Webber M, Jenkins N
Prog Cardiovasc Nurs. 1990 Apr-Jun;5(2):59-64.
The purpose of this article, directed at first-time clinical researchers, is to describe the internal review board process of one clinical research facility and to provide an example of its protocols for conducting clinical research. After a brief history depicting the need for Internal Review Boards, the review process itself, is discussed. Emphasis is placed on the patient's medical/legal rights and safety. Equipped with an understanding of why the review process is necessary and with examples of the review board criteria, the nurse researcher has the tools to begin the research project.
本文面向首次参与临床研究的人员,旨在描述一家临床研究机构的内部审查委员会流程,并提供其开展临床研究的方案示例。在简要介绍内部审查委员会的必要性的历史背景之后,将讨论审查过程本身。重点强调患者的医疗/法律权利和安全。了解审查过程为何必要并掌握审查委员会标准的示例后,护士研究人员便有了开展研究项目的工具。