20110917 Kuliah 1 - Kuliah 1 - Philosophy of Maths Education
Kuliah KEPK 2015 Prof. Firman
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Transcript of 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
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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
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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...
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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"
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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"
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!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"!,
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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#
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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$"
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W*at i" Et*i-"
,e fo$'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$ig" "o do
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9:" He%#in;i4 in%and4 /!ne 92
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De-laration o+ Hel"in#iEt*i-al Prin-i)le"
E"ica% p$incip%e# fo$ 'edica%$e#ea$c in)o%)ing !'an #!b6ec"#4inc%!ding $e#ea$c on iden"ifiab%e
!'an 'a"e$ia% and da"a
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Et*i-al Prin-i)le"
Pri-i)le" +or all Me'i-al Re"ear-* :
- ,o p$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$y
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Et*i-al Prin-i)le" -ont8888888
- M!#" be ade!a"e in confiden"ia% of pe$#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.
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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$'.
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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 "!,
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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"
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>!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
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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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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
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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
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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
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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
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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
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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
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Prin-i)le" o+ ani&al a""!,
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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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and thirstand thirst
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Free from discomfort
4"
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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.
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+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$$ie$ faci%i"y ,e'pe$a"!$e
H!'idi"y en"i%a"ion Ai$ Cange0 o!$ 7ig"ing In"en#i"y and cyc%e
Space0 cage #ize $efe$ "o ,e G!ide fo$ "e Ca$eand U#e of 7abo$a"o$y Ani'a%#
#ocia% )# #o%i"ai$e ie$a$cy
$eedo'# f$o' Di#co'fo$"
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+y p$e)en"ing "e' f$o' ge""ing i%% o$In6!$ed and by 'a;ing #!$e ani'a%# a$eDiagno#ed and "$ea"ed $apid%y if "ey do.
e" ca$e p$og$a' Coo#e non-in)a#i)e p$oced!$e# *en po##ib%e ,e !#e of ane#"e"ic# and ana%ge#ic *en needed
Coo#e an app$o)ed e!"ana#ia 'e"od AMAG!ide%ine# on E!"ana#ia
$eedo'# f$o' Fain4 In6!$y J Di#ea#e
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Free from fear and distress
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e$e a' I 3
y a' I e$e3
a" a$eyo! going "o
do "o 'e3
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A)oid )i#!a%0 a!$ic!%a$0 o%fac"o$ia%con"ac" be"*een p$ey# andp$eda"o$#
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Mini'ized #"$e## *i" en)i$on'en"a%en$ic'en"
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beha ior
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behavior
4"
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Na"!$a% bea)io$ of b!$$o*ing Jiding
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E #i" + di
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E-#i"! +$eeding
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E-#i"! +$eeding
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The love for all living
creatures is the most nobleattribute of man
(Charles Darwin)
,HE IN,ERNA,I(NA7
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Co%%abo$a"ing "e E!$opean Union4 "e Uni"edS"a"e#4 and /apan #ince 9
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Prin-i)le" o+
International on+eren-e on
Har&oni"ation IH7 Goo' lini-alPra-ti-e GP7-lini-al trial*!&an a" "!,
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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
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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
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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$#ona% benefi"
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R!%e# fo$ 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$ofe##ion
WRLD MEDIAL ASSIATIN
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WRLD MEDIAL ASSIATINDELARATIN > HELSINKI 192/7
BASI PRINIPLE >RALL MEDIAL RESEARH
App$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
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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
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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$"a"ion
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Prin-i)le" o+
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Prin-i)le" o+
International on+eren-e on
Har&oni"ation IH7 Goo' lini-alPra-ti-e GP7-lini-al trial*!&an a" "!,
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Conf%ic" of In"e$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"
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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$#ona% benefi"
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R!%e# fo$ 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$ofe##ion
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A!"o$#ip
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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$o!p
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SEJARAH DI INDNESIA :
KMISI ETIK PENELITIANKESEHATAN KEPK7
SEJARAH DI INDNESIA :
KMISI ETIK PENELITIANKESEHATAN KEPK7
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: eb$!a$i 9
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?5
Jaten$ 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
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F(,RE, DIRI BEFB
BUF-RSHSDi #e#!ai;an dengan
OPEDMAN NASINAL PENELITIANKESEHATAN 550
KEDUDUKAN ae7
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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$! !n"!;;e'!dian diang;a"0 di;!;!;an o%epi'pinan %e'baga.
