Skip to main content
SpringerLink
Log in

Xenotransplantation and Informed Consent

  • Chapter
  • First Online:
Xenotransplantation

  • 203 Accesses

Abstract

Xenotransplantation (XTx; particularly, pig-to-human transplant) clinical trials of solid organs are likely on the horizon. There is a rich literature noting ethical issues that are particular to XTx clinical trials. Because of these ethical particularities and peculiarities, the informed consent process for XTx has been seen by some commentators as a very challenging endeavor. While organ transplant appears to be on the verge of a wave of XTx clinical trials, it can be surprising that more recent standardized guidance on proper informed consent for these trials is largely missing from the literature. This chapter provides an overview of where the major debates in XTx informed consent lay and attempts to provide some clarity for a way forward.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 119.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    Researchers at The University of Maryland had applied to the FDA to begin a clinical trial of pig-to-human cardiac transplants but were not approved due to lack of non-human primate studies. The FDA granted an emergency authorization for this particular procedure.

References

  1. Kotz D. UM medicine performs historic xenotransplantation 2022 [updated January 11, 2022]. https://www.umaryland.edu/news/archived-news/january-2022/um-medicine-performs-historic-xenotransplantation.php

  2. Reardon S. First pig-to-human heart transplant: what can scientists learn? Nature. 2022;601(7893):305–6. https://doi.org/10.1038/d41586-022-00111-9.

    Article  CAS  PubMed  Google Scholar 

  3. Maschke KJ, Gordon EJ, Gusmano MK. Opinion: after the pig-to-human heart transplant, the FDA, clinicians and insurers have some catching up to do: the Washington post; 2022 [updated January 13, 2022]. https://www.washingtonpost.com/opinions/2022/01/13/what-comes-after-pig-to-human-transplant-breakthrough/

  4. Padilla LA, Hurst D, Maxwell K, Gawlowicz K, Paris W, Cleveland D, et al. Informed consent for potential recipients of pig kidney xenotransplantation in the United States. Transplantation. 2022;106(9):1754–62. https://doi.org/10.1097/TP.0000000000004144.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Hurst DJ, Padilla LA, Trani C, McClintock A, Cooper DKC, Walters W, et al. Recommendations to the IRB review process in preparation of xenotransplantation clinical trials. Xenotransplantation. 2020;27(2):e12587.

    Article  PubMed  Google Scholar 

  6. Beauchamp TL. Informed consent: its history, meaning, and present challenges. Camb Q Healthc Ethics. 2011;20(4):515–23.

    Article  PubMed  Google Scholar 

  7. Bazzano LA, Durant J, Brantley PR. A modern history of informed consent and the role of key information. Ochsner J. 2021;21(1):81–5.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Weindling P. The Nazi medical experiments. In: Emanuel EJ, Grady CA, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press; 2008. p. 18–30.

    Google Scholar 

  9. Annas GJ, Grodin MA. The Nuremberg code. In: Emanuel EJ, Grady CA, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press; 2008. p. 136–40.

    Google Scholar 

  10. The Nuremberg Code National Institutes of Health. https://history.nih.gov/display/history/Nuremberg+Code

  11. Cooper DKC, Ekser B, Tector AJ. A brief history of clinical xenotransplantation. Int J Surg. 2015;23(Pt B):205–10.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Childress JF, Childress MD. What does the evolution from informed consent to shared decision making teach us about Authority in Health Care? AMA J Ethics. 2020;22(5):E423–9.

    Article  PubMed  Google Scholar 

  13. Capron AM. Informed consent in catastrophic disease research and treatment. Univ Pa Law Rev. 1974;123(2):340–438.

    Article  PubMed  Google Scholar 

  14. U.S. Department of Health and Human Services. Informed consent FAQs. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

  15. Cooper DKC, Wijkstrom M, Hariharan S, Chan JL, Singh A, Horvath K, et al. Selection of patients for initial linical trials of solid organ xenotransplantation. Transplantation. 2017;101(7):1551–8.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Jagdale A, Kumar V, Anderson DJ, Locke JE, Hanaway MJ, Eckhoff DE, et al. Suggested patient selection criteria for initial clinical trials of pig kidney xenotransplantation in the United States. Transplantation. 2021;105(9):1904–8.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Nellore A. Infections after xenotransplantation. Curr Opin Organ Transplant. 2018;23(6):628–32.

