American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or (...) come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

The advanced donation program was proposed in 2014 to allow an individual to donate a kidney in order to provide a voucher for a kidney in the future for a particular loved one. In this article, we explore the logistical and ethical issues that such a program raises. We argue that such a program is ethical in principle but there are many logistical issues that need to be addressed to ensure that the actual program is fair to both those who (...) do and do not participate in this program. (shrink)

This book examines the ethical issues in pediatric medical research. It argues that policies and practices on the participation of children must focus primarily on minimizing risks. It offers specific recommendations to revise Subpart D of the federal regulations to provide greater protection where necessary and remove obstacles that do not provide additional protection but interfere with access. The book is divided into four sections. Section 1 focuses on the issue of access versus protection in pediatric research. Section 2 deals (...) with challenges to regulations. Section 3 discusses the strengths and limits of current regulations, while different case studies are examined in Section 4. (shrink)

The Case of Archie Battersbee in the United Kingdom (UK) is a tragic one: a 12-year-old otherwise healthy boy who suffered a cardiac arrest at home on April 7, 2022, and was subsequently diagnosed...

Although many of the congenital syndromes that used to be lethal no longer are, they are still routinely referred to as “lethal anomalies.” But the label is not only inaccurate, it is also dangerous: by portraying as a medical determination what is in fact a judgment about the child's quality of life, it wrests from the parents a decision that only the parents can make.

Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to (...) serve as the foundation for an ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation. (shrink)

ABSTRACTIn 1994, the Committee on Assessing Genetic Risks of the Institute of Medicine published their recommendations regarding the ethical issues raised by advances in genetics. One of the Committee's recommendation was to inform women when test results revealed misattributed paternity, but not to disclose this information to the women's partners. The Committee's reason for withholding such information was that “'genetic testing should not be used in ways that disrupt families”. In this paper, I argue that the Committee's conclusion in favour (...) of nondisclosure to the male partner is unethical. I argue that both parties ought to be informed. (shrink)

The fundamental principle of modern-day bioethics is that “the competent adult has the right to accept or refuse all medical care, including life-saving medical care,” a principle that has been upheld by the U.S. Supreme Court in Bouvia v. Superior Court ) and Cruzan v. Director, Missouri Department of Health ). If the adult lacks decision-making capacity, a surrogate can speak on his or her behalf. The adult may have chosen his or her surrogate through an advance directive; if not, (...) laws assign guardianship based on a hierarchy of relationships. Surrogates are expected.. (shrink)

In 1994, the Committee on Assessing Genetic Risks of the Institute of Medicine published their recommendations regarding the ethical issues raised by advances in genetics. One of the Committee's recommendation was to inform women when test results revealed misattributed paternity, but not to disclose this information to the women's partners. The Committee's reason for withholding such information was that “'genetic testing should not be used in ways that disrupt families”. In this paper, I argue that the Committee's conclusion in favour (...) of nondisclosure to the male partner is unethical. I argue that both parties ought to be informed. (shrink)

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that (...) patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk. (shrink)

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that (...) patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk. (shrink)

The argument for children's rights in health care has been long in the making. The success of this position is reflected in the 1995 American Academy of Pediatrics recommendations for the role of children in health care decisionmaking, which suggest that children be given greater voice as they mature. But there are good moral and practical reasons for exercising caution in these health care situations, especially when the child and parents disagree. Parents need the moral and legal space within which (...) to make decisions that will facilitate their child's long‐term autonomy, not only her present‐day autonomy. Moreover, third‐party intrusion, by physicians or the state, should be resisted unless negligent and abusive decisions are in the making. (shrink)

Virtually every infant in the United States (U.S.) undergoes a heel stick within the first week of life to test for a variety of metabolic, endocrine, and hematological conditions as part of state-run universal newborn screening (NBS) programs. In the U.S., NBS began in the 1960s for phenylketonuria (PKU), a metabolic condition that causes intellectual disability if left untreated. I review the history of how NBS came to be a mandatory public health program that did not require parental consent1 and (...) examine whether the policy was morally justifiable. I then examine how three changes to NBS programs are prompting a re-evaluation of the mandatory nature of NBS. The three changes are: (1) the implementation of .. (shrink)

The first principle of the Nuremberg Code requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki. U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health and Human Services (...) to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified. a. (shrink)

