i Panduan Komisi Etik Penelitian Fakultas Kedokteran Universitas Kristen Maranatha - Rumah Sakit Immanuel FAKULTAS KEDOKTERAN UK MARANATHA - R.S. IMMANUEL BANDUNG KOMISI ETIK PENELITIAN Sekretariat: Jl. Soeria Soemantri No. 65 Telp. 2012186 Bandung 40164
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i
Panduan Komisi Etik Penelitian
Fakultas Kedokteran Universitas Kristen Maranatha - Rumah Sakit Immanuel
FAKULTAS KEDOKTERAN UK MARANATHA - R.S. IMMANUEL BANDUNG
KOMISI ETIK PENELITIAN
Sekretariat: Jl. Soeria Soemantri No. 65 Telp. 2012186 Bandung 40164
J l . P r o f . d r g . S u r y a S u m a n t r i N o . 6 5 B a n d u n g 4 0 1 6 4 , J a w a B a r a t - I n d o n e s i a P h o n e : + 6 2 2 2 2 0 1 2 1 8 6 I E x t . 1 1 0 5 / 1 1 0 6 / 1 1 0 7 F a x : + 6 2 2 2 2 0 1 7 6 2 1 E m a i l : f k @ m e d . m a r a n a t h a . e d u W e b s i t e : w w w . m a r a n a t h a . e d u
F A K U L T A S K E D O K T E R A N
SURAT KEPIJTUSAN D E K A N FAKULTAS K E D O K T E R A N
No. 404/IV/S.Kep./FK-UKM/2015 tentang
PENGANGKATAN PENGURUS KOMISI E T I K PENELITIAN F A K U L T A S K E D O K T E R A N UNIVERSITAS K R I S T E N MARANATHA -
RUM A H SAKIT IMMANUEL (KEP-FKUKM-RSI) PERI ODE 2015-2017
Fakultas Kedokteran Universitas Kristen Maranatha
: 1 . B a h w a p e r l u d i l a k u k a n n y a u p a y a p e n g e m b a n g a n p e n e l i t i a n d i b i d a n g k e d o k teran. , t e r u t a m a u j i k l i n i s ;
2 . B a h w a k e b u t u h a n m a s y a r a k a t u n t u k p e l a y a n a n k e s e h a t a n s e m a k i n b e r k e m -b a n g , s e m e n t a r a da t a i l m i a h m e n g e n a i p e n e l i t i a n d i r a s a k a n m a s i h k u r a n g ;
3 . B a h w a p o t e n s i s u m b e r d a y a a l a m I n d o n e s i a d a n s u m b e r d a y a m a n u s i a y a n g b e l u m b a n y a k d i e k s p l o r a s i d a n d i k e m b a n g k a n g u n a k e p e n t i n g a n m a s y a r a k a t b a n y a k , d a l a m h a l m i u n t u k m e n i n g k a t k a n p e l a y a n a n k e s e h a t a n ;
4 . B a h w a p e n e l i t i a n b i d a n g k e d o k t e r a n , t e r u t a m a y a n g m e l i b a t k a n m a n u s i a s ebaga i s u b y e k p e n e l i t i a n m e m e r l u k a n p e r t i m b a n g a n e t i k sesua i d e n g a n D e k J a r a s i Helsinki, yang mengharuskan protokol penelitian pada manusia di-t i n j a u t e r l e b i h d a h u l u o l e h p a n i t i a u n t u k d i l a k u k a n p e r t i m b a n g a n , t u n t u n a n , d a n d i b e r i k o m e n t a r . D e k l a r a s i i n i j u g a m e n g h a r u s k a n p e n e l i t i u n t u k m e n -c a n t u m k a n p e r t i m b a n g a n e t i k (ethical clearance)
5. B a h w a p e n e l i t i a n b e l u m dapat d i p u b l i k a s i k a n s e b e l u m ada ethical clearance
: P e n e l i t i a n dosen dan m a h a s i s w a m e n g e n a i b i d a n g k e d o k t e r a n t e r m a s u k p e n e l i t i a n y a n g m e l i b a t k a n m a n u s i a sebagai S u b y e k P e n e l i t i a n c u k u p d o m i n a n
