Exploring the ethical complexity of pediatric organ transplant candidates and COVID-19 vaccination: Tensions between autonomy and beneficence, children and parents.

BACKGROUND: POT is emotionally sensitive due to cohort vulnerability, their lack of decisional capacity, and waitlist mortality. The COVID-19 pandemic has added complexity to the setting of pediatric transplantation, as well as living donation, due to tensions about COVID-19 vaccination for recipients, donors, and parent-caregivers. METHODS: In the context of COVID-19 vaccination, two ethicists present four pediatric donation and transplant dilemmas for ethical exploration and offer guidance to clinical teams, noting that mandates are controversial, and there is no global harmonization regarding requirements. RESULTS: As with all vaccinations, they are a tool of organ stewardship aimed to optimize outcomes and, in the setting of pediatrics, ensure optimal caregiving for these vulnerable recipients. Current evidence supports the ethical permissibility of COVID-19 vaccination mandates for transplant candidates aged 6 months and older. CONCLUSION: Our guidance considers the tensions of autonomy and beneficence and the ethical duty of organ stewardship. The harms of being unvaccinated and risking the harms of COVID-19 and long-COVID post-transplant support the ethical permissibility of vaccination mandates in countries where the vaccine has pediatric regulatory approval.

Arguments for 'ocular donation' as standardised terminology to reduce the 'ick factor' of 'eye donation'.

This brief report presents the global problem of the shortfall of donor corneal tissue for transplantation, a potential root cause ('ick factor' language), and a potential solution (modification of 'ick factor' language). Specifically, use of the term 'eye donation' is a potential hurdle to ocular tissue donation as it can stimulate the 'ick factor.' Verbiage such as 'ocular (eye tissue)' could be a method of providing terminology that is less emotive than 'eye donor' or 'eye donation.' The field of transplantation has experienced terminology shifts over time; for example, 'cadaver' has been replaced with 'deceased donor,' 'harvest' has been replaced with 'recover,' and 'life support' has been replaced with 'ventilated.' Notably, only a small number of regions worldwide are using 'ocular' terminology, yet it could be an important step to enhancing the informed consent process and improving donation rates, potentially increasing transplant and optimising patient quality of life for those with treatable blindness.

Polish attitudes towards unspecified kidney donation: a cross-sectional study.

BACKGROUND: Chronic kidney disease effects about 4.2 million people in Poland, yet Polish organ donation research is rare. In addition, compared to other countries in the world, Poland has a relatively low living donation rate. Still, little is known about how Poles would react to the possibility of living kidney donation to strangers. A study was conducted to examine public opinion about living kidney donation, as well as their knowledge about it, willingness to donate to a stranger, and support for a possible expansion of existing Polish organ donation legislation to include living donation to strangers. METHODS: A self-report questionnaire, which included a socio-demographic datasheet (9 questions), 16 questions about attitudes towards living donation, and 1 question about knowledge concerning transplantation law was sent to the respondents from December 2020 - February 2021. Logistic regression was used to assess factors affecting the support of the legalization of unspecified kidney donation amongst the participants. RESULTS: More than sixty percent (62.1) of respondents supported legalization of unspecified living kidney donation. Such legalization would be accepted by people who accept a choice of a family member to donate a kidney to a stranger (OR = 3.50; Cl 95%: 1.49 to 4.85), who think bone-marrow transplant is safe (OR = 2.65; Cl 95%: 1.80 to 3.91), recognize the benefit of carrying out tests before donating a kidney (OR = 2.56; Cl 95%: 1.79 to 3.69), would agree to receive a kidney from another person (OR = 2.24; Cl 95%: 2.53 to 3.13), or would agree to donate organs after death (OR = 2.06; Cl 95%: 1.45 to 2.95). However, support for unspecified living kidney donation would not be given by respondents fearing the risk of organ trafficking (OR = 0.54; Cl 95%: 0.38 to 0.79). CONCLUSIONS: In Poland there is strong support for legalization of unspecified living kidney donation. It is vital that future legislation define organ trafficking as a crime with serious punishment so that legal unspecified living kidney donation is not hindered. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (ID: NCT04789122 ) on 08/03/2021.

The Freelance Ethics Consultant: Practice Model and Opportunities.

