Members of the Transplant Ethics and Policy research program at NYU Langone are researching such topics as organ procurement, fair allocation of organs, ensuring equity in the transplant candidate selection process, living and deceased donor considerations, and transplant financing.

Our activities span all forms of transplant, from solid organ transplant procedures to novel or highly innovative forms of vascularized composite allotransplantation (VCA), including transplant of the face, hand, upper or lower limb, uterus, penis, abdominal wall, and cornea.

Our researchers partner with the world-renowned transplant programs at NYU Langone Transplant Institute and the Hansjörg Wyss Department of Plastic Surgery to establish policies and best practices for the ethics of organ donation and transplant. Recent local and national collaborations have focused on emerging ethical challenges in VCA, fairness in transplant eligibility criteria, recommendations for improving national liver allocation, and expanding organ recovery after circulatory determinations of death.

Creating Ethics Frameworks for Xenotransplant Implementation

CRISPR-based gene-editing technology has renewed excitement around xenotransplants, under the theory that these techniques—unprecedented in effectiveness and efficiency—could edit nonhuman organs to be more human compatible, thereby reducing human immune system responses. Recent advances in xenotransplant surgery open the door to a potential alternative supply of lifesaving organs. However, several ethics considerations must be incorporated into both the testing of this form of transplant and the definition of xenotransplant success. Learn more about the work we are doing to develop practical ethics criteria for xenotransplant research.

Transplant Genomics: Ethical, Legal, and Social Implications of Research and Clinical Applications

The appeal of precision medicine, wider availability of high-throughput sequencing technologies, and innovations in data cataloguing and analysis have led to expanding potential clinical applications of genomics in preventative and disease-specific care. The prospect of personalized treatment is of particular significance in transplant medicine, where treatment options are integrally dependent on genetic factors and the demand for scarce therapeutic resources—transplantable tissues and other organ replacement therapies—far outstrips the available supply.

Advances in genetic and genomic studies have identified an increasing number of novel biomarkers of potential use in transplant-related care. These include genomic predictors of disease course, graft survival, response to immunosuppression, and likelihood of post-transplant disease recurrence or other complications. Future clinical applications of these genomic findings raise ever-growing considerations of the significance of genetic variants, fair access to precision medicine therapeutics and participation in research, ethical approaches to data aggregation and analysis, and social determinants of health.

The interplay of these elements crosses disciplinary lines and compels concerns of utility, equity, privacy, consent, and adherence to best practices. Our project will examine and address the unique ethical, legal, and social issues emerging at the intersection of translational genomics and transplant clinical care.

Examining Potential Updates to the Uniform Anatomical Gift Act

Since the Uniform Anatomical Gift Act (UAGA) was last amended, there have been significant technological advances regarding tissue and organ recovery, and an increase in cultural awareness of donation. We are hosting working group meetings on topics related to a potential update of the UAGA, including regulation of whole-body donation, post-mortem recovery of gametes, reconciling end-of-life care wishes with organ donation wishes, and donation decisions from unrepresented patients.

Project on the Ethics of Transplant Research on the Newly Deceased

With support from the United Therapeutics Corporation, Arthur L. Caplan, PhD, and Brendan Parent, JD, formed an expert working group to produce a report on the ethics of using newly deceased persons to test bioengineered lobes of lung for eventual clinical use.

Our group addressed the following questions:

• Can a body that has been donated for medical research be perfused and ventilated to keep it as close to normal homeostasis as technology allows?
• Should this take place at an organ procurement organization facility or a hospital?
• Once that status is achieved, can the body be operated on to receive a manufactured lung transplant to determine whether such lungs provide reasonable gas exchange functionality for sustained periods of time—a day, a week, or months?
• Is the same possible with or without specific family consent if the deceased was simply an organ donor without specifying donation for medical research and whose ischemia time has exceeded transplant criteria?

Our final report was produced for United Therapeutics and we addressed the ethics questions in a Journal of Medical Ethics research article.

Emerging Ethical Issues in Vascularized Composite Allotransplantation

The field of vascularized composite allotransplantation (VCA) is providing promising treatment opportunities unrivaled by current standard of care for some patients, yet it does not benefit from standardized outcome metrics or universal insurance coverage. We coordinated an NYU Langone and Johns Hopkins VCA Ethics Working Group, bringing together surgeons, bioethicists, mental health professionals, organ procurement organization leaders, and other VCA experts, to map out and assess current ethical issues in the field. To move forward in an ethical, sustainable manner, VCA must balance both the continuing need for innovation and the growing need for standardization. We have since published recommendations from this working group.