kuliah kepk 2015 prof. firman

7/24/2019 Kuliah KEPK 2015 Prof. Firman

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KOMISI ETIK PENELITIAN

KESEHATAN

HEALTH RESEARCH ETHICS

COMMITTEE

Firman F. Wirakusumah


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SEJARAH ETIKA PENELITIAN

DENGAN SUBJEK MANUSIADAN HEWAN

SEJARAH ETIKA PENELITIAN

DENGAN SUBJEK MANUSIADAN HEWAN


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International:

193 T!"#e$ee% no treat&ent to "t!'( of"()*ili" +or t*e ,la-# -o&)are' to t*e.*ite "t!'( in US

19/0 N!re&,er$ o'e 192/ De-laration o+ Hel"in#i re4i"e' in 55 an' 5567 1906 Bel&ont Re)ort 3 ,a"i- et*i-" )rin-i)le"7 1991 Int8 G!i'eline" +or et*i-al re4ie. o+ e)i'e&iolo$i-al "t!'ie"

IMS;WH 1993 Int8 G!i'eline" +or Bio&e'i-al Re"ear-* In4ol4in$ H!&an S!,ERAP Re-o$nition Pro$ra&

RE>ERENES;GUIDELINES


4/203

National Re$!lation

Healt* La. 3;199 i8e *ealt* )rote-tion +or re"ear-*)arti-i)ant" an' "an-tion +or t*o"e 'i"o,e( t*e La.8

Go4t Re$ 39;199? NIHRDMoH re")on"i,le to or$ani@e ;&ana$e t*e *!&an "!,

re"ear-*er


5/203

National RE" NETWRKNational RE" NETWRK

NHRE

REC- UIREC- UGM REC-

Unpad REC...

REC-USU

NHRE 1

REC = 52Recognizedby NHREC REC...

RECUNHAS

REC...

REC

UNUD

REC...

REC...

REC...

REC... REC...

REC...


6/203

RE" Re"ear-* Et*i-" o&&ittee"7in In'one"ia

In 55/ : 2 RE" in Uni4er"itie"% tea-*in$*o")ital" an' re"ear-* in"tit!tion"

In 552 : 35 RE"% in 556 : 9RE" in 51/ : ?RE" RE" 4otin$ Me&,er -o&)o"e' o+ &!lti

'i"-i)line"% la( )er"on%$en'er ineC!alit(% / 5 4otin$ &e&,er"


7/203

Ei"tin$ et*i-"

-o&&ittee"18 National Healt* Re"ear-* Et*i-

o&&ittee NHRE8 In"tit!tional = RE;IRB38 National Bioet*i-" o&&ittee NB

Di++er in +!n-tion"


8/203

!nc"ion# NHRE

18 To en-o!ra$e t*ei&)le&entation o+ et*i-)rin-i)le" in -on'!tin$ Healt*Re"ear-* in4ol4in$ *!&an"!,


9/203

THE IRB;REIn"tit!tional Re4ie. Boar' IRB7;

Re"ear-* Et*i-" o&&ittee RE7%4er"eein$ t*e trial *ol'" t*e +inal re")on"i,ilit(+or :

Sa+e$!ar'in$ t*e ri$*t" Sa+et( Well,ein$ o+ -lini-al trial "!,


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Ho&o$eneo!" : P*("i-ian% Denti"t M!lti 'i"-i)line" : Me'i-al 'o-tor% P!,li-

*ealt*% n!tritioni"t% Biolo$i"t% 4eterinarian%)*ar&a-i"t% ani&al *!",an'r(% La.%

So-iolo$i"t;Ant*ro)olo$i"t% reli$io!"%la( )er"on La( )er"on :

Se-retariat" -ler#

St!'ent at S-*ool o+ Me'i-ine" A'&ini"tration Tea-*er Hi$* S-*ool7

In4ite' e)ert";a' *o-

REC 'e'be$ di#cip%ine#


11/203

REC# ($ganiza"ion

S!ppo$"ing #ec$e"a$ia" and office- in)e#"iga"o$ acce## "o EC

- ad'ini#"$a"ion p$oce## and fo%%o* !p

+!dge" a%%oca"ion

- In#"i"!"iona% ann!a% b!dge" Re)ie* fee Se%f #!ppo$"


12/203

W*at i" Et*i-"

,e fo$'a% #"!dy of *a" i# goodand *a" i# badW*at i" Le$al a")e-t

,e fo$'a% #"!dy of *a" i# $ig"

and *a" i# *$ong W*at Et*i-" an' Le$al a")e-t are

,e ana%y#e# of "e p$oce##e# by

*ic *e decided *a" i# good and$ig" "o do


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9:" He%#in;i4 in%and4 /!ne 92


15/203

De-laration o+ Hel"in#iEt*i-al Prin-i)le"

E"ica% p$incip%e# fo$ 'edica%$e#ea$c in)o%)ing !'an #!b6ec"#4inc%!ding $e#ea$c on iden"ifiab%e

!'an 'a"e$ia% and da"a


16/203

Et*i-al Prin-i)le"

Pri-i)le" +or all Me'i-al Re"ear-* :

- ,o p$o"ec" "e %ife4ea%"4digni"y4$ig"#e%fde"e$'ina"ion4p$i)acy4confiden"ia%

- Accep"ed #cien"ific p$incip%e#- No" a$' "o en)i$on'en"- C%ea$%y de#c$ibed in $e#ea$c p$o"oco%- Ap$op$ia"e #cin"ific "$aining and !a%ifica"ion- ,o p$o"ec" di#ad)an"age o$ )!%ne$ab%e pop!%a"ion- ,o be "o!g" of $i#; and benefi" indi)id!a% o$ co''!ni"ie#- I''edia"e%y #"op a #"!dy *en "e $i#; a$e fo!nd.- S!b6ec" in 'edica% $e#ea$c '!#" be )o%!n"a$y


17/203

Et*i-al Prin-i)le" -ont8888888

- M!#" be ade!a"e in confiden"ia% of pe$#ona% info$'a"ion4info$' of ai'#4'e"od#4 #o!$ce# f!nding

- M!#" no$'a%%y #ee; con#en" fo$ "e co%%ec"ion4 ana%y#i#4#"o$age and 0o$ $e!#e

- a%idi"y of $e#ea$c app$o)ed by a $e#ea$c e"ic# co''i"ee-

Info$'ed con#en" #o!%d be #o!g" by an app$op$ia"e%y!a%ified indi)id!a% *o i# co'p%e"e%y independen" of "i#$e%a"ion#ip

- Info$' con#en" fo$ #!b6ec"# py#ica%%y and 'en"a%%yincapab%e of gi)ing con#en" #o!%d be ob"ain# f$o' "e#!b6ec" o$ a %ega%%y a!"o$ized $ep$e#en"a"i)e.

- Repo$"# of $e#ea$c no" in acco$dance *i" "e p$incip%e# of"e Dec%a$a"ion #o!%d no" be accep"ed fo$ p!b%ica"ion.


18/203

A''itional : Et*i-al Prin-i)le"

- T*e )*("i-ian &a( -o&,ine &e'i-al re"ear-* .it* &e'i-al-are onl( :- ,e $e#ea$c 6!#"ified po"en"ia% p$e)en"i)e4 diagno#"ic o"

"e$ape!"ic )a%!e- Fy#ician a# good $ea#on "o be%i)e "a" "e pa$"icipa"ion *i%%

no" ad)e$#e%y affec" "e ea%" of pa"ien"# a# a #!b6ec"#.- +enefi" and $i#; #o!%d be "e be#" c!$$en" p$o)en

in"e$)en"ion4 e-e)t :- ,e !#e of p%acebo4 o$ no "$ea"'en" i# accep"ab%e in #"!die#

*e$e no c!$$en" p$o)en in"e$)en"ion ei#"# o$ - ,e !#e p%acebo i# nece##a$y "o de"e$'ine "e efficacy o$

#afe"y of an in"e$)en"ion and "e pa"ie"# *i%% no" be #!b6ec""o any $i#; of #e$io!# i$$e)e$#ib%e a$'.


