MHODOLOGI PENEUTlAN BIOMEDIS I 23

S
BAB II
ETIKA PENELITIAN
Prof. Dr. H. R. Muchtan Sujatno !r. S"#$. %$&
Pendahuluan
Pr'n('" Da(ar Et')a P*n*l't'an
*+ua r'(*t ,an- +*l'.at)an +anu('a (*.a-a' (u.,*) haru( .*r!a(ar)an *+"at
"r'n('" !a(ar Et')a P*n*l't'an %EP& ,a'tu/ 0. M*n-hor+at' oran- (respect for
person) 2. Manfaat (beneficence) 3. T'!a) +*+.aha,a)an (u.,*) "*n*l't'an (non
maleficence), !an 1. $*a!'lan (justice).
0. M*n-hor+at' atau +*n-har-a' oran- a!a !ua hal ,an- "*rlu !'"*rhat')an ,a'tu
a. P*n*l't' haru( +*+"*rt'+.an-)an (*cara +*n!ala+ t*rha!a" )*+un-)'nan
.aha,a !an "*n,alah-unaan "*n*l't'an
.. T*rha!a" (u.,*) "*n*l't'an ,an- r*ntan t*rha!a" .aha,a "*n*l't'an "*rlu
"*rl'n!un-an
2. Manfaat
$*haru(an (*cara *t') untu) +*n-u(aha)an +anfaat (*.*(ar2.*(arn,a !an
+*+"*r)*c'l )*ru-'an atau r'(')o .a-' (u.,*) !an +*+"*r)*c'l )*(alahan
"*n*l't'an. Hal 'n' +*+*rlu)an !*(a'n "*n*l't'an ,an- t*"at !an a)urat "*n*l't'
,an- .*r)o+"*t*n (*rta (u.,*) t*rja-a )*(*la+atan !an )*(*hatann,a. D*)lara('
H*l('n)' .ut'r 0.1/ +*laran- "*la)(anaan ,an- +*n!atan-)an r'(')o. Su.,*)
('fatn,a (u)ar*la ,an- haru( !'hor+at'.
3. Baha,a
Salah (atu .ut'r ,an- uta+a a!alah +*n-uran-' .aha,a t*rha!a" (u.,*) (*rta
+*l'n!un-' (u.,*)
1. $*a!'lan
S*+ua (u.,*) !'"*rla)u)an !*n-an .a'). A!a )*(*'+.an-an +anfaat !an r'(')o.
R'(')o ,an- !'ha!a"' (*(ua' !*n-an "*n-*rt'an (*hat ,an- +*nca)u"/ f'(')+*ntal
!an (o('al. Ol*h )ar*na 'tu r'(')o ,an- +un-)'n !'ala+' ol*h (u.,*) atau r*la3an
+*l'"ut'/ r'(')o f'(') %.'o+*!'(& r'(')o "(')olo-'( %+*ntal& !an r'(')o (o('al. Hal ini
t*rja!' )ar*na a)'.at "*n*l't'an "*+.*r'an o.at atau 'nt*r4*n(' (*la+a "*n*l't'an.
RISIKO FISIK
Tujuan uta+a )o!* *t') "*n*l't'an a!alah untu) +*l'n!un-' )*(*la+atan !an
)*a+anan (u.,*) "*n*l't'an. $*a!aan ini a)an !'ala+' (u.,*)/
a. Ef*)t'4'ta( ,an- .*lu+ !')*tahu' ,an- !'uj'
.. A)'.at "*n-h*nt'an "*n-o.atan
c. ESO ,an- .*lu+ !')*tahu'
B'a(an,a +anfaat (uatu "*n*l't'an !'ra(a)an ol*h(u.,*) !an+a(,ara)at. P*n*l't'an
ini !'la)u)an !*n-an t*l't' !an +*n!ala+. A!a )*a!aan ,an- !'(*.ut inducement, ,a'tu
(uatu aja)an !ala+ (uatu "*n*l't'an !*n-an +*njanj')an a!an,a )*untun-an f'(')
+*ntal !an (o('al.
RISIKO PSIKOLOGIS
P*n'la'an r'(')o ini a!alah )ual'tat'f +'(aln,a ra(a c*+a( atau +alu. P*n'la'an
!'"*rol*h!ar'3a3ancara%+'(aln,a!'tan,a)an+a(alahhu.un-an'nt'+"a!a"*n!*r'ta
HIV/AIDS). Hal ini !a"at !'ant'('"a(' !*n-an "*nj*la(an 5 'nfor+a(' (*.*lu+n,a.
RISIKO SO SIAL
A"a.'la !ata (u.,*) t'!a) +*n!a"at "*n-a+anan !ar' (*-' )*raha('aan (u.,*)
!a"at +*n-ala+' )*h'lan-an "*)*rjaan !''(ola(' ol*h +a(,ara)at (*)'tarn,a .*r(*l'('h
!*n-an (ua+' 5 +*rtua !'tuntut +*lan--ar hu)u+ %+'(aln,a "a!a "*n*l't'an
a.ortu(& !an la'n2la'n. R'(')o "(')olo-'( !an (o('al ju-a !'"*n-aruh' "*r)*+.an-an
)*.u!a,aan.
S*hu.un-an !*n-an 'tu "*n*l't' !an )o+o(' *t') haru( "*)a t*rha!a"/
24 I METODOLOGI PENELITIAN BlOME DIS
BAB II 2 ETI$A PENElITIAN I 2S
a. D*f'n'(' !an "*n-*rt'an +*n-*na' n'la' atau "*r(*"(' t*rha!a" (*(uatu ,an-
+*+"*n-aruh' (*-' "(')olo-'( !an (o('al (u.,*) "*n*l't'an
.. A!a "*r.*!aan tujuan antara "*n*l't' !an (u.,*) %"*n*l't' untu) +*n'n-)at)an
)*(*hatan (*!an-)an (u.,*) .*rf')'r r'(')o f'(') +*ntal !an (o('al&.
c. P*r(*"(' +*n-*na' )*raha('aan !ata ,an- .*r.*!a ,an-"*nt'n- a!alah/ )*raha('aan
'tu "*nt'n- .a-' ('a"a 6 Atau a"a)ah )*raha('aan 'tu .*r('fat a.(olut 6
!. P*r.*!aan "*r(*"(' +*n-*na' a"a ,an- !'+a)(u! !*n-an (a)'t atau (*hat
*. $*+un-)'nan t*rja!' )*(alahan t*)n'( a!an a!+'n'(tra(' !ala+ +*n-*lola !ata
f. P*n!*)atan !ar' ata( )* .a3ah atau !ar' .a3ah )* ata( +*ru"a)an "'l'han ,an-
ha+( !'(*(ua')an !*n-an )*.u!a,aan (*t*+"at.
CARA PENILAIAN MANFAAT DAN KERUGIAN
Hal ini (an-at (ul't !'la)u)an .*r.a-a' fa)tor +*+"*n-aruh' )*"utu(an ini.
