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本文引用的文献

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The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.《贝尔蒙报告》。保护人类研究受试者的伦理原则与准则。
J Am Coll Dent. 2014 Summer;81(3):4-13.
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The social value requirement reconsidered.对社会价值要求的重新审视。
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The social value of clinical research.临床研究的社会价值。
BMC Med Ethics. 2014 Sep 5;15:66. doi: 10.1186/1472-6939-15-66.
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Do U.S. regulations allow more than minor increase over minimal risk pediatric research? Should they?美国法规是否允许儿科研究的风险比最低风险有超过轻微程度的增加?应该允许吗?
IRB. 2013 Nov-Dec;35(6):1-8.
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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
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A non-paternalistic model of research ethics and oversight: assessing the benefits of prospective review.非家长式的研究伦理和监督模式:评估前瞻性审查的益处。
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Research ethics. Rethinking research ethics: the case of postmarketing trials.研究伦理。反思研究伦理:上市后试验案例。
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8
A framework for risk-benefit evaluations in biomedical research.生物医学研究中风险-效益评估的框架。
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9
Seeding trials: just say "no".接种试验:坚决说“不”。
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Pediatric research posing a minor increase over minimal risk and no prospect of direct benefit: challenging 45 CFR 46.406.儿科研究带来的风险略高于最低风险且无直接受益前景:对45 CFR 46.406提出挑战。
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审视涉及人类受试者研究中的社会利益原则。

Examining the Social Benefits Principle in Research with Human Participants.

作者信息

Resnik David B

机构信息

National Institute of Environmental Health Sciences, National Institutes of Health, 111 Alexander Drive, Mail Drop E1-06, Box 12233, Research Triangle Park, NC, 27709, USA.

出版信息

Health Care Anal. 2018 Mar;26(1):66-80. doi: 10.1007/s10728-016-0326-2.

DOI:10.1007/s10728-016-0326-2
PMID:27376952
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5215088/
Abstract

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society (or the public), the reasonable expectation of substantial public benefit should be a necessary condition for regarding research as ethical only when (a) it imposes more than minimal risks on non-consenting subjects; or (b) it is supported by public resources.

摘要

涉及人类受试者的研究应造福社会这一理念已在各种法规、政策和指导方针中牢固确立,但生物伦理学文献中对这一伦理原则的深入分析却很少。在本文中,我区分了社会效益原则的强版本和弱版本,并审视了支持该原则的六个论点。我认为,虽然涉及人类受试者的研究能为社会(或公众)带来重要益处,这在伦理上总是可取的,但只有在以下情况下,对可观公共利益的合理期望才应成为将研究视为符合伦理的必要条件:(a)研究给不同意参与的受试者带来的风险超过最低限度;或(b)研究得到公共资源的支持。