HIV and Drug Abuse Prevention Research Ethics Training Institute

CELIA B. FISHER, PH.D., DIRECTOR

AddictionResearchEthicsandtheBelmontPrinciples:

DoPeopleWhoUseDrugsHaveaDifferentMoralVoice?

CeliaB.FisherMarieWardDotyUniversityChairinEthics

DirectorCenterforEthicsEducationDirectorHIV/DrugAbusePreventionResearchEthicsInstitute

ProfessorPsychologyFisher@Fordham.edu

TheNIDASponsoredFordhamUniversityHIVandDrugAbusePreventionResearchEthicsInstituteJuly7– 15,2016NewYorkCity

Acknowledgements• ThisresearchwassupportedbyNIDAgrant#RO1DA015649-01A2.

• Fisher,C.B.(2011). AddictionresearchethicsandtheBelmontprinciples:dodrugusershaveadifferentmoralvoice? SubstanceUseandMisuse.46(6),728-741.PMID:21073412;PMCID:PMC3638744

• ThankstoMeena Mahadevan andChristopherSmithfortheirhelpindatacollection.

BelmontPrinciples

• BeneficenceandNonmaleficence

• RespectforPersons

• JusticeBelmontReportUS1979CodeofFederalRegulations45CFR46ProtectionofHumanSubjects2009FederalNurembergCode,1946UniversalDeclarationofHumanRights(UN)1947DeclarationofHelsinki,WHOfirstissuedin1964CIOMS InternationalEthicalGuidelinesforBiomedicalResearchInvolvingHumanSubjectsfirstissuedin1993

DrugUsingPopulations“SocialVulnerabilities”

• Economic• PhysicalandMentalHealth• TransientCognitive(intoxication,withdrawal)• Legal• Social

Vulnerability:TheDefinitionalProblem

• CFR46.111a(3)and46.111b:Vulnerablepopulationsrequireadditionalsafeguards toensure“selectionofsubjectsisequitable”andnotsubjectto“coercion”

• Whatareresearchspecificvulnerabilities?

• Whatsafeguardsarerequired?

Goodness-of-FitEthics(GFE)(Fisher 1999,2002,2004,2014;Fisher&Goodman, 2009;Fisher&Ragsdale,2006;Fisher&Yuko,2016;

Masty &Fisher, 2008)

• SocialVulnerability≠Researchvulnerability

• Researchvulnerability=failuretofitethicalprocedurestoparticipantcharacteristics

• Reducingresearchvulnerabilityrequiresfamiliaritywithparticipantstrengthsaswellasfrailties

• Empiricaldataiscriticaltoidentifyingresearchethicsrelevantpopulationresearchassetsandsusceptibilitytoharm

Goodness-of-FitEthics

Failuretodistinguishbetweenvulnerabilitiesinparticipants’livesandresearchvulnerabilitiescanjeopardizeparticipantautonomyandleadtounder-oroverestimationofresearchrisks

ImportanceofParticipant“Expertise”

ScienceEstablishment• Ethicalprinciples

• Regulations

• IRB&PIexperience

• Traditionalethicalprotections

Participants• Moralvalues

• Trustinthescientificenterprise

• Implementationinrealworldcontexts

• Howethicaldecisionswillaffecttheirrightsandwelfare

“FoundationalPrinciplesOftenConflict”(NationalCommission,1979)

ConflictswithBeneficence

• Ethnographyè FidelityandResponsibility

• HIVPartnerResearchè Respect

• TreatmentResearchè Justice

GFE:EthicalPrinciplesThroughaParticipantLens

• Doestablishedprinciplesreflecthowparticipantsviewthemoralworldofresearch?

• Istheprivilegedstatusofindividualprinciplescontextuallybased?

CBFisher6-27-12

Lackofunderstandingè over/under-estimationRisks&BenefitsPersonalAgency

FairAccesstoResearch

AIMSOFSTUDY• WhichethicalprinciplesdoPWUDapplyintheirmoraljustifications

forresolvingaddictionresearchethicsdilemmas?

