Dennis B P
Department of Family and Community Nursing, College of Nursing and Health Professions, University of North Carolina at Charlotte 28223, USA.
J Prof Nurs. 1999 Sep-Oct;15(5):281-7. doi: 10.1016/s8755-7223(99)80053-2.
The concept of informed consent has evolved over the past century. Today it is a mainstay of clinical practice and human subjects research. This article traces informed consent from its origins in law and bioethical thought to the creation of codes and a system of regulations. In this discussion, informed consent as a point of law and as an ethical construct is viewed from historical and contemporary perspectives in conjunction with the experiences of vulnerable population groups. This consideration does not extend to the use of specific research methodologies. The need to recognize the influence and importance of the sociocultural context in the implementation of informed consent is strongly supported. A correlation is drawn between aspects of consent and the ethical principles of beneficence, nonmaleficence, and autonomy. Four major guidelines for nurse researchers and clinicians are presented.
知情同意的概念在过去一个世纪中不断演变。如今,它已成为临床实践和人体研究的支柱。本文追溯了知情同意从其在法律和生物伦理思想中的起源到相关准则及法规体系的创立过程。在此次讨论中,从历史和当代视角,结合弱势群体的经历,审视了作为法律要点和伦理结构的知情同意。这种考量并不涉及具体研究方法的使用。文中大力支持认识社会文化背景在知情同意实施过程中的影响和重要性这一观点。还阐述了同意的各个方面与有益、无害和自主等伦理原则之间的关联。并为护士研究人员和临床医生提出了四条主要指导方针。