ABSTRACT
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.
Subject(s)
Bioethical Issues , Bioprinting/ethics , Ethical Analysis , Ethics, Research , Printing, Three-Dimensional/ethics , Social Control, Formal , Tissue Engineering/ethics , Bioethical Issues/legislation & jurisprudence , Bioprinting/legislation & jurisprudence , Humans , Internationality , Organ Transplantation , Printing , Printing, Three-Dimensional/legislation & jurisprudence , Risk Assessment , Tissue Engineering/legislation & jurisprudenceABSTRACT
Additive manufacturing has spread widely over the past decade, especially with the availability of home 3D printers. In the future, many items may be manufactured at home, which raises two ethical issues. First, there are questions of safety. Our current safety regulations depend on centralized manufacturing assumptions; they will be difficult to enforce on this new model of manufacturing. Using current US law as an example, I argue that consumers are not capable of fully assessing all relevant risks and thus continue to require protection; any regulation will likely apply to plans, however, not physical objects. Second, there are intellectual property issues. In combination with a 3D scanner, it is now possible to scan items and print copies; many items are not protected from this by current intellectual property laws. I argue that these laws are ethically sufficient. Patent exists to protect what is innovative; the rest is properly not protected. Intellectual property rests on the notion of creativity, but what counts as creative changes with the rise of new technologies.
Subject(s)
Consumer Product Safety/legislation & jurisprudence , Inventions/ethics , Printing, Three-Dimensional/ethics , Intellectual Property , Inventions/legislation & jurisprudence , Inventions/trends , Printing, Three-Dimensional/standards , Printing, Three-Dimensional/trends , Risk Reduction Behavior , United StatesABSTRACT
The beginnings of three-dimensional (3D) printing and bioprinting can be traced to as early as 1984. From printing inorganic models for the generation of biologic scaffolds, additive manufacturing (AM) developed to the direct printing of organic materials, including specialized tissues, proteins, and cells. In recent years, these technologies have gained significantly in relevance, and there have been several innovations, especially in the field of regenerative medicine. It is becoming increasingly important to consider the economic and social aspects of AM, particularly in education and information of medical human resources, society, and politics, as well as for the establishment of homogenous, globally adapted legal regulations.
Subject(s)
Bioprinting/ethics , Bioprinting/legislation & jurisprudence , Printing, Three-Dimensional/ethics , Printing, Three-Dimensional/legislation & jurisprudence , History, 20th Century , History, 21st Century , HumansSubject(s)
Craniofacial Abnormalities/pathology , Ethics, Medical , Parents/psychology , Prenatal Diagnosis/methods , Printing, Three-Dimensional , Conflict, Psychological , Craniofacial Abnormalities/diagnosis , Decision Making/ethics , Female , Humans , Maternal-Fetal Relations/psychology , Pregnancy , Prenatal Diagnosis/ethics , Printing, Three-Dimensional/ethicsSubject(s)
Bioethical Issues , Bioprinting/ethics , Ownership/ethics , Printing, Three-Dimensional/ethics , Tissue Engineering/ethics , Animals , Animals, Laboratory , Biomedical Research/economics , Biomedical Research/ethics , Biopolymers/therapeutic use , Bioprinting/economics , Bioprinting/legislation & jurisprudence , Bioprinting/trends , Culturally Appropriate Technology/economics , Culturally Appropriate Technology/ethics , Culturally Appropriate Technology/legislation & jurisprudence , Culturally Appropriate Technology/trends , Humans , Hydrogels/therapeutic use , Morale , Ownership/legislation & jurisprudence , Printing, Three-Dimensional/economics , Printing, Three-Dimensional/legislation & jurisprudence , Printing, Three-Dimensional/trends , Plastic Surgery Procedures/methods , Religion , Tissue Engineering/legislation & jurisprudence , Tissue Engineering/methods , Tissue Engineering/trends , Tissue Scaffolds/economics , Tissue Scaffolds/trends , Tissue and Organ Harvesting/economics , Tissue and Organ Harvesting/ethics , Tissue and Organ Harvesting/legislation & jurisprudence , Tissue and Organ Harvesting/trendsABSTRACT
3D bioprinting involves engineering live cells into a 3D structure, using a 3D printer to print cells, often together with a compatible 3D scaffold. 3D-printed cells and tissues may be used for a range of purposes including medical research, in vitro drug testing, and in vivo transplantation. The inclusion of living cells and biomaterials in the 3D printing process raises ethical, policy, and regulatory issues at each stage of the bioprinting process that include the source of cells and materials, stability and biocompatibility of cells and materials, disposal of 3D-printed materials, intended use, and long-term effects. This chapter focuses on the ethical issues that arise from 3D bioprinting in the lab-from consideration of the source of cells and materials, ensuring their quality and safety, through to testing of bioprinted materials in animal and human trials. It also provides guidance on where to seek information concerning appropriate regulatory frameworks and guidelines, including on classification and patenting of 3D-bioprinted materials, and identifies regulatory gaps that deserve attention.
Subject(s)
Bioprinting/ethics , Printing, Three-Dimensional/ethics , Animal Experimentation/ethics , Animal Experimentation/standards , Animals , Cell Transplantation/adverse effects , Cell Transplantation/ethics , Clinical Trials as Topic/ethics , Evaluation Studies as Topic , Human Experimentation/ethics , Humans , Implants, Experimental/adverse effects , Implants, Experimental/ethics , Intellectual Property , Patents as Topic , Policy , Practice Guidelines as Topic , Stem Cells , Tissue Engineering/ethics , Tissue Scaffolds/adverse effectsABSTRACT
New technological developments have frequently had major consequences for anatomy education, and have raised ethical queries for anatomy educators. The advent of three-dimensional (3D) printing of human material is showing considerable promise as an educational tool that fits alongside cadaveric dissection, plastination, computer simulation, and anatomical models and images. At first glance its ethical implications appear minimal, and yet the more extensive ethical implications around clinical bioprinting suggest that a cautious approach to 3D printing in the dissecting room is in order. Following an overview of early groundbreaking studies into 3D printing of prosections, organs, and archived fetal material, it has become clear that their origin, using donated bodies or 3D files available on the Internet, has ethical overtones. The dynamic presented by digital technology raises questions about the nature of the consent provided by the body donor, reasons for 3D printing, the extent to which it will be commercialized, and its comparative advantages over other available teaching resources. In exploring questions like these, the place of 3D printing within a hierarchical sequence of value is outlined. Discussion centers on the significance of local usage of prints, the challenges created by regarding 3D prints as disposable property, the importance of retaining the human side to anatomy, and the unacceptability of obtaining 3D-printed material from unclaimed bodies. It is concluded that the scientific tenor of 3D processes represents a move away from the human person, so that efforts are required to prevent them accentuating depersonalization and commodification.