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

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.

The Risks of Revolution: Ethical Dilemmas in 3D Printing from a US Perspective.

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.

Social and legal frame conditions for 3D (and) bioprinting in medicine.

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.

A review of the ethical considerations for the use of 3D printed materials in medical and allied health education and a proposed collective path forward.

3D scanning and printing technologies are quickly evolving and offer great potential for use in gross anatomical education. The use of human body donors to create digital scans and 3D printed models raises ethical concerns about donor informed consent, potential commodification, and access to and storage of potentially identifiable anatomical reproductions. This paper reviews available literature describing ethical implications for the application of these emerging technologies, existing published best practices for managing and sharing 2D imaging, and current adherence to these best practices by academic body donation programs. We conclude that informed consent is paramount for all uses of human donor and human donor-derived materials and that currently there is considerable diversity in adherence to established best practices for the management and sharing of 3D digital content derived from human donors. We propose a new and simplified framework for categorizing donor-derived teaching materials and the corresponding level of consent required for digital sharing. This framework proposes an equivalent minimum level of specific consent for human donor and human donor-derived materials relative to generalized, nonidentical teaching materials (i.e., artificial plastic models). Likewise, we propose that the collective path forward should involve the creation of a centralized, secure repository for digital human donor 3D content as a mechanism for accumulating, regulating, and controlling the distribution of properly consented human donor-derived 3D digital content that will also increase the availability of ethically created human-derived teaching materials while discouraging commodification.

Ethics and Policy for Bioprinting.

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.

Three-dimensional Printing in Anatomy Education: Assessing Potential Ethical Dimensions.

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.