The first ethicists of the 1970s paved the way for the three most familiar models of clinical ethics consultation: (1) a single consultant, (2) a member of a hospital ethics committee, and (3) a member of a subcommittee of a hospital ethics committee. Within the single consultant model there are (A) the lone ethicist (a member of hospital staff, working alone when consulting) and (B) the independent ethicist (a freelance, external consultant, working alone). This article discusses the structure and opportunities offered by the freelance, independent ethicist model, and provides guidance for those who employ freelance, independent ethicists, as well as guidance for ethicists who are considering adopting this practice model.

Exploring the motives of Israeli Jews who were living kidney donors to strangers.

Non-directed living donors are individuals who donate a kidney to a recipient with whom they have neither a genetic nor emotional relationship. Israel legalized this type of donation in 2008. After this law was implemented, living donations significantly expanded. The aim of this article was to determine the motivations, characteristics, and perioperative experiences of non-directed living donors in Israel. Three online questionnaires (own questionnaire, Rosenberg Self-Esteem Scale (RSES), Rushton Self-Report Altruism Scale) were distributed to 180 Jewish kidney donors with the help of Matnat Chaim organization. One hundred and fifteen responses were received (69.3% response rate). The motivation for most donors (60%) was a strong willingness to help and a desire to do good. The majority of donors (78.3%) reported their health status as unchanged after donation; however, 16.5% experienced clinical problems (eg, wound infection, more pain than expected), and 5.2% experienced psychological complications. About 18% reported their health to improve after donation. Most (80%) inspired someone else to also become a kidney donor. This study breaks the myth that Jews do not support organ donation. In fact, their high level of altruism and their positive experience with donation has propelled the practice of non-directed donation in Israel.

The carnage of substandard research during the COVID-19 pandemic: a call for quality.

Worldwide there are currently over 1200 research studies being performed on the topic of COVID-19. Many of these involve children and adults over age 65 years. There are also numerous studies testing investigational vaccines on healthy volunteers. No research team is exempt from the pressures and speed at which COVID-19 research is occurring. And this can increase the risk of honest error as well as misconduct. To date, 33 papers have been identified as unsuitable for public use and either retracted, withdrawn, or noted with concern. Asia is the source of most of these manuscripts (n=19; 57.6%) with China the largest Asian subgroup (n=11; 57.9%). This paper explores these findings and offers guidance for responsible research practice during pandemics.

Perspectives of US and Australian Hand Therapists About Pediatric Hand Transplantation.

INTRODUCTION: Pediatric hand transplantation (PHT), an investigational therapy, was recently performed in the United States. RESEARCH QUESTIONS: Perspectives of hand therapists about PHT patient selection (inclusion and exclusion criteria), team configuration, patient assent, and patient compliance were explored. DESIGN: Quantitative survey. We used a research ethics committee-approved 18-question e-link anonymous questionnaire to survey members of the American Society of Hand Therapists and the Australian (AU) Hand Therapy Association for their perspectives on PHT. RESULTS: All surveyed hand therapists work with children (n = 18 Australia [AU], n = 85 United States) and some had been involved in adult hand transplant rehabilitation (28% AU, 21% United States; P = .543, not significant (NS)). The US and AU therapists differ regarding their opinions on multidisciplinary team membership, smoking as an exclusion criterion, and risk of posttransplant rehabilitation noncompliance. DISCUSSION: This research opens a dialogue on the clinical and ethical complexity of PHT, including team configuration, inclusion/exclusion criteria, the assent process, and rehabilitation access/compliance. Furthermore, international perspectives are informative as they highlight funding and access issues and can potentially guide global professional society policy.

Looking the World in the Face: The Benefits and Challenges of Facial Transplantation for Blind Patients

Total bilateral blindness in the setting of facial transplantation is a controversial matter. Some transplant teams exclude these candidates, while others accept them onto their facial transplant waiting list. Using 3 cases, the clinical and ethical complexity of total bilateral blindness is explored. Guidance (medical, psychological, and social) for total bilateral blindness as both an inclusion and exclusion criterion is provided, with the stipulation that total bilateral blindness should not be an automatic exclusion criterion for facial transplantation. Additionally, guidance for corneal transplant in facial transplant candidates is discussed. Suggestions for posttransplant disability assistance for patients with total bilateral blindness are also provided.

Smoke and mirrors: unanswered questions and misleading statements obscure the truth about organ sources in China.