19/203

E"ica% F$incip%e# and G!ide%ine# fo$ Re#ea$cIn)o%)ing H!'an S!b6ec"#+o!nda$ie# be"*een F$ac"ice and Re#ea$c+a#ic E"ica% F$incip%e# 9 Re#pec" fo$ Fe$#on#4

2 +eneficence4 @ /!#"ice

App%ica"ion# 9 Info$'ed Con#en"42 A##e#'en"of Ri#; and +enefi"#4 @ Se%ec"ion of S!b6ec"#

T*e Bel&ont Re)ortEt*i-al Pri-i)le" an' G!i'eline" +or t*e )rote-tion o+*!&an "!,


20/203

6 Et*i-al Prin-i)le"

Co%%abo$a"i)e pa$"ne$#ipSocia% )a%!eScien"ific )a%idi"y

ai$ #!b6ec" #e%ec"iona)o$ab%e Ri#;-+enefi" Ra"ioIndependen" Ri)ie*Info$'ed con#en"Re#pec" fo$ En$o%%ed S!b6ec"


21/203

>!n'a&ental Prin-i)le" o+H!&an Re"ear-* Et*i-"

Re#pec" fo$ pe$#on a!"ono'o!#4p$o"ec"ion of )!%ne$ab%e g$o!p# andinfo$'ed con#en"+eneficence 'a. benefi"#4 'in. $i#;4a)oid a$'/!#"ice benefi"# and b!$den# e!a%%y

di#"$ib!"ed


22/203

F!lnera,le )er"on in

&e'i-al re"ear-*8In -onte&)orar( -o&)le "o-ietie";'i++erential "o-ial"tat!" !neC!al a--e"" to *ealt*% e-ono&i- re"o!r-e"%"o-ial an' )oliti-al )o.er78Ne$ati4el( 4al!e' "tat!"e" in an in'i4i'!al;IneC!alit(et*i-% ra-i"&% "ei"&;$en'er% a$ei"&% an' -la""i"&8H!&an "!,


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24/203

Ele&ent" o+ in+or&e' -on"entS*o!l' ,e :

Capaci"y "o 'a;e a!"ono'o!# deci#ionDi#c%o#!$e of $e%e)an" info$'a"ion

Unde$#"anding of "i# info$'a"iono%!n"a$ine## of deci#ionIndica"ion of ag$ee'en"4 e.g.#igna"!$e


25/203

Ele&ent" o+ in+or&e' -on"ent

Capaci"y "o 'a;e a!"ono'o!# deci#ion

Di#c%o#!$e of $e%e)an" info$'a"ionUnde$#"anding of "i# info$'a"iono%!n"a$ine## of deci#ion


26/203

Ri"#" an' ,ene+it" o+ -*allen$e"t!'(

ba%ancing ea'p%e Indi)id!a% $i#; - $i#; of dying of di#ea#eIndi)id!a% benefi"# - po#ibi%i"y of ge""ing a ne*

- info$'a"ion 'o$e fo$ #!b6ec"Socie"a% benefi" - p$od!ce )accine

- p!b%ica"ionFe$#ona% benefi"# - #a"ifac"ion of doing #o'e"ing

- "e#i#4 de#e$"a"ion


27/203

T()e o+ Re4ie.

>!ll Boar' Re4ie.>!ll ,oar' re4ie. &ean" t*at t*e re"ear-* i" re4ie.e' at -on4ene' &eetin$"at .*i-* a &a


28/203

T()e o+ Re4ie. 888 -ontin!e8888

Re-i)ro-al Re4ie.Un'er a re-i)ro-al a$ree&ent ,et.een RE;IRB

to a--e)t t*e re4ie. ea-* in"tit!tion re"er4e" t*e ri$*t to *a4e it" o.n

RE;IRB re4ie. t*e re"ear-*8

U&,rella Grant Re4ie.U&,rella re4ie. "*o!l' ,e reC!e"te' i+ RE;IRB a))ro4al letter i"nee'e' to t*e +!n'in$ a$en-( +or a trainin$ $rant% -enter $rant% or

)ro$ra& )ro


29/203

WRLD MEDIAL ASSIATINDELARATIN > HELSINKI 192/7

BASI PRINIPLE >RALL MEDIAL RESEARH

App$op$ia"e ca!"ion '!#" be ee$ci#ed

in "e cond!c" of $e#ea$c *ic 'ayaffec" "e en)i$on'en"4 and

"e *e%fa$e of ani'a%# !#ed fo$

$e#ea$c '!#" be $e#pec"ed


30/203

Prin-i)le" o+ ani&al a""!,


31/203

Rep%ace'en"A"e$na"i)e of canging ani'a% "o in)e$"eb$a"a o$ ce%% %ine#"i##!e c!%"!$e4 Re%a"if - !#e ani'a% o$gan#0"i##!e# f$o' #%a!g"e$ o!#e.

- !#e ani'a% of %o*e$ o$do

Ab#o%!" - $ep%ace "e !#e of ani'a% *i" "i##!e c!%"!$e0co'p!"e$p$og$a'.'enggan"i e*an coba dengan a%"e$na"if %ain #epe$"i e*anin)e$"eb$a"a0;!%"!$ 6a$ingan0p$og$a' ;o'p"e$

Red!c"ion A%"e$na"i)e 'ode%# "o a)e 'ini'a% n!'be$ of ani'a% a##!b6ec" of #"!dy4 #"$a"egie# fo$ ob"aining co'pa$ab%e %e)e%# of info$'a"ionf$o' "e !#e of fe*e$ ani'a%# o$ fo$ 'ai'izing "e info$'a"ion ob"ainedf$o' a gi)en n!'be$ of ani'a% *i"o!" inc$ea#ing pain o$ di#"$e## )ie*e$ani'a%# a$e needed "o a!i$e "e #a'e #cien"ific info$'a"ion.

'ode% a%"e$na"if aga$ dapa" 'eng!$angi 6!'%a e*an coba

Refine'en" Mini'ize #e)e$i"y of pain and #"$e## 4 'odifica"ion of!#band$y o$ epe$i'en"a% p$oced!$e# "o enance ani'a% *e%%-being o$e%i'ina"e pain and di#"$e## !#e of ana%ge#ic#4 ane#"e"ic#.'eng!$angi0'enginda$i penede$i"aan dan $a#a nye$i a"a!p!n #"$e##epe$"ipe'be$ian ana%ge#i;a dan oba" ane#"e#i


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33/203

and thirstand thirst


34/203


35/203

Free from discomfort

4"


36/203

G$o!p o!#ing*en e)e$po##ib%e

H!'an in"e$ac"ion#

Ne#"ing 'a"e$ia%#

En$ic'en"De)ice# fo$ NHF

En$ic'en" de)ice# fo$$oden"# Ig%oo4 ne#" e"c.


37/203

+y 'a;ing #!$e "a" ani'a%# a)e "e $ig" "ype of

en)i$on'en" inc%!ding #e%"e$ and #o'e*e$eco'fo$"ab%e "o $e#".

En)i$on'en" in a ba$$ie$ faci%i"y ,e'pe$a"!$e

H!'idi"y en"i%a"ion Ai$ Cange0 o!$ 7ig"ing In"en#i"y and cyc%e

Space0 cage #ize $efe$ "o ,e G!ide fo$ "e Ca$eand U#e of 7abo$a"o$y Ani'a%#

#ocia% )# #o%i"ai$e ie$a$cy

$eedo'# f$o' Di#co'fo$"


38/203

+y p$e)en"ing "e' f$o' ge""ing i%% o$In6!$ed and by 'a;ing #!$e ani'a%# a$eDiagno#ed and "$ea"ed $apid%y if "ey do.

e" ca$e p$og$a' Coo#e non-in)a#i)e p$oced!$e# *en po##ib%e ,e !#e of ane#"e"ic# and ana%ge#ic *en needed

Coo#e an app$o)ed e!"ana#ia 'e"od AMAG!ide%ine# on E!"ana#ia

$eedo'# f$o' Fain4 In6!$y J Di#ea#e


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Free from fear and distress


42/203

e$e a' I 3

y a' I e$e3

a" a$eyo! going "o

do "o 'e3


43/203

A)oid )i#!a%0 a!$ic!%a$0 o%fac"o$ia%con"ac" be"*een p$ey# andp$eda"o$#


44/203

Mini'ized #"$e## *i" en)i$on'en"a%en$ic'en"


45/203


46/203

beha ior


47/203

behavior

4"


48/203

Na"!$a% bea)io$ of b!$$o*ing Jiding


49/203

E #i" + di


50/203

E-#i"! +$eeding


51/203


52/203

E-#i"! +$eeding


53/203


54/203

The love for all living

creatures is the most nobleattribute of man

(Charles Darwin)

,HE IN,ERNA,I(NA7


55/203

Co%%abo$a"ing "e E!$opean Union4 "e Uni"edS"a"e#4 and /apan #ince 9


56/203

Prin-i)le" o+

International on+eren-e on

Har&oni"ation IH7 Goo' lini-alPra-ti-e GP7-lini-al trial*!&an a" "!,


57/203

ab$ica"ion 'engganda;an da"a4 a#i% pene%i"ianda%a' ca"a"an da"a da%a' pe%apo$an a#i%pene%i"ian.

a%#ifica"ion 'e'a%#!;an0'e'anip!%a#i baanpene%i"ian4 a%a"4 p$o#e#4 'e$!ba a"a!'engi%ang;an da"a a"a! a#i% #eingga 'eng!baa#i% penca"a"an da"a.

F%agia$i#' 'enga'bi% da"a pene%i"ian o$ang %ain ide4 p$o#e#4 a#i% a"a! ;a"a-;a"a "anpa'enyeb!";an #!'be$nya.