: S u r a t K e p u t u s a n R e k t o r U n i v e r s i t a s K r i s t e n M a r a n a t h a N o m o r 1 1 6 / S K / U K M / X / 2 0 1 4 t e n t a n g p e n g a n g k a t a n K o o r d i n a t o r U n i t - u n i t F u n g s i o n a l F a k u l t a s K e d o k t e r a n U n i v e r s i t a s K r i s t e n M a r a n a t h a P e r i o d e 2 0 1 4 - 2 0 1 5
M E M U T U S K A N
PENGANGKATAN PENGURUS KOMISI E T I K PENELITIAN F A K U L T A S K E D O K T E R A N UNIVERSITAS K R I S T E N MARANATHA -
RUMAH SAKIT IMMANUEL (KEP-FKUKM-RSI) PERIODE 2015 - 2017
M e n e t a p k a n : K e s a t u : M e m b e r h e n t i k a n d e n g a n h o r m a t P e n g u r u s K o m i s i E t i k P e n e l i t i a n F a k u l t a s K e d o k
t e r a n U n i v e r s i t a s K r i s t e n M a r a n a t h a - R u m a h S a k i t I m m a n u e l ( K E P - F K U K M - R S I ) P e r i o d e 2 0 1 3 - 2 0 1 5 , d i s e r t a i u c a p a n t e r i m a k a s i h d a n p e n g h a r g a a n y a n g sebesar-besar-n y a atas s u m b a n g a n w a k t u , t enaga d a n p i k i r a n u n t u k k e m a j u a n K E P - F K U K M - R S I ;
M e n g a n g k a t Pengurus.. . .12,
^ 3 C v s U N I V E R S I T A S I 3g 1/ K R I S T E N ^ 2 ^ 7 MARANATHA
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MARANATHA
J l . P r o f . d r g . S u r y a S u m a n t r i N o . 6 5 8 a n d u n g 4 0 1 6 4 . J a w a B a r a t - I n d o n e s i a P h o n e : + 6 2 2 2 2 0 1 2 1 8 6 I E x t . 1 1 0 5 / 1 1 0 6 / 1 1 0 7 F a x : + 6 2 2 2 2 0 1 7 6 2 1 E m a i l : f k @ m e d . m a r a n a t h a . e d u W e b s i t e : w w w . m a r a n a t h a . e d u
l a n j u t a n . . . K e d u a
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F A K U L T A S K E D O K T E R A N
: M e n g a n g k a t P e n g u r u s K E P - F K U K M - R S I y a n g b e r a n g g o t a k a n s t a f d o s e n , t o k o b m a s y a r a k a t , d a n d o k t e r y a n g n a m a n y a t e r c a n t u m d a l a m l a m p i r a n sura t k e p u t u s a n i n i sebaga i P e n g u r u s K E P - F K U K M - R S I P e r i o d e 2 0 1 5 - 2 0 1 7 ;
: T u g a s K E P - F K U K M - R S I a d a l a h m e l a k s a n a k a n p e n g k a j i a n secara e t i k p e n e l i t i a n b i d a n g k e d o k t e r a n t e r u t a m a p e n e l i t i a n d e n g a n S u b y e k P e n e l i t i a n m a n u s i a ;
: Kepada Pengurus KEP-FKUKM-RSI diberikan insentif sesuai peraturan yang berlaku;
: M a s a b e r l a k u n y a p e n u g a s a n s e b a g a i m a n a d i m a k s u d d a l a m b u t i r p e r t a m a a d a l a h se-l a m a 2 ( d u a ) t a h u n t e r h i t u n g m u l a i t a n g g a l 1 A p r i l 2 0 1 5 s a m p a i d e n g a n t a n g g a l 3 1 M a r e t 2 0 1 7 ;
: K e p u t u s a n i n i b e r l a k u se jak t a n g g a l d i t e t a p k a n , dengan k e t e n m a n a p a b i l a d i k e m u d i a n h a r i t e r n y a t a t e rdapa t k e k e l i r u a n d a l a m k e p u t u s a n i n i , a k a n d i a d a k a n p e r b a i k a n sebag a i m a n a m e s t i n y a .
