Legal Protection of Subjects' Informed Consent in Clinical Drug Trials
- VernacularTitle:浅谈受试者在药物临床试验中知情同意权的法律保护
- Author:
Kan TIAN
;
Yang TANG
- Publication Type:Journal Article
- Keywords:
Human subject;
Clinical trial;
Informed consent
- From:
China Pharmacy
2007;0(28):-
- CountryChina
- Language:Chinese
-
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.
