Slimmer Lynda, Andersen Burton
Research Subject Advocacy Program, General Clinical Research Center, University of Illinois Medical Center at Chicago, USA.
West J Nurs Res. 2004 Nov;26(7):797-803. doi: 10.1177/0193945904265922.
Evidence-based nursing practice is now the expected standard of care intensifying the need to conduct clinical research studies to investigate the efficacy of nursing interventions. To ensure that the urgency to document such efficacy does not compromise human participant safety, government research funding agencies are advocating special procedures to protect individuals who voluntarily participate in research studies. The National Institutes of Health application for clinical trial funding requires a data and safety monitoring plan (DSMP) to enhance human participant safety and clinical research integrity. This article describes an approach to developing a DSMP that includes a study risk assessment and a monitoring design based on that assessment.
循证护理实践现已成为护理的预期标准，这强化了开展临床研究以调查护理干预效果的必要性。为确保记录此类效果的紧迫性不会危及人类受试者的安全，政府研究资助机构倡导采取特殊程序来保护自愿参与研究的个人。美国国立卫生研究院的临床试验资助申请要求制定数据与安全监测计划（DSMP），以提高人类受试者的安全性和临床研究的完整性。本文介绍了一种制定DSMP的方法，该方法包括研究风险评估以及基于该评估的监测设计。
