Advertisement

Ethics and Policy for Bioprinting

  • Eliza GoddardEmail author
  • Susan DoddsEmail author
Protocol
  • 89 Downloads
Part of the Methods in Molecular Biology book series (MIMB, volume 2140)

Abstract

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.

Key words

Human research ethics Animal research ethics Governance Regulation Bioethics 3D Bioprinting Stem cells 

Notes

Acknowledgments

The authors wish to acknowledge funding from the Australian Research Council (ARC) Centre of Excellence Scheme (CE140100012).

References

  1. 1.
    Murphy SV, Atala A (2014) 3D bioprinting of tissues and organs. Nat Biotechnol 32(8):773–785CrossRefGoogle Scholar
  2. 2.
    Shafiee A, Atala A (2016) Printing technologies for medical applications. Trends Mol Med 22(3):254–265.  https://doi.org/10.1016/j.molmed.2016.01.003CrossRefPubMedGoogle Scholar
  3. 3.
    Baker HB, McQulling JP, King NM (2016) Ethical considerations in tissue engineering research: case studies in translation. Methods 99:135–144.  https://doi.org/10.1016/j.ymeth.2015.08.010CrossRefPubMedGoogle Scholar
  4. 4.
    Tuckson RV, Newcomer L, De Sa JM (2013) Accessing genomic medicine: affordability, diffusion, and disparities. JAMA 309(14):1469–1470CrossRefGoogle Scholar
  5. 5.
    Allhoff F, Lin P, Steinberg J (2011) Ethics of human enhancement: an executive summary. Sci Eng Ethics 17:201–212.  https://doi.org/10.1007/s11948-009-9191-9CrossRefPubMedGoogle Scholar
  6. 6.
    Li P, Faulkner A (2017) 3D bioprinting regulations: a UK/EU perspective. Eur J Risk Regulat 8(2):441–447.  https://doi.org/10.1017/err.2017.19CrossRefGoogle Scholar
  7. 7.
    National Health and Medical Research Council, Australian Research Council and Universities Australia (2007, Updated 2018) National Statement on ethical conduct in human research. Commonwealth of Australia, Canberra. https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018
  8. 8.
    Wallace G, Cornock R, Connell C et al (2014) 3D bioprinting: printing parts for bodies. ARC Centre of Excellence for Electromaterials Science, AustraliaGoogle Scholar
  9. 9.
    World Medical Association (1964, updated 2013) World medical association declaration of Helsinki—ethical principles for medical research involving human subjects, J Am Med Assoc 310(20):2191–2194.  https://doi.org/10.1001/jama.2013.281053. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
  10. 10.
    Council for International Organizations of Medical Sciences and World Health Organization (1982, Updated 2016) international ethical guidelines for Health related research involving humans. 4th edition. CIOMS, Geneva. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. Accessed 9 Aug 2019
  11. 11.
    The Academy of Medical Sciences (2011) Animals Containing Human Material. https://acmedsci.ac.uk/file-download/35228-Animalsc.pdf. Accessed 9 Aug 2019
  12. 12.
    Prohibition of Human Cloning for Reproduction Act 2002 (Cth). Australian Government. https://www.legislation.gov.au/Series/C2004A01081
  13. 13.
    Leberfinger AN, Ravnic DJ, Dhawan A et al (2017) Concise review: bioprinting of stem cells for translatable tissue fabrication. Stem Cells Transl Med 6:1940–1948CrossRefGoogle Scholar
  14. 14.
    de Vries RBM, Oerlemans A, Trommelmans L et al (2008) Ethical aspects of tissue engineering: a review. Tissue Eng Part B Rev 14(4):367–375CrossRefGoogle Scholar
  15. 15.
    de Wert G, Mummery C (2003) Human embryonic stem cells: research, ethics and policy. Hum Reprod 18(4):672–682CrossRefGoogle Scholar
  16. 16.
    Klitzman R, Sauer MV (2015) Creating and selling embryos for “donation”: ethical challenges. Am J Obstet Gynecol 212(2):167–170.  https://doi.org/10.1016/j.ajog.2014.10.1094CrossRefPubMedGoogle Scholar
  17. 17.
    Research Involving Human Embryos Act 2002 (Cth). Australian Government. https://www.legislation.gov.au/Series/C2004A01082
  18. 18.
