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Bioethical and legal issues in 3D bioprinting
protection rights of donors, and does not stipulate Code provides for absolute voluntary consent for
the mandatory procedure for the preliminary human participation in medical trials including
approval of research by ethical committees [38,39] . knowledge of the nature, duration, and purpose of
Another aspect that needs to be taken into the experiment, its methods, and associated risks.
consideration while evaluating the ethics of According to the Convention for the protection of
bioprinting is that the technology is set by a Human Rights and Dignity of the Human Being
digital model. A number of authors note that the with regard to the Application of Biology and
development of 3D bioprinting technology leads Medicine: Convention on Human Rights and
to the “digitalization” of objects of the material Biomedicine (ETS No. 164), medical intervention
world, the boundaries between the physical world can be performed only after the person gives
and the digital space erase, and bioprinting starts to his/her voluntary written consent based on the
digitize the person himself [40,41] . The printed organs information received on the purpose and nature of
which are biofabricated on the basis of digital the intervention, as well as its consequences and
models will replace the natural ones, and thus, risk. In 3D bioprinting, problems might arise in
models will replace nature. Therefore, a question of case of obtaining informed consent in emergency
responsibility for the development and evaluation of situations where a patient is unable to express
the 3D models arises: who and to which extent shall informed consent. Obtaining informed consent
be responsibile for the translation of the anatomical can also be challenged in situations where a
image into digital - «designers», biologists, or participant does not have the full ability to make
programmers? Who will have the legal rights for the a donation decision (e.g., some patients may be in
model? Will it be possible to use the model without a intensive care units) .
[24]
patient’s consent? Is it possible to apply the models To introduce the 3D bioprinting technology
commercially? The questions of confidentiality into clinical practice and eliminate the associated
and privacy arise regarding human digitization. In risks, clinical trials are required. Along with the
the case of bioprinting technology, the digital 3D known ethical rules and standards for conducting
model will represent personalized human data. experimental procedures involving humans, in
Such information needs to be considered private, the case of 3D bioprinting of human tissues and
and special rules regulating the receipt, storage, organs, specific issues arise regarding the design
handling, processing, and application of such of human clinical trials . As 3D bioprinting
[24]
information are required. technology develops within the personalized
The two fundamental principles of human rights medicine paradigm [13,20] , each biofabricated
protection in the field of biomedical research are product is individually tailored for a particular
the principle of informed consent and the principle person and might require additional modifications
of confidentiality. The principle of confidentiality to the experiment design in each case. Thus,
is closely related to the notion of “medical standard approaches for clinical trials such as
secrecy” and implies that the circumstances double-blind randomized control studies cannot
of treatment and the patient’s characteristics be applied to 3D bioprinting technology. Each
are kept confidential with the respect to the 3D bioprinted treatment is unique and adapted
patient’s life. Confidentiality helps to build trust to a specific individual taking into consideration
relationships that are essential for effective and only his or her conditions, and therefore, results of
timely medical care. The principle of informed each case cannot be fully extrapolated into future
consent is also one of the main in the system of treatments. Nevertheless, while the biomaterials
ethical and legal support of medical activity [42,43] . are personalized, criteria and protocols for the
It derives from the concept of general human procedures can be standardized based on the first
rights and is, therefore, generally accepted and clinical trials. The organization of the experimental
allocated in a number of international and national studies on human organ 3D bioprinting is a
documentations. For example, the Nuremberg challenging task. The study has to be ethically

10 International Journal of Bioprinting (2020)–Volume 6, Issue 3