeneficialmitigationstrategies(seebelow,2.3Revisionoftheseguidelines).
2.0Governance
2.1Responsibilitiesofresearchersandinstitutions
Asethicalguidelinesonly,thisdocumentisnon-binding.However,theseguidelinesshouldbeviewedinthewidercontextofresearchgovernance.WBEresearchersshouldconsidertheseguidelinesincombinationwithlawsandregulationsoftheircountry,and,protocolsstipulatedbytheiruniversityorplaceofemployment.WBEresearchersindifferentinstitutionsandindifferentcountrieswillfinddetailsofresearchethicsandprotocolsthatarenotcontainedintheseguidelines,egprotocolsrelatingtohowlongdataneedstoberetainedandwhenitneedstobedestroyed.
2TheideafortheseguidelinesarosefromtheEMCDDATestingtheWatersConference,PortugalMay2013,andasubsequentpublicationinScienceandtheTotalEnvironment472(2014)550-555.
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Thebroadethicslandscapeissummarisedinthefollowingextract.Itunderscorestheresponsibilityofindividualresearchersandtheirinstitutions:
Responsibilityfortheethicaldesign,reviewandconductofhumanresearchisinfactexercisedatmanylevels,by:researchers(andwhererelevanttheirsupervisors);[humanresearchethicscommittees]andothersconductingethicalreviewofresearch;institutionsthatsetuptheprocessesofethicalreview,andwhoseemployees,resourcesandfacilitiesareinvolvedinresearch;fundingorganizations;agenciesthatsetstandards;andgovernments.Whiletheprocessesofethicalreviewareimportantinthisfield,individualresearchersandtheinstitutionswithinwhichtheyworkholdprimaryresponsibilityforseeingthattheirresearchisethicallyacceptable.3[emphasisadded]
OneimplicationofthisresponsibilityisthatWBEresearchersoughtnottoassumethatexternalrequests,forexamplethosecomingfromlawenforcementagencies,necessarilysatisfyprinciplesofethicalresearch.
2.2Referencetotheseguidelinesinpublications,correspondencewithjournals&inethicsapplications
WBEresearchersmaychoosetorefertotheseguidelinesintheirpublications,indicatingthatprinciplesandriskmitigationstrategieswereadoptedoradheredto.Theguidelinesmayalsobeusedincorrespondencewithjournaleditorregardingappropriatepublicationprocesses(egforprotectinganonymity).WBEresearcherswhoareapplyingforethicsapprovalfromhumanresearchethicscommittees(egintheiruniversitiesorresearchinstitutions)oughttoreferencetheseguidelineswithintheirapplication.
2.3Revisionoftheseguidelines
TheseguidelineswillbehousedonthewebsiteofCOST–EuropeanCooperationinScienceandTechnology(www.cost.eu),whichissupportedbytheEUFrameworkHorizonProgram2020.Theauthorsoftheseguidelineswillrevisetheguidelinesasdeemednecessary.WBEresearchersareencouragedtosuggestrevisionstotheguidelinesbyemailingProfessorEttoreZuccatoettore.zuccato@marionegri.it,[email protected],ProfessorWayneHallw.hall@[email protected].
3NHMRC(2007).NationalStatementonEthicalConductinHumanResearch.Canberra:AustralianNationalHealthandMedicalResearchCouncil:4.
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2.4Promulgationoftheseguidelines
Theseguidelinesare,inasense,theproductoftheWBEfieldandtheybelongtotheWBEfield.TheirusefulnessandeffectivenessdependsonthesupportofWBEresearchersglobally.WBEresearchersareencouragedtopromulgatetheseguidelinesinthebestwaystheyseefit.Forexample,theguideline’sURLcouldbe:
• Displayedonresearchwebsites,oronWBEresearchers’personalwebpages• Listedinacademicpublications• Giventoearlycareeracademicsandpostgraduatestudents• Providedtohumanresearchethicscommitteesinuniversitiesorother
institutions.