S*.a-a' !a(ar untu) "*n-a+.'lan )*"utu(an ini a!a .*.*ra"a "ato)an ,a'tu/
0. A"a)ah r'(*t ini +*+an- !'.utuh)an 6 (necessary) !'l'hat +anfaat +a( a !*"an 6
2. A"a)ah r'(*t ini !'!a(ar' ala(an ,an- )uat 6 (justified) !'l'hat !ar' ha('l ,an-
!'hara")an
3. A"a)ah !*(a'n "*n*l't'an ,an- !'-una)an untu) r'(*t ini t*"at6
1. A"a)ah r'(*t !a"at !'la)(ana)an6 !'l'hat !ar' !ata !an (arana ,an- t*r(*!'a.
PERUBAHAN RASIO RISIKO DAN MANFAAT SELAMA PROSES
PENELITIAN
Pro(*( uj' )l'n') fa(* I II III !an I7 ,an- +ana (*t'a" fa(* +*+"un,a' tujuan
t*rt*ntu ,an- !a"at +*n'+.ul)an t*rja!'n,a r'(')o !an +anfaat .a-' (u.,*). S*cara
u+u+ !a"at !')ata)an r'(')o ,an- !'ha!a"' +*nja!' l*.'h )*c'l (*(ua' !*n-an
"*r)*+.an-an fa(* "*n*l't'an.
#a(* I/ T*r!a"at r'(')o ,an- l*.'h t'n--' ol*h )ar*na *f*) (a+"'n- o.at .*lu+
(*"*nuhn,a !')*tahu' %"a!a .'natan- t*lah !'la)u)an&. B*lu+ !a"at !'l'hat +anfaat
lan-(un- t*r+a(u) +anfaat "ro! u) ,an- !'uj' t*lah !')*+.an-)an.
28 I METODOLOGI PENEUTIAN BIOMEDIS
#a(* II/ R'(')o ,an- !'ha!a"' t'!a) t*rlalu .*(ar (u.,*) +*ra(a)an +anfaatn,a
+*()'"un (*+*ntara t*r+a(u) +anfaat ,an- a)an !'t*r'+a (*t*lah (uatu "ro!u)
!')*+.an-)an.
#a(* III !an I7/R'(')o,an- !'ha!a"' r*lat'f )*c'l ol*h )*r*na t*lah .an,a) +*n!a"at
'nfor+a(' ta"' hat'2hat' "a!a Et*) Sa+"'n- O.at %ESO&.
UPAYA MENGECILKAN RISIKO PENELITIAN
0. D*(a'n "*n*l't'an haru( (*(ua' !*n-an tujuan "*n*l't'an
2. A!an,a )r't*r'a 'n)lu(' !an *)()lu(' ,an- l*n-)a" !an (*(ua' !*n-an tujuan
"*n*l't'an
3. A!an,a )r't*r'a untu) +*la)u)an '!*nt'f')a(' !ala+ u"a,a +*n-ant'('"a(' ('tua('
(*rta cara untu) +*nan--ulan-' .aha,a t*rha!a" (u.,*)
1. P*n*l't' haru( .*.a( !ar' )*untun-an "r'.a!'
9. A!an,a (arana !an t*na-a ,an- +*+a!a' ,an- !a"at +*nan--ulan-' a)'.at
.uru) (*t*lah "*n*l't'an (*l*(a'.
PERKEMBANGAN ETIK PENELITIAN
P*r)*+.an-an Et') P*n*l't'an !' !un'a !'+ula' !*n-an "*n-*rt'an .ah3a "*n,a)'t
.*ra(al !ar' )utu)an !*3a atau (*tan. P*n,*l*(a'ann,a "a!a 3a)tu 'tu !*n-an +a-'c
atau (*cara ("'r'tual. Du)unlah ,an- +*nja!' "*rantara antara +anu('a !an !*3a.
Pa!a 3a)tu 'tu oran- "*rca,a "a!a )*+a+"uan !u)un 5 ta.'. !a"at +*n,*+.uh)an
"*n,a)'t.
S*(ua' !*n-an "*rjalanan 3a)tu +uncullah to)oh2to)oh ,an- .*r"*ran !ala+
)*+ajuan !un'a )*(*hatan (*"*rt' E!3ar! :*nn*r "*n*+u 4a)('n cacar :o(*"h L'(t*r
ahli .*!ah ,an- +*n--una)an ant'(*"t') "a!a 3a)tu +*la)u)an o"*ra('.
S*t*lah t*)nolo-' )*!o)t*ran l*.'h +aju la-' !'t*+u)an ant'.'ot')a. Na+un
+a(alah .aru t'+.ul !*n-an a!an,a r*('(t*n(' ant'.'ot') (*h'n--a "*rlu "*n*l't'an
+*n-*na' ant'.'ot') -*n*ra(' .arn.
B*la)an-an 'n' !*n-an )*+ajuan t*)nolo-' )*!o)t*ran "ara ahl' +*la)u)an
BAB II 2 ETl$A PENELlTIAN I 2;
tran("lanta(' or-an !an +*la)u)an r*)a,a(a -*n*t')a. Manu('a "a!a (uatu (aat +*ra(a
!'r'n,a (*"*rt' Tuhan. B*r.a-a' "*n*l't'an .aru ,an- +*+a)an .'a,a .*(ar t*ru(
!'la)u)an. Para ahli !' .'!an- t*rt*ntu +*nja!' ("*('al'( .ah)an +*nja!' (u"*r("*('al'(
,an- (*r'n- +*n-an--a" +anu('a han,alah (*.a-a' (*)u+"ulan or-an. A)'.atn,a
hu.un-an )*j'3aan antara !o)t*r !an "a('*n +*nja!' )a.ur !an !a+"a)n,a a!alah
t*rja!'n,a "*n,'+"an-an nor+a *t') .a') ,an- !'(*n-aja +au"un ,an- t'!a)
!'(*n-aja.
Punca) "*n,'+"an-an *t') t*r(*.ut t*rja!' "a!a (aat "*+*r'ntahan NA<I. Saat
'tu "*n*l't'an !'la)u)an t*rha!a" tahanan P*ran- Dun'a II ,an- +*n'la' )*tahanan
+anu('a "a!a (uhu = !*rajat >. P*n*l't'an t*r(*.ut !'!a(ar)an "a!a tujuan "ol't') !an
chau4'n'(+*. P*rco.aan t*r(* .ut +*n,')(a !an +*ru-')an oran- "*rco.aan.
S*.*narn,a nor+a *t') )*!o)t*ran (u!ah a!a (*ja) ?a+an !ahulu. S*.a-a' contoh
a!an,a (u+"ah !o)t*r H'n!u "a!a 09==SM ,an- '('n,a "*n!*r'ta ,an- !'o.at' jan-an
(a+"a' !'ru-')an. Su+"ah H'"ocrat*( %9==SM&,an- +*n-ata)an .ah3a ,an- "*rta+a
)al' haru( !'"*rhat')an ol*h (*oran- !o)t*r a!alah jan-an +*n,a)'t' (primum non nocere).
Pa!a tahun 0@18 !' Nur*n.*r- "ara ahl' +*n*r.'t)an "*raturan +*n-*na' "*rco.aan
"a!a +anu('a ,an- !')*nal !*n-an Nur*n.*r- >o!*. Salah (atu aturan ,an- haru( a!a
a!alah informed consent. D*n-an a!an,a aturan2aturan 'n' "*n*l't' !'hara")an t'!a)
+*ru-')an "a('*n.
