Legal Protection of Subjects' Informed Consent in Clinical Drug Trials / 中国药房

ABSTRACT

OBJECTIVE:To provide the reference for the improvement of GCP(good clinical practice)regulations and protection of subject's human rights.METHODS:The status quo of the protection of subject's right of informed consent and the elements for the right of informed consent and the existing problems in its practice in China were analyzed.RESULTS & CONCLUSIONS:China should further promote the legislation of clinical trials,reinforce the legal education of researchers,and emphasize the supervision on the illegal tort act.