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Research On The Protection Of Drug Clinical Trials Subjects

Posted on:2020-12-26Degree:MasterType:Thesis
Country:ChinaCandidate:E D K N E H M T AFull Text:PDF
GTID:2416330590954944Subject:Master of Laws
Abstract/Summary:PDF Full Text Request
As a special medical behavior,drug clinical trial is obviously different from general medical behavior.Drug clinical trials have an unpredictable high risk,which may cause physical damage or irreversible organic damage to the trial.At present,China has not made strict and unified legal provisions on the infringement of the rights and interests of drug test subjects,so the judgment results of cases of the same nature will be completely different in judicial practice.This is clearly not conducive to protecting the rights and interests of drug users.The main content of this paper is divided into five parts.The introduction mainly discusses the research background,research significance and research methods.The first chapter mainly discusses the concept and characteristics of drug clinical trials and the scope of rights and interests of drug reagents,which is the premise to further explore the protection of rights and interests of drug reagents.The second chapter mainly discusses the current situation and existing problems of the legislation related to the protection of the rights and interests of drug reagents in China’s clinical trials.Due to the defects of the legislation,the rights and interests of drug reagents cannot be fully protected.The third chapter mainly discusses the judicial status and existing problems in China’s drug clinical trials.In judicial practice,there are many problems,such as the difficulty of drug trial in providing evidence,the large difference in the amount of compensation or compensation determined by judges,etc.,which reflect that drug trial are in a weak position in the lawsuit and their rights and interests are not fully protected.Chapter four mainly discusses the legislative improvement and judicial practice Suggestions on the protection of the rights and interests of drug trial in drug clinical trials.The conclusion of this paper is that the rights and interests of drug reagents in clinical trials are not fully protected.Both legislation and judicature should be used to protect the rights and interests of the drug tester.First,perfect the relevant!Legislation;Second,the principle of presumption of fault liability should be applied in judicial practice,and thejudgment of "probable causality" should be used for causal relationship.
Keywords/Search Tags:drug clinical trials, rights and interests of drug test subjects, informed consent, principle of liability, causal relationship
PDF Full Text Request
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