Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine

• Published in: Science and engineering ethics Vol. 24; no. 1; pp. 73 - 91
• Main Authors: Gilbert, Frederic, O’Connell, Cathal D., Mladenovska, Tajanka, Dodds, Susan
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.02.2018; Springer Nature B.V
• Subjects: 3-D printers; Bioengineering; Bioethical Issues - legislation & jurisprudence; Bioethics; Biomaterials; Biomedical Engineering and Bioengineering; Biomedical materials; Bioprinting - ethics; Bioprinting - legislation & jurisprudence; Education; Engineering; Ethical Analysis; Ethics; Ethics, Research; Health services; Human subjects; Humans; International regulations; Internationality; Medical ethics; Medical treatment; Medicine; Medicine/Public Health; Organ Transplantation; Organs; Original Paper; Philosophy; Philosophy of Science; Printing; Printing, Three-Dimensional - ethics; Printing, Three-Dimensional - legislation & jurisprudence; Risk Assessment; Social Control, Formal; Three dimensional printing; Tissue Engineering - ethics; Tissue Engineering - legislation & jurisprudence; Bioprinting; FDA; Regulatory concerns; Tissues engineering; Risk of harm; Ethical issues; TGA; Stem cells; Clinical trial; Personalised medicine; Regulation; Medical device; Human experimental trials; 3D printing; Organ
• ISSN: 1353-3452; 1471-5546
• 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 it focuses 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 for 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 the regulation and testing of 3D bioprinting treatments.