Informed consent and coercion in recruitment advertisements for oocyte donors.

BACKGROUND: As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process. METHODS: Data from online advertisements for egg donors active between January 1 - August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation. RESULTS: 103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21. CONCLUSION: Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.

Marginal parent donors-Process and ethics.

BACKGROUND: Pre-emptive kidney transplantation for end-stage kidney disease in children has many advantages and may lead to the consideration of marginal parent donors. METHODS: Using the example of the transplant of a kidney with medullary sponge disease from a parent to the child, we review the ethical framework for working up such donors. RESULTS: The four principles of health ethics include autonomy (the right of the patient to retain control over his/her own body); beneficence (healthcare providers must do all they can do to benefit the patient in each situation); non-maleficence ("first do no harm"-providers must consider whether other people or society could be harmed by a decision made, even if it is made for the benefit of an individual patient) and justice (there should be an element of fairness in all medical decisions). Highly motivated donors may derive significant psychological benefit from their donation and may thus be willing to incur more risk. The transplantation team and, ideally, an independent donor advocate team must make a judgment about the acceptability of the risk-benefit ratio for particular potential donors, who must also make their own assessment. The transplantation team and donor advocate team must be comfortable with the risk-benefit ratio before proceeding. CONCLUSIONS: An independent donor advocacy team that focuses on the donor needs is needed with sufficient multidisciplinary ethical, social, and psychological expertise. The decision to accept or reject the donor should be within the authority of the independent donor advocacy team and not the providers or the donor.

Bioethical perspective of convalescent plasma therapy for COVID-19: A systematic review.

Convalescent plasma therapy (CP) has long been used to prevent and treat various infectious diseases before COVID-19 such as SARS, MERS, and H1N1. Because the viral and clinical characteristics of COVID-19 share the similarities between SARS and MERS, CP treatment could be a promising treatment option to save COVID-19. With only low quality medical evidence, but massive media support and a very significant public demand for the use of convalescent plasma for COVID-19, we are now faced with an ethical dilemma. Therefore, this paper uses a structured analysis that focuses on the preferred reporting items for a systematic review of ethical issues regarding the use of Convalescent Plasma Therapy for COVID-19. The use of convalescent plasma must meet the ethical principles of autonomy; such as voluntary, informed consent, and confidentiality. Consideration of the risk-benefit ratio for potential donor recipients also needs to be considered in order to meet the beneficence and non-maleficence principles. The principle of justice also needs to be applied both to donors, donor recipients and health workers, such as determining the priority of donor recipients, due to the increasing demand for convalescent plasma amid the limited circumstances of patients who have recovered from Covid-19 who voluntarily donate.

Uncontrolled Donation After Circulatory Death: A Unique Opportunity.

Uncontrolled donation after circulatory death (uDCD) refers to donation from persons who die following an unexpected and unsuccessfully resuscitated cardiac arrest. Despite the large potential for uDCD, programs of this kind only exist in a reduced number of countries with a limited activity. Barriers to uDCD are of a logistical and ethical-legal nature, as well as arising from the lack of confidence in the results of transplants from uDCD donors. The procedure needs to be designed to reduce and limit the impact of the prolonged warm ischemia inherent to the uDCD process, and to deal with the ethical issues that this practice poses: termination of advanced cardiopulmonary resuscitation, extension of advanced cardiopulmonary resuscitation beyond futility for organ preservation, moment to approach families to discuss donation opportunities, criteria for the determination of death, or the use of normothermic regional perfusion for the in situ preservation of organs. Although the incidence of primary nonfunction and delayed graft function is higher with organs obtained from uDCD donors, overall patient and graft survival is acceptable in kidney, liver, and lung transplantation, with a proper selection and management of both donors and recipients. Normothermic regional perfusion has shown to be critical to achieve optimal outcomes in uDCD kidney and liver transplantation. However, the role of ex situ preservation with machine perfusion is still to be elucidated. uDCD is a unique opportunity to improve patient access to transplantation therapies and to offer more patients the chance to donate organs after death, if this is consistent with their wishes and values.

