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.

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.

The effect of the COVID-19 pandemic on deceased and living organ donors in the United States of America.

A life-saving treatment, solid organ transplantation (SOT) has transformed the survival and quality of life of patients with end-organ dysfunction. The coronavirus disease (COVID-19) pandemic has impacted the practice of deceased and living donations worldwide by various resource shifting, including healthcare personnel and equipment such as ventilators and bed space. Our work explores the COVID-19 pandemic and global transplant data to create a statistical model for deducing the impact of COVID-19 on living donor and deceased donor transplants in the United States of America (USA). In severely impacted regions, transplant centers need to carefully balance the risks and benefits of performing a transplant during the COVID-19 pandemic. In our statistical model, the COVID cases are used as an explanatory variable (input) to living or deceased donor transplants (output). The model is shown to be statistically accurate for both estimation of the correlation structure, and prediction of future donors. The provided predictions are to be taken as probabilistic assertions, so that for each instant where the prediction is calculated, a statistical measure of accuracy (confidence interval) is provided. The method is tested on both low and high frequency data, that notoriously exhibit a different behavior.

Physician perceptions of surveillance: Wearables, Apps, and Chatbots for COVID-19.

Background and Purpose: To characterize the global physician community's opinions on the use of digital tools for COVID-19 public health surveillance and self-surveillance. Materials and Methods: Cross-sectional, random, stratified survey done on Sermo, a physician networking platform, between September 9 and 15, 2020. We aimed to sample 1000 physicians divided among the USA, EU, and rest of the world. The survey questioned physicians on the risk-benefit ratio of digital tools, as well as matters of data privacy and trust. Statistical Analysis Used: Descriptive statistics examined physicians' characteristics and opinions by age group, gender, frontline status, and geographic region. ANOVA, t-test, and Chi-square tests with P < 0.05 were viewed as qualitatively different. As this was an exploratory study, we did not adjust for small cell sizes or multiplicity. We used JMP Pro 15 (SAS), as well as Protobi. Results: The survey was completed by 1004 physicians with a mean (standard deviation) age of 49.14 (12) years. Enthusiasm was highest for self-monitoring smartwatches (66%) and contact tracing apps (66%) and slightly lower (48-56%) for other tools. Trust was highest for health providers (68%) and lowest for technology companies (30%). Most respondents (69.8%) felt that loosening privacy standards to fight the pandemic would lead to misuse of privacy in the future. Conclusion: The survey provides foundational insights into how physicians think of surveillance.

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.

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.

Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics.

During public health pandemics such as COVID-19, cooperative behaviors among scientists, journal editors, policy makers and research ethics committees, are essential to promote scientific integrity and societal trust in translational research and resultant public health decisions. This cooperation is possible by expanding the current way of working to include stakeholders beyond the research team via community events and special communication channels sponsored by research ethics committees. Research ethics committees with wider communication channels, increased transparency, and enhanced knowledge exchange have the potential to improve research design, performance, dissemination, and ultimately public benefit.

Integrity watchdogs, lap dogs, and dead dogs.

Integrity officers working in academic and research settings can be termed "watchdogs" based on characteristics and behaviors that align with their role: alert, loyal to their training, responders, notifiers. These watchdogs have a difficult role that involves being the receiver and transmitter of sensitive information that often relates to personal and corporate image, as well as funding. Academic and research organizations must operationalize their mission and vision with more than static policies and procedures about integrity and professionalism, or they risk their watchdogs being reduced to "lap dogs" with a diminutive and submissive presence who are merely loyal to the comfort zone of their employer. A lap dog role has several potential side effects including moral distress and moral injury for the integrity officer, as well as poor service quality for whistle-blowers and other service users. Organizations have a duty to ensure their integrity programs are meaningfully supported, including respecting the human constructs of the watchdog role.

Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters.

BACKGROUND: The COVID-19 pandemic has created a global setting of clinical crisis and human anxiety. Without available safe and effective vaccines and cures, an unscrupulous marketplace has emerged selling COVID-19 quackery (fraudulent misrepresentation of preventions and treatments). METHODS: US Food and Drug Administration (FDA) Warning Letters issued from March 2020 to July 2020 were analyzed for themes pertaining to unapproved, adulterated, and misbranded COVID-19 products. RESULTS: During this period, the FDA issued 3,139 Warning Letters of which 98 (3.14%) of these were focused on COVID-19-related drugs, devices, biologics, and dietary supplements (products and ingredients). Specifically, these Warning Letters revealed regulatory nonconformities involving 40 identified herbs, 22 minerals/compounds, 6 devices and biologicals, and 3 vitamins. Products included hand sanitizers; COVID-19 antibody test kits; herbal teas and tinctures; nasal gel; toothpaste; and 1 vaccine. Nine Warning Letters were issued for products being sold via the Amazon online shopping platform. CONCLUSION: A small percentage of FDA Warning Letters recently have been focused on COVID-19. These Letters expose the blatant and potentially harmful quackery of vendors across the world who prioritize financial gain over clinical beneficence. Patient history-taking should include queries about non-traditional and unapproved products to identify, document, and report potentially harmful quackery. FDA Warning Letters are a component of meaningful corrective action; however, greater effort in spreading awareness of such misrepresented, unapproved, and adulterated products is needed to deter purchases of such products.

