Materi Dr.meita
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Transcript of 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
f++ umj
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MUMUS4/ M/S//' D/ U5U/
MUMUS4/ '-0#S-S
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MU4/ SUMB D//
MU4/ D/ M8USU -SUM
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 $efore it can proceed.J
thics e%iew Committee /ppro%a
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Some principes from Do'=
0aragraph 12 of Do'=
I...medica research in%o%ing humansu$jects must $e justifia$e on scientific
grounds.J
Scientific Merit
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Some principes from Do'=
0aragraph 1 and 21 of Do'=
I...socia %aue has emerged as an importantcriterion for judging whether a project
shoud $e funded.J
Socia :aue
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Some principes from Do'=
0aragraph 2? of Do'=
I-f the ris+ is entire! un+nown, then theresearcher shoud not proceed with the
project unti some reia$e data are
a%aia$eJ
is+s and Benefits
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Some principes from Do'=
0aragraph 2", 2(, 2 and 2> of Do'=
6urem$erg code7
Ihe %ountar! consent of the human su$ject
is a$soute! essentia.J
-nformed Consent
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Some principes from Do'=
0aragraph 31 of Do'=
I...the ph!sicianKs roe in the ph!sician patient
reationship is different from theresearcherKs roe in the researcherEresearch
su$ject reationshipJ
Confict of roes
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Some principes from Do'=
I...research su$jects ha%e a right to pri%ac!
with regard to their persona heath
informationJ
Confidentiait!
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Some principes from Do'=
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<&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?.