pengantar dan prinsip dasar etik penelitian kesehatan...
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PengantardanPrinsipDasarEtikPenelitianKesehatansertaPertimbanganRisikodan
ManfaatdalamPenelitian
Pengenalan KEPK
Deni [email protected]
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• Sejarah• Etik• Prinsip Dasar Etik Penelitian• Pertimbangan RiskBenefit• Pengenalan KEPKFKUnpad
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• WalterReedandtheyellowFeverExperiments• TheNaziMedicalexperiment• TheImperialJapaneseExperimentsinChina• RCTofSreptomycin• SalkPolioVaccineFieldTrialof1954• TheJewishChronicDiseaseHospitalCase• TheHepatitisExperimets attheWillowbrook StateSchool
• TheTuskegeeSyphilisExperiment• HIVResearch• Gelsinger Case
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MENGELEEXPERIMENTS
• MENGELEINJECTEDCHEMICALSINTOTHEEYESOFTHECHILDRENINANATTEMPTTOCHANGETHEIREYECOLOR.
• HECARRIEDOUTTWIN-TO-TWINTRANSFUSIONS,STITCHEDTWINSTOGETHER,CASTRATEDORSTERILIZEDTWINS.
• MANYTWINSHADLIMBSANDORGANSREMOVEDINMACABRESURGICALPROCEDURES,PERFORMEDWITHOUTUSINGANANESTHETIC.
• SOMESURVIVORSWEREKEPTALIVEBECAUSETHEYWERETWINS,ANDHEWANTEDTHEMFORMEDICALEXPERIMENTSAIMEDATCREATIONOF ANARYANSUPERRACE.
Moh. Sudomo 8
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JEWISHTWINSKEPTALIVETOBEUSEDINMENGELE'SMEDICALEXPERIMENTS.THESECHILDRENWERELIBERATEDFROMAUSCHWITZBYTHEREDARMYINJANUARY1945.
Moh. Sudomo 7
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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
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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
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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
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• Etik?
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Ethics
• Asetofphilosophicalbeliefsandpracticeconcernedwithquestionsofjustice,fairness,equity,rights,allocationofresources,andcost.
• à telluswhatweoughttodo
• thestudyofdecisionsorbehaviorthatbenefitsorharmspersonsandcreatures
dks
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ModesofThinking
Ethical
Theological
Conventional
Legal
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EthicalTheory
• Virtues• NaturalLaws
• Utilitarianism• Deontology• Right
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PrinciplismBeuchamps – Childress
Respectforautonomyàmakechoicesanddecisionsforthemselves
Non- maleficenceà notharming
Beneficenceà doinggood
Justiceà fairness,equity,impartiality
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AnalysisEthical
Utilitarianism
Communitarianism
Libertarianism
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Risiko
• MinimalRisk:riskthatarenotgreaterinandofthemselvesthanthoseordinarilyencounteredindailylifeorduringtheperformanceofroutinephysicalorpsychologicalexaminationortest
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RiskBenefitAssessment
Benefit
Risk
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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
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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
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BasicInternationalGuidelinesResearchinHumanBeing
•NurembergCode1947
•DeclarationofHelsinki (revised2002,2008,2013)1964
•BelmontReport1978
•CIOMS/WHO(19931991
•ICHGoodClinical PracticeGuidelines1996•OperationalGuidelines forEthicsCommitteesReviewBiomedicalResearch2000
•SurveyingandEvaluatingEthicalReviewPractices(WHO-TDR)2002
•SIDCER-FERCAPRecognitionProgram2004
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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
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TypeofReview
FullBoardReviewFullboardreviewmeansthattheresearchisreviewedatconvenedmeetingsatwhichamajorityofthemembersoftheREC/IRBarepresent,includingatleastonememberwhoseprimaryconcernsareinnonscientificareas.Thistypeof
reviewappliestostudiesthataregreaterthanminimalrisk,orminimalriskbutdonotqualifyforexpeditedreview.