Pa!a tahun 0@81World edical Association (WMA) +*n*r.'t)an D*)lara(' H*l('n)'
I ,an- .*r'(' "an!uan .a-' !o)t*r "a!a "*n*l't'an )l'n'(. Pa! a !*)lara(' 'n' )*.'ja)an
!'la)(ana)an ol*h "*n*l't' (*n!'r' !an t'!a) !'haru()an a!an,a "*n-a3a(an ol*h
"'ha) la'n. P*n*l't' haru( +*+utu()an (*n!'r' a"a)ah a!a "*n,'+"an-an !ala+
"*n*l't'ann,a atau t'!a). Na+un t*+,ata nor+a *t') tan"a "*n-a3a(an (*r'n- t*rja!'
"*n,'+"an-an *t').
Pa!a tahun 0@;9 World Healt! Assembly )*22= !' To),o +*n*r.'t)an D*)lara('
H*l('n)' II ,an- +*ru"a)an r*4'(' D*)lara(' H*l('n)' I. D*)lara(' 'n' +*n-haru()an
"roto)ol "*n*l't'an "a!a +anu('a !'t'njau t*rl*.'h !ahulu ol*h "an't'a untu) !'la)u)an
"*rt'+.an-an tuntutan !an !'.*r' )o+*ntar. D*)lara(' 'n' ju-a +*n-haru()an "*n*l't'
untu) +*ncantu+)an "*rt'+.an-an *t'). (et!ical clearance). P*n*l't'an .*lu+ !a"at
2A I METODOLOGI PENElITlAN BIOMEDlS
!'"u.l')a(')an (*.*lurn a!a et!ical clearance.
P*r)*+.an-an *t') "*n*l't'an !' In!on*('a !'+ula' (*ja) tahun 0@;9 ,an- +ana
"a!a 3a)tu 'tu !*l*-a(' !ar' In!on*('a +*n-')ut' (uatu "*rt*+uan ,an- +*n-haru()an
a!an,a Pan't'a Et') P*n*l't'an %PEP&. Pan't'a 'n' !a"at .*r('fat 'n(t'tu('onal !*n-an
tu-a( +*n-*lola "*n*l't'an !' 'n(t'tu('2'n(t'tu(' t*rt*ntu atau .ah)an !' 'n(t'tu(' ,an-
.*r()ala na('onal. Hal la'n ,an- +*n!oron- t*r.*ntu)n,a PEP a!alah a!an,a )*haru(an
.a-' "*n*l't' untu) +*la+"'r)an et!ical clearance %E>& -una "*n-ajuan !ana. S*.*lu+
PEP t*r.*ntu) E> !'.*r')an ol*h Pan't'a Et') IDI ,an- (*.*na+,a han,a +*n-uru('
)a(u( +al"ra)t*) (aja.
Pa!a tahun 0@A2 $PPI$2UI +*+.*ntu) "an't'a )**'l ,an- +*+.aha( *t')
"*n*l't'an ,an- "a! a +ulan,a han,a !'"*runtu))an "*n*l't'an !'l'n-)un-an #$ UI
(aja. Pa!a 3a)tu 'tu !'la)u)an "*n-urn"ulan na()ah l*n-)a" #oru+ D'()u(' $o!*
Et') P*n*l't'an $*!o)t*ran. S*lanjutn,a "a! a tahun 0@A8!'la)(ana)an lo)a)ar,a ,an-
+*l'.at)an +a(,ara)at l*.'h lua( ,a'tu >HS. Dala+ lo)a)ar,a t*r(*.ut !'.*ntu) Pan't'a
Et') P*n*l't'an !' +a('n-2+a('n- #a)ulta( $*!o)t*ran !an "a!a tahun 0@A; !'t*r.'t)an
P*!o+an Et') P*n*l't'an $*!o)t*ran In!on*('a.
PERSYARAT AN PENELITIAN KEDOKTERAN
P*n*l't'an a!alah u(aha untu) +*+.u)t')an (uatu h'"ot*('( !*n-an (,arat2(,arat
,an- !'t*ntu)an atau +*n*ar' (*(uatu ,an- .*lu+ !')*tahu'.
Tujuann,a a!alah untu) +*+aju)an 'l+u "*n-*tahuan )hu(u(n,a !' .'!an-
)*!o)t*ran ,an- +*l'"ut' t*ra"' !'a-no('( "rof'la)('( !an "*+aha+an t*ntan- *t'olo-'
(*rta "ato-*n*('( (uatu "*n,a)'t.
DEFINISI PENELITIAN KEDOKTERAN
M*nurut The edical "esearc! #ouncil, P*n*l't'an .$*!o)t*ran %P$& a!alah (*t'a"
"*n,*l'!')an ,an- a!a r*l*4an('n,a !*n-an "*n-*nalan !an "*n-*lolaan (uatu
"*n,a)'t.
M*nurut S+'th P$ a!alah (*t'a" "*n*l't'an ,an- +*n-a*u )* arah "*r.a')an
BAB II 2 ETl$A PENELITIAN I 2@
)*(*hatan. Pa!a P$ (u!ah .aran- t*ntu +*n--una)an (u.,*) +anu('a na+un uj' 5 r'(*t
"a!a +anu('a t*r(*.ut (u!ah t*rl*.'h !ahulu !'la)u)an "a!a h*3an co.a +*n-*na' uj'
)*+anan !an +anfaatn,a.
P*n*l't'an "a!a +anu('a (an-at "*nt'n- !'la)u)an ol*h )ar*na/
0. Ha('l "*n*l't'an jan-)a "anjan- (*ju+lah .*(ar "a!a h*3an (*r'n-)al' ta)
+*n--ant')an ha('l jan-)a "*n!*) "*rco.aan "a!a (*!')'t +anu('a
2. B*lu+ a!an,a +o!*l *)("*r'+*n "a!a h*3an untu) "*n,a)'t t*rt*ntu
3. A!an,a )*untun-an .a-' )*+ajuan 'l+u )*!o)t*ran !*n-an .a') !*n-an r'(')o
,an- !a"at !'"*rt*n--un-ja3a.)an.
I$%&"'D #&$S'$( (I#)
Salah (atu hal ,an- haru( !'"*rol*h "*n*l't' !ar' (u.,*) a!alah informed consent
atau "*r(*tujuan (*t*lah "*nj*la(an. I* +*ru"a)an (alah (atu .a-'an "*nt'n- !ar'
"*r(,aratan !ala+ "*n*l't'an ,an- +*l'.at)an +anu('a !an or-an +anu('a t*r+a(u)
!ala+ "*n*l't'an .'o+*!'( !an r*"ro!u)(' +anu('a. Untu) tujuan t*r(*.ut "*n*l't'
haru( +*+.*r')an (*+ua )*t*ran-an ,an- !'+'l')'n,a +*n-*na' "*n*l't'an ,an- a)an
!'la)(ana)an +anfaat ,an- a)an !'"*rol*h r'(')o2r'(')o ,an- a)an t*rja!' .a') untu)
(u.,*) +au"un +a(,ara)at.