RESEARH MIS:NDUT


58/203

Conf%ic" of In"e$e#"

C(I C(I i# a #e" of condi"ion# in *icp$ofe##iona% 6!dg'en" conce$ning ap$i'a$y in"e$e#" #!c a# pa"ien" *e%fa$e

o$ )a%idi"y of $e#ea$c "end# "o be !nd!%yinf%!enced by a #econda$y in"e$e#" #!ca# financia% gain. C(I $!%e#4 fo$'a% andinfo$'a%4 $eg!%a"e "e di#c%o#!$e anda)oidance of "e#e condi"ion#

Denni# . ,o'p#on


59/203

a" i# *$ong *i"

C(I 3 C(I i# no" an e)idence of *$ongdoing o$ 'any p$ofe##iona%#4 i" i# a%'o#"

i'po##ib%e "o a)oid a)ing C(I# f$o' "i'e"o "i'e

A C(I can4 o*e)e$4 beco'e an e"ica% o$%ega% i##!e if an indi)id!a% "$ie# o$

#!cceed# in inf%!encing "e o!"co'e of adeci#ion4 fo$ pe$#ona% benefi"


60/203

R!%e# fo$ con"$o% of C(I ,o 'ain"ain in"eg$i"y of p$ofe##iona%6!dg'en"

,o p$e)en" #econda$y in"e$e#"# f$o'do'ina"ing "e p$i'a$y in"e$e#"# in "e'a;ing of p$ofe##iona% deci#ion#

,o 'ain"ain p!b%ic "$!#" in "e p$ofe##ion

WRLD MEDIAL ASSIATIN


61/203

WRLD MEDIAL ASSIATINDELARATIN > HELSINKI 192/7

BASI PRINIPLE >RALL MEDIAL RESEARH

App$op$ia"e ca!"ion '!#" be ee$ci#ed

in "e cond!c" of $e#ea$c *ic 'ayaffec" "e en)i$on'en"4 and

"e *e%fa$e of ani'a%# !#ed fo$

$e#ea$c '!#" be $e#pec"ed

A!"o$#ip


62/203

A!"o$#ip

Eac a!"o$ #o!%d a)e pa$"icipa"ed #!fficien"%yin "e *o$; "o "a;e p!b%ic $e#pon#ibi%i"y fo$app$op$ia"e po$"ion# of "e con"en"

(ne o$ 'o$e a!"o$# #o!%d "a;e $e#pon#ibi%i"yfo$ "e in"eg$i"y of "e *o$; a# a *o%e

A!"o$#ip c$edi" #o!%d be ba#ed on%y on 9#!b#"an"ia% con"$ib!"ion# "o concep"ion andde#ign4 o$ ac!i#i"ion of da"a4 o$ ana%y#i# andin"e$p$e"a"ion 2 d$af"ing "e a$"ic%e o$ $e)i#ing

i" c$i"ica%%y fo$ i'po$"an" in"e%%ec"!a% con"en" @fina% app$o)a% of "e )e$#ion "o be p!b%i#ed

Lanco!)e$ G$o!p

Ri"#" an' ,ene+it" o+ -*allen$e


63/203

Ri"#" an' ,ene+it" o+ -*allen$e"t!'(

ba%ancing ea'p%e Indi)id!a% $i#; - $i#; of dying of di#ea#eIndi)id!a% benefi"# - po#ibi%i"y of ge""ing a ne*

- info$'a"ion 'o$e fo$ #!b6ec"Socie"a% benefi" - p$od!ce )accine

- p!b%ica"ionFe$#ona% benefi"# - #a"ifac"ion of doing #o'e"ing

- "e#i#4 de#e$"a"ion


64/203


65/203


66/203

Prin-i)le" o+


67/203

Prin-i)le" o+

International on+eren-e on

Har&oni"ation IH7 Goo' lini-alPra-ti-e GP7-lini-al trial*!&an a" "!,


68/203

Conf%ic" of In"e$e#"

C(I C(I i# a #e" of condi"ion# in *icp$ofe##iona% 6!dg'en" conce$ning ap$i'a$y in"e$e#" #!c a# pa"ien" *e%fa$e

o$ )a%idi"y of $e#ea$c "end# "o be !nd!%yinf%!enced by a #econda$y in"e$e#" #!ca# financia% gain. C(I $!%e#4 fo$'a% andinfo$'a%4 $eg!%a"e "e di#c%o#!$e anda)oidance of "e#e condi"ion#

Denni# . ,o'p#on

" i i"


69/203

a" i# *$ong *i"

C(I 3 C(I i# no" an e)idence of *$ongdoing o$ 'any p$ofe##iona%#4 i" i# a%'o#"

i'po##ib%e "o a)oid a)ing C(I# f$o' "i'e"o "i'e

A C(I can4 o*e)e$4 beco'e an e"ica% o$%ega% i##!e if an indi)id!a% "$ie# o$

#!cceed# in inf%!encing "e o!"co'e of adeci#ion4 fo$ pe$#ona% benefi"


70/203

R!%e# fo$ con"$o% of C(I ,o 'ain"ain in"eg$i"y of p$ofe##iona%6!dg'en"

,o p$e)en" #econda$y in"e$e#"# f$o'do'ina"ing "e p$i'a$y in"e$e#"# in "e'a;ing of p$ofe##iona% deci#ion#

,o 'ain"ain p!b%ic "$!#" in "e p$ofe##ion


71/203

A!"o$#ip


72/203

A!"o$#ip

Eac a!"o$ #o!%d a)e pa$"icipa"ed #!fficien"%yin "e *o$; "o "a;e p!b%ic $e#pon#ibi%i"y fo$app$op$ia"e po$"ion# of "e con"en"

(ne o$ 'o$e a!"o$# #o!%d "a;e $e#pon#ibi%i"yfo$ "e in"eg$i"y of "e *o$; a# a *o%e

A!"o$#ip c$edi" #o!%d be ba#ed on%y on 9#!b#"an"ia% con"$ib!"ion# "o concep"ion andde#ign4 o$ ac!i#i"ion of da"a4 o$ ana%y#i# andin"e$p$e"a"ion 2 d$af"ing "e a$"ic%e o$ $e)i#ing

i" c$i"ica%%y fo$ i'po$"an" in"e%%ec"!a% con"en" @fina% app$o)a% of "e )e$#ion "o be p!b%i#ed

Lanco!)e$ G$o!p


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SEJARAH DI INDNESIA :

KMISI ETIK PENELITIANKESEHATAN KEPK7

SEJARAH DI INDNESIA :

KMISI ETIK PENELITIANKESEHATAN KEPK7


74/203

: eb$!a$i 9


75/203

?5

Jaten$ 7 DI /7

Ja#arta 1?7

Jati& 07

S!l"el 17

S!&,ar 7

Ja,ar 7

S!&"el 7

S!&!t 7

Bali 17

PETA KEBERADAAN

KEPK, 2012

NTB 17

S!l!t 17Ria! 17

F(,RE, DIRI BEFB


76/203

F(,RE, DIRI BEFB

BUF-RSHSDi #e#!ai;an dengan

OPEDMAN NASINAL PENELITIANKESEHATAN 550

KEDUDUKAN ae7


77/203

KEDUDUKAN a e7d. BEFB 'e%a;#ana;an f!ng#inya #eca$a

independen4 yai"! beba# da$i penga$!'anap!n4 "e$'a#!; "e;anan po%i"i;4le&,a$a4 p$ofe#i4 ind!#"$i a"a! pa#a$.

e. Un"!; pe'ben"!;an BEFB4 pi'pinan%e'baga 'enen"!;an bebe$apa o$ang#ebagai fo$'a"!$ yang be$#a'a pi'pinan%e'baga 'enen"!;an ;eanggo"aan. BEFBpada #idang pe$"a'a 'e'i%i ;e"!a dan#e;$e"a$i#. Se%an6!"nya #ebagai badan

independen 'e'i%i anggo"a ba$! !n"!;;e'!dian diang;a"0 di;!;!;an o%epi'pinan %e'baga.


78/203

PERAN DAN >UNGSI a*7

. BEFB b!;an ;o'i#i peng!6i a"a!peni%ai i%'ia a;ade'i#4 "e"api

'e$!pa;an ;o'i#i peni%ai danpenga'bi% ;ep!"!#an "en"ang ;e%ayane"i# #!a"! pene%i"ian ;e#ea"an g!na'end!;!ng "e$%a;#ananya pene%i"ian

;e#ea"an be$'!"!

Beanggo"aan a-;


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Beanggo"aan a ;

a. M!%"idi#ip%inc. M!"%a; '!%"idi#ip%in dan '!%"i#e;"o$dengan di#"$ib!#i ;epa;a$an yang$e%e)an4 di#"$ib!#i !'!$ dan gende$

yang #ei'bang4 #e$"a di%eng;apaio$ang o$ang yang "e$i'p!n padai%'! ;e#ea"an4 i%'! !;!'4#o#io%ogi4 pendidi;an dan fi%#afa"e"i;a.


