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Study On The Protection Of Rights And Interests Of Subjects In The Test Of Human Body

Posted on:2015-04-09Degree:MasterType:Thesis
Country:ChinaCandidate:S S ZhuFull Text:PDF
GTID:2296330434952807Subject:Law
Abstract/Summary:PDF Full Text Request
In recent decades, along with the breakthrough occurred continuously in medical field, behind the play play a decisive role of energy is the human body test. Research on medical person order to overcome the diseases that afflict humans, let them be healthy life, to receive modern medical treatment of people benefit from the deep is mostly achieved through human test results. However, everything has two sides, with the development of larger and side effects of human testing "". The most powerful push these side effects is not before damage occurred in the protection of human subjects, development or damage occurs without proper control of damage. Review the recording, the subjects of rights by the loss event has been highly concerned in the life of today, and these disputes are often caused concern(CCTV program also reveal). With modern Chinese medical conditions compared to other biomedical more developed countries,to protect the subjects to be in in the human body experiment appears to be more perfect, these countries through the combination of legal, ethical, social various ways of protection.In recent years, due to the increasing investment on biomedical research, technology level in the aspects of a qualitative leap,the State encourages independent innovation, which is also reflected in biomedical research, quantitative research on the technical level with soaring is human trials carried out. Learn from the developed countries to regulate human test behavior, the protection of the subjects in the trial rights and effective way,this is the need to face our country law as soon as possible to solve the problem. This paper is based on the subjects of rights protection perspective, a further study on the related legal problems in the human body experiment, seeks suits our country national condition the legislation suggestions, hope to further perfect our legal system of contributing to human trials.This paper is divided into five chapters, the first chapter introduces the significance of the research object, the research methods of this paper, the concept of human trials, the. Ananalysis of existing literature using human test developed areas of the origin, development, legal measures, and cross-border related professional medical knowledge to study human trials, toargue accurate depth effect, also reflects the complex learning background advantage. In the integration of his country and international experiences, give full consideration to Chinese situation, actively is given according to the effective implementation of the opinions and suggestions.The second chapter reviews human testing existing legal basis in the international arena, the international code of ethics to the declaration of Helsinki as representative, played an important role for the establishment of norms of behavior of human test. In the "Convention on the International Convention on Civil and political rights", the United Nations and its specialized organization by, also relates to human trials. However, this international standard due to its nature and content restrictions, the international legal status in practice has been questioned. At the regional level, the European regional organizations, including the Council of Europe and the European Union, has also developed a series of legal norms of human test.Comparison of main countries and regions of the world human test model of legal norm, and the legal status of relevant countries and regions are outlined. And the human trials in wide attention of informed consent right summarizes the theory.The third chapter studies the main participation body in the qualification test. Human trials the legal relationship between the parties, including promoters, experiment, subjects, including special subjects and subjects group. Review mechanism plays an important role in guaranteeing the rights of the subjects. Should establish a mechanism to avoid conflict of interest, the promoters etc., because of conflicts of interest and damage to the rights of the subjects. Human test subjects have right of the right to life and health, body autonomy, privacy. The subjects for the property rights and interests of test sharing right is a controversial question. At the same time, participants enjoy freedom of research, sponsors have engaged in the study of rights, but the rights and subjects in conflict of interest, the interests of the subjects should be given priority.The fourth chapter studies the legal rights and interests and guarantee system of subjects, the main mechanisms for the protection of the subjects of ethics review. The ethical review human trials are the main subjects protection mechanism of international norms and national laws and regulations required.From the organizational model of ethical review mechanism, namely institutional review board and independent ethical review two modes of organization arrangement. In this paper, through a comparative study, from the social reality, the primary value of independence of ethical review organization, shall establish a central and local level two independent ethical review system in our country, and to guarantee their representiveness, diversity and multi discipline. In human studies review operation, should according to the international standards and the experience of other countries, improve and perfect our rules. In order to ensure the effectiveness of ethical review, must carry on the effective supervision on the ethical review.A perfect system and damage the security system the fifth chapter studies the subjects of rights relief, tort liability is the general way to obtain relief. This paper introduces the legal status of Anglo American law system and continental law system human trials of tort liability, the system of compensation of ou human trials damage. Insurance is a risk and enable subjects to obtain timely relief way, have suitable space in human trials.Human trials damages including forced compensation by the government led and dominated by research institutions, voluntary compensation, can be added as a means to human trials of our subjects damage relief.
Keywords/Search Tags:human trials, subjects rights and interests protection, informed consent, imputation principle
PDF Full Text Request
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