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保护临床研究中的弱势群体:儿童、孕妇、囚犯和雇员。

Protecting vulnerable subjects in clinical research: children, pregnant women, prisoners, and employees.

作者信息

Schwenzer Karen J

机构信息

Department of Anesthesiology, University of Virginia Health System, Box 800710, Charlottesville VA 22908-0710, USA.

出版信息

Respir Care. 2008 Oct;53(10):1342-9.

PMID:18811998
Abstract

The federal government has established guidelines and regulations for the protection of vulnerable research subjects, especially children, pregnant women, cognitively impaired persons, and prisoners. In addition, students, residents, and employees are recognized as special research populations. Clinical investigators need to be aware of and use these federal guidelines appropriately. This article provides practical guidance for respiratory therapists who conduct research with these patient populations and solutions to the barriers investigators commonly encounter when studying these patient populations.

摘要

联邦政府已制定了保护弱势研究对象的指导方针和法规,特别是儿童、孕妇、认知障碍者和囚犯。此外,学生、住院医生和员工也被视为特殊研究群体。临床研究人员需要了解并适当使用这些联邦指导方针。本文为对这些患者群体进行研究的呼吸治疗师提供了实用指导,以及研究人员在研究这些患者群体时通常遇到的障碍的解决方案。

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