This response refutes the claim made in a recent article that organs for transplantation in China will no longer be sourced from executed prisoners. We identify ongoing ethical problems due to the lack of transparent data on current numbers of transplants in China; implausible and conflicting claims about voluntary donations; and obfuscation about who counts as a voluntary donor. The big unanswered question in Chinese transplant ethics is the source of organs, and until there is an open and independently audited system in China, legitimate concerns remain about organ harvesting from prisoners of conscience.

Increasing Donation Opportunities for Vascularized Composite Allografts: An Analysis of Worldwide Donor Registries and Procurement Organization Web Content (VOLAR Study)

There are 40 vascularized composite allotransplant programs across 5 continents served by 31 organ procurement organizations (or equivalent). The organizations' websites inform about organ and tissue donation. This research explored worldwide educational efforts on vascularized composite allograft (VCAG) donation via their corporate websites as well as options within donor registries and donor card systems to indicate a VCAG donation preference. Of these, 13 (41.9%) of 31 had VCAG content and 7 (22.6%) of 31 offered a mechanism for individuals to voice a preference about VCAG donation through an opt in donor registry or card or an opt out registry. In North America, the only donor registration/card system that facilitated VCAG donation is in Mexico. The resistance to consent for VACG donation is likely due to poor public education and the personal nature of face, hand, uterus, and penile allografts. Efforts to reduce this resistance can begin with the assistance of website content, registries, and donor cards.

Smoking Status at Time of Listing for a Heart Transplant Predicts Mortality on the Waiting List: A Multicenter Prospective Observational Study.

OBJECTIVE: We examined the association of smoking status at time of listing with waitlist mortality among heart transplant (HTx) candidates. PARTICIPANTS AND DESIGN: Data were analyzed from 316 participants (aged 53 ± 11; 18% female) of the Waiting for a New Heart Study, a prospective observational study of patients newly listed for HTx at 17 hospitals. RESULTS: During the study period (April 2005 to March 2010), 14% of those who never smoked died, 18% among former smokers died, and almost half (42%) died among those who reported smoking at time of wait listing. Multivariate Cox regression models controlling for age, sex, and disease severity revealed smoking at time of listing was associated with significantly higher risk of mortality compared to never smoking (hazard ratio [HR] = 3.43; P = .03). The relationship between smoking and mortality risk appeared to follow a dose-dependent pattern: adjusted HRs were 1.80 for those who quit ≤1 year ago, 1.25 for those who quit >1 to 10 years ago, and 0.90 for those quit >10 years ago, compared to never smokers. Smoking at time of listing may increase risk of mortality during the waiting period, indicating the need for improved strategies to achieve smoking cessation as early as possible in the course of HTx.

Medical Boards and Fitness to Practice: The Case of Teleka Patrick, MD.

BACKGROUND: Medical boards and fitness-to-practice committees aim to ensure that medical students and physicians have "good moral character" and are not impaired in their practice of medicine. METHOD: Presented here is an ethical analysis of stalking behavior by physicians and medical students, with focus on the case of Teleka Patrick, MD (a psychiatry resident practicing medicine while under a restraining order due to her alleged stalking behavior). CONCLUSIONS: While a restraining order is not generally considered a criminal conviction, stalking behavior is clearly unprofessional and a marker of inappropriate character and fitness, yet the reporting obligations for such matters are complex. Medical schools and training programs that fail to assess, record, and report matters of moral conduct such as this potentially allow impaired students to graduate and enter the work force (unless a robust licensing process identifies them). Patrick's case should be a wake-up call for medical schools and medical boards to better integrate the professionalism domain into their operations. Further, the professionalism of students and doctors need to be integrated into the legal domain, so that those who are unfit to practice are, in fact, prevented from doing so. Guidance for integration is provided.

Exploring the success of Good Samaritan organ donation in New Zealand.

The rate of living kidney donation from 2006 to 2012 was roughly the same in Australia and New Zealand, but the rate of Good Samaritan donation was significantly higher in New Zealand (1.49 donors/million) than in Australia (0.23 donors/million). Three possible reasons for New Zealand's high rate of Good Samaritan donation are explored: (1) since 2005, New Zealand has offered a tax-free financial safety net for living donors; (2) unlike Australia, New Zealand is not carved into jurisdictional segments with multiple policies on Good Samaritan donation, lending to a streamlined approach; (3) New Zealand embraces e-technology to communicate the concept of Good Samaritan donation to the public. Additionally, New Zealand's recent initiatives to increase the rate of living donation are described.