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f. /i;a dipe$%!;an pada #idang peni%aian

e"i; p$o"o;o% pene%i"ian BEFB dapa"'eng!ndang ;on#!%"an beba# g!na'e%eng;api ;epa;a$an e"i;nya.

i. Si#"e' $o"a#i ;eanggo"aan;. Fendidi;an a*a% dan be$;e%an6!"an

!n"!; anggo"a BEFB pe$%!di!paya;an dengan d!;!ngan%e'baga

Penilaian Eti# Proto#ol


81/203

Penelitian a)7

a. Di%a;!;an o%e #idang BEFB yang #ab. Anggo"a BEFB dapa" 'ene$i'a

i'ba%an !n"!; 6a#a peni%aian. ,ida;bo%e #ede'i;ian be#a$ #eingga'enga'ba" pe%a;#anaan pene%i"ian

c. Sa4 bi%a diadi$i o%e K #e"enga

6!'%a anggo"a


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d. Sidang di%a;!;an #e#!ai ;eb!"!an4pa%ing #edi;i" diada;an #e"iap @ b!%an

f. Conf%ic" of in"e$e#". Dia bo%e adi$4na'!n "ida; i;!" #e$"a da%a'pe'baa#an dan penga'bi%an

;ep!"!#ani. Anggo"a BEFB pe$%! dibe$i c!;!p

*a;"! !n"!; 'e'pe%a6a$i p$o"o;o%

pene%i"ian yang a;an dini%ai

% F ; % di% ; i


83/203

%. F$o"o;o% a$!# di%eng;api #!$a"pe$#e"!6!an da$i Bo'i#i I%'ia

%e'baga yang 'en6a'in ba*a'a#a%a pene%i"ian a;"!a% dan $e%e)andan did!;!ng o%e "in6a!an;ep!#"a;aanyang %eng;ap dan'!"ai$4 #e$"a de#ain pene%i"ianyang'e'en!i pe$#ya$a"an. /i;a %e'bagabe%!' 'e'i%i;i Bo'i#i I%'ia4 'a;a

"!ga# "e$#eb!" 'en6adi "angg!ng6a*ab Bo'i#i E"i;.


84/203

5 /!ni 9


85/203

? eb$!a$


86/203

T!$a" )o#o#KMITE ETIK PENELITIANKESEHATAN>K Un)a'

Me$!'!#;an "e$"ib pene%i"ian #e#!aidengan no$'a !;!' yang be$%a;!

Meni%ai dan 'e'be$i;an $e;o'enda#i;e%aya;an e"ica% c%ea$ance da%a'%ing;!ngan B Unpad


87/203

Meni%ai a#pe; e"i; pene%i"ian dan'e'be$i pendapa" dan #a$an ;epadapi'pinan B Unpad #e$"a 'e'an"a!pe%a;#anaannya di %apangan

Me'bina dan 'e'be$i;an peny!%!an'engenai e"i;a pene%i"ian ;epadaca%on pene%i"i

Me'b!a" %apo$an ;egia"an


88/203

MASALAH ETIK PENELITIAN

KESEHATAN KHUSUS DI INDONESIA

MASALAH ETIK PENELITIAN

KESEHATAN KHUSUS DI INDONESIA


89/203

PEMANFAATAN

BAHAN BIOLOGI TERSIMPAN (BBT)

PEMANFAATAN

BAHAN BIOLOGI TERSIMPAN (BBT)

+ +i % i , i


90/203

+aan +io%ogi# ,e$#i'pan

++, #pe#i'en ;%ini# a"a! 'a"e$i bio%ogi# %aincon"o i#o%a"4 DNA yang di#i'pan 0dia$#ip;an

Si#a pene%i"ian4 #i#a pe%ayanan ;e#ea"an#i#a "inda;an diagno#"i;0biop#i4 "inda;anpengoba"an0ope$a#i a"a! a!"op#i #enga6a

di#i'pan !n"!; pe'e$i;#aan di 'a#a depan

ASAL BBTF$o"o;o% Fene%i"ian


91/203

F$o"o;o% Fene%i"ian

Fe$#e"!6!an I%'ia

Fe$#e"!6!an E"i;

F S F

Feng!'p!%an+aan +io%ogi;

Si#a+aan +io%ogi;

Fe%ayanan Medi;

Diagno#i#4 ,e$api4

(pe$a#i4 Fa"o%ogi4A!"op#i

BBT


92/203

Kea'aan Per#e&,an$an BBT 17

+en"!; ++, - #ediaan 'i;$o#;opi; #%ide#

i#"opa"o%ogi4 #i"o%ogi4 #!'#!'"!%ang dan b%o;-b%o; pa$afin.

- Se$!' dan ;o'ponen da$a4

'i;$obio%ogi0i#o%a"4 d%#b.

K ' P # , BBT 7


93/203

Kea'aan Per#e&,an$an BBT 7

Fe'anfaa"an ++, 'ening;a" - +io'edica% Re#ea$c

- ,eacing - /a'inan '!"! %abo$a"o$i!' 7abo$a"o$y

P!a%i"y A##!$ance - I%'! gene"i;a dan bio%ogi 'o%e;!%e$ - ,e;no%ogi 'enega;;an diagno#a J

'e'pe%a6a$i penya;i" - +anya; +aan +io%ogi; di;i$i' %in"a# nega$a

"e$'a#!; ++, dengan 'e Be$6a#a'a i%'ia In"e$na#iona%


94/203

S#an'al Eti# Pe&an+aatan BBT

L ,e A%de$ Hey Ci%d$en Ho#pi"a% Scanda% di 7i)e$poo% UB 9


95/203

PENELITIAN MENGGUNAKAN BBT

Fene%i"ian 'engg!na;an ++, a$!#'endapa";an pe$#e"!6!an e"i; pene%i"ian

Idea%nya4 S!b6e; #!da 'e'be$i;anpe$#e"!6!annya pada #aa" pe$"a'a pene%i"iandi%a;!;an4 *a%a!p!n 6eni# pe'e$i;#aan 0pene%i"ian be%!' di"en"!;an


96/203

Ke)e&ili#an 'an Pen$elolaan BBT17

Se'!a +aan +io%ogi; yang di;!'p!%;an !n"!;pene%i"ian ;e#ea"an 'i%i; %e'baga pe%ayanana"a! pene%i"ian

Bepa%a %e'baga pene%i"ian be$"angg!ng 6a*ab penyi'panan4 pa'anfaa"an4 pe'!#naan ++,

++, ,ida; bo%e di6!a% a"a! dipe$dagang;an


97/203

FENE7I,IAN BER/ASAMA


98/203

PENGERTIAN LATAR BELAKANG RUANG LINGKUP DASAR HUKUM ASPEK ETIK ASPEK LEGAL

PRINSIP DASAR:

UPAA PRTEKSI MTAMaterial Tran"+er A$ree&ent7

PENELITI ASING BBT Ba*an Biolo$i" Ter"i&)an7

FENE7I,IAN BER/ASAMAdan

M,AMaterial Tran"+er A$ree&ent7

FENGER,IAN


99/203

FENGER,IAN

PENELITIAN KERJASAMA INTERNASINAL

Penelitian (an$ 'ila#!#an ole* Peneliti Lo#al

,er"a&a Peneliti Ne$ara lain% ata! Penelitian (an$ 'ila#!#an ole* )eneliti

,e,era)a ne$ara "e-ara ,er"a&a"a&a


100/203

FER7U DIFERHA,IBAN Fene%i"ian yang di%a;!;an o%e Fene%i"i

A#ing dan 'engi;!"#e$"a;an Fene%i"i

7o;a% #ebagai peng!'p!% #pe#i'en+UBAN FENE7I,IAN BER/ASAMA


101/203

FENE7I,IAN BER/ASAMA!'!'nya MENGGUNABAN a"a!

MENGEBSF7(RASI SUM+ER DAA7(BA7

MENGGUNABAN SUM+ER DANANEGARA MI,RA a"a! 7EM+AGAIN,ERNASI(NA74 a"a! FA,UNGAN

"e$'a#!; 'e%iba";an danapenda'ping nega$a %o;a%


102/203

,U/UAN FENE7I,IAN BER/ASAMA Me'eca;an 'a#a%a ;e#ea"an %o;a% Me'eca;an pe$'a#a%aan bebe$apa

nega$a i#! yang #a'a

Menge'bang;an 0!6icoba p$od!; "e;no%ogi;e#ea"an0;edo;"e$an

Me'an"a! penya;i" a"a! 'enginden"ifi;a#i;a$a;"e$i#"i; agen penya;i" #eca$a g%oba%

Mendidi;0'e%a"i !b!ngan g!$!-'!$id


103/203


104/203

RUANG 7INGBUF


105/203

RUANG 7INGBUF

Sanga" %!a#

Fene%i"ian 7abo$a"o$i!'4 B%ini;4 Ma#ya$a;a"47ing;!ngan4 d#b

Di#e#!ai;an dengan FRI(RI,AS NASI(NA7 Ha$!# ada ;e#ei'bangan an"a$a FRI(RI,AS

NASI(NA7 dengan FRI(RI,AS G7(+A7

DASAR HUBUM


106/203

DASAR HUBUM

UU no. 9:022 "en"ang Si#"e' Na#iona% 7I,+ANG dan IF,EB FF no.@< 0 9


107/203

ASFEB E,IB ,ida; 'e'anfaa";an ;e%e'aan

;ondi#i #e"e'pa" Ha$!# 'e'a;#i'a%;an aza# 'anfaa"

pe'be$dayaan4 pening;a"an;apa#i"a#

Ha$!# 'egac! pada #"anda$d e"i;yang !ni)e$#a%

FEB E,IB


108/203

ASFEB E,IB .......

