Post on 17-May-2018
PengantardanPrinsipDasarEtikPenelitianKesehatansertaPertimbanganRisikodan
ManfaatdalamPenelitian
Pengenalan KEPK
Deni KSunjayad.k.sunjaya@unpad.ac.idwww.deni-comhealth.org
• Sejarah• Etik• Prinsip Dasar Etik Penelitian• Pertimbangan RiskBenefit• Pengenalan KEPKFKUnpad
• WalterReedandtheyellowFeverExperiments• TheNaziMedicalexperiment• TheImperialJapaneseExperimentsinChina• RCTofSreptomycin• SalkPolioVaccineFieldTrialof1954• TheJewishChronicDiseaseHospitalCase• TheHepatitisExperimets attheWillowbrook StateSchool
• TheTuskegeeSyphilisExperiment• HIVResearch• Gelsinger Case
MENGELEEXPERIMENTS
• MENGELEINJECTEDCHEMICALSINTOTHEEYESOFTHECHILDRENINANATTEMPTTOCHANGETHEIREYECOLOR.
• HECARRIEDOUTTWIN-TO-TWINTRANSFUSIONS,STITCHEDTWINSTOGETHER,CASTRATEDORSTERILIZEDTWINS.
• MANYTWINSHADLIMBSANDORGANSREMOVEDINMACABRESURGICALPROCEDURES,PERFORMEDWITHOUTUSINGANANESTHETIC.
• SOMESURVIVORSWEREKEPTALIVEBECAUSETHEYWERETWINS,ANDHEWANTEDTHEMFORMEDICALEXPERIMENTSAIMEDATCREATIONOF ANARYANSUPERRACE.
Moh. Sudomo 8
JEWISHTWINSKEPTALIVETOBEUSEDINMENGELE'SMEDICALEXPERIMENTS.THESECHILDRENWERELIBERATEDFROMAUSCHWITZBYTHEREDARMYINJANUARY1945.
Moh. Sudomo 7
PERCOBAANPADAANAK: KURTHEISSMEYER• NOVEMBER1944:20ANAKYAHUDI(5-10TAHUN),10PRIADAN10WANITADIAMBILDARIAUSCHWITZDIBAWAKEKAMPKONSENRASINEUENGAMME,DILUARKOTAHAMBURG.
• MEREKADIJADIKAN “HUMANGUINEA-PIGS” UNTUKBERBAGAIMACAMPERCOBAANMEDISOLEHDOKTER KURTHEISSMEYER.
• ANAKANAK DISUNTIKDENGANBAKTERITBCHIDUPKEDALAMVENADANPARU UNTUKMELIHATAPAKAHMEREKAMEMPUNYAIIMUNITASTERHADAPTBC
•MEREKADIAMATIDENGANSEKSAMA,DILAKUKANPEMERIKASAAN,DIFOTOUNTUKMELIHATPERJALANANPENYAKIT.
àKONDISIANAK-ANAKLANGSUNGMEMBURUKDGCEPATDANSAKITPARAH
• TGL20APRIL1945,SEBELUMPERANGBERAKHIR, HEISSMEYER DANARNOLDSTRIPPELMEMUTUSKANUNTUKMEMBUNUHANAK-ANAKUNTUKMENYEMBUNYIKANBUKTIKEKEJAMANKEPADATENTARASEKUTUMoh. Sudomo9
THE TUSKEGEE SYPHILIS STUDY, STUDY TTG PENYAKIT YGDILAKUKAN ANTARA 1932- 1972 DI TUSKEGEE, ALABAMA.399 PENDERITA SIFILIS, AFRICAN-AMERICA, MISKIN, BUTAHURUF (DIBERIKAN BEBERAPA INSENTIF)
Moh. Sudomo 10
THE TUSKEGEE SYPHILIS STUDY, STUDY TTG PENYAKIT YGDILAKUKAN ANTARA 1932- 1972 DI TUSKEGEE, ALABAMA.399 PENDERITA SIFILIS, AFRICAN-AMERICA, MISKIN, BUTAHURUF (DIBERIKAN BEBERAPA INSENTIF)
Moh. Sudomo 10
• Etik?
