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The ethics of testing and research of manufactured organs on brain-dead/recently deceased subjects
  1. Brendan Parent1,
  2. Bruce Gelb2,
  3. Stephen Latham3,
  4. Ariane Lewis1,
  5. Laura L Kimberly1,4,
  6. Arthur L Caplan1
  7. NYU Medical Ethics Working Group on Research on the Recently Deceased
    1. 1Division of Medical Ethics, New York University School of Medicine, New York City, New York, USA
    2. 2Transplant Institute, New York University School of Medicine, New York City, New York, USA
    3. 3Interdisciplinary Center for Bioethics, Yale University, New Haven, Connecticut, USA
    4. 4Hansjörg Wyss Department of Plastic Surgery, NYU School of Medicine, New York City, New York, USA
    1. Correspondence to Dr Brendan Parent, Medical Ethics, New York University School of Medicine, New York, NY 10016, USA; brendan.parent{at}nyu.edu

    Abstract

    Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased.

    • research ethics
    • allocation of organs/tissues
    • dead donor rule
    • donation/procurement of organs/tissues
    • allocation of health care resources
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    Footnotes

    • Twitter @parent_brendan, @arthurcaplan

    • Collaborators NYU Medical Ethics Working Group: Luis Angel, NYU Langone Health; Scott Briggs, Touro College of Medicine; James Childress, University of Virginia; Nancy Dubler, NYU Langone Division of Medical Ethics; Moshe M Cohn, NYU Langone Health; Jared Eckman, NYU Langone Division of Medical Ethics; Sandy Feng, UCSF; Sander Florman, Mt Sinai; Kyle Ferguson, NYU Langone Division of Medical Ethics; Susan Gunderson, LifeSource; Megan Kitts, NYU Langone Division of Medical Ethics; Olivia Scheyer, NYU Langone Division of Medical Ethics; Tamar Schiff, NYU Langone Health; Laura Siminoff, Temple University; Brigitte Sullivan, NYU Langone Health; Angela Turi, NYU Langone Division of Medical Ethics; Stephen Wall, NYU Langone Health.

    • Contributors Each author was responsible for drafting a different primary content section. BG and SL were responsible for editing all sections down to meet word length requirements. BP is responsible for overall content as guarantor.

    • Funding This study was supported by United Therapeutics Corporation.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; internally peer reviewed.

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