Mene$ap;an #"anda$ 'ini'a% yangbe$%a;! da%a' #i#"e' pe%ayanan

;e#ea"an #e"e'pa" Me'pe$a"i;an "a"a ni%ai dan b!daya

%o;a% "ida; 'e$!#a; "a"anan yang

be$%a;!

FEB E,IB


109/203

ASFEB E,IB .......

Bepen"ingan #!bye; %ebi di!"a'a;an ,ida; be$%ebian da%a' 'e'b!6!;

#!b6e; !n"!; be$pa$"i#ipa#iINDUSEMEN

Fe$%! pe$#e"!6!an e"i; ;e d!a nega$a


110/203

ASFEB 7EGA7

,ida; 'e'baaya;an ;epen"ingan 0;ea'anan na#iona%

Me'pe$a"i;an ;eda!%a"an bang#a4a; a"a# ;e;ayaan aya"i4 dan a;a"a# ;e;ayaan in"e%e;"!a%


111/203

I"! K*!"!" : MTA Ma"e$ia% ,$an#fe$ Ag$ee'en" M,A

= Fe$6an6ian A%i Ma"e$i Dib!"!;an !n"!; L'enga'an;an

#e"iap penga%ian #pe#i'en ;e

%!a$nege$i

Titi# titi# #riti" !nt!# ter


112/203

Titi#titi# #riti" !nt!# ter


113/203

ISI MTA


114/203

ISI MTA

Siapa pengi$i'4 #iapa pene$i'a Rincian 'a"e$i yang a;an dia%i;an ,!6!an pe'e$i;#aan 0 !6i Rincian !6i4 $incian #pe#i'en yang a;an di!6i

A%a#an di;i$i' ;e %!a$nege$i Fe$nya"aan 'a"e$i "ida; a;an dia%i;an ;e pia;

;e @ Fen6e%a#an apa yang di%a;!;an "e$adap #i#a

'a"e$i Ha; p!b%i;a#i4 Ha; a"a# Be;ayaan In"e%e;"!a%


115/203

E E


116/203

PENELITI ASING

I@in 'i#el!ar#an ole* Ti& Inter'e)Ke&enterian Ri"te#

Peneliti a"in$ *ar!" &e&)!n(ai &itraIn'one"ia 'an *ar!" &e&)!n(ai le&,a$a)en


117/203

ETIK PENELITIAN

BATANTRAH;TT

ETIK PENELITIAN

BATANTRAH;TT

Sri Harsodjo WS.


118/203

Tujuan umum :

Para peserta memahami pokok-pokok

etika pada penelitian Tanaman obat

(TO), Obat tradisional (OT) / Obatbahan alam/Herbal (OBA/OH) dan

Pengobatan tradisional (Batantra)


119/203

KLASI>IKASI DAN JENISPENGBATAN TRADISINAL

Batantra Ketra&)ilan Batantra Ra&!an Batantra S!)ranat!ral;Meta+i"i#a

Batantra Pen'e#atan A$a&a

A Batantra !etrampilan :


120/203

" Pijat urut # Akupuntur

$ Patah tulang % !hiropraksi& 'eleksi *ukun ba+i

Akupresur .unat

B Batantra 'amuan :

" 'amuan ndonesia (0amu)

$ 1urah

& Aromaterapi .hinshe

# Tabib

% Homeopati (dosis minimal)

2 B t t . t l / 3 t i ik


121/203

2 Batantra .upranatural / 3etaisika

" Tenaga *alam (Prana).4, !alimasada, Perisai *iri,3erpati Putih, .inlamba, dsb

$ Paranormal (ndera ke %)

& 'eik+ 3aster (Tibet, 0epang)

5igong (2hina)# !ebatinan (0a6a)

% *sb

* Batantra Pendekatan Agama

2ara slam, !risten, !atholik, Hindu, Buddha.

11/3/15 shs 1!

1


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UJI T% DAN H BA7


123/203

PRASARAT BAHAN;

METDA UJI

BAHAN AA!"BAHAN #ASA$

Bahan AlamNabati

Bahan Alam He%aniTer'iri 'ari


124/203

BAHAN #ASA$AA! Bahan Alam !ineral

SIMPLISIA

HASIL LAHAN SIMPLISIA

&'stra' !edisinal

Sen(a%a 'imia murni untu' obat

Sen(a%a 'imia murni untu' pre'ursor

#apat berupa

Simplisianabati

SimplisiaHe%ani

Simplisia !ineral

BAHANS&)A$

*erdiri dari

+BA*

+H"+BA,

S&N-AWA ,!,A */!B/HANKarbo!idrat


125/203

SENYAWAKIMIA PADATUMBUHAN

Metabolit

tekanan

Fitokimia

Fitoaleksin

Metabolit

sekunder

Metabolitrimer

Protein

"emak

Alkaloid

Fla#onoid

Min$ak atsiri

Kuinon

Steroid

Tanin

Dsb%

Fitotoksin


126/203


127/203

PENELITIAN

T;T;BAH7

PENELITIAN

T;T;BAH7

TO/OT/OBA :


128/203

TO/OT/OBA :

OT : Ramuan/formula, atau tunggal. Berasal daritanaman, biota laut, bahan hewani dan bahanmineral. Memiliki data empirik

TO : Bentuk simplisia atau hasil olahan (ekstrak),Tidak selamanya memiliki data empirik (sebagianbesar hasil penelitian)

OBA:Ramuan, atau tunggal. Berasal dari (OH)tanaman, biota laut, bahan hewani dan bahanmineral. Tidak selamanya memiliki data empirik

Standra% material


129/203

0h(topharmacaN7&8!ed.

PreclinClin!"bservation

Cultivation

Clinical studies

!ed. plants

$ 9 # of plants

Stand extracts

7hemst: pharm:preclinical

7on;rmation of&mpirical e


130/203

elp. =Aman >?@hasiat >?@

elp. Aman >?@hasiat >8@

elp. Aman >8@hasiat >?@

elp. CAman >8@hasiat >8@

Terus beredardi mas#ara$at%diberi label&emen$es('alur non formal)

oleh beredartana $laimmanfaatindi$asi('alur non formal)

Ta$ boleh beredar%samai enelitianlebih lan*ut

Tida$ bolehberedar dandilarang dia$ai

+tandardisasi sederhana

Te$nologi Farmasi (sediaan baru)

,solat

-*i $lini$ -*i $lini$ -*i $lini$

ermanfaat ermanfaat ermanfaat

".T'.D,

F,T"F./0.&.

1.+,2

&3P-T-+.4

P/"+3+2.4'-T

/ji pra'lini'

/ji 'lini'

Produ$ a$hir

1.+,2

,solasi


131/203

SITUASI

T;T;H TERKINI

#ulu 1"T untu$ self med% trivial% self limiting!


132/203

Se'arang 1"TT" diguna$an *uga untu$ en#a$it#ang tida$ daat di$enali oleh awam!

&onse$uensin#a dalam u*i ra6$lini$ dan

$lini$% P, harus #ang $ometen dan ahli

Sebagai 'omplemen 1,ntera$si "T6T" dengan sesaman#a atau

obat $onvensional sering tida$dierhitung$an

Sebagai alternatif 1

M!n-!ln(a e&)iri# ,ar!:


133/203

a; i#"i'e*a L"$adi#iona%4 padaa% "ida; ada da"ae'pi$i;4

Te"ti&oni!& &an+aat #e"i&)!lan "t!'i #lini#

Serin$#ali 'ian$$a) a&an4

"ida; 'a#a%a. in"e$)en#i "e;ni;4 fi#i;4 'engand!ng$i#i;o

To#"i"ita"

a;!" )# ;$oni; "e$!"a'a !n"!; (,-,( pengg!naan

6ang;a pan6ang

.ituasi ilmiah terkini :


134/203

ebsite ribuan artikel Balitbangkes !""# $ %""" penelitian, $ &"" spesies. Badan 'M ui klinik # tanaman unggulan * ++ tanaman

sudah diteliti * Monografi ekstrak (standardisasi) 'okanas T $ &"- seminar, reiew B!'!T!T 0 $ !"" artikel tidak dapat di reiew

Teknologi karakterisasi/standarisasi

mplikasi ekonomilink dg industri, produkkomersial:

1esinambungan pasokan, 1eaegan kandungan,'asar yang menguntungkan

3emulai penelitian OT tidak lagi berdasar empirik

systemati2 reiew tanaman

.tudi epidemiologi : obser9asi klinik


135/203

p g

8ji pra-klinik0 17P

8ji klinik 0

" .esuai 12P / 28!B$ 3etoda 9alid : desain, one / t6o arm, randomisasi,

jumlah sub+ek, kriteria inklusi, ara makan,pengukuran respon, parameter outome,

pengamatan dan pelaporan !T* (ad9erse e9ent)& Pelaksana : kompeten atau ahli dalam hal pen+akit,

terapi standar +ang ada, dugaan mekanisme kerja,perkiraan respon, prediksi risiko-manaat

Aspe' &ti'


136/203

0enelitian&pidemiologi

&pidemiologi 1lini' dan omunitas

Polte##e" II Gar!t 151 Se)t8 51


137/203

*ujuan /mum

!emberi orientasi bagi penelititentang aspe' dan isu eti'penelitian epidemiologi>'lini' dan sosial@.


