Abigail Levin replies.

This letter responds to the letter "The Open Donor View and Procreative Beneficence," by Daniel Groll, in the same, May-June 2024, issue of the Hastings Center Report.

The Open Donor View and Procreative Beneficence.

This letter responds to the article "What Do Prospective Parents Owe to Their Children?," by Abigail Levin, in the March-April 2024 issue of the Hastings Center Report.

Ethical and Equity Guidance for Transplant Programs Considering Thoracoabdominal Normothermic Regional Perfusion (TA-NRP) for Procurement of Hearts.

Donation after circulatory determination of death (DCDD) is an accepted practice in the United States, but heart procurement under these circumstances has been debated. Although the practice is experiencing a resurgence due to the recently completed trials using ex vivo perfusion systems, interest in thoracoabdominal normothermic regional perfusion (TA-NRP), wherein the organs are reanimated in situ prior to procurement, has raised many ethical questions. We outline practical, ethical, and equity considerations to ensure transplant programs make well-informed decisions about TA-NRP. We present a multidisciplinary analysis of the relevant ethical issues arising from DCDD-NRP heart procurement, including application of the Dead Donor Rule and the Uniform Definition of Death Act, and provide recommendations to facilitate ethical analysis and input from all interested parties. We also recommend informed consent, as distinct from typical "authorization," for cadaveric organ donation using TA-NRP.

An Ethics Committee's Evaluation of Normothermic Regional Perfusion (NRP) in 2018-Unsatisfactory Answers Then-and Now.

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Restoring the Organism as a Whole: Does NRP Resurrect the Dead?

The introduction of normothermic regional perfusion (NRP) in controlled donation after circulatory determination of death (cDCDD) protocols is by some regarded as controversial and ethically troublesome. One of the main concerns that opponents have about introducing NRP in cDCDD protocols is that reestablishing circulation will negate the determination of death by circulatory criteria, potentially resuscitating the donor. In this article, I argue that this is not the case. If we take a closer look at the concept of death underlying the circulatory criterion for determination of death, we find that the purpose of the criterion is to show whether the organism as a whole has died. I argue that this purpose is fulfilled by the circulatory criterion in cDCDD protocols, and that applying NRP does not negate the determination of death or resuscitate the donor.

Squaring the Circle. Brain death and organ transplantation.

PURPOSE OF REVIEW: The adoption of brain death played a crucial role in the development of organ transplantation, but the concept has become increasingly controversial. This essay will explore the current state of the controversy and its implications for the field. RECENT DEVELOPMENTS: The brain death debate, long limited to the bioethics community, has in recent years burst into the public consciousness following several high-profile cases. This has culminated in the reevaluation of the Uniform Determination of Death Act (UDDA), which is in the process of being updated. Any change to the UDDA has the potential to significantly impact the availability of organs. SUMMARY: The current update to the UDDA introduces an element of uncertainty, one the brain death debate had not previously had.

Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

Family members as gamete donors or gestational carriers: an Ethics Committee opinion.

The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed and counseled, but consanguineous arrangements or ones that simulate incestuous unions should be prohibited. Adult child-to-parent arrangements require caution to avoid coercion, and parent-to-adult child arrangements are acceptable in limited situations. Programs that choose to participate in intrafamilial arrangements should be prepared to spend additional time counseling participants and ensuring that they have made free, informed decisions. This document replaces the document of the same name, last published in 2017.

Teaching respect for body donors: A US medical student perspective.

Recent controversies over the mismanagement of body donors in US medical schools have raised public concerns over the ethical treatment of bodies in "anatomical gift" programs. Despite widespread moral outrage at such cases, medical students may still make seemingly inconsequential mistakes or jokes that in fact constitute acts of disrespect. This may partially be attributed to the process of desensitization in working with human remains, and indicates a further need to inculcate into medical students the ethical responsibilities of working with body donors. Donation agreement statements that lack specific information about the respectful treatment of bodies in the anatomy laboratory may serve as an additional point of concern for potential donors seeking reassurance about the future treatment of their bodies. This viewpoint draws from the anecdotal experiences of medical students to portray two scenarios of medical students' disrespectful conduct toward body donors, and constructs an account of moral respect for human remains based on respect for posthumous autonomy and respect in attitude. It then provides suggestions for US medical schools to incorporate this ethical framework into their anatomy curricula to instill respectful dispositions in its students and facilitate a more robust informed consent process for potential donors who entrust their bodies to medical students.

UK guidelines on transplantation from deceased donors after circulatory death

Transplantation offers patients with end-stage organ failure a cost-effective treatment that can improve quality of life and increase life expectancy. Prior to the introduction of guidance defining the concept of brain death in the 1970s, all organs donated for transplantation were from donation after circulatory death (DCD) donors. Following the introduction of neurological testing to diagnose death, the majority of organs donated for transplantation were from donation after brain death (DBD) donors or living donors.

Who's your daddy? An ethical argument for disclosure to donor conceived children.

To our knowledge, there have been few discussions in the andrology literature regarding the ethics of disclosure to donor conceived children. Our goal in this paper is to summarize the main reasons in favor of disclosure to engender more conversations about the ethics of donor conception in andrology circles. Specifically, we argue (1) transparency regarding gamete donation upholds the ethical principle of beneficence by improving the psychological health of donor conceived children; and (2) based on the ethical principle of autonomy, donor conceived children should have the right to know their donor status.

Ethical Solutions to the Problem of Organ Shortage.

Organ shortage is a major survival issue for millions of people worldwide. Globally 1.2 million people die each year from kidney failure. In this paper, we critically examine and find lacking extant proposals for increasing organ supply, such as opting in and opt out for deceased donor organs, and parochial altruism and paired kidney exchange for live organs. We defend two ethical solutions to the problem of organ shortage. One is to make deceased donor organs automatically available for transplant without requiring consent from the donor or their relatives. The other is for society to buy nonvital organs in a strictly regulated market and provide them to people in need for free.

Ethical issues in oocyte banking for nonautologous use: an Ethics Committee opinion.

Ethical considerations for the banking of oocytes for nonautologous use are discussed.