D i t e t a p k a n d i : B a n d u n g T a n g g a l : 1 A p r i l 2 0 1 5
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FAKULTAS K E D O K T E R A N
T E M B U S A N : 1 . R e k t o r U K M ( u n t u k d i k e t a h u i ) 2 . D i r e k t u r R S I m m a n u e l ( u n t u k d i k e t a h u i ) 3 . Y a n g b e r s a n g k u t a n ( u n m k d i l a k s a n a k a n ) 4 . P e r t i n g g a l
U N I V E R S I T A S K R I S T E N MARANATHA
F A K U L T A S K E D O K T E R A N
J l . P r o f . d r g . S u r y a S u m a n t r i N o . 6 5 B a n d u n g 4 0 1 6 4 . J a w a B a r a t - I n d o n e s i a P h o n e : + 6 2 2 2 2 0 1 2 1 8 6 I E x t . 1 1 0 5 / 1 1 0 6 / 1 1 0 7 F a x : + 6 2 2 2 2 0 1 7 6 2 1 E m a i l : f k @ m e d . m a r a n a t h a . e d u W e b s i t e : w w w . m a r a n a t h a . e d u
L a m n i r a n S u r a t K e n u t u s a n D e k a n F a k u l t a s K e d o k t e r a n U n i v e r s i t a s K r i s t e n M a r a n a t h a
N o m o r T a n g g a l P e n Hc i l
4 0 4 / T V / S . K e p . / F K - U K M / 2 0 1 5 . 1 A p r i l 2 0 1 5 P e n g a n g k a t a n P e n g u r u s K o r n i s i E t i k P e n e l i t i a n F a k u l t a s K e d o k t e r a n U n i v e r s i t a s K r i s t e n K r i s t e n M a r a n a t h a - R u m a h S a k i t I m m a n u e l ( K E P - F K U K M - R S I ) P e r i o d e 2 0 1 5 - 2 0 1 7
N a m a P e n g u r j s K E P P a n g k a t / G o l o n g a n
lonoton xf ciL/ciixtii
A k a d e m i k K e t e r a n g a n
1 D e k a n F K - U K M P e m b i n a / I V a L e k t o r P e l i n d u n g 2 D i r e k t u r U t a m a R S I - - P e l i n d u n g 3 D r . dr . D i a n a K . Jasapu t ra , M . K e s . P e m b i n a /IV a L e k t o r K e t u a 4 D r . W a h y u W i d o w a t i , M . S i . P e n a t a T k . I /
I I I d L e k t o r S e k r e t a r i s
5 P d t . E m . Y a h y a P u r w a n t o , S . T h . - - A n g g o t a 6 P d t . D r s . A g u s t r i a E m p i , S . T h . , M . M i n . P e n a t a M u d a
T k . I / I I I b - A n g g o t a
7 dr . E d w i n S e t i a b u d i , S p P D . , K . K V . P e n a t a T k . I / I I I d
- A n g g o t a
8 P r o f . D r . d r . S u s y T j a h j a r i i , M . K e s . P e m b i n a U t a m a M a d y a / r V d
G u r u B e s a r A n g g o t a
9 dr . L i s a w a t y W i d h o n g j u d a n a , M H . K e s . - - A n g g o t a 10 dr . B u d i W i d y a r t o L a n a , M . H . P e n a t a T k . I /
I I I d L e k t o r A n g g o t a
11 D r . dr . H a n a R a t o a w a t i , M . K e s . , P A ( K ) P e m b i n a T k . I / r v b
A s i s t e n A h l i A n g g o t a
12 dr . K h i e K h i o n g , S . S i . , M . S i . , M . P h a r m . S c , P h . D . , P A ( K )
P e m b i n a / I V a
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13 dr . R i m o n t a F . G u n a n e g a r a , S p O G . , M . P d . K e d .
