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Abstract

Recent developments of three-dimensional printing of biomaterials (3D bioprinting)in medicine have been portrayed as demonstrating the potential to transform somemedical treatments, including providing new responses to organ damage or organfailure. However, beyond the hype and before 3D bioprinted organs are ready to betransplanted into humans, several important ethical concerns and regulatory questionsneed to be addressed. This article starts by raising general ethical concerns associatedwith the use of bioprinting in medicine, then focus on more particular ethical issuesrelated to experimental testing on humans, and the lack of current internationalregulatory directives to guide these experiments. Accordingly, this article 1) considerswhether there is a limit as to what should be bioprinted in medicine; 2) examines keyrisks of significant harm associated with testing 3D bioprinting in humans; 3)investigates the clinical trial paradigm used to test 3D bioprinting; 4) analyses ethicalquestions of irreversibility, loss of treatment opportunity and replicability; 5) exploresthe current lack of a specific framework for regulating and testing 3D bioprintingtreatments.

Item Type:	Article
Authors/Creators:	Gilbert, F and O'Connell, C and Mladenovska, T and Dodds, S
Keywords:	3D Bioprinting, Regulation, Policy, Ethics, Risk of harms,
Journal or Publication Title:	Science and Engineering Ethics
Publisher:	Springer New York LLC
ISSN:	1353-3452
DOI / ID Number:	https://doi.org/10.1007/s11948-017-9874-6
Copyright Information:	Copyright 2017 Springer Science+Business Media Dordrecht
Related URLs:	Google Scholar: Gilbert, F UTAS Profile: Gilbert, F Google Scholar: Dodds, S UTAS Profile: Dodds, S
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