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保障临床研究中的儿童权益。

Safeguarding children in clinical research.

机构信息

Department of Philosophy, History and Law, Swansea University, Swansea SA2 8PP, UK.

出版信息

Nurs Ethics. 2012 Jul;19(4):530-7. doi: 10.1177/0969733012437989. Epub 2012 Jun 12.

DOI:10.1177/0969733012437989
PMID:22691599
Abstract

Current UK guidelines regarding clinical research on children permit research that is non-therapeutic from the perspective of that particular child. The guidelines permit research interventions that cause temporary pain, bruises or scars. It is argued here that such research conflicts with the Declaration of Helsinki according to which the interests of the research subject outweigh all other interests. Given this, in the context of clinical research, who is best placed to protect the child from this kind of exploitation? Is it the medical researcher, the child's parents or the nurse advocate? This article describes the problem, possible responses to it, and closes with a consideration of, and rejection of, a defence of current guidelines that claims moral parity between clinical research and clinical education.

摘要

目前英国有关儿童临床研究的指南允许从特定儿童的角度进行非治疗性的研究。该指南允许进行可能导致暂时疼痛、瘀伤或疤痕的研究干预措施。这里有人认为,这种研究与《赫尔辛基宣言》相冲突,根据该宣言,研究对象的利益大于所有其他利益。有鉴于此,在临床研究的背景下,谁最有能力保护儿童免受这种剥削?是医学研究人员、儿童的父母还是护士倡导者?本文描述了这个问题,探讨了可能的应对措施,并以拒绝当前声称临床研究与临床教育之间存在道德等同的指南辩护为结尾。

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引用本文的文献

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Youth and Parent Appraisals of Participation in a Study of Spontaneous and Induced Pediatric Clinical Pain.青少年及家长对参与一项关于小儿自发性和诱发性临床疼痛研究的评估
Ethics Behav. 2019;29(4):259-273. doi: 10.1080/10508422.2018.1463163. Epub 2018 Apr 30.
2
Body matters: rethinking the ethical acceptability of non-beneficial clinical research with children.身体问题:重新思考针对儿童的非有益性临床研究的伦理可接受性。
Med Health Care Philos. 2015 Aug;18(3):421-31. doi: 10.1007/s11019-014-9616-3.