[Our new donation law: more autonomy?] / Onze nieuwe donorwet ­ meer autonomie?

On 1 July 2020, the registration of organ and tissue donors in the Netherlands changed from an opt-in to an opt-out system. This means that everyone in the Netherlands will be registered as an organ and tissue donor unless they have registered a different choice in the donor register. The hope is that this new method for donor registration will lead to more donors. Only a small majority of members of the Senate and the House of Representatives in the Netherlands voted for the legislative amendment that enabled this new system to come into effect. In the Senate the amendment was defended on the grounds that it would do more justice to the autonomy of the deceased; the new law will, however, have to be defended from the principles of justice and solidarity by a government that feels responsibility towards those needing a donor organ.

An Organ for My Child: Public Appeals for Limited Resources.

The case of Jamie Fiske and subsequent public appeals for particular children by President Ronald Reagan represent classic cases in pediatric bioethics in which parents or others publicly appealed for a donor organ for a particular child. These raise questions about the appropriate boundaries for public appeals for a limited resource for a particular child and how the press and medical community should respond to such appeals. Public appeals by parents to advocate for their child to receive a limited resource above others promote rationing by morally irrelevant factors and shift the public focus from the national shortage of organs for transplant to the needs of a particular child. Yet these appeals are understandable and will likely continue. Recognizing this, we consider appropriate responses by the media, transplant community, hospitals, and individual clinicians.

Ways to Overcome Organ Shortage: Increasing Donor Pool by Accepting Suboptimal Kidney Donors.

Many factors affect organ donations worldwide, including religious factors, legislative decisions, economic factors, presence of organ procurement organizations, cultural issues, the presence of commercial transplant, and other unknown factors. The number of patients with end-stage renal disease has increased by 6% worldwide. Even with more transplant procedures, these numbers have not combated the dramatically increased number of patients on wait lists. With regard to potential living donors, around 50% are either blood group or HLA incompatible with the recipient, which then requires patient desensitization or paired kidney donation or a combination of both. Survival rates of kidney donors and the general population are almost the same 35 to 40 years after donation. Although the renal consequences of diabetes after kidney donation are almost the same as that shown in the general population, other risk factors should be considered, such as hypertension, proteinuria, and low glomerular filtration rate, before donation. It is so far unknown whether donors with impaired glucose tolerance can safely donate. With diabetes, what was considered normal blood sugar in 1960 to 1990 is now considered frank diabetes. What was considered normal blood pressure is now considered hypertension. Because individuals with these parameters were accepted as organ donors in the past and have been shown to maintain good health, it is worth considering the safe use of organs from donors with early diabetes and hypertension. Whereas young donors may have not reached the age at which hypertension, diabetes, and other kidney diseases develop, older donors have the lowest likelihood of developing end-stage renal disease after donation. As a general approach, young donors can be accepted if they have high glomerular filtration rate, but young donors from certain ethnic minorities and/or extensive family history of chronic kidney disease and those less than 18 years old should not be considered.

The unique moral permissibility of uncontrolled lung donation after circulatory death.

Implementing uncontrolled donation after circulatory determination of death (uDCDD) in the United States could markedly improve supply of donor lungs for patients in need of transplants. Evidence from US pilot programs suggests families support uDCDD, but only if they are asked permission for using invasive organ preservation procedures prior to initiation. However, non-invasive strategies that confine oxygenation to lungs may be applicable to the overwhelming majority of potential uDCDD donors that have airway devices in place as part of standard resuscitation. We propose an ethical framework for lung uDCDD by: (a) initiating post mortem preservation without requiring prior permission to protect the opportunity for donation until an authorized party can be found; (b) using non-invasive strategies that confine oxygenation to lungs; and (c) maintaining strict separation between the healthcare team and the organ preservation team. Attempting uDCDD in this way has great potential to obtain more transplantable lungs while respecting donor autonomy and family wishes, securing public support, and enabling authorized persons to affirm or cease preservation decisions without requiring evidence of prior organ donation intent. It ensures prioritization of life-saving, the opportunity to allow willing donors to donate, and respect for bodily integrity while adhering to current ethical norms.

