Basic of Ethical Reviews
Basic of Ethical Reviews
When reviewing a research protocol, the basis for consideration is the documents in the following link:
Clinical Research in Resource-Limited Settings (CIOMS 2021)
Declaration of Helsinki (2013)
E6(R2) GCP Integrated Addendum to ICH E6(R1) -Guidance for Industry- (ICH GCP 2018)
EU Clinical Trials Regulations (2014)
Guideline for GCP E6(R2) (EMA-CHMP 2016)
Handbook for GCP -Guidance for Implementation- (WHO 2005)
International Ethical Guidelines for Health-related Research Involving Humans (CIOMS 2016)
Operational Guidelines for Ethic Committees that Review Biomedical Research (WHO 2000)
Pedoman Cara Uji Klinik yang Baik di Indonesia (BPOM 2016)
Pedoman dan Standar Etik (KEPPKN 2022)
Pengalihan dan Penggunaan Material, Muatan Informasi, dan Data (Permenkes RI 85_2020)