research ethics hakimi

8/7/2019 Research Ethics Hakimi

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Ethical and RegulatoryEthical and RegulatoryGuidance for ResearchGuidance for Research

with Human and Animalwith Human and AnimalSubjectsSubjects

Mohammad HakimiMohammad Hakimi


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O utline of PresentationO utline of Presentation

1.1. Pr otecting human research subjectsPr otecting human research subjects2.2. E thical research conductE thical research conduct3.3. E thics Committee/Institutional Review E thics Committee/Institutional Review

Board (IRB)Board (IRB)


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1. Protecting human research subjects1. Protecting human research subjects

a.a. JurisdictionJurisdictionResearchResearch

Human subjectHuman subject(Animal subject)(Animal subject)


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b .b . Infamous Cases: Ethical Violations inInfamous Cases: Ethical Violations inResearch Involving HumansResearch Involving Humans

N

azi War

Crimes

N

azi War

CrimesThe Tuskegee Syphilis Study The Tuskegee Syphilis Study

The Jewish Chronic Disease Hospital Study The Jewish Chronic Disease Hospital Study TheThe Willowbrook Willowbrook Study Study Radiation Tests on Mentally Impaired BoysRadiation Tests on Mentally Impaired Boys


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c.c. Protecting Research Subjects in theProtecting Research Subjects in theModern EraModern Era

JesseJesse Gelsinger

Gelsinger

E llen RocheE llen Roche( Pr of . Hwang Woo Suk)( Pr of . Hwang Woo Suk)


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d .d . Milestones in Ethical DevelopmentMilestones in Ethical Development1946 N uremberg Trial of doctors responsible for the N aziexperiments1947 N uremberg Code outlining ethical principles required for research1948 United N ations adoption of Unive rsal Declaration of Human Rights1964 Declaration of Helsinki international ag reement onrecommendations fo r the ethical1979 Belmont Repo rt promoting th ree principles for research198 2 Council for the Inte rnational O rganization of MedicalSciences (CIOMS) publication of the Inte rnational E thicsGuidelines for Biomedical Research Involving HumanSubjects (2008/200 9)199 3 WHO Inte rnational E thical Guidelines for Biomedical199 3 WHO Inte rnational E thical Guidelines for BiomedicalResearch Involving Human Subjects .Research Involving Human Subjects .


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d .d . Research ethicsResearch ethicsWhat is research ethics?What is research ethics?

Autonomy Autonomy Info rmed consentInfo rmed consentBeneficence/Beneficence/nonmaleficencenonmaleficenceJusticeJustice subject vulne rability subject vulnerability


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d .d . Research ethicsResearch ethicsWhy is research ethics important?Why is research ethics important? (contoh kasus?)(contoh kasus?)

E thicsE thicsLaw Law P olicy P olicy E mpirical studiesE mpirical studies


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d .d . Research ethicsResearch ethicsHow should I app roach research ethics in practice?How should I app roach research ethics in practice?

Good Clinical Pr actice (GCP )Good Clinical Pr actice (GCP )K N EP K K N EP K Komisi E tik FK Komisi E tik FK--UGMUGM


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d .d . Research ethicsResearch ethicsWhat Makes Clinical Research E thical?What Makes Clinical Research E thical?

1.1. Social or scientific valueSocial or scientific value2.2. Scientific validity Scientific validity 3.3. Fair subject selectionFair subject selection4.4. Favorable risk Favorable risk--benefit ratiobenefit ratio5.5. Independent review Independent review 6.6. Info rmed consentInfo rmed consent7.7. Respect for potential and en rolled subjectsRespect for potential and en rolled subjects


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2 . 2 . MMisconductisconduct inin R Researchesearch

FabricationFabricationFalsificationFalsification

P lagiarismP lagiarism


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3 . Ethics Committee/ IRB3 . Ethics Committee/ IRB

What is an E C/IRB?What is an E C/IRB?When to Submit to the E C/IRBWhen to Submit to the E C/IRB

Why Do We N eed an E C/IRB?Why Do We N eed an E C/IRB?Categories of E C/IRB reviewsCategories of E C/IRB reviews

E xemptE xempt

E xpeditedE xpeditedFull boardFull board

What do I need to do?What do I need to do?


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ReferencesReferences

Weijer C, Dickens B, Meslin E M. Bioethics for Weijer C, Dickens B, Meslin E M. Bioethics for clinicians:10. Research ethics. clinicians:10. Research ethics. CMAJ CMAJ 1997; 156:11 531997; 156:11 53--7.7.Canela MR, E stevez JI, Gonzlez MAM, G racia E Gand Crehuet JF. Methodological quality and reporting Methodological quality and reporting of ethical requirements in clinical trials. of ethical requirements in clinical trials. J Med Ethics J Med Ethics 2001; 27:17 22001; 27:17 2--176.176.E

manuelE

J, Wendler

D, Grady C

.What Makes

Emanuel

EJ, Wendle

rD, G

rady C

.What MakesClinical Research E thical?Clinical Research E thical? JAMAJAMA .. 2000; 283:27012000; 283:2701--2711. 2711.

research ethics hakimi

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