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青少年戒烟研究中的人类受试者挑战:研究者的观点

Human participants challenges in youth tobacco cessation research: researchers' perspectives.

作者信息

Diviak Kathleen R, Curry Susan J, Emery Sherry L, Mermelstein Robin J

机构信息

University of Illinois at Chicago, Institute for Health Research and Policy, 1747 W. Roosevelt Rd., Suite 558 M/C 275, Chicago, IL 60608, USA.

出版信息

Ethics Behav. 2004;14(4):321-34. doi: 10.1207/s15327019eb1404_4.

Abstract

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver.

摘要

招募青少年参与戒烟研究具有挑战性,尤其是考虑到机构审查委员会(IRB)对涉及青少年的研究所作的要求。本文简要回顾了适用于青少年研究的联邦法规,并描述了研究人员在寻求IRB批准青少年戒烟研究方面的经历。21位研究人员提供了相关信息。最常报告的困难涉及获得家长同意。文中还确定了在获得IRB批准方面常见问题的解决办法。放弃家长同意有助于招募青少年参与研究;然而,研究人员在申请放弃时必须确保其方案符合联邦法规。

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