3.0EthicalcontextInhumanresearchfieldstheterm“participant”appliestoanyindividualwhochoosestobeinvolvedinastudyaswellasindividualswhosedataareusedtoconductresearch.Insomecircumstancesitisfeasiblethatlegalentities,suchascorporations,mayberesearchparticipants.Researchistobecognisantof:
• potentialharmstoparticipantsandnon-participants(includingemotionalandeconomicharm)
• respectingparticipants’autonomy• potentialbenefitsforparticipantsandsociety.
Threerecurrentethicalconcernsinhumanresearchareensuringparticipantsprovideinformedconsent,specifyingthecircumstancesinwhichde-identifieddatamaybeusedwithoutparticipants’consent,andprotectingtheconfidentialityofsensitiveinformation.InmostWBEdrugresearchtheimpingementonparticipants’autonomyisminimal,theparticipantsareatlowriskofharmand,broadly,WBEresearchaimstobenefitsociety.However,thepotentialriskofharmmaybeheightenedincertainsituations,asdiscussedbelow.WhileattentiontodatehasfocussedparticularlyuponWBEandillicitdruguse,newandemergingethicalissuesarelikelytoarisefromWBEdataonhealthanddiseaseaswellasindicatorsofpollution.4
4IntheunlikelyeventthatSEresearcherswereinterestedinstudyingsamplesflowingfromprivateresidenceswithouttheconsentoftheoccupants,afullresearchethicsapplicationwillalmostcertainlyberequiredfromaregisteredhumanresearchethicscommittee.Seefurther2.1Responsibilitiesofresearchersandinstitutions.
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3.1.Risksarisingfromgeneralpopulationstudies
Whilethemediaplayanimportantpartindemocraticsocieties,inourviewerroneousorsensationalisedmediacommunicationmay:
• resultinminoremotionalharmsforvulnerablegroups,suchasshameorembarrassment(e.g.throughreportingdrugconsumptioninasuburbordistrictwithhighlevelsofsocialdisadvantage);
• amplifystigmatizationandlabellingofvulnerablegroups,influencinghowtheyaretreatedbysocietyandthestate;
• generatepoliticalincentivesto‘gettough’ondruguseandcrime,displacingmoreeffectivepolicingstrategiesandbringingmoredrugusersintothecriminaljusticesystem.
Localcouncilsorregionalauthorities,companies,industryandotherlegalentitiescouldforeseeablybeeconomicallyharmedthroughsimilarsortsofmiscommunicationsofWBEresults.Forexample,sensationalisedreportingofdrugconsumptionataregionaltouristeventattendedbyyoungpeoplecouldresultineconomiclossfortheregion.Inasimilarfashion,eventorganisersofmusicfestivalsmaybeeconomicallyharmedthroughmiscommunicationsofWBEdata.Samplingfromasewagetreatmentplant(STP)withouttheconsentofrelevantauthoritiesmayconstituteanoffence(egtrespass)orabreachofregulation.ThismayaffectthereputationoftheWBEfieldandaffectthewillingnessofauthoritiestosupportorcollaboratewithWBEresearchers.
3.2.Risksarisingfromsitespecificstudies(e.g.prisons,schools,hospitals&workplaces)Site-specificWBEresearchhasgoodpotentialtobenefitparticipantsandthecommunity.However,intheprisonsettingpotentialrisksinclude:
• theintroductionofaustereanti-drugstrategiesbyprisonauthorities(e.g.eliminatingcontactvisitsforinmates’families)inreactiontoWBEdataondrugconsumption.Itmaybelegitimateforauthoritiestousesuchmeasures.However,ifthemeasuresaretriggeredbyWBEresearch,andifthesemeasurescauseharm(evenemotionaldistress),thentheWBEstudymayhaveinadvertentlybreachedethicalstandardsbycausingharmtoparticipantswhodidnotprovideconsent.
• stigmatisationofinmates,ex-inmatesandtheirfamilies.MismanagementofWBEresearchfindingsmayleadtomediareportsonprisondrugconsumptionthatembarrassinmatesorcontributetonegativecommunitysentimentsabouttherehabilitationandreintegrationofex-prisonersbackintosociety.
