Medical Decision-Making for Children in Families with Siblings: parental discretion and its limits.

This article examines how parents should make health decisions for one child when they may have a negative impact on the health interests or other interests of their siblings. The authors discuss three health decisions made by the parents of Alex Jones, a child with developmental disabilities with two older neurotypical siblings over the course of eight years. First, Alex's parents must decide whether to conduct sequencing on his siblings to help determine if there is a genetic cause for Alex's developmental disabilities. Second, Alex's parents must decide whether to move to another town to maximize the therapy options for Alex. Third, Alex's parents must decide whether to authorize the collection of stem cells from Alex for a bone marrow transplant for his sibling who developed leukemia. We examine whether the consensus recommendations by Salter and colleagues (2023) regarding pediatric decision-making apply in families with more than one child.

Attitudes and beliefs regarding race-targeted genetic testing of Black people: A systematic review.

Geographical ancestry has been associated with an increased risk of various genetic conditions. Race and ethnicity often have been used as proxies for geographical ancestry. Despite numerous problems associated with the crude reliance on race and ethnicity as proxies for geographical ancestry, some genetic testing in the clinical, research, and employment settings has been and continues to be race- or ethnicity-based. Race-based or race-targeted genetic testing refers to genetic testing offered only or primarily to people of particular racial or ethnic groups because of presumed differences among groups. One current example is APOL1 testing of Black kidney donors. Race-based genetic testing raises numerous ethical and policy questions. Given the ongoing reliance on the Black race in genetic testing, it is important to understand the views of people who identify as Black or are identified as Black (including African American, Afro-Caribbean, and Hispanic Black) regarding race-based genetic testing that targets Black people because of their race. We conducted a systematic review of studies and reports of stakeholder-engaged projects that examined how people who identify as or are identified as Black perceive genetic testing that specifically presumes genetic differences exist among racial groups or uses race as a surrogate for ancestral genetic variation and targets Black people. Our review identified 14 studies that explicitly studied this question and another 13 that implicitly or tacitly studied this matter. We found four main factors that contribute to a positive attitude toward race-targeted genetic testing (facilitators) and eight main factors that are associated with concerns regarding race-targeted genetic testing (barriers). This review fills an important gap. These findings should inform future genetic research and the policies and practices developed in clinical, research, public health, or other settings regarding genetic testing.

Ignorance is Not Bliss: The Case for Comprehensive Reproductive Counseling for Women with Chronic Kidney Disease.

The bioethics literature has paid little attention to matters of informed reproductive decision-making among women of childbearing age who have chronic kidney disease (CKD), including women who are on dialysis or women who have had a kidney transplant. Women with CKD receive inconsistent and, sometimes, inadequate reproductive counseling, particularly with respect to information about pursuing pregnancy. We identify four factors that might contribute to inadequate and inconsistent reproductive counseling. We argue that women with CKD should receive comprehensive reproductive counseling, including information about the possibility of pursuing pregnancy, and that more rigorous research on pregnancy in women with CKD, including women on dialysis or who have received a kidney transplant, is warranted to improve informed reproductive decision making in this population.

Impact of education on APOL1 testing attitudes among prospective living kidney donors.

It is unknown how providing prospective living donors with information about APOL1, including the benefits and drawbacks of testing, influences their desire for testing. In this study, we surveyed 102 participants with self-reported African ancestry and positive family history of kidney disease, recruited from our nephrology waiting room. We assessed views on APOL1 testing before and after presentation of a set of potential benefits and drawbacks of testing and quantified the self-reported level of influence individual benefits and drawbacks had on participants' desire for testing in the proposed context of living donation. The majority of participants (92%) were aware of organ donation and more than half (56%) had considered living donation. And though we found no significant change in response following presentation of the potential benefits and the drawbacks of APOL1 testing by study end significance, across all participants, "becoming aware of the potential risk of kidney disease among your immediate family" was the benefit with the highest mean influence (3.3±1.4), while the drawback with the highest mean influence (2.9±1.5) was "some transplant centers may not allow you to donate to a loved one". This study provides insights into the priorities of prospective living donors and suggests concern for how the information affects family members may strongly influence desires for testing. It also highlights the need for greater community engagement to gain a deeper understanding of the priorities that influence decision making on APOL1 testing.