Ethics
• Asetofphilosophicalbeliefsandpracticeconcernedwithquestionsofjustice,fairness,equity,rights,allocationofresources,andcost.
• à telluswhatweoughttodo
• thestudyofdecisionsorbehaviorthatbenefitsorharmspersonsandcreatures
dks
ModesofThinking
Ethical
Theological
Conventional
Legal
EthicalTheory
• Virtues• NaturalLaws
• Utilitarianism• Deontology• Right
PrinciplismBeuchamps – Childress
Respectforautonomyàmakechoicesanddecisionsforthemselves
Non- maleficenceà notharming
Beneficenceà doinggood
Justiceà fairness,equity,impartiality
AnalysisEthical
Utilitarianism
Communitarianism
Libertarianism
Risiko
• MinimalRisk:riskthatarenotgreaterinandofthemselvesthanthoseordinarilyencounteredindailylifeorduringtheperformanceofroutinephysicalorpsychologicalexaminationortest
RiskBenefitAssessment
Benefit
Risk
BriefHistory• MedicalResearchEthicsTeamFacultyofMedicineUniversitasPadjadjaran (FMUP)1990
• HealthResearchEthicsCommitteeFMUP1991
• ResearchEthicsCommitteeunderMedicalCommitteedr.HasanSadikin Hospital(RSHS)1995
• HealthResearchEthicsJointCommitteeFacultyofMedicineUniversitas Padjadjaran - DrHasan Sadikin Hospital2009
• HealthResearchEthicsCommitteeFMUP(establishedJanuary3,DecreeofDeanNo.50/UN6.C/Kep/HK/2012
•Affiliation:NHREC/KNEPK,OfficeforHumanResearchProtection-NIH-USA(IORG-IRBnumber:00008626), FWAfortheProtectionofHuman Subject:00018324,&PRIM&R(PublicResponsibility inMedicineandResearch)
2012
Overviewsince2012Year 2012 2013 2014
SOP Generalguidelines
GeneralguidelinesSept:SOPdevelopment
SOP(FERCAP)Revision:AprilandJuly
Members 7 9 9(including 1 Veterinary Med)
SecretariatStaff
1 September:2 February:2March:4(3new, including1IT)
Office 1roomathospital
2 roomsatnewbuilding (admin&
meeting)
3rooms (admin,meeting,archive), independent phone line
Protocols ?? ?? 1st halfyear:378(increasing)
Reviewprocess
• Integratedwithstudentproposalexam
• Manualreview
• Integratedwithstudentproposalexam
• Manualreview
• April:separatedfromstudentproposalexam
• July:onlinereviewAdminsystem Manual Manual April:online registration
July:onlineprotocol submission
BasicInternationalGuidelinesResearchinHumanBeing
•NurembergCode1947
•DeclarationofHelsinki (revised2002,2008,2013)1964
•BelmontReport1978
•CIOMS/WHO(19931991
•ICHGoodClinical PracticeGuidelines1996•OperationalGuidelines forEthicsCommitteesReviewBiomedicalResearch2000
•SurveyingandEvaluatingEthicalReviewPractices(WHO-TDR)2002
•SIDCER-FERCAPRecognitionProgram2004
NationalRegulation&Guidelines
HealthLaw(No.36/2009)• healthprotectionforresearchparticipants
GovernmentRegulationNo.39/1995• NIHRD-MoH responsibletoorganize/managethehumansubjectprotection,reviewandapprovedinformedconsentandcompensationtothosewhowereharmedorinjuredduetoresearch
DecreeofMinistryofHealthNo.1333/2002• Informedconsentinresearchusinghumansubject
GovernmentRegulationNo.41/2005• Researchinvolvingforeigninstitution/researcher
NationalCommitteeGuidelines• Researchonclinicaltrialandarchivedmaterial
TypeofReview
FullBoardReviewFullboardreviewmeansthattheresearchisreviewedatconvenedmeetingsatwhichamajorityofthemembersoftheREC/IRBarepresent,includingatleastonememberwhoseprimaryconcernsareinnonscientificareas.Thistypeof
reviewappliestostudiesthataregreaterthanminimalrisk,orminimalriskbutdonotqualifyforexpeditedreview.
