How to Protect the Vulnerable Groups in Drug Clinical Trials / 中国医学伦理学

Objective:To find a better way to protect the security and interests of vulnerable groups by exploring the problem of protecting the vulnerable groups in drug clinical trial from the perspectives of ethics committees,organization and researchers.Methods:According to the relevant literature and the actual situation of the hospital,this paper analyzed the security issues of vulnerable groups comprehensively.Results:Only the ethics committees,organization and researchers work together,can it protect the security and interests of vulnerable groups to the greatest extents.Conclusion:Further research on the security of vulnerable groups not only promotes the development of human health,but also plays a decisive role in improving the protection of subjects in drug clinical trial.

Problems and Solving Strategies of Current Ethical Reviews from the Perspective of Informed Consent in Human Trials / 中国医学伦理学

Human trials are necessary to medical development,but the experiments need to be reviewed under the condition of informed consent.The current ethical review of informed consent in China exist some limits.For example,the corresponding normative legal status is low,the tracing review of informed consent becomes a mere formality,and the ethical review mechanism is not perfect,and so on.We should strengthen the examination of the ethical examination of human trials,increase the tracking and examination of informed consent of human trials,and improve the supporting mechanism of ethical review,and thus to safeguard the life and health rights and interests and personality dignity.

Protection the Rights and Interests of the Subjects through Independent Ethics Committee / 中国医学伦理学

The essay is composed of three parts.In the first part,it gives a brief introduction to Bases of Clinical Trial in China as well as the basic rules required by Chinese Clinical Experimentation Management Standards which are made to protect the rights and interests of the subjects.In the second part,great emphases are laid on how to establish an independent Ethics Committee which acts to meet the demands in the Helsinki Declaration and other international laws,so as to protect the right and interests of the subjects.The last part gives a brief introuduction to the independent and impartial work for the Ethic Committee,which is under the leadership of the author,in the Fourth Military Medical University.Some possible problems are also discussed in this part.