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

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.

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Notes

  1. It is possible to consider various theories of justice for understanding a fair usage of 3D bioprinting (e.g. egalitarian approach, sufficiency principle, prioritarianism, etc).

  2. Not establishing an acceptable risk level may lead to a public rejection or distrust of these technologies. These public concerns may impact the development of the technology, regardless of whether the fears which propel public rejection or distrust have any likelihood of being realized.

  3. Practically, most cancer phase 1 study evaluates efficacy endpoints like tumor response or even progression free survival.

  4. Similar to some concerns associated with nanotechnologies, one could ask whether there is a positive moral obligation to develop bioprinting technologies (Gilbert and Dodds 2014).

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Acknowledgements

We would like to thank Science & Engineering Ethics anonymous reviewers and editors for their insightful comments. As well the Brocher Foundation. Dr. Frederic Gilbert is the recipient of an Australian Research Council Discovery Early Career Researcher Award (project number DE150101390). Funding from the Australian Research Council Centre of Excellence Scheme (Project Number CE 140100012) is gratefully acknowledged.

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Correspondence to Frederic Gilbert.

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Gilbert, F., O’Connell, C.D., Mladenovska, T. et al. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine. Sci Eng Ethics 24, 73–91 (2018). https://doi.org/10.1007/s11948-017-9874-6

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Keywords

  • 3D printing
  • Bioprinting
  • Tissues engineering
  • Human experimental trials
  • Ethical issues
  • Personalised medicine
  • Regulatory concerns
  • Clinical trial
  • Risk of harm
  • Stem cells
  • Organ
  • Regulation
  • Medical device
  • FDA
  • TGA