Problems And Countermeasures For The Ethical Review On The Drug Clinical Trials

Objective: Make an analysis of the main problems of ethics review of drug clinical trials,according comparison of ethics review abroad, and make recommendations and countermeasuresto regulate the operation of the Ethics Committee and improve the quality of ethical review.Methods: Though reading and summarizing the ethical literature, analyzing typical casesand ethical review views from100projects at an institution, we summarized there are theproblems of ethical review in china and review points, and according comparison of Americanethics review regulations, combined with China’s actual situation and then provided thecountermeasures.Results: Compared with other developed countries in the Western, especially United States,the ethical review on the drug clinical trials in china started in a later time and at present thereare some problems, such as ignoring follow-up review, lacking of standardized review processand operating procedures, inadequate regulations, lacking of effective regulatory agenciesinadequate training and so on.Conclusion: In order to promote the solution of the above issues, countermeasures ofimproving our legislation on ethical review; clearing regulatory body and strengthening thesupervision and management of the Ethics Committee at all levels; establishing and improvingthe management system and the standard operating procedures and strengthening training for theEthics Committee should be taken.