138/203

*ujuan husus!embahas dan memberi penjelasan tentang1

Batasan: jenis penelitian epidemiologi

,su eti' (ang perlu diperhati'an dalam penelitianepidemiologi des'riptif 9 observasional

Apli'asi eti' dalam penelitian epidemiologiBeberapa prosedur dalamaji &ti' (ethical review

)


139/203

Perbedaan antara

penelitian klinis dan epidemiologi


140/203

Klini"

9. o;!# indi)id!2. S!b6e; #a;i"@. Sa'pe% $e%a"if ;eci%

>. Fenga'a"an $e%a"if#ing;a"

5. S!'be$ info$'a#i!'!'nya pa#ien

. Ha#i% be$'anfaa"%ang#!ng !n"!;#!b6e;

Epide'io%ogi

9. o;!# pop!%a#i

2. S!b6e; #a;i"0#ea"@. Sa'pe% $e%a"if be#a$>. Fenga'a"an $e%a"if

%a'a5. S!'be$ info$'a#i

$e#ponden4 ca"a"an0do;!'en. Ha#i% "d; #e%a%!

%ang#!ng di$a#a;an$e#ponden

Sifat husus0enelitian &pidemiologi


141/203

0enelitian &pidemiologi

di 'omunitas 0enelitian pada populasi: ter'ait dengan

ebih dari satu norma"nilai

Beberapa buda(a"agama Adan(a berbagai tabu

0opulasi marjinal

0otensi 'eamanan: 'eresahan


142/203

0&N&,*,AN &0,#&!,++),S


143/203

0&N&,*,AN &0,#&!,++),S

-AN) S&$,N) #,A/AN

#&S$,0*,F 9 +BS&$GAS,+NA

0otong lintang >cross sectional@ asus8'ontrol >case control@

ohor >cohort@

,su &ti'a*er'ait 0enelitian &pidemiologi


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=. !enghormati har'at martabat subje'

. Informed Consent: persetujuan setelah penjelasan >0S0@. Condentiality: menjaga 'erahasiaan

2Bermanfaat

. !a"imi#ing benet: mema'simal'an manfaat. !inimi#ing harm: meminimal'an 'erugian

. Adil

. *ida' ada beda dalam perla'uan: manfaat dan bebanpenelitian. Con$ict of Interest: mencegah 'oni' 'epentingan

0ersetujuan Setelah 0enjelasan>0S0@>Informed Consent@


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>Informed Consent@

0ersetujuan su'arela

0ersetujuan individuI 'elompo'" mas(ara'at

0enjelasan tida' boleh sele'tif

*ida' boleh memengaruhi secara berlebihan>pene'anan"coercion@@

0erangsangan untu' i'ut serta"iming8imingse%ajarn(a >'ompensasi@

0ersetujuan Setelah 0enjelasan


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0ersetujuan Setelah 0enjelasan>Informed Consent @ ......

,su 'husus1

populasi (ang berada di ba%ah pengaruh

populasi lain >narapidana: 0S: pe'erjapabri'@

populasi tersembun(i >ga(: penasun@

populasi terasing

0erlu modi;'asi dalam pemberian 0S0


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7atatan1

0S0 tida' mutla' dibutuh'anbila data diambil dari re'ammedis: catatan 'elurahan:data tanpa identitas

BA)A,!ANA 7A$AN-A!&!0&$+&H 0&$S&*/J/AN


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J#, !AS-A$AA*K

#&N)AN !&!0&$HA*,AN S,FA* H/S/S0&N&,*,AN &0,#&!,++), 1

0enting 1 melapor dan menjelas'an pada

pimpinan setempat: to'oh mas(ara'atmengenai rencana penelitian (ang a'andila'u'an.

#engan adan(a 0&$S&*/J/AN 0,!0,NAN

"*++H !AS-A$AA* dapat dila'u'anpende'atan 'e ting'at individu untu'memperoleh ,nformed consent >0S0@

!enjaga erahasiaan >=@


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>Condentiality@

!enjaga 'erahasiaan dengan1

!ela'u'an pengumpulan data dalam ruang

terpisah " pengaturan 'husus *ida' membahas data dengan orang selain

peneliti >terutama orang (ang dapatmemengaruhi ja%aban subje'@

!enjaga erahasiaan >@>C d ti lit @


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>Condentiality@

!enjaga 'erahasiaan data dengan1

menghilang'an identi;'asi perorangan

/nlin'ed anon(mous

in'ed anon(mous ada identi;'asi

!embatasi a'ses pada data

0en(impanan 'etat

0rinsip .

!ema'simal'an !anfaat


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!ema'simal'an !anfaat

Hasil penelitian disampai'an 'epadapopulasi (ang diteliti1 langsung"tida'langsung

0ela(anan 'esehatan bagi populasi (angditeliti 1 langsung"tida' langsung

0ening'atan 'apasitas lo'al: misalpelatihan petugas 'esehatan lo'al:'eleng'apan peralatan: dsb

! i i l' $i i' " i


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!eminimal'an $isi'o"erugian

!encegah 'erugian pada 'elompo': misal1%a'tu: privasi: nama bai': dsb

!engantisipasi dan meminimal'an risi'o

;si': psi'is: sosial 9 mencari solusi

!encegah"meminimal'an 'erugian a'ibatpubli'asi: misal1 tida' sesuai norma"buda(a:'ehilangan harga diri

>metodologi harus benar@

Prinsip &!;A*7A4 (JUSTICE)


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s p & (JUS C )

.ubjek +ang berpartisipasi penuh seharusn+a memperoleh

manaat lebih dari hasil penelitian

Pembagian keuntungan dan risiko: adil

Penting untuk menjelaskan apa +ang akan dilakukan

terhadap data/inormasi dan spesimen +ang diambil darisubjek dan memperoleh persetujuan dalam

pemanaatann+a

(Perhatian khusus pada janin, anak-anak, mahasis6a, 6anita

hamil/men+usui, narapidana, negara berkembang)


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Prinsip &


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epentingan

,denti;'asi 'oni' 'epentingan (ang mung'intimbul

Setiap 'oni' 'epentingan harus din(ata'an

secara tertulis dan dijelas'an 'epada 'omisieti': calon subje' 9 mas(ara'at (g diteliti

!enjaga obje'tivitas ilmiah

aji eti'0enelitian &pidemiologi >=@


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*ida' dapat dipisah'an dari 'ajimetodologi

!erupa'an 'eharusan dalam penelitianepidemiologi

0enelitian multisenter1 lulus 'aji eti'semua senter: 'ecuali sepa'at menunju'= 'omisi eti'

0enelitian dana luarnegeri 1 lulus 'ajieti' negara donor 9 negara penerima

Anggota tim 'aji eti' dari mas(ara'ata%am me%a'ili 'epentingan mas(ara'at(ang diteliti

aji &ti'0enelitian &pidemiologi >@


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0enelitian &pidemiologi >@

!enjaga 'eseimbangan antaraperspe'tif individu 9 mas(ara'at

!encegah e'ploitasi 'elompo' rentan

Bila mengguna'an 'ontrol: 'aji eti'menjamin 'elompo' 'ontrol tida'dirugi'an

!enjamin adan(a 'ompensasi bagisubje' bila mengalami 'erugian


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P"#$man %a&i '"nu(is #i

)urna( i(miah


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Ar*ik"( '"n"(i*ian %"risi hasi( '"n"(i*ian as(i #a(am i(mu

k"#$k*"ran #asar mau'un *"ra'an #an su%)"k k"s"ha*an

'a#a umumn+a

,"k(arasi H"(sinki -

Maka(ah '"n"(i*ian +an&

#i*"r%i*kan harus m"m'"r$("h

'"rs"*u)uan k$mi*" "*ik '"n"(i*ian

Pu%(ikasi

B!ll Worl' Healt* r$an8 55/ De-617:91/8 E)!, 55? Jan ?8Re")irator( "(n-(tial 4ir!" in+e-tion: 'eno&inator,a"e' "t!'ie" in In'one"ia%

Mo@a&,iC!e% Ni$eria an' So!t* A+ri-a8

Ro,ert"on SE% Ro-a A% Alon"o P% Si&oe" EA% Karta"a"&ita B% lale(e D% 'ai,o GN%ollin"on M Fenter M O*! Wri$*t P>


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ollin"on M% Fenter M% O*! % Wri$*t P>8