Needs must: living donor liver transplantation from an HIV-positive mother to her HIV-negative child in Johannesburg, South Africa.

The world's first living donor liver transplant from an HIV-positive mother to her HIV-negative child, performed by our team in Johannesburg, South Africa (SA) in 2017, was necessitated by disease profile and health system challenges. In our country, we have a major shortage of donor organs, which compels us to consider innovative solutions to save lives. Simultaneously, the transition of the HIV pandemic, from a death sentence to a chronic illness with excellent survival on treatment required us to rethink our policies regarding HIV infection and living donor liver transplantation . Although HIV infection in the donor is internationally considered an absolute contraindication for transplant to an HIV-negative recipient, there have been a very small number of unintentional transplants from HIV-positive deceased donors to HIV-negative recipients. These transplant recipients do well on antiretroviral medication and their graft survival is not compromised. We have had a number of HIV-positive parents in our setting express a desire to be living liver donors for their critically ill children. Declining these parents as living donors has become increasingly unjustifiable given the very small deceased donor pool in SA; and because many of these parents are virally suppressed and would otherwise fulfil our eligibility criteria as living donors. This paper discusses the evolution of HIV and transplantation in SA, highlights some of the primary ethical considerations for us when embarking on this case and considers the new ethical issues that have arisen since we undertook this transplant.

Stakeholders views on the ethical aspects of oocyte banking for third-party assisted reproduction: a qualitative interview study with donors, recipients and professionals.

STUDY QUESTION: What are the moral considerations held by donors, recipients and professionals towards the ethical aspects of the intake and distribution of donor bank oocytes for third-party assisted reproduction? SUMMARY ANSWER: Interviews with oocyte donors, oocyte recipients and professionals demonstrate a protective attitude towards the welfare of the donor and the future child. WHAT IS KNOWN ALREADY: The scarcity of donor oocytes challenges the approach towards the many ethical aspects that arise in establishing and operating an oocyte bank for third-party assisted reproduction. Including experiences and moral considerations originating from practice provides useful insight on how to overcome these challenges. STUDY DESIGN, SIZE, DURATION: The project was set-up as a qualitative interview study and took place between October 2016 and August 2017. PARTICIPANTS/MATERIALS, SETTING, METHODS: We conducted 25 semi-structured interviews with professionals engaged in the practice of oocyte banking (n = 10), recipients of donor oocytes (n = 7) and oocyte donors (n = 8). Key themes were formulated by means of a thematic analysis. MAIN RESULTS AND THE ROLE OF CHANCE: Based on the interviews, we formulated four main themes describing stakeholders' views regarding the ethical aspects of the intake and distribution of donor bank oocytes. First, respondents articulated that when selecting donors and recipients, healthcare workers should prevent donors from making a wrong decision and safeguard the future child's well-being by minimizing health risks and selecting recipients based on their parental capabilities. Second, they proposed to provide a reasonable compensation and to increase societal awareness on the scarcity of donor oocytes to diminish barriers for donors. Third, respondents considered the prioritization of recipients in case of scarcity a difficult choice, because they are all dependent on donor oocytes to fulfil their wish for a child. They emphasized that treatment attempts should be limited, but at least include one embryo transfer. Fourth and finally, the importance of good governance of oocyte banks was mentioned, including a homogenous policy and the facilitation of exchange of experiences between oocyte banks. LIMITATIONS, REASONS FOR CAUTION: The possibility of selection bias exists, because we interviewed donors and recipients who were selected according to the criteria currently employed in the clinics. WIDER IMPLICATIONS OF THE FINDINGS: Respondents' moral considerations regarding the ethical aspects of the intake and distribution of donor oocytes demonstrate a protective attitude towards the welfare of the donor and the future child. At the same time, respondents also questioned whether such a (highly) protective attitude was justified. This finding may indicate there is room for reconsidering strategies for the collection and distribution of donor bank oocytes. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by ZonMw: The Dutch Organization for Health Research and Development (Grant number 70-73000-98-200). A.M.E.B. and B.C.J.M.F. are the initiators of the UMC Utrecht oocyte bank. J.J.P.M.P. is the director of the MCK Fertility Centre. IMC is working as a gynaecologist at the AMC Amsterdam oocyte bank. During the most recent 5-year period, BCJM Fauser has received fees or grant support from the following organizations (in alphabetic order): Actavis/Watson/Uteron, Controversies in Obstetrics & Gynaecologist (COGI), Dutch Heart Foundation, Dutch Medical Research Counsel (ZonMW), Euroscreen/Ogeda, Ferring, London Womens Clinic (LWC), Merck Serono (GFI), Myovant, Netherland Genomic Initiative (NGI), OvaScience, Pantharei Bioscience, PregLem/Gedeon Richter/Finox, Reproductive Biomedicine Online (RBMO), Roche, Teva and World Health Organization (WHO). The authors have no further competing interests to declare. TRIAL REGISTRATION NUMBER: N/A.

