Restrictions on monetary payments for human biological substances in Japan: The mu-shou principle and its ethical implications for stem cell research.
Restrictions on monetary payments for human biological substances in Japan: The mu-shou principle and its ethical implications for stem cell research.
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日本人类生物物质的货币支付的限制：穆斯原理及其对干细胞研究的道德意义。
DOI：
10.1016/j.reth.2023.02.004
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发表时间：
2023-06
影响因子：
4.3
通讯作者：
Kokado, Minori
中科院分区：
文献类型：
--
作者：
Inoue, Yusuke;Masui, Tohru;Harada, Kana;Hong, Hyunsoo;Kokado, Minori
限制从人体器官的销售中获得经济收益是围绕人体组织和细胞使用的一个主要政策问题。然而，法规与现实之间存在差异。在干细胞研究中，可以使用不同来源的组织和细胞，不明确的法规可能会阻碍研究。因此，我们以日本的制度为例，考察了多年来在干细胞研究中实施“无报酬”或“无守原则”所面临的挑战。我们回顾了28项日本法律和政府指南，并总结了对捐赠和提供人类生物样本（HBS）的付款限制范围。作为对经济奖励的限制的一部分，20世纪90年代日本法律和行政文件中出现了无守原则。虽然日语中的mu-shou在英语中通常是“免费”或“免费”的意思，但在研究和开发环境中的解释仍然模糊不清。传统上，这一原则被用来拒绝向捐助者提供报酬。然而，在处理和转移捐赠后的人体组织时，这一原则的适用也不一致，这在各利益攸关方之间造成了混乱。最近的政策以多种方式解释了这一原则：（1）将使用HBS进行细胞处理视为非营利活动;（2）灵活解释这一原则，以扩大用户付费的范围;以及（3）取消这一原则本身，以允许商业用途。哈佛商学院的货币支付要求不一致，可能会阻碍研究和开发。在仔细研究了该原则的背景之后，需要一种有效的方法来考虑提供者、用户和社会的关切。日本的无守原则规定了向捐赠者支付人类生物样本的费用。“不守原则”的范围各不相同，而且往往没有明确规定。对样品的付款要求不一致是一个不稳定因素。有效的办法必须考虑到提供者和社会的需要。
Restrictions on financial gains from the sale of human body parts is a leading policy issue surrounding the use of human tissues and cells. However, discrepancies exist between regulations and reality. In stem cell research, in which diverse sources of tissues and cells can be used, unclear regulations can impede research. Thus, using the Japanese system as a case study, we examined the challenges in the implementation of the “no payment” or the mu-shou principle in stem-cell research over the years. We reviewed 28 Japanese laws and governmental guidelines and summarized the scope of restrictions on payments for the donation and supply of human biological samples (HBS). As part of restrictions on financial rewards, the mu-shou principle emerged in Japanese laws and administrative documents in the 1990s. Although the Japanese mu-shou generally means “free” or “gratis” in English, its interpretation in research and development settings remains ambiguous. Traditionally, this principle was used to deny remuneration to donors. However, it is also inconsistently applied while processing and transferring human tissue after donation, which creates confusion among the various stakeholders. Recent policies have interpreted the principle in multiple ways: (1) treating the use of HBS for cell-processing as a non-profit activity; (2) a flexible interpretation of the principle to broaden the scope of user payments; and (3) removal of the principle itself to allow for commercial use. The inconsistencies in the monetary payment requirements for HBS could hinder research and development. After scrutinizing the principle's background, an effective approach is needed that considers the concerns of the providers, users, and society alike. Japan’s mu-shou principle regulates payments to donors for human biological samples. The scope of the mu-shou principle varies and is often not explicitly stated. Inconsistent monetary payment requirements for samples are a destabilizing factor. An effective approach must consider the needs of the providers and society alike.
影响因子：
4.1
作者：
Lenk, Christian;Beier, Katharina
通讯作者：
Beier, Katharina