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临床研究中一个未被探索的伦理问题:在 Creando Posibilidades [创造可能性]研究中披露个体研究结果。

An unexplored ethical issue in clinical research: disclosure of individual findings in the Creando Posibilidades [Creating Possibilities] study.

机构信息

School of Nursing, University of Rochester, Box SON, Helen Wood Hall, 601 Elmwood Avenue, Rochester, NY 14642, USA.

出版信息

Res Nurs Health. 2013 Jun;36(3):311-9. doi: 10.1002/nur.21533. Epub 2013 Feb 13.

DOI:10.1002/nur.21533
PMID:23408475
Abstract

Individual disclosure refers to the presumptive ethical responsibility of an investigator to communicate to a study participant information that was collected as a part of a research study protocol and is specific to the individual. Currently, there are no federal regulatory guidelines specifying the conditions and management of disclosure of health-related individual-specific information. In this report, the authors discuss the challenges associated with individual disclosure in the context of a longitudinal descriptive study. Arguments favoring disclosure and those challenging disclosure as a general ethical duty are presented. Finally, strategies for addressing individual disclosure are discussed using a research exemplar in which risk behaviors related to health outcomes were measured.

摘要

个体披露是指调查员的推定伦理责任,即向研究参与者传达作为研究方案一部分收集的、与个体特定相关的信息。目前,尚无联邦监管指南具体规定披露与健康相关的个体特定信息的条件和管理。在本报告中,作者讨论了在纵向描述性研究背景下个体披露所面临的挑战。本文介绍了支持披露的观点和将披露作为一般伦理义务的观点,并讨论了使用研究范例解决个体披露问题的策略,该范例中测量了与健康结果相关的风险行为。

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