Instudiesofschoolsandworkplacesapparentrisksare:
• stigmatisationandlabellingthroughmediareportingforchildren,parents,teachersandworkersofspecificschoolsandworkersatotherworkplaces;
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• adverseeffectsforthereputationofaschoolorworkplace;• economicharmforworkplaces;• theintroductionofaustereorunfairworkingconditions.
Othernegativeoutcomesmightoccurifparticularbuildingsorworkplaces(eghospitals)iftheyareerroneouslyidentifiedascausingenvironmentaldamageorpollution.Clearlysamplingfromaparticularbuilding(egprison,school,workplace,hospital,musicfestivaletc)withoutconsentmaybeanoffenceoraregulatorybreach.EithersituationmayaffectthereputationoftheWBEfieldandaffectthewillingnessofauthoritiestosupportorcollaboratewithWBEresearchers.
4.0Mitigationstrategies
4.1ResearchplanningAnonymisingdata.Byconsideringtheissuesraisedintheseguidelines,WBEteamsmaybeabletoadoptsimplestrategiesthatmitigateriskandthataretailoredtotheirspecificsocialandculturalcircumstances.Forexample,mixingsamplesobtainedfrommultiplesitesmayensurethatonlyaggregatedatacanbereported(e.g.therebyhidingtheresultsofaparticularsuburb,workplaceorschool).Oritmaybefeasibletosimplyomitthenameandlocationwheretheresearchwasconducted.ItisnotsuggestedthatthesebecomestandardpracticesfortheWBEfield–onlythattheymaybeconsiderednecessaryinsomecircumstances.Plansforeffectivecommunicationofresearchoutcomestomedia.Researchplanningshouldentailsomeconsiderationofhowfindingsmightbeinterpretedwithinthesocio-politicalcontextofthestudy.Attentionneedstobegiventohowmediaoutletsmightmisrepresentfindingsandhowpolicymakersmayfeeltheyhavetorespond.Researchplanningmayincludedecidinghowresultsmaybeclearlyandconciselycommunicatedtothemediaandinawaythatconvincesmediaoutletstohighlightthebenefitsoftheresearchinsteadofblamingthebehavioursofparticipants.Seekingapprovalofahumanresearchethicscommittee(HREC).Consistentwithsection2.1Responsibilitiesofresearchersandinstitutions,above,WBEresearchersholdresponsibilityfordeterminingwhethertheyarerequiredbytheiruniversityorworkplacetoseekHRECapprovalfortheirplannedstudies.TypicallyHRECarehappytorespondtoqueriesabouttheneedforethicsapproval.(SomeHREChaveautomatedonline‘ethicscheckers’.)Insomecases,evenifethicsapprovalisrequired,theprocesswillberelativelysimple(egfor‘minimalriskapplications’).ThelikelihoodthatWBEresearcherswillneedHRECethicsapprovalincreasesforallsite-specificstudies(egprisons,schools,workplaces,hospitals,musicfestivalsetc).In
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addition,theHRECineachcountrywillknowofparticularlawsandregulationsthatapplytocertaingroupsofpeople.Forexample,regulationsinsomecountries(butnotothers)mayrequirethatWBEresearcherssecuretheconsentoftheparentsofschoolchildrenbeforetheyundertakeaschool-focussedstudy.ItisworthhighlightingthatapprovalfromaHRECmayhavestrategicbenefitforWBEresearchers.Inadditiontopeaceofmindfortheresearchteam,theethicsapprovalmaybeusefulinestablishingrelationshipswithstakeholdersbecauseitdemonstratesthepreparednessoftheWBEteam.Theprocessofseekingforethicsapprovalisalsoaneffectivewaytoplanaspectsofresearchprojectsandtodevelopprocedurestailoredtospecificcontexts.SeefurtherbelowregardingusingHRECapprovaltomanagestakeholderexpectations(section4.2).
