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基于社区的口腔健康研究中的知情同意。

Informed consent in community-based oral health research.

作者信息

Singh Shenuka

机构信息

Discipline of Dentistry, School of Health Sciences, University of KwaZulu-Natal, South Africa.

出版信息

J Forensic Odontostomatol. 2014 Nov 30;32 Suppl 1(Suppl 1):15-21.

Abstract

The ethical principle of respect for persons presents multiple dimensions to stimulate debate around issues related to informed consent for participation, data management, confidentiality and privacy. The informed consent process is built on a continuum involving a comprehensive explanation of the proposed study; and the declaration of consent (the right to withdraw from at anytime from the study without any negative consequences). All research involving human participants carry a certain level of risk (physical or informational) and it is not possible for the researcher to know all the consequences of participation before a study commences. This presentation will focus around the key issues of information, consent' and competence in relation to community-based oral health research and outlines some of debates in the informed consent process.

摘要

尊重人的伦理原则具有多个层面,以激发围绕参与的知情同意、数据管理、保密和隐私等相关问题的辩论。知情同意过程建立在一个连续统一体之上,包括对拟议研究的全面解释;以及同意声明(有权在任何时候退出研究而不会产生任何负面后果)。所有涉及人类参与者的研究都存在一定程度的风险(身体或信息方面),并且研究人员在研究开始前不可能知晓参与的所有后果。本报告将聚焦于与社区口腔健康研究相关的信息、同意和能力等关键问题,并概述知情同意过程中的一些辩论。

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