ExpeditedReviewExpeditedreviewmeansthatthereviewcanbedonebyaqualifiedIRBreviewerratherthanataconvenedIRBmeeting.Reviewersconductinganexpedited
reviewmayexercisealloftheauthorityoftheREC/IRBexceptthattheymaynotdisapproveastudy.Whenreviewerscannotapprovetheresearchunder
expeditedreview,thestudyisreferredforfullboardreview.
ExemptReviewThecategoriesofresearchwhichareexemptfromtheregulations.Althoughthecategoryiscalled"exempt,“thedeterminationofexemptionmustbemadebytheREC/IRBOffice.ExemptprojectsaredifferentfromExpeditedorFullBoardreviewinthattheyarenotassignedanexpirationdate,donothavetoundergocontinuingreviewandareabletoundergoalterationwithoutREC/IRBapproval.
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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)
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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.
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WORLDMEDICALASSOCIATIONDECLARATIONOFHELSINKI (1964- 2013)
BASICPRINCIPLEFORALLMEDICALRESEARCH
lAppropriatecautionmustbeexercisedintheconductofresearchwhichmayaffecttheenvironment,and
lthewelfareofanimalsusedforresearchmustbe respected
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Reduction:alternativemodelstohaveminimalnumberofanimalassubjectofstudyReplacement:alternativeofchanginganimaltoinvertebrataorcelllines(tissueculture)Refinement:minimizeseverityofpainandstress
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ANIMALRESEARCH
• Replacement:Methodsthatavoidusinganimals.– Relatif:- useanimalorgans/tissuesfromslaughterhouse.
- useanimaloflowerordo– Absolut:- replacetheuseofanimalwithtissueculture/computerprogram.(menggantihewancobadenganalternatiflainsepertihewaninvertebrata/kulturjaringan/programkompter)
• Reduction:Strategiesforobtainingcomparablelevelsofinformationfromtheuseoffeweranimalsorformaximizingtheinformationobtainedfromagivennumberofanimalwithoutincreasingpainordistressà vieweranimalsareneededtoaquirethesamescientificinformation.(modelalternatifagardapatmengurangijumlahhewancoba)
• Refinement:Modificationofhusbandryorexperimentalprocedurestoenhanceanimalwell-beingoreliminatepainanddistressà useofanalgesics,anesthetics.(mengurangi/menghindaripenederitaandanrasanyeriataupunstressepertipemberiananalgesikadanobatanestesi)
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5 Freedoms from
Hungerandthirst Discomfort
Pain,injuryanddisease Fearanddistress
Expressnaturalbehavior
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Free from hunger and thirstFree from hunger and thirst
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“The love for all living creatures is the most noble attribute of man”
(Charles Darwin)
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CollaboratingtheEuropeanUnion,theUnitedStates,andJapan(since1991)
↓
THEINTERNATIONALCONFERENCEONHARMONISATION(ICH)
TechnicalRequirementforRegistrationofPharmaceuticalsforHumanUse
TechnicalRequirementforRegistrationofPharmaceuticalsforHumanUse
ICHHarmonised TripartiteGuidelinesforGoodClinicalPractise (1996) ->GCPICHHarmonised TripartiteGuidelinesforGoodClinicalPractise (1996) ->GCP
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PrinciplesofInternationalConferenceonHarmonisation
(ICH)GoodClinicalPractice(GCP)(clinicaltrial-humanassubject)
Objective:TodefinetheICHanditsorigin
TolisttheuniversalprinciplesthatformthebasisofGCP
ToidentifythosewhobenefitfromGCP
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Fabrication : menggandakandata,hasilpenelitiandalamcatatandatadalampelaporanhasilpenelitian.Falsification :memalsukan/memanipulasibahanpenelitian,alat,proses,merubahataumenghilangkandataatauhasilsehinggamengubahhasilpencatatandata.Plagiarism :mengambildatapenelitianoranglain;ide,proses,hasilataukata-katatanpamenyebutkansumbernya.
