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研究不端行为的规范是否应与《贝尔蒙报告》中颁布的伦理框架相结合?

Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?

机构信息

Associate in the Division of Medical Ethics at NYU Grossman School of Medicine and an adjunct professor in the NYU School of Nursing.

Drs. William F. and Virginia Connoly Mitty Professor of Bioethics at NYU Langone Medical Center and the founding director of the Division of Medical Ethics at NYU Grossman School of Medicine.

出版信息

Ethics Hum Res. 2021 Jan;43(1):37-41. doi: 10.1002/eahr.500078.

DOI:10.1002/eahr.500078
PMID:33463076
Abstract

The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such.

摘要

2005 年最终确定的联邦研究不端行为规定没有纳入《贝尔蒙报告》中阐述的关于保护人类受试者的重要原则,但研究不端行为可能会对研究对象和随后依据虚假研究结果进行治疗的患者造成伤害。与《贝尔蒙原则》保持一致将要求确保定期监测以发现研究不端行为,追踪研究不端行为对试验参与者的影响并告知他们这些影响,如果随后发现与该研究有关的研究不端行为,则确保及时更正研究结果的发表报告。研究不端行为历来被视为科学界管理的问题;实际上,它是对人类受试者福祉的威胁,从伦理上讲,应该将其视为此类问题。

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Should the Regulation of Research Misconduct Be Integrated with the Ethics Framework Promulgated in The Belmont Report?研究不端行为的规范是否应与《贝尔蒙报告》中颁布的伦理框架相结合?
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