入排标准在知情同意中的伦理价值研究

Research on the Ethical Value of Include and Exclude Criteria in Informed Consent

知情同意是伦理审查的重要组成部分,落实知情同意权有利于充分保障受试者的权益,并使其在充分知情的前提下积极配合试验进程,为安全、准确地完成临床试验提供基本保障。在试验研究中维护受试者知情权时,入排标准是否需要作为知情同意的一部分值得分析,从入排标准在伦理审查中的意义以及构成知情同意权的必要性和条件入手,阐述了入排标准在知情同意中的伦理价值,以期为入排标准是否应纳入知情同意提供一定理论依据,更好地维护受试者权利,也更好地保障临床试验的准确、顺利进行。

Informed consent is an important part of ethical review,and the implementation of informed consent is conducive to fully protect the rights and interests of subjects,and enable them to actively cooperate with the trial under the premise of fully informed,to provide a basic guarantee for the safe and accurate completion of the trial clinical trial.When maintaining the subjects'right to know in experimental studies,it is worth analyzing whether the include and exclude criteria should be taken as part of informed consent.From its significance in ethical review and constitute as well as a necessity and conditions of the right of informed consent,this paper expounded in all criteria of the ethical value of informed consent,so as to provide certain theoretical basis for whether include and exclude criteria should include informed consent,better safeguard the subjects right,also better ensure guarantee the accuracy and smoothness of medical experiments.