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纳米医学创新中的伦理和法律挑战:一项范围综述

Ethical and legal challenges in nanomedical innovations: a scoping review.

作者信息

Wasti Sophia, Lee Il Ho, Kim Sumin, Lee Jae-Hyun, Kim Hannah

机构信息

Asian Institute of Bioethics and Health Law, Yonsei University, Seoul, Republic of Korea.

Institute for Legal Studies, Yonsei University, Seoul, Republic of Korea.

出版信息

Front Genet. 2023 May 12;14:1163392. doi: 10.3389/fgene.2023.1163392. eCollection 2023.

Abstract

Rapid advancements in research and development related to nanomedical technology raise various ethical and legal challenges in areas relevant to disease detection, diagnosis, and treatment. This study aims to outline the existing literature, covering issues associated with emerging nanomedicine and related clinical research, and identify implications for the responsible advancement and integration of nanomedicine and nanomedical technology throughout medical networks in the future. A scoping review, designed to cover scientific, ethical, and legal literature associated with nanomedical technology, was conducted, generating and analyzing 27 peer-reviewed articles published between 2007-2020. Results indicate that articles referencing ethical and legal issues related to nanomedical technology were concerned with six key areas: 1) harm exposure and potential risks to health, 2) consent to nano-research, 3) privacy, 4) access to nanomedical technology and potential nanomedical therapies, 5) classification of nanomedical products in relation to the research and development of nanomedical technology, and 6) the precautionary principle as it relates to the research and development of nanomedical technology. This review of the literature suggests that few practical solutions are comprehensive enough to allay the ethical and legal concerns surrounding research and development in fields related to nanomedical technology, especially as it continues to evolve and contribute to future innovations in medicine. It is also clearly apparent that a more coordinated approach is required to ensure global standards of practice governing the study and development of nanomedical technology, especially as discussions surrounding the regulation of nanomedical research throughout the literature are mainly confined to systems of governance in the United States.

摘要

与纳米医学技术相关的研发迅速发展,在疾病检测、诊断和治疗等相关领域引发了各种伦理和法律挑战。本研究旨在概述现有文献,涵盖与新兴纳米医学及相关临床研究相关的问题,并确定纳米医学和纳米医学技术在未来整个医疗网络中负责任地发展和整合所产生的影响。开展了一项范围综述,旨在涵盖与纳米医学技术相关的科学、伦理和法律文献,共生成并分析了2007年至2020年间发表的27篇同行评议文章。结果表明,提及与纳米医学技术相关的伦理和法律问题的文章涉及六个关键领域:1)危害暴露及对健康的潜在风险;2)纳米研究的知情同意;3)隐私;4)纳米医学技术和潜在纳米医学疗法的获取;5)纳米医学产品与纳米医学技术研发相关的分类;6)与纳米医学技术研发相关的预防原则。对文献的这项综述表明,很少有切实可行的解决方案能全面缓解围绕纳米医学技术相关领域研发的伦理和法律担忧,尤其是随着该技术不断发展并为未来医学创新做出贡献。同样明显的是,需要采取更协调一致的方法来确保纳米医学技术研究和开发的全球实践标准,特别是因为整个文献中关于纳米医学研究监管的讨论主要局限于美国的治理体系。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2da6/10213273/bb7d85e96dce/fgene-14-1163392-g001.jpg

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