• DothesepreceptscorrespondtoBelmontprinciples?

• DoPWUDapplythesepreceptsrigidlyoronacase-by-casebasissensitivetothecontextualnatureofeachethicaldilemma?

Recruitment

• InclusionCriteria:Illegaldrugusepast30days(otherthanalcohol,marijuana)PreviousdruguseresearchparticipationEnglishproficiency

• Recruitment:shelters,harmreductioncenters,methadonemobiledistributionsites

Participants(N=90)Demographics• 51% Male• Age range: 18 – 61 (M = 34.7)• 42% PWID• 22% MSM • 21% Caring for child 21%• 55%unemployed• 54%livedatashelter, communityhousing, boarding homeorwithafamilymember

• 68%< highschooleducation• 66%Historyincarceration

Ethnicity• 31%Blacknon-Hispanic• 34%Hispanic(PR)• 31%Non-HispanicWhite• 1%Other

Commonlyuseddrugs

• Cocaine(34%)• Heroin(26%)• Crack(47%)• Amphetamines (100%)• Streetmethodone (14%)

ObtainingParticipantPerspectives

• Researchdefinedpriortoscenarios

• Scenariosreadtoparticipants

• Mixedmethod:4-pointLikert-typescaleresponsetoscenarioquestionfollowedbynarrativerationale

• Coding:Inter-rateragreement=94%,89%,96%

Scenario1:LegalRiskFormonthsDr.Jonesconductsstreetinterviewsonproblemsfacedby

poorfemaledrugusersraisingyoungchildren—includingsharingherownparentingstorieswithparticipants

Justpriortoananticipatedpoliceraid,Terry,afemaleparticipantasksDr.Jonestohideherdrugsforfearherchildwillbetakenaway.

Dr.JonesdoesnotknowwhetherornotsheshouldbreakthelawandhidethedrugsforTerry.

Likert-typescale:Inthissituation,howimportantisitforDr.Jonestoobeythelaw?

Scenario2:HIVPartnerRisk• Dr.Albahangsoutwithstreetdrugusersinterviewing themaboutHIVrisk.

• Through interviewshelearnsthatoneparticipant,John, isintentionallyhidinghissero-positiveHIVstatusfromandhavingunprotectedsexwithanotherparticipant,Chris,whotheDr.Albaknowstobeseronegative

• Dr.AlbatriestoconvinceJohntotellChrisabouthisHIV,but JohnrefusesandremindsDr.Albathatduring informed consenthepromised tokeepeverythingconfidential

Dr.Albadoesnotknowwhetherheshould tellChristhatJohn isHIVpositive.

Likert-typequestion: Inthissituation,howimportantisitforDr.AlbatokeephispromisetoJohn?

Scenario3:RCTs• Totestanexperimental medication forcocaineaddictionDr.Rosswillfollowresearch

guidelines thatsaythebestwaytoknowifamedicine reallyworksistorandomlyassignhalfthepeoplethemedicationandhalfasugarpill calledaplacebo.

• Mary,oneofDr.Ross’sresearchassistants,volunteersataclinic forhomelesspersonswhoaredesperatetoquittheir cocaineaddictions

• Marymakesanexception totheguidelinesbyputtingall thehomelessindividuals intothemedicationgroup

Inthissituation,howimportantisitforDr.RosstofireMaryformakinganexceptiontotheguidelines?

Theme1:Beneficence

• Investigators shouldstrivetodogoodandpreventharm• Maximizescientificknowledge• Protectresearchparticipantsandothersfromharm

Case1:HoldDrugs Case2:Disclose Case3:FireAsst“Idon’tcareifDr.Jonesisaresearcher…Terrycould loseherkid…Sosheshould trytohelpTerry.”