P e n a t a / I I I c - A n g g o t a
1 4 D e n i F i r m a n s y a h , S . S i . I l i a
- 1 ? ^ a ^ G e r V a l
T u g a s P e n g u r u s K E P - F K U K M - R S f :
M e l a k s a n a k a n p e n g k a j i a n secara e t i k p e n e l i t i a n b i d a n g k e d o k t e r a n t e r u t a m a p e n e l i t i a n d e n g a n s u b y e k p e n e l i t i a n m a n u s i a
v
PRAKATA
Puji syukur kepada Tuhan Yang Maha Esa, atas tersusunnya buku panduan Komisi
Etik Penelitian Fakultas Kedokteran Universitas Kristen Maranatha-Rumah Sakit Immanuel
(KEP FK UKM-RSI). Buku panduan KEP FK UKM-RSI ini dapat tersusun tidak lain
karena adanya kerja sama yang baik antara anggota KEP FK UKM-RSI yang berasal dari
berbagai multi disiplin, yang diwakili oleh unsur Fakultas Kedokteran, Rumah Sakit
Immanuel, Pakar Hukum dan Tokoh Agama.
Keberadaan Komisi Etik Penelitian FK UKM-RSI dirasakan sangat dibutuhkan
mengingat banyaknya penelitian yang membutuhkan ethical clearance.
Penyusun juga ingin berterima kasih kepada Pimpinan FK UKM dorongannya
sehingga buku ini dapat tersusun dengan baik.
Akhir kata, penulis mohon kritik dan saran para pembaca guna perbaikan buku ini
di masa yang akan datang.
PENYUSUN
vi
DAFTAR ISI
SK Pembentukan dan Pengangkatan Pengurus KEP FK UKM-RSI …………. ii
PRAKATA ……………………………………………………………………. v
DAFTAR ISI ....................................................................................................... vi
BAB I. PENDAHULUAN ……………………………………………………. 1
BAB II. PERAN / TANGGUNG JAWAB, FUNGSI DAN TUGAS ………… 4
BAB III. LANDASAN, PRINSIP, SYARAT PENELITIAN ………………… 10
BAB IV. PROSEDUR TATA KERJA KOMISI ETIK PENELITIAN ………. 30
DAFTAR PUSTAKA …………………………………………………………. 33
Lampiran 1. Assessment Form for research using human subjects
1 Estimated time to complete research on any / all over the subject Perkiraan waktu untuk menyelesaikan penelitian terhadap setiap/seluruh subjek
2 Summary of proposed research includes the objective / purpose of research benefits /
relevans of research results and the reasons / motivation of doing research and the risks that may
arise with how to solve it (written in a language that is easily understood by non-physicians)
Ringkasan usulan penelitian mencakup objektif/tujuan penelitian manfaat/relevans dari
hasil penelitian disertai alasan/motivasi dilakukannya penelitian dan risiko yang mungkin timbul
disertai cara mengatasinya (ditulis dalam bahasa yang mudah dipahami oleh orang yang bukan
dokter)
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 2 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
3
Need for Human Participants Kebutuhan menyertakan subjek manusia
4 Methodology The procedures for the conduct of research or experimentation (frequency, interval and the
total number of invasive actions to be performed, the dose and mode of administration of
drugs, isotopes, radiation or other action):
Explain how the recording during the study, including side effects and complications, if any!
Is a blood specimen / tissue sent overseas?
Metodologi • Prosedur pelaksanaan penelitian atau eksperimen (frekuensi, interval dan jumlah total segala
tindakan invasif yang akan dilakukan, dosis dan cara pemberian obat, isotop, radiasi atau
tindakan lain):
• Jelaskan cara pencatatan selama penelitian, termasuk efek samping dan komplikasi bila ada!
• Apakah spesimen darah/ jaringan dikirim ke luar negeri?
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 3 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
5 Background Information and Data (investigator brochure, animal studies and similar studies that have been done) have been
studied and the data to support the formulation of the problem.
Kelengkapan data dan informasi (brosur investigator, penelitian pada hewan coba dan penelitian sejenis yang pernah dilakukan)
Penelitian yang pernah dilakukan dan data sebagai penunjang perumusan masalah.
