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重新定义负责任的研究与创新以推动生物样本库和生物医学研究的发展。

Redefining responsible research and innovation for the advancement of biobanking and biomedical research.

作者信息

Yu Helen

机构信息

University of Copenhagen, Faculty of Law, Center for Information and Innovation, Studiestræde 6, 1455 Copenhagen K, Denmark.

出版信息

J Law Biosci. 2016 Oct 10;3(3):611-635. doi: 10.1093/jlb/lsw047. eCollection 2016 Dec.

DOI:10.1093/jlb/lsw047
PMID:28852540
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5570717/
Abstract

One of the core objectives of responsible research and innovation (RRI) is to maximize the value of publicly funded research so that it may be returned to benefit society. However, while RRI encourages innovation through societal engagement, it can give rise to complex and previously untested issues that challenge the existing legal frameworks on intellectual property (IP) and public entitlement to benefits of research. In the case of biobanking, the personal nature of human biological materials and often altruistic intention of participants to donate samples intensifies the need to adhere to RRI principles with respect to the research, development, and commercialization of innovations derived from biobanks. However, stakeholders participate and collaborate with others in the innovation process to fulfill their own agenda. Without IP to safeguard investments in R&D, stakeholders may hesitate to contribute to the translation of discoveries into innovations. To realize the public benefit objective, RRI principles must protect the interests of stakeholders involved in the translation and commercialization of knowledge. This article explores the seemingly contradictory and competing objectives of open science and commercialization and proposes a holistic innovation framework directed at improving RRI practice for positive impact on obtaining the optimal social and economic values from research.

摘要

负责任的研究与创新(RRI)的核心目标之一是使公共资助研究的价值最大化,以便其能回馈社会。然而,尽管RRI通过社会参与鼓励创新,但它可能引发复杂且前所未有的问题,这些问题对现有的知识产权(IP)法律框架以及公众对研究利益的权利构成挑战。在生物样本库的情况下,人类生物材料的个人性质以及参与者捐赠样本时通常的利他意图,强化了在源自生物样本库的创新的研究、开发和商业化方面遵循RRI原则的必要性。然而,利益相关者在创新过程中与他人参与合作是为了实现自身议程。如果没有知识产权来保障研发投资,利益相关者可能会犹豫是否为将发现转化为创新做出贡献。为实现公共利益目标,RRI原则必须保护参与知识转化和商业化的利益相关者的利益。本文探讨了开放科学与商业化这两个看似矛盾且相互竞争的目标,并提出了一个整体创新框架,旨在改进RRI实践,以对从研究中获取最佳社会和经济价值产生积极影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9fc/5570717/242d05bfa8ed/lsw047fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9fc/5570717/a2dab096e5f8/lsw047fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9fc/5570717/242d05bfa8ed/lsw047fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9fc/5570717/a2dab096e5f8/lsw047fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9fc/5570717/242d05bfa8ed/lsw047fig2.jpg

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