Fa--ine" an' Biolo$i-al"% De)art&ent o+ I&&!ni@ation% Worl' Healt* r$ani@ation% 111Gene4a 0% S.it@erlan'8 ro,ert"on".*o8intBJETIFE: To a""e"" t*e ,!r'en o+ re")irator( "(n-(tial 4ir!" RSF7a""o-iate' lo.erre")irator( in+e-tion" LRI7 in -*il'ren in +o!r 'e4elo)in$ -o!ntrie"8 METHDS: A WH)roto-ol +or )ro")e-ti4e )o)!lation,a"e' "!r4eillan-e o+ a-!te re")irator( in+e-tion" in-*il'ren a$e' le"" t*an ? (ear" .a" !"e' at "ite" in In'one"ia% Mo@a&,iC!e% Ni$eria an'So!t* A+ri-a8 RSF anti$en .a" i'enti+ie' ,( en@(&elin#e' i&&!no"or,ent a""a(

)er+or&e' on na"o)*ar(n$eal ")e-i&en" +ro& -*il'ren &eetin$ -lini-al -a"e 'e+inition"8>INDINGS: A&on$ -*il'ren a$e' Q ? (ear"% t*e in-i'en-e o+ RSFa""o-iate' LRI )er1555 -*il'(ear" .a" 3/ in In'one"ia an' 9/ in Ni$eria8 T*e in-i'en-e o+ RSFa""o-iate' "e4ere LRI )er 1555 -*il'(ear" .a" ? in Mo@a&,iC!e% 15 in In'one"ia% an' 9in So!t* A+ri-a8 At all "t!'( "ite"% t*e &a


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+or t!,er-!lo"i" treat&ent +ail!re in In'one"ia8

Fa$*a"i I4 A%i#6abana +4 Ap$iani 74 Soe"i;no RD4 (""enoff ,H4 )an de$Qanden AG4 )an de$ Mee$ /4 )an Soo%ingen D4 )an C$e)e% R.

Depa$"'en" of C%inica% Fa"o%ogy4 Ha#an Sadi;in Ho#pi"a%4 Medica% ac!%"y4Uni)e$#i"a# Fad6ad6a$an4 +and!ng4 Indone#ia.

Ani'a% #"!die# a)e #o*n "a" "e g%oba%%y e'e$ging +ei6ing geno"ype #"$ain#of Mycobac"e$i!' "!be$c!%o#i# a$e 'o$e )i$!%en" "an o"e$ #"$ain#. eea'ined *e"e$ +ei6ing #"$ain# inc$ea#e "$ea"'en" fai%!$e in a p$o#pec"i)ecoo$" #"!dy in Indone#ia. A'ong :9: "!be$c!%o#i# ca#e#4 po#i"i)e #p!"!'c!%"!$e $e#!%"# af"e$ 'on"# of "$ea"'en" *e$e 'o$e co''on a'ongpa"ien"# infec"ed *i" +ei6ing #"$ain# @@.> "an a'ong "o#e infec"ed *i"

non-+ei6ing #"$ain# $e%a"i)e $i#;4 9. ?9 F!bMed - in p$oce##T

/ (b#"e" Gynaeco% ,o;yo 9


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De)art&ent o+ :,"tetri-" an' G(ne-olo$(% S-*ool o+ Me'i-ine%Pa' 8Wira#!"!&a*1% Tri H A-*&a'% >err( San'ra3% Dann( Hali&an' A*&a' >arie'

9Depa$"'en" of (b#"e"$ic# and Gyneco%ogy4 ac!%"y of Medicine4 Uni)e$#i"a# Fad6ad6a$an-D$. Ha#an Sadi;in Gene$a% Ho#pi"a%4+and!ng Indone#ia
http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/http://www.biomedcentral.com/1756-0500/4/371/


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+and!ng4 Indone#ia2S"e' Ce%% o$;ing G$o!p4 ac!%"y of Medicine4 Uni)e$#i"a# Fad6ad6a$an-D$. Ha#an Sadi;in Gene$a% Ho#pi"a%4 +and!ng4Indone#ia@S"e' Ce%% and Cance$ In#"i"!"e4 /a;a$"a4 Indone#ia+MC Re#ea$c No"e#2994 /@?9 doi9.99:09?5-5->-@?9F!b%i#ed 2 Sep"e'be$ 299

A,"tra-tBa-#$ro!n',e finding of !'an !'bi%ica% co$d b%ood a# one of "e 'o#" %i;e%y #o!$ce# of e'a"opoie"ic #"e' ce%%# offe$# a %e## in)a#i)ea%"e$na"i)e fo$ "e need of e'a"opoie"ic #"e' ce%% "$an#p%an"a"ion. D!e "o "e once-in-a-%ife "i'e cance of co%%ec"ing i"4 anop"i'!' c$yop$e#e$)a"ion 'e"od "a" can p$e#e$)e "e %ife and f!nc"ion of "e ce%%# con"ained i# c$i"ica%%y needed.Met*o'"Un"i% no*4 #%o*-coo%ing a# been "e $o!"ine 'e"od of c$yop$e#e$)a"ion o*e)e$4 $apid-coo%ing offe$# a #i'p%e4 efficien"4and a$'%e## 'e"od fo$ p$e#e$)ing "e %ife and f!nc"ion of "e de#i$ed ce%%#. ,e$efo$e4 "i# #"!dy *a# cond!c"ed "oco'pa$e "e effec"i)ene## of #%o*- and $apid-coo%ing "o p$e#e$)e !'bi%ica% co$d b%ood of 'onon!c%ea"ed ce%%# #!#pec"ed ofcon"aining e'a"opoie"ic #"e' ce%%#. ,e pa$a'e"e$# !#ed in "i# #"!dy *e$e diffe$ence# in ce%% )iabi%i"y4 'a%ondia%deydecon"en"4 and apop"o#i# %e)e%. ,e iden"ifica"ion of e'a"opoie"ic #"e' ce%%# "e'#e%)e# *a# ca$$ied o!" by en!'e$a"ing CD@>V

in a f%o* cy"o'e"e$.Re"!lt"

(!$ $e#!%"# #o*ed "a" 'onon!c%ea"ed ce%% )iabi%i"y af"e$ $apid-coo%ing


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H8 Na.an$"ari8 DK S!n> Wira#!"!&a*Pro$ra& St!'i Ma$i"ter Ke,i'anan >a#!lta" Ke'o#teran Uni4er"ita" Pa'

rele4an !nt!# &en


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DENGAN HASIL LUARAN BAI DI KABUPATEN KUDUS

Na"ri(a*% oni >8 S(!#riani% >ir&an >8 Wira#!"!&a*ABSTRAKLatar Bela#an$ : Ha"il l!aran ,a(i &er!)a#an *a"il 'ari #e*a&ilan (an$ 'a)at ,er!)a *a"ill!aran &en$!nt!n$#an 'an ti'a# &en$!nt!n$#an8 K!ne,r!ari A)ril 513 'en$an ran-an$an )enelitian )oton$ lintan$ 'an 'i'a)at#an 9re")on'en8Meto'e :Anali"i" 'ila#!#an "e-ara ,i4aria,el 'en$an &en$$!na#an !

*a"il l!aran ,a(i% "e&a#in ,an(a#


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Wa*(! N!rai"(a% >ir&an >8 Wira#!"!&a*% Tina De.i J!'i"tiani>a#!lta" Ke'o#teran Uni4er"ita" Pa': be"*een *o$; 'o"i)a"ion andpe$fo$'ance. ,e $e#!%"# of ana%y#i# !#ing pa" ana%y#i# #o*ed a inf%!ence be"*een #"$e##o$# and #i'!%"aneo!#%y*i" "e pe$fo$'ance of *o$; 'o"i)a"ion *i" #!a$e )a%!e# of $=.@5< and "e inf%!ence of o"e$ )a$iab%e# "a"a$e no" ob#e$)ed a" .>9.Conc%!#ion 7o* *o$; #"$e##o$# and ig%y 'o"i)a"ion co!%d $ai#e "e pe$fo$'ance of "e ed!ca"iona% pe$#onne% a"ea%" ed!ca"ion in#"i"!"e Ba$ya H!#ada Bedi$i #o in "a" *ay "e$e i# '!c 'o$e "ing "o do o* "o dea% *i" *o$;

#"$e##o$# and 'o"i)a"iona% i'p$o)e'en" "o gain be""e$ pe$fo$'ance.Bey*o$d# pe$fo$'ance4 *o$; 'o"i)a"ion4 6ob #"$e##o$#4 ed!ca"iona% pe$#onne%4 6ob de#c$ip"ion#

/!$na% ($a#i +i#ni# Edi#i ;e-III4 No)e'be$ 292. ISSN 2:5-9@?5

KRELASI KEPEMIMPINAN DENGAN KMITMEN DAN LINGKUNGANKERJA DSEN BERDASARKAN KRITERIA MALLM BALDRIGE

S!at! S!r4ei E#")lanatori Pa'a Do"en Pro$ra& St!'i D3 Ke,i'anan 'i Pro)in"i Daera* I"ti&e.a o$(a#arta7


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S!at! S!r4ei E#")lanatori Pa'a Do"en Pro$ra& St!'i D3 Ke,i'anan 'i Pro)in"i Daera* I"ti&e.a o$(a#arta7