    Article  PubMed  Google Scholar 

  18. Fishman JA. Infectious disease risks in xenotransplantation. Am J Transplant. 2018;18(8):1857–64.

    Article  PubMed  Google Scholar 

  19. Pierson RN, Fishman JA, Lewis GD, D’Alessandro DA, Connolly MR, Burdorf L, et al. Progress toward cardiac xenotransplantation. Circulation. 2020;142(14):1389–98.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Daar AS. Animal-to-human organ transplants--a solution or a new problem? Bull World Health Organ. 1999;77(1):54–61.

    CAS  PubMed  PubMed Central  Google Scholar 

  21. Bach FH. Putting the public at risk. Bull World Health Organ. 1999;77(1):65–7.

    CAS  PubMed  PubMed Central  Google Scholar 

  22. Sparrow R. Xenotransplantation, consent and international justice. Dev World Bioeth. 2009;9(3):119–27.

    Article  PubMed  Google Scholar 

  23. Rothblatt M. Your life or mine: how geoethics can resolve the conflict between public and private interests in xenotransplantation. London: Routledge; 2004. p. 142–62.

    Google Scholar 

  24. United Nations. Sustainable Development Goals. 2015. https://sdgs.un.org/goals/goal3

  25. Hawthorne WJ, Cowan PJ, Buhler LH, Yi S, Bottino R, Pierson RN 3rd, et al. Third WHO global consultation on regulatory requirements for xenotransplantation clinical trials, Changsha, Hunan, China December 12-14, 2018: “the 2018 Changsha communique” the 10-year anniversary of the international consultation on xenotransplantation. Xenotransplantation. 2019;26(2):e12513.

    Article  PubMed  Google Scholar 

  26. Hurst DJ, Padilla LA, Cooper DKC, Paris W. Factors influencing attitudes toward xenotransplantation clinical trials: a report of focus group studies. Xenotransplantation. 2021;28(4):e12684.

    Article  PubMed  Google Scholar 

  27. Mitchell C, Lipps A, Padilla L, Werkheiser Z, Cooper DKC, Paris W. Meta-analysis of public perception toward xenotransplantation. Xenotransplantation. 2020;27(4):e12583. https://doi.org/10.1111/xen.12684.

    Article  PubMed  Google Scholar 

  28. US Department of Health and Human Services. PHS guideline on infectious disease issues in xenotransplantation. 2001.

    Google Scholar 

  29. Hurst DJ, Padilla LA, Walters W, Hunter JM, Cooper DKC, Eckhoff DM, et al. Paediatric xenotransplantation clinical trials and the right to withdraw. J Med Ethics. 2020;46(5):311–5.

    Article  PubMed  Google Scholar 

  30. Spillman MA, Sade RM. Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required. J Law Med Ethics. 2007;35(2):265–72.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Family Medicine, Rowan-Virtua School of Osteopathic Medicine, Stratford, NJ, USA

    Daniel J. Hurst

Authors
  1. Daniel J. Hurst
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Daniel J. Hurst .

Editor information

Editors and Affiliations

  1. Department of Family Medicine, Rowan-Virtua School of Osteopathic Medicine, Stratford, NJ, USA

    Daniel J. Hurst

  2. Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA

    Luz Padilla

  3. Department of Social Work (Emeritus), Abilene Christian University, Abilene, TX, USA

    Wayne D. Paris

Rights and permissions

Reprints and permissions

Copyright information

© 2023 The Author(s), under exclusive license to Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Hurst, D.J. (2023). Xenotransplantation and Informed Consent. In: Hurst, D.J., Padilla, L., Paris, W.D. (eds) Xenotransplantation. Springer, Cham. https://doi.org/10.1007/978-3-031-29071-8_6

Download citation

  • DOI: https://doi.org/10.1007/978-3-031-29071-8_6

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-29070-1

  • Online ISBN: 978-3-031-29071-8

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation