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临床研究中的儿童:道德价值观的冲突。

Children in clinical research: a conflict of moral values.

作者信息

Sharav Vera Hassner

机构信息

The Alliance for Human Research Protection.

出版信息

Am J Bioeth. 2003 Winter;3(1):W-IF 2. doi: 10.1162/152651603322781639.

DOI:10.1162/152651603322781639
PMID:14560714
Abstract

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children.

摘要

本文探讨了决定美国如何对儿童进行医学研究的文化、动态因素和经济基础。儿童越来越多地成为实验对象,这些实验对他们没有潜在的直接益处,却使他们面临伤害和痛苦的风险。将审视一系列此类实验,包括一项致命的胃灼热药物测试、起搏器的实验性植入、侵入性胰岛素输注实验以及芬氟拉明“暴力预测”实验。然而,由于在缺乏任何客观、可验证的诊断工具的情况下存在固有的伦理和诊断问题,本文将重点关注精神活性药物测试。努力为读者提供关于这些药物对成人和儿童构成的严重风险的循证报告的全面参考资料,以便读者能够判断这些益处(如果有的话)是否超过对儿童的风险。

相似文献

1
Children in clinical research: a conflict of moral values.临床研究中的儿童:道德价值观的冲突。
Am J Bioeth. 2003 Winter;3(1):W-IF 2. doi: 10.1162/152651603322781639.
2
The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research.《食品药品管理现代化法案》对招募儿童参与研究的影响。
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Human subjects research. Pediatric study of ADHD drug draws high-level public review.人体受试者研究。多动症药物的儿科研究引发高级别公众审查。
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When do the federal regulations allow placebo-controlled trials in children?联邦法规何时允许在儿童中进行安慰剂对照试验?
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6
A response to "Children in clinical research: a conflict of moral values" by Vera Hassner Sharav.
Am J Bioeth. 2003 Summer;3(3):W-C1. doi: 10.1162/152651603322874807.
7
Central ethical dilemmas in research involving children.涉及儿童的研究中的核心伦理困境。
Account Res. 2002 Jul-Dec;9(3-4):127-42. doi: 10.1080/08989620214686.
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The long arm of financial conflicts of interest: extensions into lined pockets, research and review, and the United States Senate.经济利益冲突的深远影响:延伸至中饱私囊、研究与评审以及美国参议院。
J Pediatr Endocrinol Metab. 2008 Jul;21(7):607-9.
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Conflicts of interest in medical research: how much conflict should exceed legal boundaries?医学研究中的利益冲突:多大程度的冲突会超越法律界限?
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10
Ethics. Human health research ethics.伦理。人类健康研究伦理。
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Eur J Pediatr. 2022 Nov;181(11):3805-3816. doi: 10.1007/s00431-022-04609-2. Epub 2022 Sep 9.
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Non-static framework for understanding adaptive designs: an ethical justification in paediatric trials.理解适应性设计的非静态框架:儿科试验中的伦理辩护。
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Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews.
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Med Health Care Philos. 2015 Aug;18(3):421-31. doi: 10.1007/s11019-014-9616-3.
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Regulating research with human subjects--is the system broken?规范涉及人类受试者的研究——这个体系出问题了吗?
Trans Am Clin Climatol Assoc. 2005;116:91-101; discussion 101-2.
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Protection of children and adolescents in psychiatric research: an unfinished business.保护儿童和青少年参与精神科研究:一项未竟事业。
HEC Forum. 2005 Sep;17(3):210-26. doi: 10.1007/s10730-005-2548-9.