“Chriscoulddiethen[Dr.Alba]willneverbeabletolivewiththat.”

“Thiswouldviolatetheintegrityofthestudyandwouldnotnecessarilyhelptheaddictssincethemedicine’seffectsareyetunproven.”

“[Hidingthedrug]wouldperpetuateariskysituationforthechildwithoutnecessarilyhelpingTerry.”

“Dr.AlbashouldtellChrisbecausethatisonlytherightthingtodo,Thatgoesbeyondthedutiesofaresearcher’spromisetokeepconfidentiality

“Dr.Rossshouldmakeanexception…becauseinthiscase[Mary]isnot justbreakingtherules,sheistryingtohelpthosepeople.”

Theme2:Respect

Participants• Areresponsible forthechoicesthattheymake• Havetheright toknowledge thatwillaffecttheirsafetyor• Havearighttoprivacy.

Case1:HoldDrugs Case2:DiscloseHIV“IfTerrywassoconcernedaboutherkid,shewouldn’tbedoingdrugsandhidingfromthecopsinthe1st placeifyouaskme.”

“John isagrownadultwhocanletChrisknow ifhewants.Sono[Dr.Alba]shouldnottellChris.”

“[Terry]isgrownand[should]know….theconsequences.” “IfChrishadsomesense,hewouldhavedonesomehomeworkofhisownandfoundout forhimself.ItisnotDr.Alba’sjob.”

“Johnhasarighttohisprivacy.”

“Ifyourgoingtodosomethingthatwillhurtpeople’slives,confidentialitydoesnotapplyanymore.”

Theme3:JusticeFairnessrequiresinvestigators• Ensureequalresearchopportunity• Eliminatebias• Makeupforhistoricandcurrenthealthdisparities.

Case3:FireAssistant“Everyoneshouldbetreatedthesamewhichiswhytheguidelineswerethatway.”

“Whenyoumakeexceptionslikethatyouarenotgivingeveryoneanequalchance.”

“ByfiringMaryDr.Rossdidtherightthingbecauseheissayingthathedoesnot supportpreferentialtreatment.”

“Becausenobody everdoesanythingforpeople thatarehomeless.Theydeserveexceptions.”

Theme4:Relationality

Researchersandparticipantsareinrelationshipsthatobligateinvestigatorsto:• maintainparticipanttrust• honor thereciprocityofrelationshipswhereboth“getandgive”.

Case1:HidetheDrugs Case2:DiscloseHIV“Justbecausesheisaresearcherdoesn’tmeanshestopsbeingafriend”

“John trustedhimwithsomethingpersonal,soheshouldnotlethimdownIfeel.”

“Howcanyou trustaresearcheriftheresearcherisgoingaroundhidingdrugsintheirbags?”

Becausewhenyouagreetoparticipateinastudy,youtrusttheresearcherwithsomethingverypersonal.Soitisallabouttrust.”

“Yougotta helpthepersonthat’shelpinghergetthedataforherresearch”.

Theme5:ProfessionalObligationsInvestigatorsmust• serveasamodelofrightconduct;• maintainprofessional-personal boundaries withparticipants;• preservethegoodreputationoftheprofession; • ensurethegoodconductofothermembersoftheprofession.

Case1:HideDrugs Case2:Disclose HIV Case3:FireAsst.“Dr.Jonesshouldjustdoherjobandnotgetinvolved…That’sgettingtoopersonalwithyoursubjectsandfeelswrong….”

“AllthatisnotDr.Alba’sbusinessifyouaskme.Heshould juststayoutofitandnotgetinvolved.InformingChrisisnothisresponsibility.”

[Mary]shouldhavecheckedwith[Dr.Ross]first.Howcanshetakethedecisionintoherownhandslikethat?Shedeserves[tobefired].”

“[Dr.Jones]shouldsetanexampleforTerry,not theotherwayaround.”