APOL1 Genetic Testing in Living Kidney Transplant Donors.

The presence of 2 apolipoprotein L1 gene (APOL1) risk variants is associated with increased risk for chronic kidney disease and end-stage kidney disease. Inferior allograft outcomes following transplantation with kidneys from donors with 2 risk variants have also been reported. These data, coupled with anecdotal case reports and a recent cohort study of living donors, raise important questions about the potential increased kidney disease risk for living donors with APOL1 risk variants and the need for testing as part of the standard living donor evaluation process. We identify a series of questions that are central to the development of clinical policy regarding APOL1 testing of potential living kidney donors given the current uncertainty over the clinical implications of having 2 risk variants. We explore the ethical challenges that arise when determining when and to whom APOL1 testing should be offered, what potential donors should be told about APOL1 testing, how test results should be used to determine suitability for donation, if and when recipients should have access to results, and how clinical policy regarding APOL1 testing should be established.

Building Norms for Organ Donation in China: Pitfalls and Challenges.

In most, if not all, jurisdictions with active organ transplantation programs, there is a persistent desire to increase donation rates because the demand for transplantable organs exceeds the supply. China, in particular, faces an extraordinary gap between the number of organs donated by deceased donors and the number of people seeking one or more transplants. China might look to Western countries with higher donation rates to determine how best to introduce Western practices into the Chinese system. In attempting to increase its organ donation rate, China must not only ensure that its organ donation system reflects different Chinese cultural values, but also that it avoids the ethical problems of the United States and of other Western systems. This article examines four such problems. They concern the family, obtaining permission for organ donation, the definition and diagnosis of "brain death," and trust. Revisions to the Chinese system should involve a careful look to China and Chinese cultural resources rather than to Western models.

Prenatal screening and prenatal diagnosis: contemporary practices in light of the past.

The 20th century eugenics movement in the USA and contemporary practices involving prenatal screening (PNS), prenatal diagnosis (PND), abortion and preimplantation genetic diagnosis (PGD) share important morally relevant similarities. I summarise some features of the 20th century eugenics movement; describe the contemporary standard of care in the USA regarding PNS, PND, abortion and PGD; and demonstrate that the 'old eugenics' the contemporary standard of care share the underlying view that social resources should be invested to prevent the birth of people with certain characteristics. This comparison makes evident the difficulty of crafting moral arguments that treat some uses of PNS, PND, abortion and PGD as licit and others as illicit.

Expertise, Ethics Expertise, and Clinical Ethics Consultation: Achieving Terminological Clarity.

The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this "knowing" or "being better at judging" is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts.

The "Ethics" Expertise in Clinical Ethics Consultation.

The nature, possibility, and implications of ethics expertise (or moral expertise) in general and of bioethics expertise in particular has been the focus of extensive debate for over thirty years. What is ethics expertise and what does it enable experts to do? Knowing what ethics expertise is can help answer another important question: What, if anything, makes a claim of expertise legitimate? In other words, how does someone earn the appellation "ethics expert?" There remains deep disagreement on whether ethics expertise is possible, and if so, what constitutes such expertise and what it entails and legitimates. Discussion of bioethics expertise has become particularly important given the growing presence of bioethicists in the clinical setting as well as efforts to professionalize bioethics through codes of ethics and certification (or quasi-certification) efforts. Unlike in the law or in engineering, where there may be a body of knowledge that professional organizations or others have articulated as important for education and training of experts, ethics expertise admits of no such body of knowledge or required experience. Nor is there an entity seen as having the authority to articulate the necessary scope of knowledge. Questions about whether there is such a body of knowledge for particular areas within bioethics have emerged and played a central role in professionalization efforts in recent years, especially in the area of clinical ethics.

Unproven stem cell-based interventions and achieving a compromise policy among the multiple stakeholders.

BACKGROUND: In 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once (and often still are) the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process? DISCUSSION: In this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation. CONCLUSION: The current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort.

The Practice of Electroconvulsive Therapy in US Correctional Facilities: A Nationwide Survey.

