A review of the ethical considerations for the use of 3D printed materials in medical and allied health education and a proposed collective path forward.

3D scanning and printing technologies are quickly evolving and offer great potential for use in gross anatomical education. The use of human body donors to create digital scans and 3D printed models raises ethical concerns about donor informed consent, potential commodification, and access to and storage of potentially identifiable anatomical reproductions. This paper reviews available literature describing ethical implications for the application of these emerging technologies, existing published best practices for managing and sharing 2D imaging, and current adherence to these best practices by academic body donation programs. We conclude that informed consent is paramount for all uses of human donor and human donor-derived materials and that currently there is considerable diversity in adherence to established best practices for the management and sharing of 3D digital content derived from human donors. We propose a new and simplified framework for categorizing donor-derived teaching materials and the corresponding level of consent required for digital sharing. This framework proposes an equivalent minimum level of specific consent for human donor and human donor-derived materials relative to generalized, nonidentical teaching materials (i.e., artificial plastic models). Likewise, we propose that the collective path forward should involve the creation of a centralized, secure repository for digital human donor 3D content as a mechanism for accumulating, regulating, and controlling the distribution of properly consented human donor-derived 3D digital content that will also increase the availability of ethically created human-derived teaching materials while discouraging commodification.

Ethical and Policy Issues Arising in Crowdfunding for Solid Organ Transplantation: A Content Analysis of Newspaper Coverage of Recipient and Donor Fundraising Campaigns.

BACKGROUND: Solid organ transplantation improves the quality of life for patients but has significant out-of-pocket expenses for donors and recipients in the USA, leading many to utilize crowdfunding for donations to cover expenses. We sought to characterize crowdfunding for transplant patients and to identify ethical and policy issues. METHODS: We obtained newspaper articles that described crowdfunding campaigns for organ transplant patients from Nexis-Uni. Using Nvivo, we identified and analyzed article details, patient characteristics, features of campaigns, additional fundraisers, and policy and ethical issues related to crowdfunding. RESULTS: Most sources were published between 2015 and 2020. Of 231 patients identified, 43% were thoracic organ recipients and 42% were kidney recipients. GoFundMe was the most popular platform. 78% of patients reported at least one intended use of crowdfunding; medical expenses were the most cited reason. Ten percent of articles described at least one ethical or policy consideration related to crowdfunding for organ transplant. Concerns included violations of federal laws prohibiting donors from receiving "valuable consideration" for an organ, taxation of funds, loss of Medicaid or disability benefits, accountability for fund usage, and crowdfunding requirements for organ waiting list placement. In several cases, transplants were delayed due to crowdfunding concerns. CONCLUSIONS: Our findings reveal crowdfunding characteristics and financial barriers present among transplant patients. Furthermore, our study suggests that the ethical and policy implications for crowdfunding in the transplant population are not yet adequately assessed. National regulations and transplant center policies may need to be modified to address issues raised by patient crowdfunding.

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.

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.

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.

Facilitating the ethical sourcing of donor hematopoietic stem cells for cell and gene therapy research and development.

Aim: Unrelated stem cell donor registries (DRs) are increasingly engaging in the field of cell and gene therapy (CGT). This study aims to explore the values, concerns, needs and expectations of donors and members of the public on donating hematopoietic stem cells (HSCs) for CGT.Methods: Seven focus groups were conducted in 2019 with members of the public, prospective donors and donors on the Anthony Nolan DR in the UK.Results: Participants expressed concerns over increased frequency of donation and incidental findings and required more information on the type of research including the purpose and possible outcomes.Conclusion: Addressing donors' concerns, needs and expectations on donating cellular materials for CGT research and development is essential to maintaining the highest standards for donor care and safety within this rapidly emerging field.

This study aims to explore the values, concerns, needs and expectations of people who donate, or consider donating, their stem cells (cells that can develop into many different types of cells) for research that could lead to new medical treatments. We focused on the thoughts of these donors about providing their cells for use in cell and gene therapy (CGT) research, a field that is rapidly advancing but still forming its rules and ethical guidelines. In 2019, we conducted seven focus groups (FGs) with a total of 73 people in the UK. This included individuals who are registered as potential stem cell donors on the Anthony Nolan unrelated stem cell donor register (DR), those who have already donated stem cells and members of the general public. We explored their thoughts about their donated cells being used for research to develop new therapies rather than for direct treatment of patients. Questions during the FGs touched on topics such as the roles of various organizations in managing donated cells, the commercial use of these cells and where responsibilities lie in ensuring ethical practices. Participants expressed a strong desire for openness and clear communication regarding how their donated cells are used in research. They wanted to ensure that any use of their cells aligns with their personal values and the ethical standards of the organizations handling the donations. Participants expected DRs like Anthony Nolan to safeguard their interests and the ethical use of their cells. This study highlights that while donors are generally willing to contribute to advancements in CGT research, they need clear, understandable information about how their donations are used. This is crucial for maintaining their trust and willingness to donate. Overall, this study underscores the importance of ethical practices and donor engagement in the growing field of CGT, ensuring that donor contributions are respected and used responsibly.

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.

Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.

BACKGROUND: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. MATERIALS AND METHODS: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. RESULTS: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. CONCLUSIONS: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns.

Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United Kingdom 2022 Workshop.

BACKGROUND: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). METHODS: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. RESULTS: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. CONCLUSIONS: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.

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.

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.

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.