Picture1

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 -