References of Ethic Committee
| INTERNATIONAL ETHICAL GUIDELINES for HEALTH-RELATED RESEARCH INVOLVING HUMANS - CIOMS Tahun 2016 | File |
|---|---|
| KESELAMATAN PASIEN - PERMENKES No.11 Tahun 2017 | Download |
| TATA LAKSANA PERSETUJUAN UJI KLINIK - PERMENKES BPOM No.21 Tahun 2015 | Download |
| PENGIRIMAN DAN PENGGUNAAN SPESIMEN KLINIK,MATERI BIOLOGIK DAN MUATAN INFORMASINYA - PERMENKES No.657 Tahun 2009 | Download |
| STANDARTS AND OPERATIONAL GUIDANCE FOR ETHICS REVIEWS OF HEALTH-RELATED RESEARCH WITH HUMANS PARTICIPANTS - WHO Tahun 2011 | Download |
| GUIDE for PRINCIPAL INVESTIGATORS | Download |
| ICH GCP – E6 R2 2016 | Download |
| Pedoman Nasional Etik Penelitian Kesehatan, Kemenkes RI, 2011 | Download |
| Pedoman Nasional Etik Penelitian Kesehatan, Kemenkes RI, 2007 | - |
| Pedoman Nasional Etik Penelitian Kesehatan , Suplemen VI Etik Penelitian Sel Punca, Komisi Nasional Etik Penelitian Kesehatan, Depkes RI, 2008 | - |
| Pedoman Nasional Etik Penelitian Kesehatan, Suplemen V Etik Penelitian Epidemiologi, Komisi Nasional Etik Penelitian Kesehatan, Depkes RI, 2007 | - |
| Pedoman Nasional Etik Penelitian Kesehatan, SuplemenIV Etik Penelitian Genetika, Komisi Nasional Etik Penelitian Kesehatan, Depkes RI, 2008 | - |
| Pedoman Nasional Etik Penelitian Kesehatan, Suplemen III Jaringan Komunikasi Nasional Etik Penelitian Kesehatan, Komisi Nasional Etik Penelitian Kesehatan, Depkes RI, 2008 | - |
| Pedoman Nasional Etik Penelitian Kesehatan, Suplemen I Etik Pemanfaatan Bahan Biologik Tersimpan (BBT), Komisi Nasional Etik Penelitian Kesehatan, Depkes RI, 2008 | - |
| Himpunan UU Nomor 18 Tahun 2002 danTurunannya, JDIH, 2002 | - |
| Prosedur Izin Penelitian Bagi Perguruan Tinggi Asing, Lembaga Penelitian dan Pengembangan Asing, Badan Usaha Asing dan Orang Asing Dalam Melakukan Kegiatan Penelitian dan Pengembangan di Indonesia, Ristek, 2008 | - |
| A Practical Guide for Health Researchers , WHO, 2004 | - |
| Guidance on Ethics and Equitable Access to HIV Treatment and Care, UNAID, WHO, 2004 | - |
| The Belmont Report, Ethical Principles and Guidelines for Protection of Human Subjects of Research, DHEW | - |
| Operational Guidelines for Ethics Committees That Review Biomedical Research, WHO, 2000 | - |
| The Value and Benefits of ICH to Drug Regulatory Authorities – Advancing Harmonization for Better Health, ICH, 2010 | - |
| World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects,2008 | - |
| International Ethical Guidelines for Epidemiological Studies,CIOMS 2008 | - |
| The Process of obtaining Informed Consent | - |
| Guideline for Good Clinical Trial in Indonesia Version II,2015 | - |
| Guideline for Good Clinical Trial in Indonesia, Version III,2016 | - |
| Global Health Ethics Key Issues by WHO, 2015 | - |
| Pedoman Riset Sel Punca Manusia Edisi Pertama 2010 | - |
| Guidelines for Stem Cell Research and Clinic Translation 2016 | - |
| Integrated Addendum to ICH E6(R1) Guideline for good clinical practice E6(R2) | - |
| Guidelines on the Quality , safety, and Eficacy of respiratory syncytial virus vaccines 2019 | - |
| UU Nomor 11 Tahun 2019 - Sistem Nasional Ilmu Pengetahuan dan Teknologi | - |
| PMK No. 85 Th 2020 ttg Pengalihan dan Penggunaan Material, Muatan Informasi, dan Data_sign | - |
| RSV_Guidelines_POST_ECBS | - |
| Peraturan Menteri Kesehatan Republik Indonesia, Pengiriman dan Penggunaan Spesimen Klinik, Materi Biologik dan Muatan Informasinya | - |
| Pedoman Nasional Etik Penelitian Kesehatan Suplemen VI Etik Penelitian Sel Punca 2008 | - |
| Pedoman Nasional Etik Penelitian Kesehatan Suplemen V Etika Penelitian Epidemiologi 2007 | - |
| Pedoman Nasional Etik Penelitian Kesehatan Suplemen IV Etika Penelitian Genetika 2008 | - |
| Pedoman Nasional Etik Penelitian Kesehatan Suplemen III Jaringan Komunikasi Nasional Etik Penelitian Kesehatan 2007 | - |
| Pedoman Nasional Etik Penelitian Kesehatan Suplemen I Etik Pemanfaatan Bahan Biologik Tersimpan 2006 (BBT) | - |
| Keputusan Menteri Kesehatan Republik Indonesia Nomor 118 (Kompendium Alat Kesehatan) | - |
| isscr-guidelines-for-stem-cell-research-and-clinical-translation | - |
| Ethics_basic_concepts_ENG | - |
| Ethics Review Committee Guidelines, A guide for developing standard operating procedures for committees that review biomedical research proposals | - |
| Declaration Helsinki 2013 | - |
| 2009 WHO Ethic Guideline for Epidemiology | - |