Utilisation of small paediatric donor kidneys for transplantation.

With the increasing need for kidney transplantation in the paediatric population and changing donor demographics, children without a living donor option will potentially be offered an adult deceased donor transplant of marginal quality. Given the importance of long-term graft survival for paediatric recipients, consideration is now being given to kidneys from small paediatric donors (SPDs). There exist a lack of consensus and a reluctance amongst some centres in transplanting SPDs due to high surgical complication rates, graft loss and concerns regarding low nephron mass and long-term function. The aim of this review is to examine and present the evidence base regarding the transplantation of these organs. The literature in both the paediatric and adult renal transplant fields, as well as recent relevant conference proceedings, is reviewed. We discuss the surgical techniques, long-term graft function and rates of complications following transplantation of SPDs. We compare graft survival of SPDs to adult deceased donors and consider the use of small paediatric donors after circulatory death (DCD) organs. In conclusion, evidence is presented that may refute historically held paradigms regarding the transplantation of SPDs in paediatric recipients, thereby potentially allowing significant expansion of the donor pool.

Understanding the sex disparity in living kidney donation.

Living donors are the preferred source of organs for kidney transplantation, which is the treatment modality of choice for end-stage kidney disease. Health care systems widely promote living kidney donation. However, women are consistently overrepresented among living donors. The reasons behind the sex-based disparity in living kidney donation remain poorly understood. Compared to women, men possess a greater amount of kidney function, and the higher deceased donation rate among men reflects their higher overall kidney quality. A plausible medical explanation for the sex-based disparity in living kidney donation includes an uncompromising emphasis on preserving donor health, with less emphasis placed on organ quality, which is the main criterion in deceased donor selection. On the other hand, consent to deceased donation is also greater in women, indicating their greater desire to donate even though fewer women actually become deceased donors. Therefore, nonmedical reasons for the sex disparity in living donation must be sought. Increased empathic distress or emotional memory; a greater sense of responsibility, urgency, and impulsiveness with increased reaction to empathy; a different body image; and a different social status may all contribute to greater living kidney donation in women. Economic inequity may be the singular explanation when personal worth links to economic worth. To better understand the sex disparity in living kidney donation, we need better data on the reasons behind both nondonation and donor rejection after evaluation in clinical practice. Nondirected living kidney donation provides unique opportunities to minimize factors such as emotional distress, empathy, and impulsiveness. More liberal acceptance criteria for donors with isolated medical abnormalities and testing legitimate donor reimbursement strategies based on actual income levels rather than a fixed amount can assist in both ascertaining the reasons behind the sex disparity in living kidney donation and increasing overall living kidney donation rates.

Uterus Transplantation: The Ethics of Using Deceased Versus Living Donors.

Research teams have made considerable progress in treating absolute uterine factor infertility through uterus transplantation, though studies have differed on the choice of either deceased or living donors. While researchers continue to analyze the medical feasibility of both approaches, little attention has been paid to the ethics of using deceased versus living donors as well as the protections that must be in place for each. Both types of uterus donation also pose unique regulatory challenges, including how to allocate donated organs; whether the donor / donor's family has any rights to the uterus and resulting child; how to manage contact between the donor / donor's family, recipient, and resulting child; and how to track outcomes moving forward.