RESEARCHMISCONDUCT
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ConflictofInterest(COI)
• COIisasetofconditionsinwhichprofessionaljudgmentconcerningaprimaryinterest(suchaspatient’swelfareorvalidityofresearch)tendstobeundulyinfluencedbyasecondaryinterest(suchasfinancialgain).COIrules,formalandinformal,regulatethedisclosureandavoidanceoftheseconditions
(DennisF.Thompson)
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WhatiswrongwithCOI?
• COIisnotanevidenceofwrongdoing• Formanyprofessionals,itisalmostimpossibletoavoidhavingCOIsfromtimetotime
• ACOIcan,however,becomeanethicalorlegalissueifanindividualtriesorsucceedsininfluencingtheoutcomeofadecision,forpersonalbenefit
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RulesforcontrolofCOI
• Tomaintainintegrityofprofessionaljudgment
• Topreventsecondaryinterestsfromdominatingtheprimaryinterestsinthemakingofprofessionaldecisions
• Tomaintainpublictrustintheprofession
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Authorship
• Eachauthorshouldhaveparticipatedsufficientlyintheworktotakepublicresponsibilityforappropriateportionsofthecontent
• Oneormoreauthorsshouldtakeresponsibilityfortheintegrityoftheworkasawhole
• Authorshipcreditshouldbebasedonlyon(1)substantialcontributionstoconceptionanddesign,oracquisitionofdata,oranalysisandinterpretation;(2)draftingthearticleorrevisingitcriticallyforimportantintellectualcontent;(3)finalapprovaloftheversiontobepublished
(“VancouverGroup”)
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MemberAppointment
• Voluntaryandindependent• ProposedbyCommitteeà DecreeofDean• 9membersfrommultidiscipline• Atleast1frommedicine,1nonaffiliated(currently:4MD,4nonaffiliated)
• 6male,3female• 4yearsappointment,decreeannuallyrenewed(Universityregulation)
• Possibletowithdraw• Subjecttobereplacedordisqualified
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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
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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
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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
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AppointmentofSecretariatStaffs
• DecreeofDean• Employmentstatusisintegratedwithinthe
StateUniversityemploymentsystem• StatementofConfidentiality
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Secretariat
• HeadofSecretariat:– IpurPurwatiningsih(September,2013)
• Staffs:– SitaPurnadewi(ITstaff)(March,2014)
– Lilik (August,2016)
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StructureofOrganization
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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
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ReviewProcess
• FERCAPbasedSOP- January2,2014• FirstrevisionforcertainSOPs- AprilandJuly,2014
• Onlineprotocolregistration- April15,2014• Onlinereviewsince- July17,2014• ManualsystemforRevision,Amendment,Continuous(ITsystemunderdevelopment)
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Funding
Before2012• Independentfunding• Feeperreview• Researcherpaysapplicationfeeperproposal
After2012• Freeapplicationforresearcher• Monthlysalaryforcommitteemembersonly• Nofeeperreviewformembersandconsultants• SecretariatisfacilitatedfullybyFacultyofMedicine• BudgetingandremunerationsystemhavebeenproposedthroughUniversity,waitingfordecisionfromMinistryofFinance
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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
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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
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• Address:Gedung RSPendidikan 3rdfloorJl.EijkmanNo.38,Bandung40161INDONESIATel/Fax(direct):+62-22-2038697email:[email protected](URL):kepk.fk.unpad.ac.id
Secretariat
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FMUPRSHS
GlobalNetwork
INFRASTRUCTURE:Program/activitiesICTsystem
DevelopmentofNetworkingSystemà providecomplexinfrastructurenetworkbetween FMUP; departments,librariesandadministrationinsideintoglobalnetwork
RSM-C
UNPAD
HospitalNetwork
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Contoh:e-governmentonlineservicekepk.fk.unpad.ac.id
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Submission2014
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