Study on Damage Compensation for Subjects in Drugs Clinical Trials / 中国医学伦理学

ABSTRACT

Objective:To investigate the current situation of damage compensation for subjects in drugs clinical trials.Methods: Retrospective analyzes was conducted on 70 drug clinical trail from January 2008 to December 2014 in our hospital , including protocols、informed consent and insurance .Results: It was written in most proto-cols that sponsor undertook damage compensation due to experimental drugs , however , lack of detailed rules .Dam-age compensation for subjects was missed in some informed consents .17 drugs clinical trials provided insurance , the rate of jointing insurance 24 .3%.In international trail , the rate of jointing insurance ( 100%) was higher than that in domestic trail (9.1%).As to domestic trail, the rate of jointing insurance increased gradually .There was no difference between insurance of different periods .In 17 insurance , 13 were clinical trial liability insurance , oth-ers were product and general liability insurance;5 provided insurance instruction , only insurance certificate or poli-cy in others;2 insurance applied foreign language .Conclusion:Through project access system , strengthening the ethical approval , strengthening quality management to prevent the damage occurred , participants damage happened after fully protect the health and rights and interests of the subjects , and actively promote clinical trial insurance to perfect our subjects′damage compensation mechanism , the protection of the rights of the subjects , and reduce the risk of clinical trials .