OBJECTIVES: There are little data regarding the practice of electroconvulsive therapy (ECT) in correctional settings in the United States. A survey was conducted to study the current practice of ECT in US prisons. We hypothesize that ECT is underutilized in the correctional setting. We also review the ethical aspects of using ECT for the treatment of mental illness in the prison population. METHODS: A 12-question survey via a Survey Monkey link was emailed to chiefs of psychiatry, or the equivalent, of each state's department of corrections. We examined the frequency of Likert-type responses, tabulated individual comments for qualitative review, and grouped for comparison. RESULTS: Email contacts for chiefs of psychiatry, or the equivalent, for the department of corrections in 45 states (90%) were obtained and a survey link was sent. Thirty-one (68.9%) of 45 responded to the survey. Respondent estimates of the number of inmates with mental illness in 31 prison systems varied from less than 500 to more than 4500. Of these 31, 12 (38.7%) had more than 4500 inmates with mental illness. Four systems reported the use of ECT within the last 5 years. Of those, one reported use in the last 1 to 6 months, and 3 reported use in the last 2 to 5 years. Of these 4 prison systems, all felt that they had up to 10 patients who would benefit if ECT continued to be offered or became available in the future. None of these systems provided ECT within the prison. The inmates were referred to a local state psychiatric facility, a university hospital, or other institutions. The reasons for not using ECT as reported by the respondents are grouped under subheadings of stigma, ethical concerns, logistical concerns, and others. CONCLUSIONS: Considering the high prevalence of mental illness in prisons, one might expect a high prevalence of ECT responsive mental illness and, hence, provision of ECT to some prisoners with mental illness. However, our survey suggests that the use of ECT in prisons in the United States is low. Stigma, ethical concerns, and logistical concerns were the main hindrances for providing ECT to prisoners with mental illness. Given that ECT is the standard of care in certain clinical scenarios, physicians are obligated to offer such treatment to inmates when necessary. It can be argued that failure of the prison to offer the standard of care is unethical and unconstitutional.

Risk-Taking: Individual and Family Interests.

Decisions regarding clinical procedures or research participation typically require the informed consent of individuals. When individuals are unable to give consent, the informed permission of a legally authorized representative or surrogate is required. Although many proposed procedures are aimed primarily at benefiting the individual, some are not. I argue that, particularly when individuals are asked to assume risks primarily or exclusively for the benefit of others, family members ought to be engaged in the informed consent process. Examples of procedures in which individuals are asked to assume risks primarily or exclusively for the benefit of others include living organ donation and research participation.

Health care voluntourism: addressing ethical concerns of undergraduate student participation in global health volunteer work.

The popularity and availability of global health experiences has increased, with organizations helping groups plan service trips and companies specializing in "voluntourism," health care professionals volunteering their services through different organizations, and medical students participating in global health electives. Much has been written about global health experiences in resource poor settings, but the literature focuses primarily on the work of health care professionals and medical students. This paper focuses on undergraduate student involvement in short term medical volunteer work in resource poor countries, a practice that has become popular among pre-health professions students. We argue that the participation of undergraduate students in global health experiences raises many of the ethical concerns associated with voluntourism and global health experiences for medical students. Some of these may be exacerbated by or emerge in unique ways when undergraduates volunteer. Guidelines and curricula for medical student engagement in global health experiences have been developed. Guidelines specific to undergraduate involvement in such trips and pre-departure curricula to prepare students should be developed and such training should be required of volunteers. We propose a framework for such guidelines and curricula, argue that universities should be the primary point of delivery even when universities are not organizing the trips, and recommend that curricula should be developed in light of additional data.

Transparency in controversial research: A review of human embryo research publication ethical disclosure statements.

In 2021, the International Society for Stem Cell Research (ISSCR) released updated guidelines that included human embryo research guidance. Requiring ethics statements in publications using human embryos is one way to verify adherence to these guidelines. A review of top-tier biomedical journal requirements identified only one publisher that requires a human embryo statement. A review of articles using human embryos from top-tier biomedical journals found that all contain some form of ethics statement, but they differ in content and location. Requiring ethics statements with specific elements could improve transparency and adherence to research guidelines.