“Peopleneedtoknowboundariesespeciallywhenitcomestowork.Otherwisetheydonotlearn.

“IfDr.Jonesgetsbustedthentheresearchorganizationsheworksforendsuplookingbadtoo.”

“ifshegetsawaywithit,nexttimeanotheroneofhisstaffwill.Soitisimportanttosetexamples.”

Theme6:RulesRuleshaveintrinsicmoralvalue--Investigators’aremorallyobligatedto• obeythelaw,• adheretoinformed consentagreementswithparticipants, • followresearchguidelines.

Case1:Hide Drugs Case2:DiscloseHIV Case3:FireAsst.“Youshouldobey thelaw…nomatterwhatitis.Itiswhatkeepssocietygoing”.

“Ifyoupromisemetokeepmyinfosafe,thenyoushouldnotgobackon it.”

“Everybodyshould followrulesbecauseotherwisetherewillbenoorder.Soyes,[Mary]shouldbepunishedforthat.”

“Asahumanbeing[Dr.Jones]shouldhelpoutTerry,butsincesheisatajobsheshouldobey thelaw.”

“Asaresearcher,Dr.AlbahasaresponsibilitytobothChrisandJohn.ButbecausehepromisedJohnheshouldkeepthatendofhisprofessionalobligation.”

“Dr.RossshouldhaveconsideredthatMarywastryingtohelp,butsinceshedidbreaktherulessheshouldbefiredIfeel.”

Theme 7: Pragmatic Self-Interest

• Themoralpriority inagivensituationistomaximizetheresearcher’sownneedsandminimizenegativeconsequencestotheself.

Case1:HideDrugs Case2:DiscloseHIV Case3:FireAsst.“Idon’tthink that[Dr.Jones]shouldbreakthelaw….thatwouldendupwithherinjail.”

“[Dr.Alba]hastofollowtherulesbecausehecouldlosehislicense”

“Whatifthey, thepeoplewhogavehimthemoneyforthestudycomeafterDr.Ross?Soheisdoingtherightthing– heisprotectinghisjob.”

DoDrugUsersApplyPrinciplesContextually?

Rankings

Case1:HideDrugs Case2:DiscloseHIV Case3:Fire Asst.Beneficence26% Rules26% ProfessionalObligations 26%

PragmaticSelf-Interest22% Beneficence24% Rules22%

ProfessionalObligations 20% Relationality 18% Beneficence20%

Justice20%

PersonsWhoUseDrugsareMoralAgents

• PWUD have the ability and willingness to grapple withcomplex dimensions ofmorality

• They share with investigators an appreciation for foundationalmoral principles guiding research

• These include the Belmont principles as well as principlesreflecting a valuingof professional obligation and relationality

• Their application of these principles are contextually sensitive

Goodness-of-FitEthicsLessonsLearned

IndividualandProfessionalResponsibility

Theyexpectinvestigatorsto• Upholdprofessionalstandards• Actasrolemodels• Avoidblurringofroles

• PWUDseethemselvesasresponsiblefortheconsequencesoftheiractions

• Theyholdresearcherstoahigherstandardofmoralexcellence

GFEandEthnographicResearch

Researchersconductingethnographicresearchshould• clarifypersonalv.professionalroleexpectationsduringinformedconsent,

• revisittheseexpectationsduringthecourseoftheresearchrelationshipand

• avoidblurringofprofessionalandpersonalboundaries

RelationshipsofTrustandCare

• PWUDvalueparticipant-scientistrelationshipsbasedontrust

• Theyvaluescientistandparticipantobligationsbasedon“contractual”agreementsmadeduringinformedconsent

• Believesomemoralidealssupersedeprofessionalobligations,includingprotectingchildren,savingalife,andhelpingtheneedy

GFEandConfidentiality• Priortostudydeterminethelimitsofconfidentialitybasedonharmsthat

canbeanticipatedinthepopulationandresourcesavailabletoassistifreportingisnecessary

• Clearlyspecifyextentandlimitsofdisclosureduringinformedconsent—simplystatingdisclosuresmayoccurifthereisevidenceof“harmtoselforothers”isnotsufficient

• Assumingaprotectivestanceoverparticipantswithoutconsideringtheirowndefinitionsofautonomymayleadtodignitaryharm.