6 Risks and Benefits Assessment (benefits both for science or for the subject; research commensurate with the risk / discomfort
should be borne subject)
Contribution to the other research in the area of R & D capabilities and health care
Benefits to local community
Conduct Problems (state your opinion about the ethical issues that may be encountered)
Potential hazards which, directly or indirectly, immediately or later and ways to prevent or
overcome (including pain and other complaints)
Previous experience (their own or others) of the action to be performed:
If the study is to use the sick, what are the reasons and describe the benefits to the subject!
Penilaian rasio risiko - manfaat (manfaat baik bagi ilmu pengetahuan atau bagi subjek; penelitian ini sepadan dengan risiko /
rasa tidak nyaman yang harus ditanggung subjek)
Sumbangan peneltian terhadap kemampuan daerah dalam litbang dan pelayanan kesehatan
Manfaat untuk masyarakat setempat
Masalah etik (nyatakan pendapat anda tentang masalah etik yang mungkin akan dihadapi)
Bahaya potensial yang langsung atau tidak langsung, segera atau kemudian dan cara-cara
untuk mencegah atau mengatasinya (termasuk rasa nyeri dan keluhan lain)
Pengalaman yang terdahulu (sendiri atau orang lain) dari tindakan yang akan dilakukan:
Jika penelitian ini menggunakan orang sakit, apa alasannya dan uraikan manfaatnya bagi
subjek yang bersangkutan!
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 4 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
7 Inclusion Criteria Kriteria Inklusi
8 Exclusion Criteria Kriteria Eksklusi
9 Procedures involving the subject (inclusion and exclusion criteria, to include vulnerable groups, the adequacy of the number of
subject, explain about sample size)
How to select patients or healthy volunteers?
If this research using human subjects, indicate a personal relationship between the principal
investigator with the subject under study: doctor-patient / student-teacher / employer-men /
Other .........................
If the study is to use the sick, explain the diagnosis and name of the doctor in charge to take
care!
If use traditional healthy people, explain how the medical examination!
Prosedur mengikutsertakan subjek (kriteria inklusi dan eksklusi, mengikutsertakan kelompok rentan, kecukupan jumlah subjek,
jelaskan mengenai besar sampel)
Bagaimana cara memilih penderita atau sukarelawan sehat?
Jika penelitian ini menggunakan subjek manusia, sebutkan hubungan pribadi antara peneliti
utama dengan subjek yang diteliti: dokter-penderita / guru-murid / majikan-anak buah /
lainnya …...................... Jika penelitian ini menggunakan orang sakit, jelaskan diagnosis dan nama dokter yang
bertanggung jawab merawatnya!
Jika mengggunakan orang sehat, jelaskan cara pemeriksaan kesehatannya!
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 5 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
10 The process of getting inform consent When this research using human subjects, explain how to tell and invite the subject (patient
consent letter sample attachments and details of the information to be provided to research
subjects)! If the notice is oral and the willingness of the subject, or if for some reason the patient
can not or should not be approved, give a good reason for it!
Proses mendapatkan persetujuan (kelayakan cara mendapatkan persetujuan subjek)
Bila penelitian ini menggunakan subjek manusia, jelaskan bagaimana cara memberitahu dan
mengajak subjek (lampiran contoh surat persetujuan penderita dan rincian informasi yang akan
diberikan kepada subjek penelitian)! Bila pemberitahuan dan kesediaan subjek bersifat lisan,
atau bila karena suatu hal penderita tidak dapat atau tidak perlu dimintakan persetujuan, berilah
alasan yang kuat untuk itu!
When this research using human subjects, whether using the subject
vulnerable (children, people with mental illness, etc.) Yes / No
Bila penelitian ini menggunakan subjek manusia, apakah menggunakan subjek rentan (anak-
anak, penderita penyakit jiwa, dll)? Ya / Tidak
When this research using human subjects, whether the subjects
participated voluntarily, Non-Coercive, not threatened Yes / No
Explain withdrawal criteria!
Is there contact persons for participants?
Bila penelitian ini menggunakan subjek manusia, apakah subyek ikut secara sukarela, tanpa
paksaan, tidak diancam? Ya / Tidak
Jelaskan kriteria pengunduran diri!
Apakah ada kontak person bagi peserta?
When this research using human subjects, whether the cost reduction side
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 6 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
effects are the responsibility of this research? Yes / No
When this research using human subjects, whether the subject is insured!