Informed concent ,an- !'+a)(u! !' ('n' a!alah (*oran- "*n*l't' ,an- +*+.*r')an
'nfor+a(' ,an- 'a +'l')' +*n-*na' "*n*l't'an ,an- a)an !'la)(ana)an +*l'"ut'
+anfaat n'la'2n'la' .a-' +a(,ara)at r'(')o2r'(')o ,an- a!a !an a!an,a ho)u+ ,an-
+*n-'(,arat)an a!an,a !ua (,arat "*n*l't'an +*!'( "a!a +anu('a ,a'tu/ )r't*r'a
)*"atutan !an )r't*r'a "*r(*tujuan
$r't*r'a )*"atutan %03 (,arat&
0. Hara"an a!an,a "*n-*+.an-an .aru ,an- t'!a) !a"at !*n-an cara la'n
2. Art' "*n*l't'an (*.an!'n- !*n-an r'(')o %D*)l H*l('n)'&
3. $*"*nt'n-an (u.,*) !' ata( )*"*nt'n-an 'l+u "*n-*tahuan
1. Haru( (*(ua' "r'n('" !*n-an 'l+'ah ata( !a(ar "*n*l't'an la.orator'u+ !an h*3an
(*rta cu)u" )*"u(ta)aan 'l+'ah.
9. B*ntu) !an cara "*la)(anaan haru( j*la( t*rtul'( !an haru( !'n'la' ol*h Pan't'a
,an- 'n!*"*n!*n.%D*)l H*l('n)'&
8. D'la)(ana)an ol*h "*n*l't' .*r)ual'ta( .a') %)o+"*t*n& !an !'a3a(' ol*h !o)t*r
;. P*n*l't'an t*rha!a" +anu('a .*rla)u (tan!ar "rof*(' t*rt'n--' .u)an ol*h !o)t*r
!*n-an )*+arn"uan rata2rata. (de )emiddelde be*+ame arts)
A. S*cara hu)urn "*n*l't' .*rtan--un-ja3a. (*cara "r'.a!'
@. Int*-r'ta( "(')'( !an f'(') oran- "*rco.aan haru( !'ja-a !an !'l'n!un-' %D*)l
H*l('n)'&
0=. Raha('a oran- "*rco.aan haru( !'junjun- t'n--'
00. P*n!*r'taan rohan' !an f'(') oran- "*rco.aan haru( !'.ata(' (*+a)('+al
+un-)'n.
02. Haru( !'u(aha)an "*nc*-ahan )*ru-'an 'n!'4'!ual'ta( !an )*+at'an oran-
"*rco.aan.
03. T'a" "*n*l't'an haru( !'h*nt')an .'la a!a 'n4al'!'ta( atau )*+at'an.
KHUSUS PENELITIAN KLINIK, mempuna! "a#a$%"a#a$ $e#$en$u
an$a#a la!n&
0. P*n*l't'an "a!a "a('*n (*.a')n,a ata( !a(ar 'n!')a(' +*!'(
2. B'la tan"a 'n!')a(' +*!'( !an ata( !a(ar "*r(*tujuan "a('*n "*n*l't'an !'la)u)an
ol*h !o)t*r ,an- .u)an +*ra3atn,a %D*)l H*l('n)'&.
3. Haru( +*+"un,a' n'la' !'a-no(t') !an n'la' t*ra"' untu) +*ra3at "a('*n.
1. P*n--unaan o.at atau !an (uatu "ro(*!ur han,a untu) )*"*rluan 'nfor+a(' t'!a)
!'"*r)*nan)an.
9. T'a" "a('*n haru( ,a)'n +*to!* !'a-no(t') !an t*ra"' ,an- t*r.a').
8. :')a a!a r'(')o t*rt*ntu !ar' "*n*l't' 5 ,an- +*ra3at haru( !'la)u)an )on(ulta('
!*n-an TIM "*na(*hat.
;. B'la a!a "a('*n t'!a) +*+.*r')an "*r(*tujuan t'!a) .ol*h a!a !arn"a) n*-at'f
hu.un-an !o)t*r2"a('*n.
A. Pa(*n )o+a t'!a) .ol*h ja!' oran- "*rco.aan.
3= I METODOLOGI PENELITlAN BIOMEDlS
BAB II 2 ETI$A PENELITlAN I 30
@. Pa('*n !*n-an fa(* t*ra)h'r h'!u" t'!a) .ol*h ja!' oran- "*rco.aan
0=. Pa('*n ,an- "un,a "*n,a)'t t'!a) !a"at !'(*+.uh)an (*.a')n,a t'!a) !'ja!')an
oran- "*rco.aan.
KRITERIA PERSETU'UAN
P*n*l't'an ta) .ol*h !'la)(ana)an .'la ta) a!a "*r(*tujuan !ar' "a('*n atau .u)an
"a('*n (*l*n-)a" +un-)'n ta) a!a 'nfor+a(' ,an- !'raha('a)an ol*h "*n*l't'.
Be#!(u$ !n! )e)e#apa pe$!(an da#! de(l Hel"!n(! dan Nu#en)e#*&
D*)l H*l('n)'/ Th* a'+*! +*tho!( ant'c'"at*! .*n*f't( an! "ot*nt'al ha?ar!( of
th* (tu!, an! th* !'(co+fort 't +a, *nta'l.
B Nur*n.*r- Rul*(/ Natur* !urat'on an! "ur"o(* of th* *C"*r'+*nt th*
+*tho!( an! +*an( ., 3h'ch 't '( to .* con!uct*! all 'ncon4*n'*nc* an!
ha?ar!( r*a(ona.l* to .* *C"*ct*! an! th* *ff*ct u"on h'( h*alth or "*r(on
3h'ch +a, "o(('.l, corn* fro+ h'( "art'c'"at'on 'n th* *C"*r'+*nt.
B Nur*n.*r- >o!* tt- "*r(*tujuan/
Th* "*r(on 'n4ol4*! (houl! ha4* l*-al ca"ac't, to -'4* con(*nt (houl! .* ('tuat*!
a( to .* a.l* to *C*rc'(* fr** "o3*r of cho'c* 3'thout 'nt*r4*nt'on of an, *l*+*nt of
forc* frau! !*c*'t !ur*(( o4*r r*ach'n- or *Ct*r'or .
Lanjutan.... #or+ of con(tra'n or co*rc'on an! (houl! ha4* (uff'c'*nt )no3l*!-*
an! co+"r*h*n('on of th* *l*+*nt( of th* (u.j*ct2+att*r 'n4ol4*! a( to *na.l* h'+ to
+a)* an un!*r(tan!'n- and an enli)!tened decision.