ExpeditedReviewExpeditedreviewmeansthatthereviewcanbedonebyaqualifiedIRBreviewerratherthanataconvenedIRBmeeting.Reviewersconductinganexpedited
reviewmayexercisealloftheauthorityoftheREC/IRBexceptthattheymaynotdisapproveastudy.Whenreviewerscannotapprovetheresearchunder
expeditedreview,thestudyisreferredforfullboardreview.
ExemptReviewThecategoriesofresearchwhichareexemptfromtheregulations.Althoughthecategoryiscalled"exempt,“thedeterminationofexemptionmustbemadebytheREC/IRBOffice.ExemptprojectsaredifferentfromExpeditedorFullBoardreviewinthattheyarenotassignedanexpirationdate,donothavetoundergocontinuingreviewandareabletoundergoalterationwithoutREC/IRBapproval.
Jateng(1) DIY(3)
Jakarta(9)
Jatim(6)
Sulsel(1)
Sumbar(1)
Jabar(3)
Sumsel(1)
Sumut(1)
Bali(1)
ResearchEthicsCommittees(RECs)
INDONESIA
NTB(1)
Sulut(1)
TypeofReview...continue....
ReciprocalReviewUnderareciprocalagreementbetween REC/IRB
toaccepttherevieweachinstitutionreservestherighttohaveitsownREC/IRBreviewtheresearch.
UmbrellaGrantReviewUmbrellareviewshouldberequestedif;REC/IRBapprovalletter isneededtothefundingagencyforatraininggrant,centergrant,orprogramprojectgrant
thatwill supportmultipleresearchprojectsinvolvinghumansubjects.REC/IRBapprovalrepresentsapprovalofthegrantinconceptonly.SeparateREC/IRBapprovalmustbeobtainedforeachhumansubjectsresearchproject
thatreceivesfundsfromthegrant.
DevelopmentGrantReviewDevelopmentgrantreviewshouldberequestedif;REC/IRBapprovalletter isneeded foragrantapplicationbutarenotyetreadytobeginresearchwith
humansubjects."Development-only"approvalshowsthattheIRBhasapprovedthestudyinconcept. Whenyouarereadytobeginyour
researchwithhumansubjects,submitanewstudytoreceive thefinalapproval.
WORLDMEDICALASSOCIATIONDECLARATIONOFHELSINKI (1964- 2013)
BASICPRINCIPLEFORALLMEDICALRESEARCH
lAppropriatecautionmustbeexercisedintheconductofresearchwhichmayaffecttheenvironment,and
lthewelfareofanimalsusedforresearchmustbe respected
Reduction:alternativemodelstohaveminimalnumberofanimalassubjectofstudyReplacement:alternativeofchanginganimaltoinvertebrataorcelllines(tissueculture)Refinement:minimizeseverityofpainandstress
ANIMALRESEARCH
• Replacement:Methodsthatavoidusinganimals.– Relatif:- useanimalorgans/tissuesfromslaughterhouse.
- useanimaloflowerordo– Absolut:- replacetheuseofanimalwithtissueculture/computerprogram.(menggantihewancobadenganalternatiflainsepertihewaninvertebrata/kulturjaringan/programkompter)
• Reduction:Strategiesforobtainingcomparablelevelsofinformationfromtheuseoffeweranimalsorformaximizingtheinformationobtainedfromagivennumberofanimalwithoutincreasingpainordistressà vieweranimalsareneededtoaquirethesamescientificinformation.(modelalternatifagardapatmengurangijumlahhewancoba)
• Refinement:Modificationofhusbandryorexperimentalprocedurestoenhanceanimalwell-beingoreliminatepainanddistressà useofanalgesics,anesthetics.(mengurangi/menghindaripenederitaandanrasanyeriataupunstressepertipemberiananalgesikadanobatanestesi)
5 Freedoms from
Hungerandthirst Discomfort
Pain,injuryanddisease Fearanddistress
Expressnaturalbehavior
Free from hunger and thirstFree from hunger and thirst
“The love for all living creatures is the most noble attribute of man”
(Charles Darwin)
CollaboratingtheEuropeanUnion,theUnitedStates,andJapan(since1991)
↓
THEINTERNATIONALCONFERENCEONHARMONISATION(ICH)
TechnicalRequirementforRegistrationofPharmaceuticalsforHumanUse
TechnicalRequirementforRegistrationofPharmaceuticalsforHumanUse
ICHHarmonised TripartiteGuidelinesforGoodClinicalPractise (1996) ->GCPICHHarmonised TripartiteGuidelinesforGoodClinicalPractise (1996) ->GCP
PrinciplesofInternationalConferenceonHarmonisation
(ICH)GoodClinicalPractice(GCP)(clinicaltrial-humanassubject)
Objective:TodefinetheICHanditsorigin
TolisttheuniversalprinciplesthatformthebasisofGCP
ToidentifythosewhobenefitfromGCP
Fabrication : menggandakandata,hasilpenelitiandalamcatatandatadalampelaporanhasilpenelitian.Falsification :memalsukan/memanipulasibahanpenelitian,alat,proses,merubahataumenghilangkandataatauhasilsehinggamengubahhasilpencatatandata.Plagiarism :mengambildatapenelitianoranglain;ide,proses,hasilataukata-katatanpamenyebutkansumbernya.