Yes / No
Bila penelitian ini menggunakan subjek manusia, apakah biaya penanggulangan efek samping
menjadi tanggung jawab penelitian ini? Ya / Tidak
Bila penelitian ini menggunakan subjek manusia, apakah subjek diasuransikan! Ya / Tidak
Explain the control group (placebo) if any Jelaskan mengenai kelompok pembanding (plasebo) jika ada.
11 Study termination procedure Potential hazards directly or indirectly, immediately or later and ways to prevent or overcome
(including pain and other complaints)
Prosedur penghentian studi Bahaya potensial yang langsung atau tidak langsung, segera atau kemudian dan cara-cara untuk
mencegah atau mengatasinya (termasuk rasa nyeri dan keluhan lain)
Disclosure or Declaration of Potential Conflicts of Interest Penjelasan tidak ada potensi perbedaan kepentingan (conflict of interest)
Facilities and infrastructure of Participating Sites Penjelasan mengenai fasilitas yang ada di daerah penelitian
Public health research Is there Community Consultation?
Is there Involvement of Local Researchers and Institution in the Protocol Design, Analysis and
Publication of Results?
Is there any Contribution to Development of Local Capacity for Research and Treatment?
Is there any Benefit to Local Communities?
website:
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ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 7 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
Is there a community assessment to be studied?
Penelitian ilmu kesehatan masyarakat Apakah ada konsultasi pada masyarakat?
Apakah ada keterlibatan peneliti lokal dan lembaga dalam protokol desain, analisis dan publikasi
hasil?
Apakah ada sumbangan pengembangan kapasitas lokal untuk riset dan perawatan?
Apakah ada manfaat untuk masyarakat lokal?
Apakah ada penjajakan masyarakat yang akan diteliti?
Availability of similar Study / Results Adanya penelitian serupa dan hasilnya
12 Name, address the research team and sponsors! Nama, alamat tim peneliti dan sponsor!
Name Nama
Address Alamat
Phone / Fax Telp./Fax.
Principal
Investigators
Peneliti
Utama:
Head of
departement Ka. Bagian
Sponsor
Promotor
Co-Promotor
Pembimbing/
Pembimbing
pendamping
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 8 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
Co-
Investigator
Peneliti lain
13 Allocation of research funds and details Alokasi dan rincian dana penelitian:
14 Place of study:
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 9 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
(Indicate the name of the hospital, treatment rooms, poly clinic or other
health facility) Tempat Penelitian:
(Sebutkan nama rumah sakit, ruang perawatan, poli klinik atau tempat pelayanan kesehatan
lainnya)
15. The following data is filled when the research involves clinical trials of drug
Data berikut diisi bila penelitian ini menyangkut uji klinik obat:
Drugs are tested
Obat yang diuji
Companion /
Standard Drug
Obat pendamping
a Generic name Nama generik:
b Trade name Nama dagang:
c Chemical name Nama kimia:
d Pharmacological class Kelas farmakologi:
e drug form and strength of drug Bentuk sediaan dan kekuatan obat:
f Packaging Kemasan:
g Drug administration Cara pemberian:
h Expiration Date Tanggal Kadaluarsa:
i Batch number Nomor Batch:
j Certificate analysis Sertifikat analisa:
k Certificate Good Manufacturing
Practice Sertifikat CPOB:
l The type and amount of drugs to be
imported
Jenis dan jumlah obat yang akan
diimpor:
m Name and address of manufacturer
Nama dan alamat produsen:
n Name and address of the importer
Nama dan alamat importir:
o Drug status in other countries Status peredaran obat uji di negara lain:
p Phase clinical trials Fase uji klinik: Phase I Phase II Phase III Phase IV
(beri tanda silang)
16 research schedule jadwal penelitian:
Start Completed
website:
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edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 10 of 10
Title:
Assessment Form
File Name: Assessment Form for research using human subjects Ethic Committee Faculty of Medicine,
MCU-Immanuel Hospital
Mulai ………………………………………… Selesai …………………………………….
Bandung, ………………………………
Head of departement / Kepala. Bagian
Principal Investigator / Peneliti Utama,
Signature signature
website:
fk.maranatha.