Dala+ "*nj*la(an/ t'!a) !a"at (*+ua 'nfor+a(' !'(arn"a')an )ar*na (ul't !ala+
.aha(a 5 '(t'lah. "*n*l't' ju-a .*lu+ tahu (*-alan,a %ju(tru 'n-'n tahu& Dar' (*-' hu)urn/
"*n*l't' haru( +*+.*r')an "*nj*la(an a-ar (u.,*) haru( +*n-*rt' *(*n(' "*n*l't'an
r'(')o "*n*l't'an !ll. B'la ta) +*n-*rt'D (u.,*) t*r(*.ut t'!a) .ol*h !'')ut(*rta)an
penelitian.Infonned consent t*r+a(u) )r't*r'a "*r(*tujuan. Haru( !''n-at "ula a("*)
hu)urn "'!ana !an "*r!ata (*"*rt' t'!a) +*+*nuh' )r't*r'a )*"atutan !an .*lurn a!a
5 t'!a) a!a "*r(*tujuan oran- "*rco.aan !a"at !')at*-or')an "*n-an'a,aan !*n-an
32 I METODOLOGI PENElITlAN BrOMEDlS
"*lan--aran "a(al 390 $UHP atau !*n-an "*r)ataan la'n/ j')a t'!a) a!a )*"atutan
!an "*r(*tujuan +a)a t*r+a(u) "*n-an'a,an %"a(al 390 $UHP& ,an- '('n,a (*.a-a'
.*r')ut/
0. P*n-an'a,aan !'"'!ana "*njara (*la+a2la+an,a !ua tahun !*la"an .ulan atau
!*n!a (*.an,a)2.an,a)n,a R" 19====
2. :')a "*r.uatan .*ra)'.at lu)a .*rat !'"*njara (*la+a2la+an,a 9 tahun
3. B*ra)'.at +at'n,a (*(*oran- !'"'!ana (*la+a2la+an,a ; tahun
1. P*n-an'a,aan !'(a+a)an !*n-an +*ru(a) )*(*hatan !*n-an (*n-aja.
9. P*rco.aan +*la)u)an )*jahatan 'tu t'!a) !a"at !'"'!ana.
A!a .*r.a-a' "*naf('ran +*n-*na' "*n-an'a,aan (*"*rt' !o)tr'n "*r.uatan
"*n-an'a,aan !'taf('r)an (*.a-a' "*r.uatan !*n-an (*n-aja untu) +*n'rn.ul)an ra(a
(a)'t "a!a oran- la'n. M*nurut Ho-* Raa! %MA& "*n-an'a,aan a!alah "*r.uatan ,an-
!'(*n-aja untu) +*n'rn.ul)an ra(a (a)'t atau lu)a "a!a oran- la'n !an (*+ata2+ata
+*ru"a)an tujuan "*r.uatan t*r(*.ut.
Do)t*r !'(*.ut +al"ra)t*) !ala+ "*n*l't'an ,a'tu .'la al"a 50 ala' (*h'n--a
+*n-a)'.at)an )*ru-'an %"a(al 39@ 38= 380 $UHP&.
P*n*+uan (*(uatu hal ,an- .aru !a"at +*lalu' .*.*ra"a cara ,a'tu )*.*tulan
("*)ula(' +*to!* trial and error, +*to!* "*n-ala+an !an +*to!* 'l+'ah.
Ran-)a'an "*n*l't'an +*to!* 'l+'ah +*l'"ut'/
0. P*ru+u(an +a(alah !an "*n*ta"an tujuan "*n*l't'an
2. P*ru+u(an h'"ot*('(
3. M*to!* )*rja !an .ahan "*n*l't'an
1. P*n-u+"ulan !ata
9. P*n-olahan !ata !an !'()u('
8. P*n,'+"anan !ata
;. Pu.l')a('
BAB II % ETIKA PENELITIAN I 33
SEGI ETIK PENELITIAN
Et') P*n*l't'an !a"at +*n,an-)ut "*n*l't'an t*ra"*ut') ,an- !'la)u)an t*rha!a"
oran- (a)'E !an .*rhu.un-an !*n-an "*nan--ulan-an "*n,a)'tn,a .a') !*n-an
+*n--una)an o.at +au"un !*n-an cara la'n (*"*rt' "*+.*!ahan. S*la'n 'tu *t')
"*n*l't'an ju-a +*n,an-)ut "*n*l't'an non t*ra"*ut') ,an- t'!a) +*n-o.at' "*n,a)'t
(*cara lan-(un- !an .*rtujuan +*ncar' !ata. Et') "*n*l't'an !'"*rlu)an "ula untu)
"*n*l't'an +a(alah )hu(u( (*"*rt' 3an'ta ha+'l !an dependent person. Dependent person
!'-olon-)an "a! a +a(alah )hu(u( )ar*na 'n!'4'!u t*r(*.ut .*lu+ atau t'!a) !a"at
+*+.*r')an "*r(*tujuan !*n-an +*n,a!ar' a)'.atn,a %ana)2ana) atau 'n!'4'!u
!*n-an -an--uan j'3a&.
SEGI ETIK EKSPERIMENT ASI KEDOKTERAN
Et') *)("*r'+*ntal )*!o)t*ran !'!a(ar)an "a!a Nur*n.*r- >o!* 0@18,an- .*r'('
antara la'n/
Informed consent a+at *(*n('al
P*n*l't'an haru( !'!ahulu' ol*h "*rco.aan .'natan-
Haru( +*n-h'n!ar' "*n!*r'taan f'(') !an +*ntal
B Haru( !'la)u)an ol*h (*oran- ahli
B P*(*rta "*n*l't'an .*rha) +*nola) untu) ')ut (*rta
P*n*l't'an ha+( !'h*nt')an .'la a!a !u-aan a)'.at "*n*l't'an (*"*rt'/ cacat c*!*ra
atau )*+at'an
FMA "a! a tahun 0@81 +*n,u(un $o!* Et') P*n*l't'an %D*)l H*l('n)'& !an
!'(*+"urna)an World edical Assembly (o*yo %0@;9&!an World edical Assembly
Venesia %0@A3&.*r'(' antara la'n/
B R'(*t.'o+*!') "a!a +anu('a han,a .ol*h !'la)u)an ol*h ahl' !' .a3ah "*n-a3a(an
t*na-a +*!'( )o+"*t*n(' )l'n'(
B
$*"*nt'n-an (u.,*) !'!ahulu)an !ar' "a!a )*"*nt'n-an 'l+'ah atau +a(,ara)at
B Para !o)t*r t'!a) .ol*h t*rl'.at "a!a "*n*l't'an +anu('a )*cual' ,a)'n .aha,an,a
!a"at !'ra+al)an !an .'la a!a "*n*l't'an t*r(*.ut ha+( !'h*nt')an
31 I METODOLOGI PENHITlAN BrOMEDlS
B Su.,*) haru( !'.*r'tahu/ !a(ar tujuan r'(')o !an la'n2la'n.