RESEARCHMISCONDUCT
ConflictofInterest(COI)
• COIisasetofconditionsinwhichprofessionaljudgmentconcerningaprimaryinterest(suchaspatient’swelfareorvalidityofresearch)tendstobeundulyinfluencedbyasecondaryinterest(suchasfinancialgain).COIrules,formalandinformal,regulatethedisclosureandavoidanceoftheseconditions
(DennisF.Thompson)
WhatiswrongwithCOI?
• COIisnotanevidenceofwrongdoing• Formanyprofessionals,itisalmostimpossibletoavoidhavingCOIsfromtimetotime
• ACOIcan,however,becomeanethicalorlegalissueifanindividualtriesorsucceedsininfluencingtheoutcomeofadecision,forpersonalbenefit
RulesforcontrolofCOI
• Tomaintainintegrityofprofessionaljudgment
• Topreventsecondaryinterestsfromdominatingtheprimaryinterestsinthemakingofprofessionaldecisions
• Tomaintainpublictrustintheprofession
Authorship
• Eachauthorshouldhaveparticipatedsufficientlyintheworktotakepublicresponsibilityforappropriateportionsofthecontent
• Oneormoreauthorsshouldtakeresponsibilityfortheintegrityoftheworkasawhole
• Authorshipcreditshouldbebasedonlyon(1)substantialcontributionstoconceptionanddesign,oracquisitionofdata,oranalysisandinterpretation;(2)draftingthearticleorrevisingitcriticallyforimportantintellectualcontent;(3)finalapprovaloftheversiontobepublished
(“VancouverGroup”)
MemberAppointment
• Voluntaryandindependent• ProposedbyCommitteeà DecreeofDean• 9membersfrommultidiscipline• Atleast1frommedicine,1nonaffiliated(currently:4MD,4nonaffiliated)
• 6male,3female• 4yearsappointment,decreeannuallyrenewed(Universityregulation)
• Possibletowithdraw• Subjecttobereplacedordisqualified
IndependentConsultantAppointment• Tobeconsultedincertainfieldofexpertise• ProposedbyCommitteeà DecreeofDean• 41consultantsfrom24fieldofexpertise• 8nonaffiliated
Anesthesiologist 2 Biochemistry2 Radiologist2
Pharmacist/Pharmacologist 3
CellBiology/MolecularBiologist3
Dermatology/Venerealogist 1
Surgeon2 Epidemiology 2 Nutritionist 1
Obgyn 3 Internist2 Physiologist1Psychiatry1 Sociologist1 Neurologist1
Paeditrician 2 Dentist3 Ortophaedics 2
ENT 1 PublicHealth1 Pathologist1
Ophtalmologist 2 Microbiologist 1 ClinicalPathologist1
IndependentConsultantsNo Name Specialty Affiliation1 Dr.IkeSriRedjeki,dr.,SpAn-KIC, KMN,M.Kes Anesthesiology FMUP
2 Prof.Dr.TatangBisri,dr.,SpAn-KNA Aneshtesiology FMUP
3 Dr.DiahDhianawaty,Dra.,M.Si Biochemistry FMUP
4 Prof.Dr.M.NurhalimShahib, dr Biochemistry FMUP
5 Dr.Achadiyani, dr.,M.Kes CellBiology FMUP
6 Dr.HadyanaSukandar,Drs.,M.Sc Epidemiology FMUP
7 Dr.Rd.TinaDewiJudistiani, dr.,SpOG Epidemiology FMUP
8 Dr.AhmadMuhtadi,MS.,Apt Pharmacy Pharmacy Unpad
