eCite Digital Repository

Print me an organ? Ethical and regulatory issues emerging from 3D bioprinting in medicine


Gilbert, F and O'Connell, CD and Mladenovska, T and Dodds, S, Print me an organ? Ethical and regulatory issues emerging from 3D bioprinting in medicine, Science and Engineering Ethics, 24, (1) pp. 73-91. ISSN 1353-3452 (2018) [Refereed Article]

Copyright Statement

Copyright 2017 Springer Science+Business Media Dordrecht

DOI: doi:10.1007/s11948-017-9874-6


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

Item Details

Item Type:Refereed Article
Keywords:3D printing, bioprinting, regulatory concerns, ethics, risk of harm, tissues engineering, human experimental trials, clinical trial, bioprinting, personalised medicine, regulatory concerns, stem cells, organ, regulation, medical device, FDA, TGA
Research Division:Philosophy and Religious Studies
Research Group:Applied ethics
Research Field:Ethical use of new technology
Objective Division:Culture and Society
Objective Group:Ethics
Objective Field:Bioethics
UTAS Author:Gilbert, F (Associate Professor Frederic Gilbert)
UTAS Author:Dodds, S (Professor Susan Dodds)
ID Code:113053
Year Published:2018
Funding Support:Australian Research Council (DE150101390)
Web of Science® Times Cited:69
Deposited By:College Office - CALE
Deposited On:2016-12-09
Last Modified:2022-07-01
Downloads:2 View Download Statistics

Repository Staff Only: item control page