B M*n!a"at "*r(*tujuan (*cara .*.a( !an t*rtul'(
B B'la (u.,*) t'!a) !a"at +*+.*r')an "*r(*tujuan t*r(*.ut .ol*h !'"*rol*h !ar'
wali ,an- (ah
FHO Scientific ,roup %0@81&+*ru+u()an .*r.a-a' "'ha) !*n-an )*"*nt'n-ann,a
,an- t*rl'.at !ala+ "*n*l't'an/
B I?'n ,an- !'"*rol*h !ar' (u.,*) ,an- t*lah !'.*r'tahu ('fat tujuan "*rco.aan
.aha,an,a )*ru-'ann,a !an )*uhtun-ann,a. I?'n 'n' !a"at !'"*rol*h !ar' (u.,*)
Glan-(un- atau 3al'n,a
B P*rco.aan haru( a+an +*n-an!un- r'(')o t*r)*c'l !an .'la a!a tan!a2tan!a
.aha,a "*n*l't'an haru( !'h*nt')an
I+.alan t'!a) untu) +*ran-(an- "art'('"a('
B B'a,a "*n*l't'an !'.*.an)an "a!a ("on(or .u)an (u.,*) "*n*l't'an
B'a,a "*la)(anaan haru( a!a
B $o+"*n(a(' haru( a!a .'la t*rja!' )*c*la)aan
PENYUSUNAN ETIK KEDOKTERAN INDONESIA, )e#da"a#(an
De(la#a"! Hel"!n(!& +E$!( Da"a# Penel!$!an+
1. P*n*l't'an Klinik %P$& haru( (*(ua' !*n-an "r'n('" +oral !an )*'l+uan (*rta
"*n*l't'an "*n!ahuluan !an-an la.orator'u+ *)("*r'+*ntal atau fa)ta 'l+'ah
,an-+a"an
2. P$ han,a .ol*h ol*h oran- ,an- +*+"un,a' )ual'f')a(' )*'l+uan !an tan--un-
ja3a. !' .a3ah (u"*r4'(' (*oran- ahl' )*!o)t*ran
3. P$ .ol*h !'la)u)an a"a.'la ha('l ,an- !'hara")an .*r'+.an- !*n-an r'(')o
(u.,*) "*n*l't'an
1. S*t'a" "*rco.aan haru( !'"*rt'+.an-)an untun- ru-'n,a
9. P*rhat'an )hu(u( .a-' "*n*l't'/ )*"r'.a!'an oran- ,an- +u!ah !'"*n-aruh'
Bu$!# , dan - 'en!" penel!$!an $e#apeu$!(
8. P*n*l't' .*.a( +*n*ntu)an t*ra"' a(al +anfaat .a-' oran- (u.,*) "*n*l't'an a!a
"*r(*tujuan !ar' ,an- .*r(an-)utan atau 3al'n,a
BAB II 2 ETI$A PENELlTIAN I 3S
;. Do)t*r +*+an!u !an +*ra3at (u.,*) "*n*l't'an untu) +*+"*rol*h "*n-*tahuan
)*!o)t*ran !an !a"at !'"*rtan--un-ja3a.)an t*ra"*ut') .a-' "*n!*r'ta
Bufu A 202 Nont*ra"*ut')
A. Haru( a!a !o)t*r untu) "*rl'n!un-an (u.,*) "*n*l't'an
@. S'fat tujuan !an r'(')o "*n*l't'an haru( !'j*la()an )*"a!a (u.,*) "*n*l't'an
0=. a. P*n*l't'an !a"at !'la)u)an (*t*lah a!a "*r(*tujuan ol*h ,an- .*r(an-)utan atau
3al'n,a.
.. P*r(*tujuan haru( t*rtul'( !*n-an "*n-*rt'an tan--un- ja3a. !an a!a !o)t*r
"*n*l't'
00. a. P*n*l't' haru( +*n-har-a' )*.*.a(an 'n!'4'!u untu) +*l'n!un-' !'r'n,a
+'(aln,a (alah (atu (*-' )*h'!u"an (u.,*) "*n*l't'an ,an- .*r-antun- "a!a
"*n*l't' atau tahanan
.. Su.,*) "*n*l't'an (*3a)tu23a)tu .ol*h +*n-un!ur)an !'r'
02. P*nan--un- ja3a. "*n*l't'an +*n-h*nt')an "*rco.aan .'la +*ru-')an (u.,*)
"*n*l't'an
But'r 03 !an 01/ -an--uan j'3aj)*(a!aran
03. P*n*l't'an t*rha!a" "*n!*r'ta -an--uan j'3a han,a .ol*h !'la)u)an +*n,an-)ut
+a(alah )hu(u( -an--uan j'3a.
01. T'!a) .ol*h !'la)u)an "a!a "*n!*r'ta .u)an -an--uan j'3a
But'r 09 !an 08 / ana)
09. Pa! a ana) han,a .ol*h !'la)u)an +*n,an-)ut +a(alah )hu(u( ana)
08. Bu)an +*n,an-)ut +a(alah ana) t'!a) .ol*h !'la)u)an "a!a ana)
But'r 0; !an 0A/ 3an'ta ha+'l
0;. Fan'ta ha+'l han,a !'.*nar)an a"a.'la "*n*l't'an +*+.a3a +anfaat .a-' 3an'ta
!anjan'n
0A. Bu)an +*n,an-)ut +a(alah 3an'ta ha+'l t'!a) .ol*h !'la)u)an "a!a 3an'ta
ha+'l
38 I METODOLOGI PENELlTlAN BIOMEDlS
P ANITIA ETIK PENELITIAN KESEHAT AN
S*t'a" (*nt*r haru( +*+"un,a' Pan't'a Et') P*n*l't'an %PEP&. Di :a3a Barat PEP
!a"at !'jurn"a' !' Rurnah Sa)'t Ha(an Sa!')'n Ban!un-. S*(ua' )*.utuhann,a PEP ini
!a"at !')*+.an-)an +'(aln,a !' Rurnah Sa)'t I++anu*l.
T'a" !a*rah (tru)tur or-an'(a('n,a +un-)'n .*rla'nan .*r-antun- "a! a )on!'('
!an ('tua(' (*t*+"at. Rurnah Sa)'t P*n!'!')an (*,o-,an,a +*+'l')' PEP )ar*na
.an,a)n,a "*n*l't'an ,an- !'la)u)an .a') ol*h "ara +aha('(3a atau ol*h "'ha)
("on(or.