Using cultural immersion as the platform for teaching Aboriginal and Torres Strait Islander health in an undergraduate medical curriculum.

INTRODUCTION: In 2011 Bond University was looking for innovative ways to meet the professional standards and guidelines in Aboriginal and Torres Strait Islander health in its Bachelor of Medicine, Bachelor of Surgery (MBBS) curriculum. In 2012 Bond piloted a compulsory cultural immersion program for all first year students, which is now a usual part of the MBBS program. METHODS: Three phases were included - establishing an Indigenous health group, determining the Aboriginal and Torres Strait Islander educational content based on the professional standards and developing nine educational sessions and resources - as well as significant administrative processes. The cultural immersion was piloted in 2012 with 92 first year medical students. Following refinements it was repeated in 2013 with 95 students and in 2014 with 94 students. A comprehensive evaluation process was undertaken that included a paper-based evaluation form using a five-point Likert scale, as well as a confidential talking circle evaluation. The response rate was 95.4% (n=271, pooled cohort). Data were entered separately into SPSS and annual reports were written to the Faculty. Descriptive statistics are reported alongside themed qualitative data. RESULTS: The three combined student evaluation results were extremely positive. Students (n=271) strongly agreed that the workshop was well organised (M=4.3), that the facilitators contributed very positively to their experience (M=4.3), and that they were very satisfied overall with the activity (M=4.2). They agreed that the eight overall objectives had been well met (M=3.9-4.3). The nine sessions were highly evaluated with mean ratings of between 3.9 and 4.8. The 'best thing' about the immersion identified by more than half of the students was overwhelmingly (n=140) the Storytelling session, followed by bonding with the cohort, the Torres Strait Islander session and learning more about culture. The item identified as needing most improvement was the food (n=87), followed by the accommodation (n=65). CONCLUSIONS: The use of immersion in the early part of a cultural awareness program for medical students provides an extremely valuable platform from which to launch more detailed information about the history of Aboriginal and Torres Strait Islander Australia and its impact on the current health status of Aboriginal and Torres Strait Islander Australians. Doing this in a safe, supportive cross-cultural environment with highly skilled facilitators is essential. Key to success is strong leadership, commitment and support from Faculty level, a structured educational program and educating all staff and students about its importance throughout the journey.

Telemedicine as an ethics teaching tool for medical students within the nephrology curriculum.

A novel patient-centered approach was used to deliver ethics curriculum to medical students. Two medical school clinicians designed a telemedicine session linking their facilities (across 2 continents). The session, Exploring the Patient Experience Through Telemedicine: Dialysis and End-Stage Renal Disease, allowed second-year medical students to explore various parameters of quality of life experienced by dialysis patients. A panel of 4 medical students interviewed a dialysis patient via Skype video connection between the medical school and the hospital's dialysis unit. Interview questions were adapted from the Kidney Disease Quality of Life instrument. During the live video-streamed interview, the remaining 23 second-year medical students observed the session. Afterward, the 23 were offered a voluntary anonymous online feedback survey (15 responded). The 4 panelists submitted narrative responses to 2 open-ended questions about their experience. All 15 responding students "Strongly agreed" or "Agreed" that the session was an aid to their professionalism skills and behaviors; 14 of 15 "Strongly agreed" or "Agreed" that telemedicine technology contributed to their understanding of the topic; 12 of 15 "Strongly agreed" that the session improved their understanding of the psychosocial burdens of dialysis, quality of life, and human suffering, and increased their empathy toward patients; and 12 of 15 "Strongly agreed" or "Agreed" that the session encouraged reflective thinking and was an aid to improving their communication skills. Telemedicine can be an effective and feasible method to deliver an ethics curriculum with a patient-centered approach. Additionally, the cross-cultural experience exposes students to additional contextual features of medicine.

Human Whole-Eye Donation for Research-Optimizing Clinical Trial Informed Consent.

