Research On Legal Issues Of Ethical Review Of Drug Clinical Trials

Human trials continue to promote the development of modern medicine.Drug clinical trials are a type of human trials.Clinical trials are an indispensable link in the development of medical drugs.In order to make the process of drug clinical trials both reasonable and legal,each country and region has established ethical review committees to conduct ethical review of drug clinical trials according to their own national conditions.In this context,China has also established a corresponding ethical review system for drug clinical trials and promulgated a series of legal documents to regulate the ethical review of ethics committees,which has solved the legal and ethical issues of drug clinical trials to a certain extent.However,China’s ethical review legal system in the current price segment still faces many difficulties and deficiencies in the operation process.Compared with some developed countries in the West,there is a large gap.Therefore,the legal approach to the ethical review of the ethics committee for drug clinical trials in China still needs to be constantly improved through exploration.This article is divided into four parts:The first part is the basic theory of ethical review of drug clinical trials.The ethical review of drug clinical trials refers to the clinical research of drugs that are used in humans.The scientific and ethical reviews are conducted to ensure the personal dignity and life safety of the subjects,and to promote the healthy development of drug clinical trials.It should be said that the ethical review of drug clinical trials is an administrative act and is in line with the characteristics of industry administrative licensing.Ethical review has the particularity of medical ethics and legal characteristics,and it is beneficial not to hurt and the right to informed consent constitutes the basic principles of ethical review of clinical trials of drugs.The second part is the legislative examples and evaluation of ethical review of foreign drug clinical trials.Throughout the relevant legal systems of the United States,Britain,Sweden and other countries,they have formulated a more comprehensive ethical review legal system,established a clearer ethical review supervision system,and provided a more detailed ethical review relief mechanism.The third part is the legal status and existing problems of ethical review of drug clinical trials in China.The current ethical review of drug clinical trials in China is not ideal.There are problems in the review subject,review standards and procedures,review supervision and relief,and review accountability mechanisms.The fourth part is to improve the legal countermeasures of ethical review of drug clinical trials in China.First of all,the construction of the ethics committee system should be strengthened.It can be improved by setting up specialized regional committees,promoting the certification and licensing system,and improving the internal governance mechanism of the ethics committee.Secondly,it proposes strict and unified standards from the perspectives of ethical review standards,review procedures,and follow-up reviews;again,the establishment of ethical review supervision and relief mechanisms,the regulatory body and supervisory authority should be clearly defined,and ethical review relief mechanisms should be established to enable effective implementation of ethical review.To achieve better results;finally,from the perspective of clarifying the subject of responsibility,clear legal responsibilities,etc.,explore the personnel and institutions that carry out experiments in violation of the rules to bear the corresponding legal responsibilities.