國外法規

國外法規

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

International Ethical Guidelines for Health-related Research Involving Humans

ICH E6(R3)

ICH Efficacy Guidelines

Belmont Report 

Declaration of Helsinki 

45 CFR 46

21 CFR 50-PROTECTION OF HUMAN SUBJECTS

21 CFR 56-INSTITUTIONAL REVIEW BOARDS

21 CFR 312-INVESTIGATIONAL NEW DRUG APPLICATION 

21 CFR 812-INVESTIGATIONAL DEVICE EXEMPTIONS