    Advanced Human Fertilisation and Embryology Act (HFEA) 2008 (c22). http://www.legislation.gov.uk/ukpga/2008/22/contents
  19. 19.
    Gilbert F, O’Connell CD, Mladenovska T et al (2018) Print me an organ? Ethical and regulatory issues emerging from 3D bioprinting in medicine. Sci Eng Ethics 24(1):73–91.  https://doi.org/10.1007/s11948-017-9874-6CrossRefPubMedGoogle Scholar
  20. 20.
    Vijayavenkataraman S, Lu WF, Fuh JYH (2016) 3D bioprinting—an ethical, legal and social aspects (ELSA) framework. Bioprinting 1–2:11–16CrossRefGoogle Scholar
  21. 21.
    Enoch S, Shaaban H, Dunn KW (2005) Informed consent should be obtained from patients to use products (skin substitutes) and dressing containing biological material. J Med Ethics 31(1):2–6CrossRefGoogle Scholar
  22. 22.
    European Parliament and Council of the European Union European Tissues and Cells Directive, Directive 2004/23/EC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32004L0023
  23. 23.
  24. 24.
    Varkey M, Atala A (2015) Organ bioprinting: a closer look at ethics and policies. Wake Forest Journal of Law and Policy 275–298Google Scholar
  25. 25.
    Harbaugh JT (2015) Do you own your 3D bioprinted body? Analyzing property issues at the intersection of digital information and biology. Am J Law Med 41:167–189CrossRefGoogle Scholar
  26. 26.
    National Institutes of Health (NIH) (2009) Guidelines on Human Stem Cell Research. https://stemcells.nih.gov/policy/2009-guidelines.htm
  27. 27.
    Kantor J (2017) Public support in the U.S. for human-animal chimera research: results of a representative cross-sectional survey of 1,058 adults. Stem Cells Transl Med 6:1442–1444CrossRefGoogle Scholar
  28. 28.
    Koplin JJ, Savulescu J (2019) Time to re-think the law on part-human chimeras. J Law Biosci 6:37.  https://doi.org/10.1093/jlb/lsz005CrossRefPubMedPubMedCentralGoogle Scholar
  29. 29.
    Moy A (2017) Why the moratorium on human-animal chimera research should not be lifted. Linacre Quarterly 84:226–231CrossRefGoogle Scholar
  30. 30.
    World Health Organization, Laboratory Biosafety Manual 3rd Ed. https://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2004_11/en/
  31. 31.
    Bishop ES, Mostafe S, Pakvasa M et al (2017) 3-D bioprinting technologies in tissue engineering and regenerative medicine: Current and future trends. Genes Dis 4:185–195CrossRefGoogle Scholar
  32. 32.
    Mandrycky C, Wang Z, Kim K et al (2016) 3D bioprinting for engineering complex tissues. Biotechnol Adv 34(4):422–434CrossRefGoogle Scholar
  33. 33.
    Office of the Federal Registrar, Code of Federal Regulations Title 21, Parts 1270 and 1271. US Government. https://www.ecfr.gov/cgi-bin/text-idx?SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
  34. 34.
    World Health Organization (1997) Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development–2nd ed. https://www.who.int/tdr/publications/training-guidelinepublications/good-laboratory-practice-handbook/en/
  35. 35.
    Office of the Federal Registrar Code of Federal Regulations, Title 21, Part 58. US government. https://www.ecfr.gov/cgi-bin/text-idx?SID=59467274f688447a894544906d008a39&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
  36. 36.
  37. 37.
    World Health Organization, Good Manufacturing Practices for Biological Products, Technical Report Series no 999, Annex 2. https://apps.who.int/medicinedocs/documents/s22400en/s22400en.pdf. Accessed 9 Aug 2019
  38. 38.
    Office of the Federal Registrar (2011) Code of Federal Regulations, Title 21, Part 210 and 211. US GovernmentGoogle Scholar
  39. 39.
    European Parliament and Council of the European Union, Commission directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf. Accessed 9 Aug 2019
  40. 40.
    National Health and Medical Research Council NHRMC (2013) Australian code for the care and use of animals in research. Government of Australia, Canberra. https://nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposesGoogle Scholar