9 Prof.Dr.AnasSubarnas,M.Sc.,Apt Pharmacy Pharmacy Unpad
10 Dr.EriskaRiyanti,drg.,SpKGA Dentist Dentistry Unpad
11 Dr.MiekeHemiawatiSatari,drg.,MS Dentist DentistryUnpad
12 Prof.Dr.HerriS.Sastramihardja,dr.,SpFK(K) Pharmacology FMUP
13 PrihatiniAmbaretnani,Dra.,MA.,Ph.D Sociology Social&PoliticalScience
14 Dr.HermawanN.Rasyid,dr.,SpOT-K.,MT(BME).,FICS Orthopaedics Dr. Hasan Sadikin Hospital
15 Prof.Dr.FachryAmbiaTandjung, dr.,SpB.,SpOT-K,M.Phil(Orth)., FICS Orthopaedics Dr. Hasan Sadikin Hospital
No Name Background Affiliation17 Dr.BambangS.Noegroho, dr.,SpB.,SpU Surgeon Dr. Hasan Sadikin Hospital18 Prof.Dr.Hendro Sudjono Yuwono, dr.,Sp.B-KBV Surgeon FMUP19 Dr.R.ReniFareniaSoedjanaNingrat,dr.,M.Kes.,AIF Physiology FMUP20 Dr.VitaMurniatiTarawan,dr.,SpOG.,AIFO.,M.Kes.,SH Obstetrics&Gynaecology FMUP21 Dr.DewiMarhaeniDiahHerawati,drg.,M.Si Nutrition FMUP22 Dr.HadiSusiarno, dr.,SpOG.,M.Kes.,MH.Kes Obstetrics&Gynaecology FMUP23 Prof.Dr.Johanes C.Mose,dr.,SpOG-K Obstetrics&Gynaecology FMUP24 Prof.Dr.TutiWahmurtiArieSapiie,dr.,SpKJK Psychiatry FMUP25 Dr.MeitaDhamayanti,dr.,SpA(K).,M.Kes Paediatrician FMUP26 Prof.H.HerryGarna,dr.,SpA-K.,Ph.D Paediatrician FMUP27 Dr.OkiSuwarsa,dr.,SpKK(K).,M.Kes Dermatology &VenerealDis FMUP28 Dr.ElsaPudji Setiawati,dr.,MM PublicHealth FMUP29 Dr.AriefSyamsulaksanaK,dr.,SpM(KVR).,MM.,M.Kes Ophtalmology FMUP30 Dr.SutaryaEnus.,dr.,SpM-K Ophtalmology FMUP31 Dr.RatnaAnggraeniAgustian.,dr.,M.Kes..,SpTHT-KL(K) ENT FMUP32 Dr.ArtoYuwono Soeroto,dr.,SpPD-KP InternalMedicine FMUP33 Prof.Dr.H.M.RachmatSoelaeman, dr.,SpPD-KGH InternalMedicine FMUP34 Dr.Anam,dr.,SpS Neurology FMUP35 Dr.SadeliMasria,dr.,DMM.,MS.,SpMK Microbiology FMUP36 HerryHerman,dr.,PhD.,SpOT MolecularBiology FMUP37 BethySuryawathyHernowo,dr.,SpPA(K), Ph.D Pathology FMUP38 Prof.Dr.IdaParwati,dr.,SpPK-K, Ph.D Clinical Pathology FMUP39 Dr.RistaniahD.Soetikno,dr.,SpRad(K).,M.Kes Radiology FMUP40 Dr.SetiawanSutopo,dr.,SpRad. Radiology FMUP41 Dr.AniMelaniM.,drg.,M.Kes Dentist FMUP
AppointmentofSecretariatStaffs
• DecreeofDean• Employmentstatusisintegratedwithinthe
StateUniversityemploymentsystem• StatementofConfidentiality
Secretariat
• HeadofSecretariat:– IpurPurwatiningsih(September,2013)
• Staffs:– SitaPurnadewi(ITstaff)(March,2014)
– Lilik (August,2016)
StructureofOrganization
ReviewPolicy
• Independentreview• Confidential• Reviewers:Committeemembersand/orindependentconsultants
• ConflictofInterestmanagement– Reviewercannotreviewhis/herownresearchproject– Reviewercannotinvolveinfull-boardmeetingdiscussinghis/herownresearchproject
