Ethical Review Of Medical Research Human Test Subjects Informed Consent

Informed consent of subjects is one of the most important ethical issues in medical research.Informed consent is the process by which the medical researchers have informed the subjects of the study of the medical research and the subjects independently confirmed whether they agreed to participate in the trial.The informed consent signed and dated by the subjects is the document of informed consent.The ethical review of informed consent of human subjects in medical research was carried out by the ethics committee of the Research Institute.The ethics committee's responsibilities,is the medical research involving human subjects and related medical technology application research review and independent monitoring,protection of subjects of dignity,life,health,safeguard the legitimate rights and interests of the subjects,maximize the prevention of subjects hurt in the test.Ethical review includes whether the trial is ethical,and whether the study is scientific.Study on medical research human test subjects informed consent,is conducive to the prevention of human test subjects to risk,is conducive to safeguarding the rights and interests of the subjects of human trials,is conducive to improve the level of medical research,is conducive to the construction of the ethics committee,is conducive to the prevention of medical disThe ethical review originated from the formation of the Nuremberg code in 1947,and it is the first time to put forward the moral principles of human trials.After that,the subjects of informed consent and the degree of attention more and more,all the countries in the world to implement international ethical guidelines at the same time,combined with their own reality,formulated in line with their actual subjects informed consent principle and standard,make the subjects informed consent principle has a specific and comprehensive.After the establishment of the ethical review system of the human body experiment of medical research in China in 1980 s,after two stages of development.Among them,the examination of the informed consent of the subjects is also improving.The ethical review of informed consent in medical research has differentclassifications.In accordance with the classification review,including ethical review on recruitment of subjects,the ethical review of informed consent and informed consent for ethical review process and on Exemption of subjects informed consent for the research project of ethical review.In accordance with the classification of the review,including formal review,review of the meeting,the trial committee review and follow-up review.It is found that the lack of informed consent is still more in the form of formal review.The problems of the meeting review include the review of the meeting too many projects,the lack of time for review;meeting review report of the project is lack of guidance requirements.Members of the review of informed consent is not comprehensive enough questions.The trial review of the judges in the trial to be further improved.Follow up review of informed consent should not only be a review of the informed consent amendment,but should also include a review of the informed consent process.This paper puts forward the methods to solve the problems in the ethical examination of informed consent.Firstly,improve the ability of medical research on human test subjects informed consent and ethical review,we should strengthen the system construction of informed consent and ethical review,so that the full range of informed consent and ethical review process.Secondly,in order to improve the informed consent ethical review as the goal of strengthening the construction of the ethics committee,improve the work system,in strict accordance with the formulation of regulatory documents and SOP to carry out the requirements of informed consent on the ethical review subjects,strengthen the training of members of the ethics committee of ethics.Thirdly,to strengthen the content of informed consent of the participants in the training of the researcher's ethics,and to ensure the strict implementation of ethical requirements in the actual work of informed consent.Fourthly,to strengthen the supervision of the informed consent of the subjects,to ensure that the relevant departments and agencies of the informed consent of the ethical review of supervision and management,in order to ensure the level of ethical review and justice.This paper summarizes the situation of the implementation of the abovemeasures by the medical ethics committee of the Second Hospital of Tianjin Medical University.