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PERAN DAN >UNGSI a*7
. BEFB b!;an ;o'i#i peng!6i a"a!peni%ai i%'ia a;ade'i#4 "e"api
'e$!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$%!di!paya;an dengan d!;!ngan%e'baga
Penilaian Eti# Proto#ol
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Penelitian a)7
a. Di%a;!;an o%e #idang BEFB yang #ab. Anggo"a BEFB dapa" 'ene$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
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%. 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$#eb!" 'en6adi "angg!ng6a*ab Bo'i#i E"i;.
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5 /!ni 9
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? eb$!a$
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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
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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$an ;egia"an
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MASALAH ETIK PENELITIAN
KESEHATAN KHUSUS DI INDONESIA
MASALAH ETIK PENELITIAN
KESEHATAN KHUSUS DI INDONESIA
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PEMANFAATAN
BAHAN BIOLOGI TERSIMPAN (BBT)
PEMANFAATAN
BAHAN BIOLOGI TERSIMPAN (BBT)
+ +i % i , i
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+aan +io%ogi# ,e$#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$o"o;o% Fene%i"ian
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F$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
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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
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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%
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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
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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
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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$dagang;an
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FENE7I,IAN BER/ASAMA
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PENGERTIAN LATAR BELAKANG RUANG LINGKUP DASAR HUKUM ASPEK ETIK ASPEK LEGAL
PRINSIP DASAR:
UPAA PRTEKSI MTAMaterial Tran"+er A$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
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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$ara "e-ara ,er"a&a"a&a
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FER7U DIFERHA,IBAN Fene%i"ian yang di%a;!;an o%e Fene%i"i
A#ing dan 'engi;!"#e$"a;an Fene%i"i
7o;a% #ebagai peng!'p!% #pe#i'en+UBAN FENE7I,IAN BER/ASAMA
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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%
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,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
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RUANG 7INGBUF
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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$a FRI(RI,AS
NASI(NA7 dengan FRI(RI,AS G7(+A7
DASAR HUBUM
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DASAR HUBUM
UU no. 9:022 "en"ang Si#"e' Na#iona% 7I,+ANG dan IF,EB FF no.@< 0 9
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ASFEB E,IB ,ida; 'e'anfaa";an ;e%e'aan
;ondi#i #e"e'pa" Ha$!# '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
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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
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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
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ASFEB 7EGA7
,ida; 'e'baaya;an ;epen"ingan 0;ea'anan na#iona%
Me'pe$a"i;an ;eda!%a"an bang#a4a; a"a# ;e;ayaan aya"i4 dan a;a"a# ;e;ayaan in"e%e;"!a%
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I"! K*!"!" : MTA Ma"e$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
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Titi#titi# #riti" !nt!# ter
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ISI MTA
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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%
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E E
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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$a)en
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ETIK PENELITIAN
BATANTRAH;TT
ETIK PENELITIAN
BATANTRAH;TT
Sri Harsodjo WS.
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Tujuan umum :
Para peserta memahami pokok-pokok
etika pada penelitian Tanaman obat
(TO), Obat tradisional (OT) / Obatbahan alam/Herbal (OBA/OH) dan
Pengobatan tradisional (Batantra)
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KLASI>IKASI DAN JENISPENGBATAN TRADISINAL
Batantra Ketra&)ilan Batantra Ra&!an Batantra S!)ranat!ral;Meta+i"i#a
Batantra Pen'e#atan A$a&a
A Batantra !etrampilan :
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" 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
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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
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PRASARAT BAHAN;
METDA UJI
BAHAN AA!"BAHAN #ASA$
Bahan AlamNabati
Bahan Alam He%aniTer'iri 'ari
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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
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SENYAWAKIMIA PADATUMBUHAN
Metabolit
tekanan
Fitokimia
Fitoaleksin
Metabolit
sekunder
Metabolitrimer
Protein
"emak
Alkaloid
Fla#onoid
Min$ak atsiri
Kuinon
Steroid
Tanin
Dsb%
Fitotoksin
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PENELITIAN
T;T;BAH7
PENELITIAN
T;T;BAH7
TO/OT/OBA :
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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
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0h(topharmacaN7&8!ed.
PreclinClin!"bservation
Cultivation
Clinical studies
!ed. plants
$ 9 # of plants
Stand extracts
7hemst: pharm:preclinical
7on;rmation of&mpirical e
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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$hir
1.+,2
,solasi
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SITUASI
T;T;H TERKINI
#ulu 1"T untu$ self med% trivial% self limiting!
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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$an
Sebagai alternatif 1
M!n-!ln(a e&)iri# ,ar!:
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a; i#"i'e*a L"$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 :
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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
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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'
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0enelitian&pidemiologi
&pidemiologi 1lini' dan omunitas
Polte##e" II Gar!t 151 Se)t8 51
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*ujuan /mum
!emberi orientasi bagi penelititentang aspe' dan isu eti'penelitian epidemiologi>'lini' dan sosial@.
