materi dr.meita

7/21/2019 Materi Dr.meita

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Research EthicsEthics in Clinical

ResearchDr. Meita Dwi Utami, MSc


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Whats past is prologue(William Shakespeare, The Tempest)


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Research is the repeatedsearch to the unknown

Hypothesis (cause-efect)Thesis

Cause Independent

aria!le Efect "ependent aria!le

Research


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Science and Scientific method

Mathematical logic

SCIENCE RATIONAL WORLD HYOTHESIS

EMIRICAL WORLD

IND!CTION TESTS

"ACTS

DED!CTION

STATISTIC RESEARCH METHOD


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Scientific Methods

Characteristics of Scientific Method

1. Based on facts

2. Free from prejudice

3. Using ana!tica principes

". #$jecti%e measurements

&. 'as h!pothesis

(. )uantitati%e techni*ues


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Characteristic ofResearch

1. Problem oriented2. Curiosity3. Originality

4. Phenomena: Law and Order. !oal !enerali"ation#. Cause and $%ect &tudy'. (ccurate measurement). &ound and *nown methods and

techni+ues


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RESEARCH

ROCED!RES

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M9UM0U4/ D/ //-S-S D//

MMBU/ 4S-M0U/ dan /0#/

Studi

0endahuuan

Merumus+an #0-4/tau 5UDU

#-, 'U4UM, D/-

MU4/ :/-/B


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Relation o# $ro!le%s& 'oalsandConclusionsin a Research

$ro!le%s

uestion

'oals

*nswer

Conclusions* de+ned answer


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Research com#onents

Research

Who

When

Whom

Ho$

Where

What


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O%er%ie$ to Research St&dies

Why Do Research Studies?

o coect data

o test h!potheses formuated fromo$ser%ations and;or intuition

o understand $etter


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The Ten Co%%and%ents #or $ickin, aResearch $roect

(C. Ronald /ahn& 0."& 1E20& 334 5634& 5778)

,. Pic* an (rea on the -asis of the ,nterest of theOutcome.

,,. Loo* for an nderoccu/ied 0iche that has Potential.

,,,. !o to al*s and Read Pa/ers outside our (rea of

,nterest.,. -uild on a heme.

,. ind a -alance -etween Low5Ris* and 6igh5 Ris*Pro7ects8 but (lways ,nclude a 6igh5Ris*8 6igh

,nterest Pro7ect in our Portfolio.,,. -e Pre/ared to Pursue a Pro7ect to any 9e/th

0ecessary.

,,,. 9i%erentiate ourself from our entor.

,;. 9o 0ot (ssume that Outstanding8 or $


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:arious t!pes of research stud!

design


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Classifications of Research St&dies'

Three Main T(#es

)* O+ser%ational St&dies'

,ros are st&died - contrasts made +et$een gros

Anal(.ing the o+ser%ed data

/* Anal(tic 0E1#erimental2 St&dies '

St&d( the im#act of a certain thera#(3treatment

4* Clinical Trial'

5,old Standard6 of clinical research


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Stud! designs

Case

control Case

Re#orts

S&r%e(

Case series

Meta

anal(sis

Cohort

RCT


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Historical min&tes of clinical trials

"ormal record of clinical trials dates

+ac7 to the time of the Trialists: Dr* 8an Helmont9s #ro#osal for a

thera#e&tic trial of +loodletting for fe%ers:);/ a shi# s&rgeon> trial of oranges

- limes for sc&r%( :)?@?=


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Historical Highlights of Dr&g Trials

)B'a&l Ehrlich Ars#henamine

)/'Ale1ander "leming enicillin

)4' ,erhard Domag7 S&lfonamide

)@@' Schat.3&gie3Wa7sman F Stre#tom(cin

( )B> the ritish Medical Res* Co&ncil

de%elo#ed a s(stematic methodolog( forst&d(ing - e%al&ating thera#e&tic

inter%entions


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Another selecti%e histor( of clinical

research

Who When What

-$nu Sina >?? C.E. @ater $orne transmission

'ippocrates 'ippocratic method= #$ser%ation in adisease

Frederich -- 12?? C.E. ffect of eAercise on digestion

@ren 1(&( First -: ine for first $ood transfusion

/nthonj %an eeuwenhoe+ 1(" Microscop!$acteria, !east,protooa,


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Core Com#onents of Clinical Trials

)* In%ol%e h&man s&+Gects/* Mo%e for$ard in time

4* Most ha%e a com#arison CONTROL gro

@* M&st ha%e method to meas&re inter%ention* "oc&s on &n7no$ns' effect of medication

;* M&st +e done +efore medication is #art of

standard of care

?* Cond&cted earl( in the de%elo#ment of

thera#ies


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Core Com#onents of Clinical Trials

#roced&res>

and3or other inter%entions


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hases of Clinical Trials

Most trials that in%ol%e ne$ dr&gs go

thro&gh a series of ste#s'

)' E1#eriments in the la+orator(

/' Once deemed safe> go thro&gh )