4.2Identifyingandmanagingstakeholders
Generalpopulationstudies.Careneedstobetakeninstudiesofthegeneralpopulationtoseekapprovalsfrom‘relevantauthorities’thatown,controloroperateSTPsorrelatedfacilities.Failingtodosomayconstituteanoffenceorabreachofaregulation(seefurther3.1),ormaybringthefieldintodisrepute.Whenseekingconsent,WBEresearchersshoulddisclosethenatureandpurposeoftheanalyses.Inotherwords,whenauthoritiesconsiderprovidingconsenttheyshouldbegivenenoughinformationtounderstandwhetherthestudyconcernsillicitdrugsuse,health,theenvironmentoracombinationofthesethings.
CautionisnecessaryifWBEresearchersareapproachedbyagenciestoconductanalyses(eginacertainarea).Itisimportanttoverifywhethertheagencymakingtherequestisinfacta‘relevantauthority’.Ifnot,inmostcasesnoanalysesshouldbeconducteduntilapprovalisgrantedfromarelevantauthority.
Site-specificstudies(prisons,schoolsetc).Clearlythesameprinciplesapplytostudiesofprisons,schools,workplaces,hospitalsandsoforth.However,inthesecontextstheguidelinesrecommendthatconsentshouldbesoughtfromtherelevantstakeholder(egprisondirector,schoolprincipal)regardlessofwhethertheagencyhasanycontrolovertheSTPorrelatedfacility.(Forexample,someSTPsthatserviceprisoncomplexesarecompletelyexternaltotheprisonbuildingandareoperatedbydifferentauthorities.Itcouldalsobethecasethatsewageleadingfromaparticularbuilding,likeaschoolorworkplace,canbelawfullyaccessedatapointoutsideofthebuildingproperty.5)
5EgseeanalysesofAustralianpropertylawandsewagefacilitiesinGriggs,L,Henning,T&Prichard,J,(2012)‘DoestheDespoilerofWaterHaveaProprietaryRightintheCommingledProduct?ImplicationsforPropertyLawandCriminalProcedure’,MonashUniversityLawReview,38(3)pp.35-54.
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Understandingstakeholders.Beforeembarkingoncollaborativeresearchwithastakeholderlikeaprison,school,orworkplace,itisadvisedthatWBEresearchersseektounderstandthestakeholder’sethicalpractices.Forexample,ifresearchistobeconductedataworkplace,doesthatworkplacehaveahistoryoftreatingitsemployeesfairly,orhasitdemonstratedawillingnesstotreatitsworkforceharshly(e.g.bysackingemployees,dockingpay,orsettingdifficultworkrequirements).Whereprisonsareconcerned,acarefulassessmentofprisondrugpolicieswouldbewise.ThispointisparticularlypertinentifWBEresearchteamsareinvitedtodoresearchincountrieswithpoorrespectforprisoners’humanrights.OfcourseWBEresearcherscannotcontrolthebehaviourofstakeholders.However,theymaybeabletomitigaterisksbyavoidingcollaborationswithstakeholderswho,onavailableadviceorevidence,appearunlikelytorespecttheethicalboundariesoftheWBEresearchers.WBEresearcherswillhavetodetermineasbesttheycanhowtoassessastakeholder’spracticesonacase-by-casebasis.However,thefollowingsuggestionsmaybeuseful:
• useasearchenginetosourcepubliccriticismofastakeholder(egbyhumanrightsagencies,childprotectionagencies,ombudsman,orlawyers)orformalfindingsofmisconduct(eganti-discriminationauthoritiesorworkplacetribunals)
• readanagency’smissionstatementorannualreports• conductpreliminarymeetingswithanagency• askresearchersfromotherdisciplineswhomayknowaboutanagency’s
reputationandethicalpractices.Inearlydiscussionswithstakeholders,WBEresearchersoughttoexplaintheethicalboundariestowhichtheymustadhere.ResearchersmayfindthatHRECoversightisstrategicallyusefulinmanagingstakeholders’expectations.ThisisbecausetheWBEresearcherscanstatethattheresearchdependsonnon-negotiableethicalprotocolsbeingfollowedandthatbreachesofprotocolsmaybringanendtothestudy–adecisionwhichwouldbemadebyathirdparty(theHREC).