Perceptions regarding genetic testing in populations at risk for nephropathy.

BACKGROUND: Population ancestry-based differences exist in genetic risk for many kidney diseases. Substantial debate remains regarding returning genetic test results to participants. African-Americans (AAs) and European-Americans (EAs) at risk for end-stage kidney disease were queried for views on the value and use of genetic testing in research. METHODS: A standardized survey regarding attitudes toward genetic testing was administered to 130 individuals (64 AA, 66 EA) with first-degree relatives on dialysis. Fisher's exact test was used to assess differences in participant attitudes between population groups. RESULTS: Mean (SD) age of surveyed AAs and EAs was 45.5 (12.8) and 50.5 (14.4) years, respectively (p = 0.04), with similar familial relationships (p = 0.22). AAs and EAs wished to know their test results if risk could be: (1) reduced by diet or exercise (100 and 98%, p = 0.99); (2) reduced by medical treatment (100 and 98%, p = 0.99), or (3) if no treatments were available (90 and 82%, p = 0.21). If informed they lacked a disease susceptibility variant, 87% of AAs and 88% of EAs would be extremely or pretty likely to inform family members (p = 0.84). If informed they had a disease susceptibility variant, 92% of AAs and 89% of EAs would be extremely or pretty likely to inform their family (p = 0.43). CONCLUSIONS: Attitudes toward obtaining and using genetic test results for disease in research contexts were similar in AAs and EAs at risk for end-stage kidney disease. A substantial majority would want information regardless of available treatments and would share the information with the family. These results have important implications for patient care, study design and the informed consent process.

Parents, adolescents, and consent for research participation.

Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as "mature" and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement.

Ethics Considerations in Laws Restricting Incapacitated Patients' Access to ECT.

Electroconvulsive therapy (ECT) is a safe and effective treatment used for numerous psychiatric conditions. While many patients for whom ECT is indicated are able to give voluntary informed consent, some lack decision-making capacity (DMC), at least temporarily. Case reports from numerous countries involving ECT for patients who lack DMC indicate overall positive outcomes and high patient satisfaction with results comparable with those of consenting patients; some patients regain DMC with ECT. Laws and regulations pertaining to ECT vary widely around the world and across the United States. Many United States jurisdictions over-regulate ECT relative to other interventions with comparable risks and potential benefits. While laws restricting whether and under what circumstances patients who lack DMC may receive ECT likely are aimed at protecting incapacitated persons, such laws sometimes undermine important ethics obligations and should be re-evaluated.

Ethical, legal, regulatory, and policy issues concerning embryoids: a systematic review of the literature.

Recent advances in methods to culture pluripotent stem cells to model human development have resulted in entities that increasingly have recapitulated advanced stages of early embryo development. These entities, referred to by numerous terms such as embryoids, are becoming more sophisticated and could resemble human embryos ever more closely as research progresses. This paper reports a systematic review of the ethical, legal, regulatory, and policy questions and concerns found in the literature concerning human embryoid research published from 2016 to 2022. We identified 56 papers that use 53 distinct names or terms to refer to embryoids and four broad categories of ethical, legal, regulatory, or policy considerations in the literature: research justifications/benefits, ethical significance or moral status, permissible use, and regulatory and oversight challenges. Analyzing the full range of issues is a critical step toward fostering more robust ethical, legal, and social implications research in this emerging area and toward developing appropriate oversight.

Counselling, Research Gaps, and Ethical Considerations Surrounding Pregnancy in Solid Organ Transplant Recipients.

Survival after solid-organ transplantation has improved significantly, and many contemporary transplant recipients are of childbearing potential. There are limited data to guide decision-making surrounding pregnancy after transplantation, variations in clinical practice, and significant knowledge gaps, all of which raise significant ethical issues. Post-transplant pregnancy is associated with an increased risk of maternal and fetal complications. Shared decision-making is a central aspect of patient counselling but is complicated by significant knowledge gaps. Stakeholder interests can be in conflict; exploring these tensions can help patients to evaluate their options and inform their deliberations. We argue that uniform, evidence-based recommendations for pregnancy after solid organ transplantation are needed. Conducting research, including patient-engaged studies, in this area should be priority for the transplant community.