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*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
)
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Perbedaan antara
penelitian klinis dan epidemiologi
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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
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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
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0&N&,*,AN &0,#&!,++),S
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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
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!ng4 Indone#ia 2S"e' Ce%% o$;ing G$o!p4 ac!%"y of Medicine4 Uni)e$#i"a# Fad6ad6a$an-D$. Ha#an Sadi;in Gene$a%
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+and!ng4 Indone# a S"e' Ce%% o$; ng G$o!p4 ac!%"y of Med c ne4 Un )e$# "a# Fad6ad6a$an D$. Ha#an Sad ; n Gene$a%Ho#pi"a%4 +and!ng4 Indone#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->-@?9
F!b%i#ed 2 Sep"e'be$ 299A,"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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Mintarea"L an' FAM1in 31 "!,
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(b6ec"i)e e ep%o$ed "e #"ab%e $efe$ence gene# fo$ 'iRNA 9> A by R, FCR in "e ce%% %ine#Hep-G2 "a" *e$e "$ea"ed c%o$ogenic acid. e '!#" do a #e$ie# of "e#"# in o$de$ "o ge" a
$efe$ence gene#+a#ed on "e %i"e$a"!$e "e$e a$e ? candida"e# $eco''ended $efe$encegene#'i$@p4 5p4 9@4 294 and %e"-e cond!c"ed !#ing fo!$ candida"e# $efe$ence gene'i$@p4 94 and . ->2@->2@-4 92@-9@4 29.Me"od# In )i"$o #"!dy *a# pe$fo$'ed in Hep-G2 ce%%#. ,e #a'p%e# *e$e di)ided in"o con"$o%g$o!p and epe$i'en" g$o!p "$ea"ed *i" ?2?WM c%o$ogenic acid. Sa'p%e# *e$e ana%yzed a" 4 24 :49:4 and 2> o!$# af"e$ being"$ea"ed *i" c%o$ogenic acid.,o"a% RNA *a# i#o%a"ed f$o' Hep-G2 *i" RNA e"$ac"ion ;i" 'iRCUR,M RNA I#o%a"ion Bi"-Ce%%and p%an" Eion4 Code N!'be$ @99 and $e)e$#e "$an#c$ibed "o cDNA *i" F$i'e$#c$ip" R,
Reagen" Bi" 'iRCUR 7NA,M Uni)e$#a% R, 'ic$oRNA FCR4 Fo%yadeny%a"ion and cDNA #yn"e#i# ;i"Eion4 Code N!'be$ 2@@. ,e p$i'e$# fo$ 'iRNA 9> A *e$e Code N!'be$ 2>:: f$o'Eion fo$*a$d and $e)e$#e4 and !an"i"a"i)e $ea% "i'e $e)e$#e "$an#c$ip"ion po%y'e$a#e cain$eac"ion *a# pe$fo$'ed !#ing S+R Ma#"e$ Mi *i" Code N!'be$ 2@>5 Eicon. MiRNAp$ofi%ing *a# pe$fo$'ed in fo!$ pai$# of 'i$4 con#i#" of 'i$->2@-@p4 9@4 294 and 'i$-9. +y !#ing"e 'ean ep$e##ion )a%!e of a%% ep$e##ed 'i$4 *e iden"ified "e 'o#" #"ab%e candida"e $efe$encegene# fo$ #!b#e!en" )a%ida"ion *i" no$'finde$ #of"*a$e.
Re#!%"# Da"a f$o' R,-FCR *e$e ana%yzed !#ing No$'finde$ #of"*a$e. e fo!nd o!" "a" 'i$ep$e##ion *i" good #"ab%i"y i# 'i$-9@ and "e be#" co'bina"ion f$o' "*o gene# a$e 'i$-9@ and'i$->2@-@p. ina%%y 'i$->2@-@p i# fo!nd 'o$e #"ab%e "an 'i$-94 294 and [email protected]%!#ione conc%!de "e #"ab%e $efe$ence gene# fo$ 'iRNA 9> A "$ea"ed *i" c%o$ogenic acid i# 'i$-2@[email protected]*o$d# C%o$ogenic acid4 Hep-G24 Mi$na 9> ARefe$ence gene#4 'i$->2@-@p4 Refe$ence gene#.
Wa#t!
