Komisi Etik Penelitian Kesehatan, KEPK, Institutional Review Board, Ethical Clearance

Unduh

unduh

Dimenu ini Anda dapat mengunduh baik formulir yang dibutuhkan untuk mengajukan ethical clearance maupun materi-materi presentasi dari kegiatan Komisi Etik Penelitian Kesehatan.

 

 

 

 

Formulir

  1. Formulir Pengajuan Dokumen Protokol
  2. Formulir Pengajuan Penelitian Hewan Coba
  3. Formulir Pengajuan Penelitian Non Uji Klinik (Epid, Sosial, Survey, dll)
  4. Formulir Pengajuan Uji Klinik
  5. Formulir Pengajuan Pengecualian Kaji Etik (Exempted)
  6. Formulir Pengajuan Amandemen
  7. Formulir Pengajuan Laporan Akhir

Materi Presentasi

  1. PP41-Presentation 13 Maret 2010 – Ristek
  2. Syarat Administrasi Pengajuan Kaji Etik 1

Template Formulir Informed Consent milik WHO (World Health Organization)

  1. ICF Parental Consent-clinicalstudies
  2. ICFparentalConsent-qualitative
  3. Informed consent for sample storage
  4. InformedAssent
  5. InformedConsent-clinicalstudies
  6. InformedConsent-qualitativestudies

*Untuk lebih jelas dapat meng-akses tautan berikut ini: WHO IC Templates

 

Pedoman Operasional Baku (POB) Komisi Etik dapat diunduh disini.

Referensi Pedoman Lain :

  1. CIOMS Ethical Guidelines 2016
  2. ICH GCP E6(R2) Step 5 December 2016
  3. Pedoman Cara Uji Klinik Yang Baik BPOM 2001
  4. Pedoman Nasional Etik Penelitian Kesehatan 2011 (Unedited Version)
  5. PKBPOM No 21 Tahun 2015 tentang Tata Laksa Persetujuan Uji Klinik
  6. WHO Standard and Guidelines for Ethics 2011

 

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