Emerging Ethical Challenges Raised by the Evolution of Vascularized Composite Allotransplantation

Abstract

Background. Despite early skepticism, the field of vascularized composite allotransplantation (VCA) has demonstrated feasibility. The ethics of VCA have moved past doubts about the morality of attempting such transplants to how to conduct them ethically. Methods. Leaders of each program performing and/or evaluating VCA in the United States were invited to participate in a working group to assess the state and future of VCA ethics and policy. Four meetings were held over the course of 1 year to describe key challenges and potential solutions. Results. Working group participants concluded that VCA holds great promise as treatment for patients with particular injuries or deficits, but the field faces unique challenges to adoption as standard of care, which can only be overcome by data sharing and standardization of evaluation and outcome metrics. Conclusions. Adequate attention must be given to concerns including managing the uniquely intense physician-patient relationship, ethical patient selection, ensuring patients have adequate representation, informing and earning the trust of the public for donation, standardizing metrics for success, and fostering an environment of data sharing. These steps are critical to transitioning VCA from research to standard of care and to its insurance coverage inclusion.

The Baltimore Criteria for an ethical approach to penile transplantation: a clinical guideline

“…Over the course of six months, the group held several discussions to refine these considerations. Then, using the Montreal Criteria for Ethical Feasibility in Uterus Transplantation as a model, we created the Baltimore Criteria for an Ethical Approach to Penile Transplantation, which builds upon the foundation laid by prior recommendations while incorporating the current approach developed and used at Johns Hopkins.…”

“…Preliminary recommendations to help navigate such difficult issues have been previously proposed . These include recommendations regarding candidate selection, balancing benefits and risks, informed consent of the donor and recipient, use of a patient advocate and the funding implications of penile transplantation as a standard of care.…”

“…For example, a research protocol has been developed that delineates the technical and logistical aspects of the procedure . In addition, some ethics protections have been employed for early penile transplants and recommendations regarding them have been offered . However, a more comprehensive ethical framework, akin to that which is available for uterus transplant that is often referred to as the “Montreal Criteria”, is not currently available for penile transplantation .…”

<p>Public attitudes toward vascularized composite allograft donation: a literature review</p>

“…This may result in unhealthy attention or prioritizing of the patient or patient having an unrealistic expectation of the provider. 46 This is reinforced by the media attention that many VCA patients are quick to receive. This may interfere with informed consent as patients may feel obligated to go through the procedure due to the fear of disappointing their surgeon or health care team.…”

“…From the surgeon's perspective, there may be (unethical) inherent biases in selecting the recipient for the VCA as patients who have less psychological issues, better social support or are able to afford long-term post-operative therapy, and as such have higher chances of successful outcome and favorable press coverage. 46 Standardization of surgeon-reported and patient-reported outcome data to be collected pre-and post-operatively on expectations and health-related quality of life outcomes is an important step to prevent such biases, in addition to increasing public awareness of such procedures.…”