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