PROTOKOL

Etik Penelitian Kesehatan

Yang Mengikutsertakan Manusia Sebagai Subyek

HUBUNGAN ALERGI SUSU SAPI TERHADAP KEJADIAN STUNTING

PADA ANAK USIA DI BAWAH DUA TAHUN
DI KOTA BANDA ACEH

Lokasi Penelitian : RSUD Zainoel Abidin Banda Aceh dan Praktik Dokter

Spesialis Anak Konsultan Imunologi

Waktu Penelitian direncanakan : Juni - September 2019

Peneliti Utama : Intan Chaharunia Mulya

Institusi : Universitas Syiah Kuala

Pembimbing : Dr. dr. Sulaiman Yusuf, Sp.A (K)

dr. Soraya Rezeki, MKT

PRODI PENDIDIKAN DOKTER FAKULTAS KEDOKTERAN

UNIVERSITAS SYIAH KUALA BANDA ACEH

2019
 HALAMAN PENGESAHAN

Judul : Hubungan Alergi Susu Sapi terhadap Kejadian Stunting pada

Anak Usia di Bawah Dua Tahun di Kota Banda Aceh

Peneliti Utama : Intan Chaharunia Mulya

NIM : 1607101010079

Fakultas : Kedokteran Universitas Syiah Kuala

Alamat : Darussalam, Banda Aceh

E-mail : icmulya@yahoo.com

Pembimbing : 1. Dr. dr. Sulaiman Yusuf, Sp.A(K)

2. dr. Soraya Rezeki, MKT

Lokasi Penelitian : RSUD Zainoel Abidin Banda Aceh dan Praktik Dokter

Spesialis Anak Konsultan Imunologi

Mengetahui,
Dosen Pembimbing 1 Dosen Pembimbing 2

Dr. dr. Sulaiman Yusuf, Sp.A(K) dr. Soraya Rezeki, MKT

NIP. 19630202 1992013 1002 NIP. 119850913 2010122007

Banda Aceh, 27 Mei 2019

Peneliti Utama

Intan Chaharunia Mulya

NIM. 1607101010079

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 DAFTAR ISI

LEMBAR PENGESAHAN ............................................................................................. ii

DAFTAR ISI ..................................................................................................................... iii

A. Ringkasan Usulan penelitian ................................................................................... 1

B. Isyu Etik yang mungkin dihadapi ........................................................................... 2
C. Ringkasan Tinjauan Pustaka ................................................................................... 2
D. Kondisi Lapangan ..................................................................................................... 5
E. Disain Penelitian ....................................................................................................... 6
F. Sampling .................................................................................................................... 6
G. Intervensi ................................................................................................................... 6
H. Monitor Hasil ............................................................................................................ 7
I. Penghentian Penelitian dan Alasannya ................................................................... 7
J. Adverse Event dan Komplikasi (Kegiatan yang tidak diharapkan) .................... 7
K. Penanganan Komplikasi .......................................................................................... 7
L. Manfaat ...................................................................................................................... 7
M. Jaminan Keberlanjutan Manfaat ............................................................................ 8
N. Informed Consent ...................................................................................................... 8
O. Wali ............................................................................................................................ 8
P. Rencana Analisis ....................................................................................................... 8
Q. Monitor Keamanan ................................................................................................... 8
R. Konflik Kepentingan ................................................................................................ 9
S. Manfaat Sosial ........................................................................................................... 9
T. Hak Atas Data ........................................................................................................... 9
U. Publikasi .................................................................................................................... 9
V. Pendanaan .................................................................................................................. 9
W. Komitmen Etik .......................................................................................................... 9

DAFTAR PUSTAKA ...................................................................................................... 11

LAMPIRAN ...................................................................................................................... 13

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