@ #hases


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hases of Clinical Trials

hase I'Sma group 2?E?G for 1st time

to e%auate safet!, determine safe dosage

range H identif! S hase II'R13t1 gi%en to larger gro

:)BB4BB= to confirm effecti%eness>

monitor SE> - f&rther e%al&ate safet(


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hases of Clinical Trials 0cont*2

hase III'R13t1 gi%en to e%en larger gro

:)>BBB4>BBB= to f&lfill all of hase II

o+Gecti%es - com#are it to other commonl(&sed t1s - collect data that $ill allo$ it to

+e &sed safel(

hase I8'Done after r13t1 has +een

mar7eted st&dies contin&e to test r13t1 tocollect data a+o&t effects in %ario&s

#o#&lations - SE from long term &se*


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'istor! of Medica esearch thics

Year Doc&ments

1>" urem$erg Code= -nternationa Code of thic

1>&" -' CC Medica Board= ca for informed consent and protoco

re%iew

1>(3 FD/ re*uires informed consent

1>(",2???6re%7

Decaration of 'esin+i

1>>3, 2??26re%7

-nternationa ethica guideines for Biomedica esearch -n%o%ing'uman Su$ject


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Case

9r. R8 a general /ractitioner in a small rural town8 isa//roached by a contract research organi"ation>C.R.O.? to /artici/ate in a clinical trial of a newnon5steroidal antiin=ammatory drug >0&(,9? forosteoarthritis. 6e is o%ered a sum of money foreach /atient that he enrols in the trial.

he C.R.O. re/resentati


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Some principes from Do'=

0aragraph 1& of Do'=

I...e%er! proposa for medica research onhuman su$jects must $e re%iewed and

appro%ed $! an independent ethics

committee $efore it can proceed.J

thics e%iew Committee /ppro%a


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0aragraph 12 of Do'=

I...medica research in%o%ing humansu$jects must $e justifia$e on scientific

grounds.J

Scientific Merit


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0aragraph 1 and 21 of Do'=

I...socia %aue has emerged as an importantcriterion for judging whether a project

shoud $e funded.J

Socia :aue


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0aragraph 2? of Do'=

I-f the ris+ is entire! un+nown, then theresearcher shoud not proceed with the

project unti some reia$e data are

a%aia$eJ

is+s and Benefits


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0aragraph 2", 2(, 2 and 2> of Do'=

6urem$erg code7

Ihe %ountar! consent of the human su$ject

is a$soute! essentia.J

-nformed Consent


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0aragraph 31 of Do'=

I...the ph!sicianKs roe in the ph!sician patient

reationship is different from theresearcherKs roe in the researcherEresearch

su$ject reationshipJ

Confict of roes


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I...research su$jects ha%e a right to pri%ac!

with regard to their persona heath

informationJ

Confidentiait!


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I...there ha%e $een numerous recent

accounts of dishonest practices in the

pu$ication of research resutsJ

'onest reporting of the resuts


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-ntegrit!

Iin%estigators shoud $e *uaified and

competent to conduct the stud! $! %irtue

of their education and eAperienceJ

LLLLLL.pus 'onest!


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!Iomite aGi Eti7 "!I

!nhasomisi Eti7 "!H

!,M

&sat aGian ioeti7 dan

H&maniora edo7teran

Setia# RS +iasan(a memili7i

omite Eti7


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4omisi ti+ mem$ahas usuanEusuan peneitin

$iomedis !ang mengguna+an manusia se$agai

su$!e+ peneitian, $ai+ untu+ +egiatan peneitian!ang dia+u+an oeh unitEunit peneitian di

ing+ungan Badan it$ang+es, ataupun +egiatan

peneitian !ang dimonitor oeh Badan

it$ang+es.

omnas Eti7 enelitian esehatan

Se7retariat ersama omisi Eti7 enelitian


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Se7retariat ersama omisi Eti7 enelitian

dan omisi Ilmiah

9edung Se+retariat Badan it$ang+es

5. 0erceta+an egara, o. 2>

5a+arta 0usat, 1?&(?ep. ?21 "2(1? eAt. 11" ; 12

http=;;www.it$ang.dep+es.go.id


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9r. R should not ha


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6e should ensure that he acts in the best interestsof his /atients and only enrols those who will notbe harmed by changing their current treatment tothe e@/erimental one or to a /lacebo.

6e must be able to e@/lain the alternati


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6e should not agree to enrol a A@ed number of/atients as sub7ects since this could lead her to/ressure /atients to agree8 /erha/s against theirbest interests. &he should carefully monitor the/atients in the study for une@/ected ad


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Concusion

The histor( of clinical research can +e

traced to all c&lt&res*

The f&t&re reJ&ires information

e1change to ma1imi.e #rogress in

health care*

Ethical clearance is strongl( ad%ised in

medical research $ith h&man +eing asthe s&+Gect*


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Whats past is prologue

(William Shakespeare, The Tempest)

@assaamu aai+um @r.@$


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eferences

@ord Medica /ssociation, Medica thics Manua=Chapter &, 2??&.

&>th@ord Medica /ssociation 9enera /ssem$!.

Decaration of 'esin+i= ethica principes for medica

research in%o%ing human su$jects. 2??. -', 'istor! of Cinica esearch and Choosing a

esearch )uestion, 2??.

Fade, thics of Cinica esearch= /n -samic

0erspecti%e, 5-M/ %o. "2, 2?1?.

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