Discussion and analysis on legal protection of human subjects’ informed consent in drug clinical research

Objective: To provide references for legal protection of human subjects’ informed consent in drug clinical research in China.Methods: We explained the significance of human subjects’ informed consent in drug clinical research,found some problems in the realization of human subjects’ informed consent and then analyzed the reasons.Besides,we introduced interrelated legislation and explored legislation defect.Results Conclusions: At present,we should improve legal protection of human subjects’ informed consent by strengthening legal education for both human subjects and researchers,building a sound regulation system,perfecting regulatory mechanism of Ethics Committee and so on.