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D!a &in$$! "e#ali ra)at )leno ,!lanan
>!ll Boar' Meetin$7% 'ari !"!lan )enelitian(an$ 'i,a$i 3 Di4i"i :
17 Il&! Ke'o#teran Da"ar% 7 U
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ara U
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ara U
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>AKULTAS KEDKTERANUNIFERSITAS PADJADJARAN
BANDUNG
KOMISI ETIK PENELITIAN KESEHATAN
HEALTH RESEARCH ETHICS COMMITTEE
3l. 4ikman 5o. 67 [ @4 Bandung "+%+*eb ***.;ep;.f;.!npad.ac.id
E-'ai% e$c.f;!npad\yaoo.co'Afi%ia#i Bo'i#i Na#iona% E"i; Fene%i"ian Be#ea"an BEFB
NIH-USA I(RG-IR+ N!'be$ :24
A fo$ "e F$o"ec"ion of H!'an S!b6ec" 9:@2>ERCAF Acc$edi"ed
M"kanism" S"minar su(an P"n"(i*ianK"s"ha*an T"r'a#u /S!0
http://www.kepk.fk.unpad.ac.id/mailto:[email protected]:[email protected]://www.kepk.fk.unpad.ac.id/http://www.kepk.fk.unpad.ac.id/http://www.kepk.fk.unpad.ac.id/http://www.kepk.fk.unpad.ac.id/http://www.kepk.fk.unpad.ac.id/ -
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Pr$'$sa( '"n"(i*ian /Aka#"mik1E*ik0
n#an&an s"minar /K"*ua PPs1K$mi*" E*ik0
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San!r Bea-* Hotel% Bali105 No4e&,er 513
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Kon"!ltan In'e)en'enN
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N
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Nama Spesialisasi A;liasi
7 Dr! ,$e +ri /ed*e$i% dr!% +.n6&,C% &04%0!&es .nesthesiolog# F&-P F0-P
8 Prof! Dr! Tatang isri% dr!% +.n6&4. .neshtesiolog# MUF
9 Dr! Diah Dhianawat#% Dra!% 0!+i iochemistr# MUF
: Prof! Dr! 0! 4urhalim +hahib% dr iochemistr# MUF
5 Dr! .chadi#ani% dr!% 0!&es Cell iolog# MUF
; Dr! 1ad#ana +u$andar% Drs!% 0!+c 3idemiolog#MUF< Dr! /d! Tina Dewi 'udistiani% dr!% +"= 3idemiolog# MUF
> Dr! .hmad 0uhtadi% 0+!% .t Pharmac# Pharmac# -nad
? Prof! Dr! .nas +ubarnas% 0!+c!% .t Pharmac# Pharmac# -nad
7@ Dr! 3ris$a /i#anti% drg!% +&=. Dentist Dentistr# -nad
77 Dr! 0ie$e 1emiawati +atari%drg!%0+ Dentist Dentistr# -nad
78
Prof! Dr! 1erri +! +astramihard*a% dr!%
+F&(&) Pharmacolog# F0-P
79 Prihatini .mbaretnani% Dra!% 0.!% Ph!D +ociolog#+ocial A Political
+cience
7:Dr! 1ermawan 4! /as#id% dr!% +"T6&!%0T(03)!% F,C+
"rthoaedicsDr! 1asan +adi$in
1osital
75Prof! Dr! Fachr# .mbia Tand*ung% dr!% +!%+"T6&% 0!Phil("rth)!% F,C+
"rthoaedicsD$. Ha#an Sadi;in
Ho#pi"a%
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Sta+ Kantor A'&ini"tra"i
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Ka!r : I)!r P!r.atinin$"i* Se)te&,er% 5137
Sta+: i-i* arna"i*Maret% 51/7 A'e Ko&ar!'in Maret% 51/7 Sita P!rna'e.i "ta+ IT7 Maret% 51/7
IN>RASTRUTURE : Pro$ra&;a-ti4itie" IT "("te&
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Kantor A'&ini"tra"i KEPK >K Un)a'
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A%a'a" Ged!ng RS Fendidi;an @$d f%oo$/%. Ei6;'an No. @:4
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LAPRAN KEMAJUAN ETIKPERIDE JANUARI MARET 51?
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JUMLAH /1
LAPRAN KEMAJUAN ETIKPERIDE JANUARI MARET 51?
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LAPRAN KEMAJUAN ETIKPERIDE JANUARI MARET 51?
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LAPRAN KEMAJUAN ETIKPERIDE JANUARI MARET 51?
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>ERAP AREDITED
Ta$a(ta( it( THE PHILIPPINES
51/
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>ERAP AREDITED
Ta$a(ta( it( THE PHILIPPINES
51/
.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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