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ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective date:
Januari 2014
Page 1 of 3
Titel:
Information for subjects
File Name: Information for subjects Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
ANNEX 2
INFORMATION FOR SUBJECTS
INFORMASI UNTUK SUBJEK PENELITIAN
Titel/Judul
Objective/Tujuan
Benefits of research / Manfaat penelitian
Procedures The treatment of research subjects
Long treatment of the subject
Tata Cara/Prosedur
Perlakuan yang diterima subjek penelitian
Lama perlakuan terhadap subjek (keikutsertaaan)
Why you selected Characteristics of study subjects
The number of study subjects needed
Benefits to research subjects
The right to resign at any time without any penalties
Mengapa anda terpilih Karakteristik subjek penelitian
Jumlah subjek penelitian yang diperlukan
Manfaat bagi subjek penelitian
Hak mengundurkan diri sewaktu-waktu tanpa ada sanksi
Risk and discomfort: Possible health risks to the research subjects
Risiko dan ketidaknyamanan: Kemungkinan risiko penelitian terhadap kesehatan subjek
Confidentiality of data:
Kerahasiaan data:
website:
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ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective date:
Januari 2014
Page 2 of 3
Titel:
Information for subjects
File Name: Information for subjects Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
Complications and compensation Compensation given to the subject (Undue inducement-existing or not)
Explanation of medical treatment and compensation if required
Penyulit dan kompensasi Kompensasi yang diberikan kepada subjek (bujukan ada atau tidak)
Penjelasan pengobatan medis dan ganti rugi apabila diperlukan
Volunteerism: The element of compulsion (coersient) or not
Kesukarelaan: Unsur paksaan (coersient) ada atau tidak
Alternative procedures: Treatment options other than those referred to in the research (if any)
Prosedur alternatif: Pilihan pengobatan selain yang disebut dalam penelitian (bila ada)
Full name, address and no. telephone in charge of research
Nama jelas, alamat dan no. telepon penanggung jawab penelitian
Full name, address and no. telephone in charge of medical
Nama jelas, alamat dan no. telepon penanggung jawab medik
An explanation of the substance or action that will be tested (whether pre-clinical trials in animal or human clinical trials have already been conducted, data from the
security and benefits of previous studies / in another country)
Is biological samples will be shipped overseas?
Penjelasan tentang bahan atau tindakan yang akan diuji (apakah uji pre klinik pada hewan atau uji klinik pada manusia sudah pernah dilakukan, data dari keamanan
dan manfaat dari studi terdahulu / di negara lain)
Apakah sampel biologis akan dikirim ke luar negeri?
website:
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edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective date:
Januari 2014
Page 3 of 3
Titel:
Information for subjects
File Name: Information for subjects Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
Responsibilities of the post of research: (contribution of capacity building for research site, the benefits for local communities, for the benefit of
continued treatment subjects)
Tanggung jawab pasca penelitian: (kontribusi capacity building bagi tempat penelitian, manfaat bagi komunitas lokal, manfaat bagi pengobatan
lanjutan subjek)
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HORPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 1 of 4
Title:
Informed consent form
File Name: Informed consent form Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
ANNEX 3
STATEMENT OF APPROVAL
TO PARTICIPATE IN RESEARCH
(INFORMED CONSENT)
The undersigned is:
N a m e :
Age :
Address :
Work :
ID Card ( KTP/others) :
By actually states that:
after receiving information fully aware of, understand, and understanding of the purpose,
benefits and risks that may arise in the study, and may at any time resign from participation
sertaannya, then I agree to participate in the study entitled:
A statement we make with full awareness without coercion
Bandung, ....................
The states on the study
The person in charge of research, Research participants,
( ) ( )
witness
1. …………………………… ( )
2. …………………………… ( )
*) The letter informed consent of research / clinical trials
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HORPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 2 of 4
Title:
Informed consent form
File Name: Informed consent form Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
STATEMENT OF APPROVAL
TO PARTICIPATE IN RESEARCH
(INFORMED CONSENT)
The undersigned is:
N a m e :
Age :
Address :
Work :
ID Card ( KTP/others) :
By actually states that:
after receiving information fully aware of, understand, and understanding of the purpose,
benefits and risks that may arise in the study, and may at any time resign from participation
sertaannya, then I agree to participate in the study entitled:
A statement we make with full awareness without coercion
Bandung, ....................
