On The Legal Relatlonship Test Drug Problems In The Allocation Of Responsibilities

Data shows that new drugs is now declare tens of thousands of species in China, by the State Food and Drug Administration approval, there are about 800 species of new drugs approved.as a special group, The people of drugs trial also came into being. Within legal relationship of drug trial, the rights, duties and responsibilities of the distribution problems of the study and subjects follow. According to recent media reports of groups of drug trial it is being gradually applied to an understanding of the legal relationship of drug trial However, because media coverage is biased, it is tilted of subjects side of sympathy, compassion, except research side. China's "Good Clinical Practice" This acts specifically standardized test departmental rules and regulations of the provisions of the legal relationship about drug trial is imperfect, especially for relief of subjects side are too abstract, in judicial practice, due to evidentiary issues and compensation standard issues, there is no legal basis for the phenomenon. scholars have called for the improvement of legislation as soon as possible and put forward the burden of proof reversal, concrete compensation standard, and compulsory insurance measures in order to be more effectively protect the legitimate rights and interests of subjects side.In my view, whether it is media coverage, or the recommendations of scholars. without exception, generally speaking drug trial as a whole.through concerning their socio-economic status and psychological status and physical and mental pain of subjects.within the legal relations in the drug trial, the subjects side of course, be the victim of the legal relationship, the corresponding study side of the relationship are beneficiaries of this law.taking it for granted that if there was danger, study shall unconditionally assume full responsibility for the drug trial. However, the author through a careful screening, analysis, research that in my view,it should be classified within this group and be divided into a fully informed the people of drug trial and not knowing the drug trial. according to research the people of drug trial in the subjects about state of mind, behavior characteristics of different circumstances, different allocation system of responsibilities should be defined. Accordingly, the writer is based on informed consent,through three parts to prove this proposition.The first part, the author speaks informed consent as a starting point to illustrate that in the pre-trial drug, research side fulfills the obligations in order to obtain the legitimacy of aggressive behavior of trial, so that the the right of informed consent of subjects side required by law be realized. The medical instrument,as legal documents of informed consent procedure, should be agreed upon proof of the role of the division of responsibility in judicial practice. However, in clinical trials, because informed consent is non-standard and having not played its due role,this results in the judicial practice,the legal nature and the legal effect of informed consent being a point of contention, therefore wo must research the legal nature of this instrument, the legal effectiveness, to explore with a view to play a guiding role in judicial practice.The second part, in theory, subject side should be fully informed and independently decided to participate in drug trial,that is nothing wrong. However, writer analysts that the practice in drug clinical trials, there is research side give clear explanation or even deliberately unclear, subject side were deceived to participate in tyial. but there are also subject side fully informed and involved in drug trial because they are motivated by financial gain, in this case,they should bear due responsibility as a modern civic. Research side performs their duties according to law even after shoulders the assignment (?) responsibility. that is unreasonable manner and no legal basis.The third part, the author analyzes the remedies of drug trial. As China's "Good Clinical Practice" is imperfect, the rights of subject side can not be guaranteed. Having to improve the legislation is not the matter overnight. Because clinical trials act should be in accordance with the medical nature,it belongs to the broad medical practices, sc knowledge of subjects for subject side damages should be involved in medical treatment. This will also be able to temporarily solve burden of proof issue and the compensation standards,Which can be based on specific legal settlement of such disputes.