E Aspek Etik Penelitian Eksperimental dengan Hewan Percobaan 1 Butir 11 2 Butir 12 F Aspek Etik Penelitian Pemanfaatan Bahan Biologik Tersimpan BBT G Aspek Etik Uji Klinik 1 Pendahuluan 2 Fase Fase Uji Klinik 3 Etik Uji Klinik 4 Desain 5 Sponsor 6 Subyek 7 Peneliti 8 Contract Research Organization CRO 9 Aspek regulasi 10 Penutup 147 149 149 152 155 155 156 159 160 161 162 162 164 164 165 Bab 8 KOMISI NASIONAL ETIK PENELITIAN KESEHATAN KNEPK DAN KOMISI ETIK PENELITIAN KESEHATAN KEPK A KNEPK 1 Pendahuluan 2 Tujuan 3 Tugas dan Fungsi 4 Kedudukan 5 Keanggotaan 6 Susunan Organisasi 7 Tata Kerja 8 Pembiayaan B KEPK 1 Kedudukan KEPK 2 Peran dan fungsi KEPK 3 Proses Penilaian Etik Penelitian Kesehatan 4 Prosedur Penilaian Etik Penelitian Kesehatan 5 Jaringan Komunikasi Nasional JARKOMNAS Komisi Etik Penelitian Kesehatan 167 168 168 169 169 170 170 171 171 172 172 173 173 174 195 DAFTAR PUSTAKA LAMPIRAN LAMPIRAN 201 207 x 197E. Aspek Etik Penelitian Eksperimental dengan Hewan Percobaan ... 1. Butir 11 ............................................................................ 2. Butir 12 ............................................................................ F. Aspek Etik Penelitian Pemanfaatan Bahan Biologik Tersimpan (BBT) ...................................................................................... G. Aspek Etik Uji Klinik ................................................................ 1. Pendahuluan ..................................................................... 2. Fase-Fase Uji Klinik ........................................................... 3. Etik Uji Klinik ................................................................... 4. Desain .............................................................................. 5. Sponsor ............................................................................... 6. Subyek .............................................................................. 7. Peneliti ............................................................................. 8. Contract Research Organization (CRO) .............................. 9. Aspek regulasi ................................................................... 10. Penutup ............................................................................ 147 149 149 152 155 155 156 159 160 161 162 162 164 164 165 Bab 8 KOMISI NASIONAL ETIK PENELITIAN KESEHATAN (KNEPK) DAN KOMISI ETIK PENELITIAN KESEHATAN (KEPK) ............................... A. KNEPK .................................................................................... 1. Pendahuluan ..................................................................... 2. Tujuan .............................................................................. 3. Tugas dan Fungsi ............................................................... 4. Kedudukan ....................................................................... 5. Keanggotaan ..................................................................... 6. Susunan Organisasi ............................................................ 7. Tata Kerja .......................................................................... 8. Pembiayaan ....................................................................... B. KEPK ...................................................................................... 1. Kedudukan KEPK .............................................................. 2. Peran dan fungsi KEPK ...................................................... 3. Proses Penilaian Etik Penelitian Kesehatan .......................... 4. Prosedur Penilaian Etik Penelitian Kesehatan ....................... 5. Jaringan Komunikasi Nasional (JARKOMNAS) Komisi Etik Penelitian Kesehatan .......................................................... 167 168 168 169 169 170 170 171 171 172 172 173 173 174 195 DAFTAR PUSTAKA ......................................................................... LAMPIRAN-LAMPIRAN .................................................................. 201 207 x 197