$r't*r'a An--ota Pan't'a Et') P*n*l't'an
An--ota PEP !'tunju) !an !'t*ta")an ata( !a(ar )*ahl'an )*ca)a"an !ala+
.'!an- M*to!olo-' P*n*l't'an (*rta )*ar'fan !ala+ +*l'hat "*r+a(alahan *t')
"*n*l't'an .'o+*!') !an t*"ro!u)(' +anu('a (*rta +t*-r'ta( !an )r*!'.'l'ta( !ala+
.'!an- )*"a)arann,a. A!a "un (u(unan PEP a!alah/
0. An--ota t*r!'r' !ar' l'+a (a+"a' tujuh oran-. Satu oran- )*tua +*ran-)a"
an--ota (atu oran- (*)r*tar'( +*ran-)a" an--ota
2. $o+"o('(' )*an--otaan !'u"a,a)an t*r!'r' !ar' an--ota "r'a !an 3an'ta !*n-an
Iatar .*la)an- )*ahl'an .*ra-a+/ .a') !ar' .'!an- )*!o)t*ran hu)u+ (o('al
. "(')olo-' )*(*hatan +a(,ara)at )*a-a+aan +au"un to)oh +a(,ara)at
3. :a.atan )*tua !'t*ntu)an !*n-an +u(,a3arah +ufa)at !' antara "ara an--ota
1. Dala+ +*la)(ana)an tu-a( a"a.'la !'"an!an- "*rIu PEP !a"at +*n-ha!'r)an
ahl' (*.a-a' nara (urn.*r untu) !'!*n-ar "*n!a"atn,a .*r)a'tan !*n-an
"*r+a(alahan *t') "*n*l't'an ,an- cu)u" (ul't !'"utu()an
Tu-a( !an tan--un- ja3a. PEP
0. PEP .*rtu-a( +*+.*r')an (aran "*r(*tujuan atau "*nola)an t*rha!a" rancan-an
"*n*l't'an ,an- t*lah (*l*(a' !'t*Iaah .*r!a(ar)an *t') "*n*l't'an ,an- t*lah
!'t*ntu)an
2. M*la)u)an "*n-a3a(an "*la)(anaan "*n*l't'an .'o+*!') !an r*"ro!u)(' +anu('a
,an- +*l'.at)an +anu('a (*.a-a' (u.,*) !an !a"at +*+.*r')an "*r'n-atan .'la
+*lan--ar *t')
3. In!*"*n!*nc* %(*.a')n,a (*"*rt' ini) atau +o!'f')a(' la'n
BAB II 2 ETI$A PENELITIAN I 3;
Pro(*!ur !an +*)an'(+* )*rja PEP
0. Ma(a "*r('!an-an (*!')'tn,a !ua )al' !ala+ (atu tahun atau (*(ua' !*n-an
)*.utuhan %.an,a) (*!')'tn,a ,an- +*+ohon et!ical clearance)
2. $*tua atau (*)r*tar'( !a"at +*n-un!an- "ara an--ota PEP
3. S'!an- PEP +*+*nuh' )uoru+ %t*r(*rah "a!a PEP +a('n-2+a('n-&
1. $*"utu(an ('!an- !'(*tuju' ol*h !ua "*r t'-a an--ota
P*n-a+.'lan $*"utu(an PEP
0. $*"utu(an t*rha!a" ha('l t*laah rancan-an "*n*l't'an !'a+.'l (*cara o.,*)t'f
!*n-an +*n--una)an "*ran-)at c!ec* list
2. P*n-a+.'lan )*"utu(an +*lalu' ('!an- PEP ,an- haru( !'ha!'r' ol*h (*)uran-
)uran-n,a (*t*n-ah ju+lah an--otan,a
3. B'la )*tua .*rhalan-an +a)a ,an- +*+'+"'n ('!an !'tunju) an--ota ,an- "al'n-
(*n'or
1. B'la )*"utu(an .*lu+ f'nal %"*rlu "*r.a')an atau .*lu+ !'.aha(& +a)a (*)r*tar'(
+*n'n!a)lanjut' (*(ua' !*n-an (aran ,an- !'.*r')an PEP
9. B'la t*rja!' "*r.*!aan "*n'la'an ,an- taja+ +a)a PEP !a"at +*n-ha!'r)an nara
(u+.*r ,an- ahli !' .'!an-n,a
8. $*"utu(an ha('l "*n*laahan PEP !a"at .*ru"a/
1. D'(*tuju'
2. D'tola)
3. P*rlu !'"*r.a')'
1. B*lu+ !a"at !'.aha(
S*t*lah "*n-a+.'lan )*"utu(an PEP .*rfun-(' untu) +*+.uat et!ical clearance,
!an (*(ua' !*n-an tata ra" at )*rja PEP (*-*ra +*+.*r'tahu "*n*l't' 5 'n(t'tu(' (*cara
t*rtul'( +*n-*na'/
B $*"utu(an 5 "*n!a"at .*r)a'tan !*n-an uj' klinik
B Ala(an !ar' )*"utu(an 5 "*n!a"at
B Pro(*!ur untu) na') .an!'n- t*rha!a" )*"utu(an 5 "*n!a"at
3A I METODOLOGI PENHITlAN BIOMEDIS
R*)a+an
B M*n,'+"an (*+ua r*)a+an ,an- r*I*4an
$*"utu(an ra"at
B M*n,'+"an (*la+a 3 tahun !an +*+.*r' 5 +*n,*!'a)an 'nfor+a(' .'la !'+'nta
BENTUK PENELITIAN
B*ntu) "*n*l't'an !a"at .*ru"a (tu!' non )l'n') !an (tu!' )l'n').
Stu!' non )l'n') .*ru"a (tu!' far+a)olo-') to)(')olo-') far+a)o)'n*t') !an
+*ta.ol'(+* "ro!u) !ala+ .*ntu) r'n-)a(an. La"orann,a !a"at .*ru"a r'n-)a(an
,an- +*n,*.ut)an +*to!olo-' ha('l *f*) t*ra"' !an *f*) ,an- +*ru-')an ,an-
+un-)'n t'+.ul "a!a +anu('a.
A!a "un "*n*l't'an ,an- l*.'h lua( !a"at .*ru"a/
0. P*n*l't'an *"'!*+'olo-')
P*n*l't'an +*n-u+"ul)an .ahan2.ahan 'nfor+a(' !ar' oran-2oran- tan"a +*r*)a
')ut (*rta !ala+ "*n*l't'an atau "*+*r')(aan t*rt*ntu +'(aln,a "*n*l't'an t*ntan-
)or*la(' antara +*ro)o) !an )an)*r "aru. Ma(alah ,an- (*r'n- +uncul a!alah
+a(alah pri-acy, hal ini !a"at !'ata(' !*n-an/
a. "ara "*n*l't' !an "*+.antun,a !'(*l*)(' (*cara .a') haru( !'j*la()an
"*nt'n-n,a +*n,'+"an raha('a
.. "ara "*n*l't' !an "*+.antun,a +*nan!atan-an' (uatu "*+,ataan .ah3a
(*-ala 'nfor+a(' ,an- !'!a"at a!alah raha('a
c. (*t*lah (*l*(a' "*n*l't'an (*+ua for+ul'r ,an- ta) t*r"a)a' !'+u(nah)an
!an +*n,*.ut)an cara "*n,'+"anan 'nfor+a(' t*r(*.ut
2. P*n*l't'an )l'n') (clinical trial)
3. P*n*l't'an non t*ra"*ut') .'o+*!') (non clinical biomedical researc!)
U.! "a! a He/an C0)a
P*n*l't'an ,an- +*n--una)an h*3an co.a haru( +*ncantu+)an ("*('*(
h*3an ,an- !'t*l't' j*n'( !an ju+lah h*3an co.a !ala+ (atu )*lo+"o) !an ju+lah
)*lo+"o)n,a. Do('( ,an- !'-una)an haru( "ula !'cantu+)an 'nt*r4al !o('( cara
BAB II 2 ETI$A PENELITIAN I 3@
"*+.*r'an la+a "*+.*r'an 'nfor+a(' !'(tr'.u(' ('(t*+') !an la+a t'n!a) lanjut "a(ca
"*+.*r'an haru( !'ja.ar)an !*n-an j*la(.
O.at ,an- !'-una)an haru( !'j*la()an !ar' .*r.a-a' a("*) (*"*rt' ('fat2('fatn,a
*f*) far+a)olo-')n,a ,an- +*l'"ut' *f*) +ula )*rja la+a )*rja !an hu.un-an antara
!o('( !an r*("on !an to)('('ta(n,a .a') ,an- r*4*r('.*l atau ,an- t'!a) r*4*r('.*l.