The states on the study
The person in charge of research, parent / guardian,
( ) ( )
Study Participants Family / clinical trials,
( )
*) The letter informed consent of research / clinical trials
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HORPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 3 of 4
Title:
Informed consent form
File Name: Informed consent form Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
SURAT PERNYATAAN PERSETUJUAN
UNTUK IKUT SERTA DALAM PENELITIAN
(INFORMED CONSENT)
Yang bertanda tangan dibawah ini:
N a m a :
U s i a :
Alamat :
Pekerjaan :
No. KTP/lainnya:
Dengan sesungguhnya menyatakan bahwa:
setelah mendapat keterangan sepenuhnya menyadari, mengerti, dan memahami tentang
tujuan, manfaat dan risiko yang mungkin timbul dalam penelitian, serta sewaktu-waktu
dapat mengundurkan diri dari keikut sertaannya, maka saya setuju ikut serta dalam
penelitian yang berjudul:
Demikian surat pernyataan ini kami buat dengan sesungguhnya dan tanpa paksaan.
Bandung, ....................
Mengetahui, Yang menyatakan
Penanggung jawab penelitian, Peserta penelitian,
( ) ( )
Saksi-saksi:
1. …………………………… ( )
2. …………………………… ( )
*) Surat pernyataan persetujuan penelitian/uji klinik
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY
- IMMANUEL HORPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 4 of 4
Title:
Informed consent form
File Name: Informed consent form Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
SURAT PERNYATAAN PERSETUJUAN
UNTUK IKUT SERTA DALAM PENELITIAN
(INFORMED CONSENT)
Yang bertanda tangan dibawah ini:
N a m a :
U s i a :
Alamat :
Pekerjaan :
No. KTP/lainnya:
Dengan sesungguhnya menyatakan bahwa:
setelah mendapat keterangan sepenuhnya menyadari, mengerti, dan memahami tentang
tujuan, manfaat dan risiko yang mungkin timbul dalam penelitian, serta sewaktu-waktu
dapat mengundurkan diri dari keikut sertaannya, maka saya setuju ikut serta dalam
penelitian yang berjudul:
Demikian surat pernyataan ini kami buat dengan sesungguhnya dan tanpa paksaan.
Bandung,
Mengetahui, Yang menyatakan,
Penanggung jawab penelitian, Orangtua/wali subjek
( ) ( )
Keluarga Peserta penelitian/uji klinik,
( )
*) Surat pernyataan persetujuan penelitian/uji klinik
website:
fk.maranatha.
edu/ethic
ETHIC COMMETTEE
FACULTY OF MEDICINE
MARANATHA CHRISTIAN UNIVERSITY -
IMMANUEL HOSPITAL BANDUNG
No Reg : 033/KNEPK/2008
Effective
date: Januari 2014
Page 1 of 1
Title:
Serious Adverse Event Report Form
File Name: SAE Report Form Ethic Committee Faculty of Medicine, MCU-Immanuel Hospital
Serious Adverse Event Report
Principal Investigator:…………………………………….. Protocol No.:
Study Title:……………………………………………………….
Name of the study medicine/device………………………..…………………
Report Date :…………
initial follow-up
Onset date:……………
Sponsor:………………………………………………… Date of first use:
………………………..
Subject’s initial/number: Age: Male Female
Subject’s history:
Laboratory findings:
SAE:
Treatment:
Outcome: resolved on-going
Seriousness:
Death
Life Threatening
Hospitalization – initial prolong
Disability / Incapacity
Congenital Anomaly
Other…………………………………
Relation to Drug Device study
Not related
Possibly
Probably
Definitely related
Unknown
Changes to the protocol recommended? No Yes , attach proposal
Principal Investigator:…………………………………………………………………………..................................................................................
Study Title:…………………………………………………………………………………….................................................................................... Protocol No.:
Name of the studied medicine/device………………………..……………………………......................................................................................... This report covers the period :