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Development and Inadequacy: Research on the Rights and Interests Protection of the Subjects in Chinese Drug Clinical Trials

机译:发展与不足:中国药物临床试验中受试者的权利和利益研究

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Chinese drug clinical trial subjects are large, and constantly improve the protection of the legitimate rights and interests of this group is the Chinese government for many years the goal. By continuously improving the legislation, strengthening the supervision and management of the relevant subjects, regulating the operation of a series of measures such as the operation of the ethics committee, the level of the rights and interests of the Chinese drug clinical trial subjects is progressing rapidly. But there is still need to improve the aspects, such as the law of the update is lagging behind, the sponsor and drug clinical trial organization of the process of inadequate regulation, part of the ethics committee is not standardized operation, the insurance link defects affect the realization of the rights of the subjects. It is proposed to better protect the rights and interests of the subjects and promote the progress of medical technology by timely revision of the law, to achieve unified institutional supervision, to ensure the independence of the ethics committee, to strengthen the drug clinical trial liability insurance.
机译:中国药物临床试验科目大,不断完善保护本集团的合法权益和利益是中国政府多年的目标。通过不断提高立法,加强相关科目的监督管理,规范了一系列措施,如道德委员会的运作,中国药物临床试验受试者的权益水平迅速发展。但仍有需要改进方面,如更新的法律落后,提案国和药物临床试验组织的过程不足的过程,部分道德委员会不是标准化的运作,保险链接缺陷的影响实现受试者的权利。建议更好地保护受试者的权益,并通过及时修改法律来促进医疗技术的进步,实现统一的机构监督,确保伦理委员会的独立性,加强药物临床试验责任保险。

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