Aaron Wightman

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Update on Ethical Issues in Pediatric Dialysis: Has Pediatric Dialysis Become Morally Obligatory?

Improvements in pediatric dialysis over the past 50 years have made the decision to proceed with dialysis straightforward for the majority of pediatric patients. For certain groups, however, such as children with multiple comorbid conditions, children and families with few social and economic resources, and neonates and infants, the decision of whether to proceed with dialysis remains much more controversial. In this review, we will examine the best available data regarding the outcomes of dialysis in these populations and analyze the important ethical considerations that should guide decisions regarding dialysis for these patients. We conclude that providers must continue to follow a nuanced and individualized approach in decision making for each child and to recognize that, regardless of the decision reached about dialysis, there is a continued duty to care for patients and families to maximize the remaining quality of their lives.

Who Should Get the Last PICU Bed

Administrators sometimes face ethical dilemmas about the allocation of institutional resources. One such situation is when elective surgery cases require reserved ICU beds and the ICU is full. Such situations arise frequently in children’s hospitals today. They are sometimes complicated by questions about whether every patient in the ICU belongs there. We present such a situation and responses from Mark Del Becarro, Vice President for Medical Affairs at Seattle Children’s Hospital; Aaron Wightman, a nephrology fellow and bioethicist at Seattle Children’s Hospital; and Emily Largent, a doctoral student in the joint JD/PhD Program in Health Policy at Harvard University.

Is it permissible for a child with neurodevelopmental disabilities to be a living donor transplant candidate, but not a deceased donor candidate? Should donor source influence transplant center deliberations?

Limited data from surveys and highly publicized cases suggest that pediatric transplant providers and the public may use different standards when evaluating a potential transplant candidate with severe neurodevelopmental disabilities depending on whether a parent or other living donor has been identified. The purpose of this article is to explore the arguments in favor and against differing standards of candidacy for living and deceased donor transplants in pediatric solid organ transplantation using the example of children with severe neurodevelopmental disabilities. I conclude that donor source should not be a relevant consideration of pediatric transplant teams when considering the candidacy of a potential recipient.

Fairness, severe intellectual disability, and the special case of transplantation

Children with severe intellectual disability have historically been excluded from solid organ transplantation. The purpose of this article was to review the arguments for excluding this population, including claims of poorer recipient and graft survival, a lower QoL as pediatric recipients become adults, and poorer outcomes for other, more deserving pediatric transplant candidates, and make the case that these arguments are no longer persuasive. We will argue that pediatric transplant centers for reasons of social justice, value of relationships, power differential, and fairness should generally not consider intellectual ability or disability as a criterion when making decisions regarding organ transplant eligibility.

Consideration of children with intellectual disability as candidates for solid organ transplantation-A practice in evolution

Children with intellectual disability were historically excluded from consideration as recipients of solid organ transplants. In light of an evolution in provider practices, this commentary will define intellectual disability and review the relevant provider attitudes and guidelines and known outcomes of solid organ transplant in this population.

Responding to parental requests for life-sustaining treatment - relational potential revisited

One of the most challenging situations for paediatric clinicians is responding to parental requests for life-sustaining medical therapies for a child with profound neurodevelopmental disabilities. These therapies (e.g. intravenous medications and fluids, gastrostomy tube feeds, dialysis, tracheostomy and/or mechanical ventilation) offer the possibility for the child to live, at home or in a facility, formonths or years as opposed to experiencing their imminent death. While relatively rare, the tension surrounding these requests canbeexceptionallyhigh, as illustratedby the casesofBabyK, Baby Joseph, Jahi McMath, Charlie Gard and many others from our own experience. In these situations, clinicians may strongly recommend against life-sustaining medical therapies, but receive persistent andoften impassioned requests for such interventions from a child’s family. For clinicians, some of the discomfort in responding to these requests may be related to concerns not that life-sustaining interventions will not work, but rather the likelihood that they will. It highlights the inadequacy of applying the best-interests standard for medical decision-making for children with profound neurodevelopmental disabilities who may appear to be noncommunicative and to have limited awareness of their surroundings, somethingnotedby thephilosopher JohnArras more than 30 years ago (1). Drawing in part from Arras’s work, we propose that clinicians should use a relational potential standard rather than solely a best-interests standard when considering parental requests for life-sustaining medical therapies for children with profound disabilities.

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.

Controversy About Dialysis for an Adolescent

An adolescent would rather die than be dialyzed through her fistula. Doctors think any other route would be too dangerous. Should they let her die? For patients on dialysis, 1 frequent cause of death is their voluntary decision to discontinue dialysis. Such decisions raise complex questions when the patient is a competent adult. The decisions are even more complex when the patient is an adolescent. In this article, we present a case in which a 17-year-old adolescent decided that she no longer wished to undergo dialysis through her fistula. Her doctors thought that dialysis using any other technique would be too dangerous. Four experts in pediatric nephrology, bioethics, and palliative care discuss this decision and the different ways that the health care team might respond.

Management dilemmas in pediatric nephrology: time-limited trials of dialysis therapy

AbstractBackgroundTime-limited trials of dialysis have been proposed as a third option in addition to initiation of treatment and comfort-care only in the setting of high uncertainty or discordance between the treating team and child/family or among the treating team.Case-diagnosis/treatmentThe index case was noted antenatally to have severe kidney disease and pulmonary hypoplasia. In light of the guarded, but uncertain prognosis and a lack of consensus among the treating team, as well as between the treating team and the family, a time-limited trial of dialysis was initiated. Six days later the child developed bacteremia due to infection of the dialysis catheter. The treating team felt this was a failure of the trial and that future dialysis should be withheld, the family disagreed.ConclusionA time-limited trial is a problematic option. Providers may be better suited by returning to the dichotomous choice of withholding or initiating treatment.Key management points• Time-limited trials offer potential benefits in terms of alleviating the burden of decision-making in the setting of uncertainty, offering an opportunity to forecast a poor prognosis, help avoid interprofessional conflict, and providing support for patients, their families, and staff. • Time-limited trials have important limitations, including the use of time limits, difficulty in determining clear, meaningful endpoints, and different interpretations of a trial of therapy between parents and providers. • Decisions regarding the initiation, withholding, and withdrawal of dialysis should be made based on regular assessments of the benefits and burdens of the intervention for the child. • Pediatric nephrologists are better served to abandon the concept of time-limited trials.