Uj' (l!n!( pada Manu"!a
S*.*lu+ uj' klinik "a!a +anu('a "*n*l't'an "a!a h*3an co.a haru( !'la)u)an
t*rl*.'h !ahulu. P*n*l't'an 'n' +*l'"ut' uj' far+a)o!'na+') far+a)o)'n*t') !an uj'
to)('('ta( ,an- !')*nal ju-a (*.a-a' uj' )*a+anan !an *f')a('. O.at2o.at ,an- (u!ah
!'"ro!u)(' +a('h haru( !'uj' klinik ,a'tu !*n-an uj' klinik fa(* I7 (post mar*etin)
sur-eillance)
P*la)(anaan uj' )l'n') +*+*rlu)an !o)u+*n *(*n('al ,a'tu !o)u+*n ,an-
(*cara t*r(*n!'r' +au"un )*(*luruhan +*+un-)'n)an untu) "ro(*( *4alua(' t*rha!a"
"*la)(anaan uj' )l'n') t*r(*.ut ,an- +*n'la' +utu !ar' !ata ,an- !'ha('l)an.
Do)u+*n t*r(*.ut .*r-una untu) +*nunju))an )*"atuhan "*n*l't' !an
("on(or !ala+ +*n-')ut' (tan!ar >ara Uj' $l'n') ,an- Ba') %>U$B&-una +*+.antu
)*.*rha('lan +anaj*+*n untu) "*n*l't'.("on(or !an oran- ,an- .*rtan--un- ja3a.
untu) +*+on'tor "*n*l't'an t*r(*.ut.
Do)u+*n *(*n('al t*r(*.ut !a"at !')*lo+"o)an +*nja!' t'-a )*lo+"o) ,a'tu/
0. S*.*lu+ uj' klinik !'+ula'
2. S*la+a uj' klinik
3. S*t*lah uj' klinik
$*t*ran-an P*r(*tujuan Etik ( 't!ical appro-al)
>ontoh/
$o+'(' *t') #a)ulta( $*!o)t*ran .... !ala+ u"a,a +*l'n!un-' ha) !an )*(*jaht*raan
(u.,*) "*n*l't'an )*!o)t*ran t*lah +*n-)aj' !*n-an t*l't' "roto)ol .*rju!ul/ .
40 I METODOLOGI PENEUTlAN BrOMEDlS
(!e et!ics committee of t!e faculty of medicine ..... +it! re)ards of t!e protection
of !uman ri)!ts and +elfare in medical researc! !as carefully re-ie+ed t!e proposal
entitled.
/ Version/ 4*r('
B Na+a P*n*l't' Uta+a
$ame of t!e principle in-esti)ator
B Na+a 'n(t'tu('5 $ame of institution
B !an t*lah +*n,*tuju' "roto)ol t*r(*.ut !' ata(
and appro-ed t!e abo-ed mentioned proposal
Ban!un-
$*tua
Infonned consent.
0. P*nj*la(an !'.*r')an )*"a!a calon (u.,*) "*n*l't'an
2. #or+ul'r +*+.u.uh)an tan!a tan-an.
A! 0. Ba-'an 'n' t*r!'r' !ar' !ua .a-'an.
a. El*+*n !a(ar (basicelement)
2 )*-'atan (uatu "*n*l't'an
2 tujuan !an +*n-a"a calon (u.,*) !'+'nta untu) ')ut
2 "ro(*!ur "*n*l't'an
2 r'(')o "ot*n('al !an ra(a ta) *na)
2 +anfaat lan-(un- .a-' (u.,*) %h'la a!a&
2 "ro(*!ur alt*+at'f
)*raha('aan !ata
2 )o+"*n(a(' .'la t*rja!' )*c*la)aan
2 "art'('"a(' (u)ar*la
2 na+a !an ala+at "*n*l't' ,an- haru( !'hu.un-' .'la (u.,*) .*rtan,a.
.. El*+*n ta+.ahan % additional element)
2 "*r)'raan ju+lah (u.,*) ,an- a)an !'')ut(*rta)an
BABll2 ETI$APENELITlAN I 10
2 )*+un-)'nan a)an t'+.ul r'(')o ,an- .*lu+ !')*tahu'.
2 (u.,*) !a"at !')*luar)an !ar' "*n*l't'an
2 .aha,a "ot*n('al .a-' (u.,*)
2 +*n-un!ur)an !'r' (*.*lu+ "*n*l't'an
2 t'+.ul .'a,a a(uran('
2 'n(*nt'f .a-' (u.,*) %h'la a!a&.
Ad 12 F0#mul!# $anda $an*an
>atatan/

P*nj*l*(an informed consent haru( !'(u(un !*n-an )al'+at !an )ata2)ata

,an- +u!ah !'+*n-*rt'.
B Tan!a tan-an (u.,*)5 "a('*n
t-l/ .
%Na+a j*la(&
B Tan!a tan-an (a)('
%Na+a j*la(&.
P*n-*rt'an '(t'lah/
CVKB H >ara Uj' $l'n') Ian- Ba').
B Do)u+*n Uj' $I'n')/ Suatu !o)u+*n l*n-)a" "*r+ohonan uj' )l'n') "!
u+u+n,a t*r!'r' !ar'/ "roto)ol uj' )l'n') .ro(ur "*n*l't'an "*r(*tujuan
(*t*lah "*nj*la(an (informed consent), "*r(*tujuan )orn'(' 'lrn'ah "*r(*tujuan
)orn'(' *t').
B $orn'(' Et')/ .a! an 'n!*"*n!*n %(uatu !*3an "*n'la' atau )o+'('
'n(t'tu('onal r*-'onal na('onal atau (u"rana('onal ,an- t*r!'r' !ar'
"rof*('onal +*!') 5 'lrn'ah !an an--ota non +*!') 5 'lrn'ah.
B I(t'lah2'(t'lah la'n/ )*ja!'an ,an- ta) !''n-'n)an $orn'(' 'lrn'ah Or-an'(a('
r'(*t )ontra) >OPB P*n*l't' Uj' $I'n') "ra2"*+a(aran Uj' )I'n') t*r.ata(
untu) "*n!'!')an !an la'n2la'n.
12 I METODOLOGI PENELlTlAN BIOMEDIS
$EPUSTA$AAN/
$o+'(' Na('onal Et') P*n*l't'an $*(*hatan D*")*( RI. 2==1. P*!o+an Na('onal
Et') P*n*l't'an $*(*hatan. :a)arta.
Pu(at (tu!' B'o+*!'( !an R*"ro!u)(' Manu('a B$$BN. 0@@@. Pan!uan Et')
P*n*l't'an B'o+*!'( !an R*"ro!u)(' Manu('a. :a)arta.
Sa+'l R.S. 2==0. Et')a $*!o)t*ran In!on*('a. Ia,a(an B'na Pu(ta)a Sar3ono
Pra3'rohar!jo. :a)arta. hal. 00;203A.
S*t'a.u!, !an Sa+(u!'n.U. 0@A9.$o!* Et') P*n*l't'an $*!o)t*ran. Na()ah L*n-)a"
#oru+ D'()u('. #a)ulta( $*!o)t*ran Un'4*r('ta( In!on*('a. :a)arta.