When Is It Appropriate to Put a Live Donor at Risk to Help Another Patient?

This article considers the nature and scope of ethical decision making in monozygotic sibling (MZS) skin grafting. Although rare, identical twin-to-twin skin grafting has been reported with excellent survival rates in burn patients. Of 16 cases published to date, only a few address the ethical decision making process that is involved with monozygotic sibling skin grafting; this article discusses clinical indications and ethical challenges.

Swaps and Chains and Vouchers, Oh My!: Evaluating How Saving More Lives Impacts the Equitable Allocation of Live Donor Kidneys.

Live kidney donation involves a delicate balance between saving the most lives possible and maintaining a transplant system that is fair to the many thousands of patients on the transplant waiting list. Federal law and regulations require that kidney allocation be equitable, but the pressure to save patients subject to ever-lengthening waiting times for a transplant has been swinging the balance toward optimizing utility at the expense of justice. This article traces the progression of innovations created to make optimum use of a patient's own live donors. It starts with the simplest - direct donation by family members - and ends with voucher donations, a very recent and unique innovation because the donor can donate 20 or more years before the intended recipient is expected to need a kidney. In return for the donation, the intended recipient receives a voucher that can be redeemed for a live kidney when it is needed. Other innovations that are discussed include kidney exchanges and list paired donation, which are used to facilitate donor swaps when donor/recipient pairs have incompatible blood types. The discussion of each new innovation shows how the equity issues build on each other and how, with each new innovation, it becomes progressively harder to find an acceptable balance between utility and justice. The article culminates with an analysis of two recent allocation methods that have the potential to save many additional lives, but also affirmatively harm some patients on the deceased donor waiting list by increasing their waiting time for a life-saving kidney. The article concludes that saving additional lives does not justify harming patients on the waiting list unless that harm can be minimized. It also proposes solutions to minimize the harm so these new innovations can equitably perform their intended function of stimulating additional transplants and extending the lives of many transplant patients.

Did parents have it right all along? Parents, risk, and living kidney donation: Revisiting the arguments for and against parental living donation of kidneys.

Historically, living kidney donation has been justified in part by our belief that living donors face minimal risks of subsequent disease. Recent research has brought that presumption into question, particularly for younger donors including parents. In light of this finding, we re-examine many of the traditional arguments both for and against the practice of parental living kidney donation. We then propose an alternative framework in which the burden of having a child with end-stage kidney disease can be considered as an illness experienced by the potential donor parent. We believe this allows a more straightforward, as well as more accurate, assessment of the risks and benefits of donation for the potential parental donor. This assessment might then be used to best inform the decision whether or not to proceed with kidney donation using a shared decision-making model, while reflecting the appropriate ethical roles of both the potential donor and the transplantation program.

Donor blood screening and moral responsibility: how safe should blood be?

Some screening tests for donor blood that are used by blood services to prevent transfusion-transmission of infectious diseases offer relatively few health benefits for the resources spent on them. Can good ethical arguments be provided for employing these tests nonetheless? This paper discusses-and ultimately rejects-three such arguments. According to the 'rule of rescue' argument, general standards for cost-effectiveness in healthcare may be ignored when rescuing identifiable individuals. The argument fails in this context, however, because we cannot identify beforehand who will benefit from additional blood screening tests. On the 'imposed risk' argument, general cost-effectiveness standards do not apply when healthcare interventions impose risks on patients. This argument ignores the fact that imposing risks on patients is inevitable in healthcare and that these risks can be countered only within reasonable limits. Finally, the 'manufacturing standard' argument premises that general cost-effectiveness standards do not apply to procedures preventing the contamination of manufactured medical products. We contend that while this argument seems reasonable insofar as commercially manufactured medical products are concerned, publicly funded blood screening tests should respect the standards for general healthcare. We conclude that these particular arguments are unpersuasive, and we offer directions to advance the debate.