He"t( Wi'(a"i*% Ma&!n S!ti"na% >ir&an >8 Wira#!"!&a*

A,"tra-tLea'er"*i) in t*e +iel' o+ &i'.i+er( 'i)lo&a 3 *o)e+!ll( -an ,rin$ to )o"iti4e -*an$e% t*e in-rea"e o+or$ani@ation C!alit( .*i-* i" a )la-e o+ &i'.i+e $ra'!ate" .ill ei"t in "o-iet(8 Lea'er"*i) +a-tor .ill+a-ilitate to ,!il' *i$* .or# -o&&it&ent an' $oo' .or# en4iron&ent8 Mal-ol& Bal'ri$e -riteria i" a .or#&ana$e&ent "("te& t*at -an &ea"!re lea'er"*i)% .or# -o&&it&ent an' .or# en4iron&ent8 T*i" "t!'( ai&" toanal(@e -orrelation ,et.een lea'er"*i) .it* .or# -o&&it&ent an' en4iron&ent ,a"e' on Mal-ol& Bal'ri$eriteria8 Re"ear-* 'e"i$n !"in$ anal(ti- -orrelati4e "t!'( .it* e)lanator( "!r4e(8 T*i" "t!'( i" C!antitati4ere"ear-* .it* -ro"""e-tional "t!'(8 S!,


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A,"tra#

Tran"+or&in$ $ro.t* +a-torV TG>7 'i'!$a ,er)eran )a'a )ree#la&"ia8 Re"e)tor TG>V ti)eII TVRII7'i*a"il#an 'ari tran"#ri)"i $en TG>V re-e)tor t()e II TG>BR78 Poli&or+i"&e $enTG>BR )a'a ,a"a 1120T'a)at &en(e,a,#an *i)o#"ia (an$ &en$in'!#"i i"#e&ia "erta&enin$#at#an )ro'!#"i "ol!,el en'o$lin "En$7 'an4a"-!lar -ell a'*e"ion &ole-!le1 FAM178T!BR )a'a ,a"a 1120T'en$an #a'ar "En$ 'an FAM1 i,! )ree#la&"ia8 S!,BR% #a'ar "En$% 'an FAM1 antara

)ree#la&"ia 'an #e*a&ilan nor&al8

Kata #!n-i: Poli&or+i"&e $en TG>BR% )ree#la&"ia% "En$% FAM1

MB+. 29>2>9T.

Peran Si#loo#"i$ena"e 'ala& Pert!&,!*an Kan#er Le*er Ra*i&

S!)ria'i Gan'a&i*ar'ir&an >8 Wira#!"!&a*% N!r*ali& S*a*i,% Herri S8 Sa"tra&i*ar'ari' A@i@


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>ari' A@i@

A,"tra-t

E#")re"i 'an )en$*a&,at "ele#ti+ "i#loo#"i$ena"e \7% "e)erti "ele#o#"i, (an$ tela* 'i)a#ail!a" "e,a$ai antiin+la&a"i% 'i#eta*!i ,er)eran )a'a #an#er 'en$an &en$*a&,at )roli+era"i 'an)ert!&,!*an t!&or "erta &enin$#at#an a)o)to"i"8 T!

Re#ea$c A$"ic%e ISSN 2@9< 8 A (N HEFA,(CE77U7AR CARCIN(MA CE77S


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A#ep S!;oa$4 Hening He$a*a"i4 A$ief +. i"a$"o4 Se"ia*an4i$'an . i$a;!#!'a4 He$$y S. Sa#"$a'ia$d6a

A+S,RAC,,e !#e of e$b "o c!$e cance$ "a;e# a conc$e"e b$ea;"$o!g. I" 'ean# "a" i" i# )e$y e##en"ia% "o a)e ade)e%op'en" on e$b $efe$$ing "o a #"anda$ !a%i"y4 efficacy and #afe"y. ,e$efo$e4 *e need an ana%y#i# again#" "e'ecani#' of e$b on 'o%ec!%a$ %e)e%.C%o$ogenic Acid CA i# an ac"i)e co'po!nd i#o%a"ed f$o' "$adi"iona% p%an"# f$o' $ob!#"a coffee "a" i# !#ed a# ace'op$e)en"i)e "e$apy Hepa"oce%%!%a$ Ca$cino'a HCC4 a%%eged%y *o$;# a# an an"icance$ and p$e)en"# "e ce%%f$o' de#"$!c"ion4 a%#o inibi"# "e g$o*" of "e cance$ ce%%# "$o!g "e inibi"ion of f$ee $adica%#. ,e $e#ea$c*a# done by in )i"$o4 by !#ing "e Ce%% 7ine# Hep-G2 #e$ie# 9::4 ob"ained f$o' Ri;en Ce%% +an;-,oo;! Uni)e$#i"y.

,e ai' of "e $e#ea$c i# o* "o !nde$#"and "e 'ecani#' of CA in inibi"ing HCC g$o*" by !#ing "e 'ode% ofCe%% 7ine# Hep-G2 #e$ie# 9:: "$o!g a #e$ie# of gene ep$e##ion. ,e "ype of $e#ea$c i# epe$i'en"a% on ?2#a'p%e g$o!p#. 9 g$o!p con#i#"# of 25 "o!#and# cance$ ce%%#. ,e $e#ea$c !#e# @ do#e# of CA ?2?4 5 and 25WM4 *i" @ "i'e# $epea"ed 'ea#!$e'en"4 and "en co'pa$ed af"e$ and befo$e "e epo#!$e. ,e $o%e of "o#e do#e#CA again#" Hep-G2 i# ana%y#ed by co'pa$ing "e ep$e##ion of 'iRNA 9> A4 befo$e and af"e$ "e epo#!$e on 4 :49: and 2> o!$#. ,e da"a i# "e#"ed #"a"i#"ica%%y *i" diffe$en" "e#"4 "4 $epea"ed 'ea#!$e'en"4 pea$#on and '!%"ip%e%inea$ $eg$e##ion.,e %o*e#" ep$e##ion dec$ea#e of 'iRNA 9> A appened in "e g$o!p 2> o!$# af"e$ "eepo#!$e a" do#e# of ?2? WM CA .:54 fo%%o*ed by 5 WM 9.2: and "e ige#" ep$e##ion inc$ea#e appened a"a do#e of 25 WM 9.94 con"in!ed *i" a #"a"i#"ica% "e#" a" "e :"and "e 9:" o!$ C )a%!e# 'iRNA 9> A

#ignifican" diffe$ence pX.5 a" a%% do#e# CA ?2?45 and 25 WM. ,e conc%!#ion of "e $e#ea$c i# CA p%ay# "ei'po$"an" $o%e on "e $ed!c"ion of 'iRNA 9> A ep$e##ion.

BE(RDS C%o$ogenic Acid4 Hepa"oce%%!%a$ Cance$ and 'iRNA 9> A.

International Jo!rnal o+ Re"ear-* in P*ar&a-e!ti-al an' Nano S-ien-e" 27% 513% 002 6/8

Re#ea$c a$"ic%e

A -o&)ari"on o+ -r(o)re"er4ation &et*o'": Slo.-oolin$ 4"8 ra)i'-oolin$ ,a"e' on -ell 4ia,ilit(% oi'ati4e "tre""%a)o)to"i"% an' D3/ en!&eration o+ *!&an !&,ili-al -or' ,loo' &onon!-leate' -ell"

,ono D6!*an"ono942Z4 i$'an .i$a;!#!'a94 ,$i H Ac'ad24 e$$y Sand$a@4 Danny Ha%i'2and A'ad a$ied

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>AKULTAS KEDKTERANUNIFERSITAS PADJADJARAN

BANDUNG

KOMISI ETIK PENELITIAN KESEHATAN

HEALTH RESEARCH ETHICS COMMITTEE

3l. 4ikman 5o. 67 [ @4 Bandung "+%+*eb ***.;ep;.f;.!npad.ac.id

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LAPRAN KEMAJUAN ETIKPERIDE JANUARI MARET 51?


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>ERAP AREDITED

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.3P87A4Aspek ;tik penting +ang perlu diperhatikan dalam

Penelitian !esehatan, dibahas :

* j / 0 liti dibid h t


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*ujuan /mum 0enelitian dibidang esehatan 1

Filsafat 0enelitian: aturan perundang8undangan: 'omisi eti' di,ndonesia: prinsip eti' secara umum dan 'husus1 subje'manusia: he%an coba: obje'1 BB*: tanaman obat"batantra:penelitian &pidemiologi: 'erjasama penelitian dengan uarNegeri >!*A@

*ujuan husus pada Subje' !anusia 1Subje' dipilih secara adil: manfaat 9 beban sesuai: 0rosedur 0S0ade'uat: 0rivasi subje' 9 'erahasiaan data terjaga: risi'odiminimal'an 9 manfaat melebihi risi'o: ada aturan 'etat untu'Imelindungi subje' lemah: prosedur untu' memantauperlindungan subje': prosedur pen(ampaian hasil

Harapan 1Hasil penelitian

dapat &thical Approval"7learance untu' di publi'asi'an dalamJurnal ,lmiah di #alam Negeri maupun di uar Negeri


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Terima kasih

kuliah kepk 2015 prof. firman

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