Importance: Posthumous whole-eye (globe) donations for research lack a mechanism that reinvolves the existing ophthalmic research team of the donor unless there is a preplanned donor directive. Disconnection between the deceased and their research team equates to lost opportunities for the research team to have a longitudinal view of the eyes that have been involved in their research. Objectives: To use the clinical trial informed consent process to create a posthumous research donation opportunity that directs the donation to the currently affiliated research team of the donors (preserving the longitudinal research experience). Evidence Reviewed: Current globe donation pathways were reviewed. Additionally, published advice from the fields of ophthalmology, brain banking, and implantable medical devices were used as reference points. Findings: Globe donation represents a small but valuable type of ocular donation. Globe donation for research purposes is useful for investigators performing total human eye allotransplantation clinical trials, as well as for ophthalmic drug or device researchers. Results suggest that those performing invasive eye research should include the option of posthumous globe donation in their study protocols and informed consent forms to facilitate more opportunities for the generation of scientific knowledge. Conclusions and Relevance: The longitudinal perspective can be valuable especially for eyes that have received long-term treatment with an investigational drug or device. This article poses a research-informed consent framework for posthumous globe donation.

Dietary habits are related to outcomes in patients with advanced heart failure awaiting heart transplantation.

BACKGROUND: Empirical evidence supporting the benefits of dietary recommendations for patients with advanced heart failure is scarce. We prospectively evaluated the relation of dietary habits to pre-transplant clinical outcomes in the multisite observational Waiting for a New Heart Study. METHODS AND RESULTS: A total of 318 heart transplant candidates (82% male, age 53 ± 11 years) completed a Food Frequency Questionnaire (foods high in salt, saturated fats, poly-/monounsaturated fats [PUFA+MUFA], fruit/vegetables/legumes, and fluid intake) at time of waitlisting. Cox proportional hazard models controlling for heart failure severity (eg, Heart Failure Survival Score, creatinine) estimated cause-specific hazard ratios (HRs) associated with each dietary habit individually, and with all dietary habits entered simultaneously. During follow-up (median 338 days, range 13-1,394), 54 patients died, 151 received transplants (110 in high-urgency status, 41 electively), and 45 became delisted (15 deteriorated, 30 improved). Two robust findings emerged: Frequent intake of salty foods, which correlated positively with saturated fat and fluid intake, was associated with transplantation in high-urgency status (HR 2.90, 95% confidence interval [CI] 1.55-5.42); and frequent intake of foods rich in PUFA+MUFA reduced the risk for death/deterioration (HR 0.49, 95% CI 0.26-0.92). CONCLUSIONS: These results support the importance of dietary habits for the prognosis of patients listed for heart transplantation, independently from heart failure severity.

The silence of Good Samaritan kidney donation in Australia: a survey of hospital websites.

It is common for living donor candidates to use the Internet as a tool to enhance their decision-making process. Specifically, the websites of transplant hospitals can potentially be a vital source of information for those contemplating living donation. In an effort to explore the low incidence of Good Samaritan kidney donation (donations to strangers) in Australia, two raters conducted a nine-attribute website content analysis for all hospitals which participate in these transplants (n = 15). Overall, the concept of living donation is relatively silent on Australian hospital websites. Only four hospitals mention their living donor program, and only one mentions their Good Samaritan program. No site linked directly to Australia's AKX Paired Kidney Exchange Program - the only program which facilitates pair and chain transplants in Australia. Further, information about deceased donation is nearly absent as well. An individual with the altruistic desire to donate will generally find scant or absent information about donation at the website of their local transplant hospital, although this information could easily be present as an educational tool which supports the consent process. Using a hospital website to educate the public about a clinical service should not be viewed as ethically problematic (solicitation), but rather an ethical essential.

Harms and responsibilities associated with battery-operated implants (BOI): who controls postmortem explantation?

The postmortem issues raised by battery-operated implants (BOI) are complex and issues of consent, setting (clinical vs research), and environmental risks have received little attention in bioethics literature. Analyzing the issues, the following are argued: (1) Patients receiving BOIs should sign a consent form that includes a requirement for postmortem explant of the device; (2) BOI consent forms should require the explanted devices be returned to their manufacturers for Returned Product Analysis; (3) Failure to explant and analyze devices from the research setting fails the research goal of generation of knowledge for the benefit of future patients; (4) Failure to explant and analyze devices from the clinical setting allows product defects to be potentially hidden from patients, families, clinicians, manufacturers, and regulatory agencies; (5) Bodies buried with BOIs potentially harm the environment; (6) Religious or philosophical objections to autopsy should not supersede the duty to explant and analyze BOIs; (7) The concepts herein for BOIs could potentially extend to non-BOI if the device has failure modes that can lead to a potentially life-threatening event or can cause permanent debilitating health issues, and the burial or cremation of the device poses environmental harm. In these situations, neither the patient (premortem) nor family (postmortem) should have the right to refuse explant.