知情同意:定义、模式和挑战

Informed consent: definition, practice and challenge

从知情同意产生和发展的历史、知情同意的含义和模式方面来说明产生于一定历史背景下的知情同意,在临床和研究领域,以及生物信息库的建设中,具有一定的局限性,也面临着挑战。面对这样的挑战,不应该拘泥于对知情同意概念本身如何准确表述、模式如何创新,而更应该从知情同意所要达到的目的——保护患者、受试者和样本提供者的权益来考虑。

Following the historical development of informed consent,this paper touches upon the definition,practice and challenge——the three key issues in the area of informed consent.It opens by stating that informed consent is not a panacea in all circumstances.Then it goes on by arguing that over-involvement in the effort to define informed consent ＂accurately＂ and to formulate ＂effective＂ models for its application does not really help to serve the purpose of informed consent.Finally it suggests that more attention should be paid duly to the challenges and difficulties connected with the application of informed consent since in essence what matters in informed consent is the best interest of the patients,subjects and donors.