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4.3AdoptingmediacommunicationprotocolsAsnotedearlier,akeyfocusofplanningWBEresearchwouldbetoensuretheanonymityofregionswherespecialsensitivitiesmayapply,suchasmarginalisedresidentialdistricts,prisons,schoolsandworkplaces.AllmembersofanWBEteamshouldbemadeawareofcommunicationprotocols,suchasthoserelatingtoresearchpublications,non-academicpublications,publicforums,andinteractionwiththemedia.Although‘mediacommunicationprotocols’maysoundcomplex,inmostinstancestheywillsimplyinvolvedeciding:
• whatcannotbecommunicated(eginformationthatgivesawaytheidentityofasuburboraprison);and/or
• whoinaWBEteamisthemediacontactperson.MediacommunicationprotocolsmaybecriticalevenwhereWBEresearchers’onlypublicoutputisinacademicpublications.Inotherwords,risksdonotonlyarisewhenWBEresearchersdirectlyengagewiththemedia(egthroughradio,televisionorprint).Boundariesbetweenscholars’privatecommunicationsandtheirresearchisnormallyuncontentious.However,insomecircumstancesWBEresearchersmayneedtobewaryaboutcommentingaboutsensitiveresearch-relatedissuesonsocialmedia(egTwitter,Facebook,Netlog).Thisisbecausetheseforumscanbeopentothegeneralpublicandconsequentlycommentsfromparticularresearcherscanlegitimatelybereportedbymediaoutlets.
4.4ProtectinganonymitythroughthescientificpublicationprocessTheWBEpublicationprocessshouldretainscientificrigourwhileprotectingtheanonymityofdisadvantagedsuburbs,prisons,schoolsandsoforth.IndiscussionswithWBEauthors,journaleditorsandpeerreviewersshouldbeamenabletodevisingpracticalsystemsofprotectinganonymityinpublications–notasstandardpracticeforWBEresearchbutonlywhenthesystemsaredeemednecessarybecauseoftheethicalcontext.ItmaybethatWBEauthorsproposesuchsystems.Ontheotherhand,editorsorpeerreviewersmaybethefirsttodetectgenuineethicalrisks.InthiswaythepublicationprocesscanprovideanimportantservicetoWBEscholars.WherejournaleditorsareunfamiliarwithWBEresearch,scholarsinthisfieldmayhelptoraiseawarenessoftheethicalissuesbygivingeditorscopiesoftheseguidelines.Withoutlimitingotherpotentialstrategies,itisfeasiblethatdatacouldbeprovidedtopeerreviewersthatisnotincludedinapublication.Forexample,inWBEpublicationsitistypicaltoreporttheestimatedpopulationsizeofthecatchmentstudied.Yet,insomecircumstancessuchinformationcouldbeusedtoidentifyavulnerableregionorgroupthattheresearcherswouldpreferremainedunidentified.Inthesescenariosalldata
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couldbescrutinizedthroughthepeerreviewprocess.However,intheresultingpublicationtheriskofidentifyingthesitecouldbeminimisedbyonlyreportingpopulationrates(e.g.per100,000people).Afterpublication,anyWBEscholarswhowishedtoseethecompletepopulationestimatescouldcontacttheauthors.Thiswoulddramaticallyreduceanyriskthatthescientificreportwasmisinterpretedormisusedbymediasources.
5.0Usefulsourcesandothermaterials
• WorldMedicalAssociation,DeclarationofHelsinki-EthicalPrinciplesforMedicalResearchInvolvingHumanSubjectshttp://www.wma.net/en/30publications/10policies/b3/
• AustralianGovernment,NationalHealthandMedicalResearchCouncil,NationalStatementonEthicalConductinHumanResearch(2007)-UpdatedMay2015https://www.nhmrc.gov.au/book/national-statement-ethical-conduct-human-research