Justice&Fairness

• MostPWUDbelieverandomassignmentisafairprocessfordistributingthebenefitsandburdensofresearch

• Theyexpectinvestigatorstoactfairlyandtotakeresponsibilityforthosewhoworkforthem

• Thereasonsforrandomassignmentshouldbeexplainedduringinformedconsent

ResearchEthicsThroughaParticipantLens

• Research is a moral endeavor

• Participant perspectives are essential toinform but cannot dictate ethical decisions

• Participantperspectiveslendsmoralauthoritytoethicaldecisions

References

• Fisher,C.B.(1997).Arelationalperspectiveonethics-in-sciencedecisionmakingforresearchwithvulnerablepopulations.IRB:ReviewofHumanSubjectsResearch, 19, 1–4.PMID:11655184. (ReprintedinResearchEthics:TextandReadings,byD.R.Barnbaum &M.B.Kent,Eds.,2001,NewYork:Prentice-Hall.).

• Fisher,C.B.(1999).Relationalethicsandresearchwithvulnerablepopulations.InReportsonresearchinvolvingpersonswithmentaldisordersthatmayaffectdecision-makingcapacity,Vol.2.CommissionedPapersby theNationalBioethicsAdvisoryCommission.Rockville,MD:NationalBioethicsAdvisoryCommission,29-49.RetrievedOctober26,2009,fromhttp://www.bioethics.gov/reports/past_commissions/nbac_mental2.pdf.

• Fisher,C.B.(2003).Agoodness-of-fitethicforinformedconsenttoresearchinvolvingpersonswithmentalretardationanddevelopmentaldisabilities.MentalRetardationandDevelopmentalDisabilitiesResearchReviews, 9,27–31.PMID:12587135.

• Fisher,C.B.(2004).EthicsindrugabuseandrelatedHIVriskresearch.AppliedDevelopmentalScience, 8(2),90–102.• Fisher,C.B.(2011). AddictionresearchethicsandtheBelmontprinciples:dodrugusershaveadifferentmoral

voice? SubstanceUseandMisuse. 46(6),728-741.PMID:21073412;PMCID: PMC3638744• Fisher,C.B.(2014).EnhancingtheResponsibleConductofSexualHealthPreventionResearchAcrossGlobalandLocal

Contexts:TrainingforEvidence-BasedResearchEthics.Ethics&Behavior,19,1-10.• Fisher,C.B.(2015).Enhancingtheresponsibleconductofsexualhealthpreventionresearchacrossglobalandlocalcontexts:

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behaviors.In:BuchananDR,FisherCB,GableL,eds.Researchwithhigh-riskpopulations:balancingscience,ethics,andlaw.1sted.Washington,DC:AmericanPsychologicalAssociation,25-46.

• Fisher,C.B.,&Ragsdale,K.(2006).Agoodness-of-fitethicsformulticulturalresearch.InJ.TrimbleandC.B.Fisher(Eds.),Thehandbookofethicalresearchwithethnocultural populationsandcommunities(pp.3–26).ThousandOaks,CA:Sage.

• Fisher,C.B.,&Yuko,E.(2015). TheHIVandDrugAbusePreventionResearchEthicsTrainingInstitute:Trainingearly-careerscientiststoconduct researchon researchethics. JournalofEmpiricalResearchonHumanResearchEthics 10,470-480.doi:10.1177/1556264615614937

• Masty,J.,&Fisher,C.B.(2008).Agoodnessoffitapproachtoparentpermissionandchildassentpediatricinterventionresearch.Ethics&Behavior, 13,139–160.