180124 ethics in medical research & intro to gcp...
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ETHICSINMEDICALRESEARCH&INTRODUCTIONTOTHEGCP
RovinaRuslami
Pelatihan Etik Dasar dan Lanjutan, 24 Januari 2018
Theprimarypurposeofmedicalresearch(involvinghumansubjects)is
tounderstandthecauses,developmentandeffectsofdiseasesandtoimprovepreventive,diagnosticandtherapeuticinterventions(methods,proceduresandtreatments).
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WMADeclarationofHelsinki,v2013:A6
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Eventhebestproveninterventionsmustbeevaluatedcontinuallythroughresearchfortheirsafety,effectiveness,efSiciency,accessibilityandquality.
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WMADeclarationofHelsinki,v2013:A6
Howcantherightsofindividualpersonsbereconciledwiththedemandsofmedicalresearch?§ BeneSitsofmedicalresearchhavecomewithaheavyprice
§ Therearemanyexamplesofstudiesthathaveviolatedtherightsand
dignityofparticipants
§ Insomecases,costingparticipantstheirhealthoreventheirlives
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§ Thegoodphysician,Sirst,donoharm§ Butthen…historyshowsus…L
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WWIII
(NAZI
experiments)
1939-1945
TuskegeeSyphilis
experiment1932-1972
Willowbrook1963-1966
AsthmaStudy2001
Trovan(PSiz
er)
1996
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NAZIdoctors(WWII)
TheTuskegeeSyphilisStudy(1932-1972)
WillowbrookHepatitisStudy(1950s)
TheJewishChronicDiseaseHospital(1960s)
SanAntonioContraceptionStudy(1970s)
TheThalidomideExperience
JohnHopkinsStudy
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• ExperimentationtoHolocaustVictims
• Novoluntaryconsent• Subjectsnotkilledby
experimentswouldbekilledanddissected
• 1947:Doctor’strialatNuremberg
1947:theNurembergCode
• MentallycompromisedchildrenattheWillowbrookStateSchoolinNYCwhowerepurposelyexposedtohepatitisvirus.
• Problemofhepatitis(theriskofhavinghepatitisis30-50%).
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• HealthychildrenintentionallygivenhepatitisCvirus• Monitoredtoseeeffectsof
γ-globulin“Theywillgetitanyway”
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• 22elderlychronicallyill(old)patientsinjectedwithlivecancercells• Purposewasto“discoverthesecretofhowthebodiesSightthe
invasionofmalignantcells”• Covered-upbyhospitaladministration
“Theywilldieanyway”
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• Evaluatetheeffectivenessoffemalebirthcontrolpills.
• Indigentpatientswithnootherplacetogoforadviceormedicationbuttheclinic.
• Randomized:activecontraceptiveandPLACEBO.
• Womennotinformed.• Results:Highnumberofunplanned
pregnanciesinplacebogroup.
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• Safetyinpregnantwomenhasnotbeenestablished.• Itcaused10,000-20,000birthdefectsWITHINYEARS
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THEESSENCE&LESSONSLEARNT
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UnfairnessDishonesty
Researchactivitiesé
Competitioninresearchenvironment
Interests• Sponsor• Researchers• Subjects• Government
Needsofethicalguidelines
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NationalCommissionfortheProtectionofHumanSubjectofBiomedicalandBehavioralResearch
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• Treatindividualsasautonomousagents(Autonomy)&selfdetermination• Voluntary• Informedconsent• ConUidentiality• Canstopparticipationanytime
• personswithdiminishedautonomy(vulnerablesubjects)
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• Children• MentallyChallenged• InstitutionalizedIndividuals• Subordinates/Staff/employee• Students• Prisoners• Pregnant/Lactatingwomen• Disease/condition• Poor• Military• Tribal• Uneducated• Ethnicminorities/refugees• Homeless/frailandold
• Nottoincludeunlessthestudydemandsspecialgroups
• Informedconsentfromthelegalguardians
• Informedconsentfromtheindividualswhereverpossible
• Noinducementofguardians• Assentfromminors• Respecttheirrighttorefuse
participation
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• DONOHARM• MaximizepossiblebeneSitandminimizepotentialrisk
“Do unto others as you would have them do unto you”
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• Totreateachpersonaccordingtowhatismorallyrightandproper
• EquitabledistributionofbothburdensandbeneUitsoftheresearch
• Individualjustice&Socialjustice(we’lldiscussedinthenexttopic)
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• TheHelsinkiDeclaration,theBelmontReport&otherdocumentsgive“ethicalprinciples”toguidedecision-makinginmedicalresearch.
• Thisprinciplesaretranslatedinpracticalstandardsof
workingintheGoodClinicalPractices(GCP)guidelines• WorldHealthOrganization,1995• InternationalConferenceofHarmonization,1996• NationalGuidelines
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GCP(GoodClinicalPractices)isaninternationalstandard(ethical&scienti>icquality)in:
trialsthatinvolveparticipationofhumansubjects
Designing
Conducting
Recording
Reporting
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• Ensurepatients’protection• Ensurequalityofdata
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ethics
quality
Thisguidelineshouldbefollowed:
generatingCTdatathatintendedtobesubmittedtoregulatoryauthority/bepublished
anyresearchthatmayhaveanimpactonthesafety&well-beingofhumansubjects
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critical
always
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1.ethicalprinciplesinconductingclinicaltrial(CT)
2.Performrisk-beneUitanalysisbeforeinitiationofthetrial
3.Safeguardingtheparticipants
4.Adequatedata(preclinicaldata)tosupportproposedCT
5.ScientiUicallysoundàclearlydescribedinprotocol
6.ComplywithprotocolwhenconductingtheCT
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7.Medicareforparticipant(qualiUiedphysician)
8.QualiUiedtrialpersonnel
9.Freelygiveninformedconsent(beforeandduringthestudy)
10.Qualityofthedata
11.RespectparticipantconUidentiality
12.InvestigationalProduct
13.Qualityassurance
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• a-3-dayscourse• byacompetenttrainer/institution
• itisencouragedthatallresearcher&supervisorsofresearcherstakethecourse
• in-housetrainingispossible(capacitybuilding)
moreandmoreofferscomefromtheCROtoconducttheCT(phase2-3CT)
àAndthisisoneoftherequirement
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renewalevery2years
thesystematicanalysisofsuchquestionstoensurethatstudyparticipantsareprotected,
andultimately,thatclinicalresearchisconductedinawaythatservestheneedsofsuchparticipantsandofsocietyasawhole.
(Weijer,Dickens&Meslin,1997)
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• ClinicalTrialisapartofmedicalresearch(involvinghumansubject)
• Indoingso…• ICH-GCPistheinternationalethical&scientiSicqualitystandard
• allinvestigatorsshouldbeawareofthis
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Betterresearch
Betterresults(evidence)
Betterpatientcare
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“Mostpeoplesaythatitistheintellectwhichmakesagreat
scientist.Theyarewrong:itischaracter.” 33
THANKYOU