• CategoryofDecision:– Exemption(Chair/Secretary)– Expedited(2reviewers,1fromrelatedexpertise)– Fullboard(initialreviewers2,distributedtoallmembers)
• Fullboarddecisionrequiresquorum:50%+1
ReviewProcess
• FERCAPbasedSOP- January2,2014• FirstrevisionforcertainSOPs- AprilandJuly,2014
• Onlineprotocolregistration- April15,2014• Onlinereviewsince- July17,2014• ManualsystemforRevision,Amendment,Continuous(ITsystemunderdevelopment)
Funding
Before2012• Independentfunding• Feeperreview• Researcherpaysapplicationfeeperproposal
After2012• Freeapplicationforresearcher• Monthlysalaryforcommitteemembersonly• Nofeeperreviewformembersandconsultants• SecretariatisfacilitatedfullybyFacultyofMedicine• BudgetingandremunerationsystemhavebeenproposedthroughUniversity,waitingfordecisionfromMinistryofFinance
Trainings
BasicResearchEthics• Requiredforallmembers(eachhadreceiveddifferenttrainingsandperiod)• InhousetrainingisobligatoryforeachSecretariatStaffs
ResearchEthicsTraining• January,2013– inhouse,forconsultants,researchers,refreshingformembers• July,2013– traineesinFERCAPsurveyatUnud,Bali• November,2013– seminarattendance,FERCAPconference,Bali• April2014– refreshingforconsultantsandmembers,SOPsintroduction• May2014– studyatECLitbangkes,Jakarta• May2014– traineesinFERCAPSurveyatMRIN,Jakarta• May2014– studyatECUnhas,Makassar• July2014– trainingforallresearchersinUnpad,refreshingformembers• July2014– trainingofonlinereviewsystemformembersandconsultants
Chair :Prof.Dr.FirmanF.Wirakusumah
Secretary :Dr.MeitaDamayanti
Clinical Trial
Chair :Prof.Dr.Diah Dhianawaty
Secretary:Nur AtikPhD.
Members :Prof.Dr.AnasSubarnas,M.Sc.,Apt,
Prof.Dr.EfaLaelaFakhriah
Rovina, PhD
Dr.Tono DjuwantonoIhsan Hikmawan,S,Pd
Basic Medical Science
Chair :Prof. Dr.Ramdan Panigoro
Secretary:Dr. Agnes Rengga Indrati
Members:
Prof.Dr.Dany Hilmanto
Dr. BambangSetiohaji
Dr. Eriska Riyanti
Drh. Yusni
Asri Wijayanti,S.Si
Community Health Sciences
Chair : Dr.Deni KSunjaya
Secretary:ShellyIskandar,PhD
Members :
Prof.Dr.Tuti Wahmurti Sapiie
Prof.Dr.HaryoS.Martodirdjo
Dr. EddyFadlyana
Dr.Hadi Susiarno
Dr.YantiHermayanti
Dr. R.TinaDewiJudistiani
CurrentCommitteeMembers
• Address:Gedung RSPendidikan 3rdfloorJl.EijkmanNo.38,Bandung40161INDONESIATel/Fax(direct):+62-22-2038697email:kepk.fk.unpad@gmail.comInformationsystem(URL):kepk.fk.unpad.ac.id
Secretariat
FMUPRSHS
GlobalNetwork
INFRASTRUCTURE:Program/activitiesICTsystem
DevelopmentofNetworkingSystemà providecomplexinfrastructurenetworkbetween FMUP; departments,librariesandadministrationinsideintoglobalnetwork
RSM-C
UNPAD
HospitalNetwork
Contoh:e-governmentonlineservicekepk.fk.unpad.ac.id
Submission2014