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.

Antibodies as Currency: COVID-19's Golden Passport.

Due to COVID-19, the fragile economy, travel restrictions, and generalized anxieties, the concept of antibodies as a "declaration of immunity" or "passport" is sweeping the world. Numerous scientific and ethical issues confound the concept of an antibody passport; nonetheless, antibodies can be seen as a potential currency to allow movement of people and resuscitation of global economics. Just as financial currency can be forged, so too is the potential for fraudulent antibody passports. This paper explores matters of science, ethics, and identity theft, as well as the problems of bias and discrimination that could promulgate a world of pandemic "golden passports."

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.

Luxembourg's approach to research integrity during the COVID-19 pandemic.

The COVID-19 pandemic has accelerated the pace of research from its routine marathon to a sprint, and this can increase the risk of both human error (mistakes) as well as research misconduct. In an effort to save time, researchers can be tempted to "cut corners", discount ethical complexity, or use methods and approaches that fall outside of good research practice. Ethically, it is vital that research outputs during a pandemic be robust because clinical decision-making may reflect on these research results. Luxembourg, while a small European nation, is known for its well-ranked global research and innovation. Accordingly, Luxembourg's national organization for research integrity has taken several proactive measures to help researchers nationally and globally, foster robust research. This paper reports on these measures and encourages other nations to similarly assist the research community.

A 10-year follow up of publishing ethics in China: what is new and what is unchanged.

BACKGROUND: Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines. METHODS: Eleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored. RESULTS: Most journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access. CONCLUSIONS: Most journals have improved their general ethical publishing requirements but none address unethical organ donation practices.

A Lifesaving View of Vascularized Composite Allotransplantation: Patient Experience of Social Death Before and After Face, Hand, and Larynx Transplant.

INTRODUCTION: Most solid organ transplantation is viewed as lifesaving, whereas vascularized composite allotransplantation (VCA) has been viewed as life enhancing. This article challenges the latter and argues that "social death" evident in severe face, hand, and larynx disfigurement can be potentially treated via VCA. Social death (from a social science perspective) consists of a combination of 7 components: social isolation, loneliness, ostracism, loss of personhood, change of role and identity, harm, and disfigurement. METHODS: In February 2016, PubMed and Google were searched for case reports of human face, hand, and larynx transplantation. Patient and team narratives were then coded for components of social death using social science and medical model criteria. RESULTS: Eleven narratives were identified among 9 articles. The social science model (but not the medical model) described pretransplant social death and the resolution of social death by receiving VCA. Notably, the medical model of social death was deemed unsuitable for application to VCA. This is because case narratives consistently contradict elements of the medical model. CONCLUSIONS: By including social death as a patient inclusion criterion for face, hand, and larynx VCA, these transplants can be considered lifesaving. Additionally, because VCA requires lifelong immunosuppressant medication, considering VCA as a lifesaving intervention improves the technology's risk-benefit analysis. Guidance for assessing social death is provided.

What's Mine is Yours: Long-Term Experiences of Good Samaritan Organ Donors.

This study is a long-term follow-up on the health and quality of life of Good Samaritan living organ donors who donated an average of 10 years ago. Thirteen donors (kidney, liver, and lung) completed 2 surveys. Data from the RAND 36-Item Health Survey showed that for all domains, as well as the physical and mental component summary scales, the Good Samaritan donor outcomes were superior to the general population (P < .0001). Data from the European Living Donor Satisfaction Survey (EULID) showed that in all 8 theme areas, the donors reported statistically significant positive reactions as compared to negative reactions. With regard to self-reported health status, there was a strong, positive correlation between the RAND 36-Item Health Survey and the EULID (n = 13, Pearson correlation coefficient: 0.874). All but 1 donor reported good, very good, or excellent health status. Although donors overwhelmingly reported positivity about the donation experience, narrative comments about adverse events and recipient death must keep transplant teams alert to these critical areas. Good Samaritan organ donors come to the hospital healthy, give a gift to a stranger, and sometimes leave and linger disabled. Donor teams should be observing, questioning, and responding in an effort to maximize their welfare. This research is unique because investigation of the long-term health and psychosocial outcomes of Good Samaritan organ donors is rare. Existing studies that report long-term outcomes of kidney donors do not separately analyze Good Samaritan donor data from related living donors.

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.