  41. 41.
    Festing S, Wilkinson R (2007) The ethics of animal research. Talking Point on the use of animals in scientific research. EMBO Rep 8(6):526–530. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2002542/pdf/7400993.pdfCrossRefGoogle Scholar
  42. 42.
    The Animals (Scientific Procedures) Act 1986. https://www.legislation.gov.uk/ukpga/1986/14/contents
  43. 43.
  44. 44.
  45. 45.
    European Parliament and Council of the European Union, Directive 210/63/EU on the protection of animals used for scientific purposes. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010L0063
  46. 46.
    Ogden BE, Wanyong P, Agui T et al (2016) Laboratory animal laws, regulations, guidelines and standards in China Mainland, Japan, and Korea. ILAR J 57(3):301–311.  https://doi.org/10.1093/ilar/ilw018CrossRefPubMedGoogle Scholar
  47. 47.
    European Parliament and Council of the European Union, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. https://ec.europa.eu/growth/sectors/medical-devices_en
  48. 48.
    Hourd P et al (2015) 3D-bioprinting exemplar of the consequences of the regulatory requirement on customized process. Regen Med 10(7):863–883CrossRefGoogle Scholar
  49. 49.
    Commonwealth of Australia (2018) Therapeutic Goods (Medical Devices) Regulations 2002. https://www.legislation.gov.au/Series/F2002B00237
  50. 50.
    Commonwealth of Australia (July 2019) Commonwealth of Australia (July 2019) Therapeutic Goods Regulations (1990). https://www.legislation.gov.au/Series/F1996B00406
  51. 51.
    Commonwealth of Australia (2011) Australian Regulatory Guidelines for Medical Devices. https://www.tga.gov.au/sites/default/files/devices-argmd-01.pdf Accessed 9 Aug 2019
  52. 52.
    Commonwealth of Australia Australian Regulatory Guidelines for Biologicals. https://www.tga.gov.au/publication/australian-regulatory-guidelines-biologicals-argb
  53. 53.
    European Parliament and Council of the European Union. Therapy Medicinal Products (ATMP) Regulation. Regulation (EC) No 1394/2007 of the European Parliament and the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf. Accessed 9 Aug 2019
  54. 54.
    Li P (2014) 3D bioprinting technologies: patents, innovation and access. Law Innov Technol 6:282–304CrossRefGoogle Scholar
  55. 55.
    Bauer HKM, Heller M, Fink M et al (2016) Social and legal frame conditions for 3d (and) bioprinting in medicine. Int J Comput Dentist 19(4):293–299Google Scholar
  56. 56.
    Mendis D, Nielsen J, Nicol D et al (2017) The coexistence of copyright and patent laws to protect innovation: a case study of 3D printing in UK and Australian Law. The Oxford Handbook of Law, Regulation and Technology. Edited by R Brownsword, E Scotford, and K Yeung. doi:  https://doi.org/10.1093/oxfordhb/9780199680832.013.80
  57. 57.
    Tran JL (2015) To bioprint or not to bioprint. N C J Law Technol 17:123–178Google Scholar
  58. 58.
    Nielsen J, Nicol D (2019) The reform challenge: Australian patent law and the emergence of 3D printing. 3D printing and beyond: intellectual property and regulation. Edited by D Mendis, M Lemley and M Rimmer. Edward Elgar Publishing, Cheltenham, UK, pp 325–346Google Scholar
  59. 59.
    European Patent Convention (EPC), Article 53(a). https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar53.html
  60. 60.
    India, Patents Act, 1970, Chapter II, Section 3b (amendments). http://www.ipindia.nic.in/writereaddata/Portal/IPOAct/1_31_1_patent-act-1970-11march2015.pdf. Accessed 9 Aug 2019

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  1. 1.ARC Centre of Excellence for Electromaterials Science, Humanities and Social SciencesLa Trobe UniversityMelbourneAustralia
  2. 2.ARC Centre of Excellence for Electromaterials Science, Office of the Deputy Vice-Chancellor (Research and Industry Engagement)La Trobe UniversityMelbourneAustralia

Personalised recommendations