In 1999, a case was described on national television in which a woman had enlisted onto an international bone marrow registry with the altruistic desire to offer her bone marrow to some unidentified individual in need of a transplant. The potential donor then was notified that she was a compatible match with someone dying from leukemia and gladly donated her marrow, which cured the recipient of the disease. Years later, though, the recipient developed end-stage renal disease, a consequence of the (...) high-dose chemotherapy she received earlier to destroy her stem cells and prepare her for the bone marrow transplant. Finding a suitable donor for a kidney transplant proved extremely difficult. Desperate, she requested that the donor registry personnel help her locate the individual who earlier was determined to be a compatible donor and asked this now-identifiable individual to consider donating one of her two normally functioning kidneys for a kidney transplant. (shrink)

Healthcare decision making for children has adopted the best interest of the child standard, a principle originally employed by judges to adjudicate child placement in the case of parental death, divorce, or incompetence. Philosophers and medical ethicists have argued whether the best interest principle is a guidance principle (informing parents on how they should make healthcare decisions for their child), an intervention principle (deciding the limits of parental autonomy in healthcare decision making), or both. Those who defend it as only (...) a guidance principle often cite the harm principle as the appropriate intervention principle. In this article, I challenge current use of the best interest principle in pediatric decision making as a guidance principle and as an intervention principle. I propose a model that I call constrained parental autonomy, which focuses on promoting and protecting the child’s primary goods or basic needs. I show that constrained parental autonomy can serve as both a guidance principle and an intervention principle in making decisions. I conclude by examining a case study involving bone marrow donation by a young child to her sister. (shrink)

Book reviewed in this article: Women & Children in Health Care: An Unequal Majority. By Mary Briody Mahowald.

In February 1997, the Committee on Bioethics of the American Academy of Pediatrics updated its position on religious exemptions to medical care. In its earlier statement, the committee noted that forty-four states have religious exemptions to the child abuse and neglect statutes, and they argued for the repeal of these exemptions. The committee did not indude in its statement a position on religious exemptions to childhood immunization requirements that exist in forty-eight states, although this issue was discussed in committee meetings. (...) In its revised statement, the committee concluded that “The AAP does not support the stringent application of medical neglect laws when children do not receive recommended immunizations.” In this paper, we consider whether failure to immunize one's child is a form of medical neglect and, if so, whether states should repeal their religious exemptions to the immunization statutes. We argue that failure to vaccinate a child properly is medical neglect. (shrink)

In February 1997, the Committee on Bioethics of the American Academy of Pediatrics updated its position on religious exemptions to medical care. In its earlier statement, the committee noted that forty-four states have religious exemptions to the child abuse and neglect statutes, and they argued for the repeal of these exemptions. The committee did not indude in its statement a position on religious exemptions to childhood immunization requirements that exist in forty-eight states, although this issue was discussed in committee meetings. (...) In its revised statement, the committee concluded that “The AAP does not support the stringent application of medical neglect laws when children do not receive recommended immunizations.” In this paper, we consider whether failure to immunize one's child is a form of medical neglect and, if so, whether states should repeal their religious exemptions to the immunization statutes. We argue that failure to vaccinate a child properly is medical neglect. (shrink)

In August 2000, Arthur Matas and his colleagues de scribed a protocol in which their institution began to accept as potential donors, individuals who came to the University of Minnesota hospital offering to donate a kidney to any patient on the waiting list. Matas and his colleagues refer to these donors as nondirected donors by which is meant that the donors are altruistic and that they give their organs to an unspecified pool of recipients with whom they have no emotional (...) relationship. This paper represents an ethical and policy critique of the nondirected donation protocol that was implemented at the University of Minnesota in August 1999. Specifically, I address the ethical questions: Whether altruistic living solid organ donations by strangers should be permitted? And if so, What are appropriate ethical guidelines for such donations? (shrink)

Controversies surrounding the determination of death by neurologic criteria (DNC), also known as brain death, have become increasingly common over the last decade, occasionally leading to parental refusal of all or part of an evaluation or declaration of DNC. We performed a prospective, crosssectional study of pediatric neurologists and intensivists who participate in professional listservs to ascertain perspectives and practices concerning the evaluation of DNC, specifically on obtaining permission for evaluations and managing refusals. Of the 334 respondents who had performed (...) an evaluation for DNC, 35 percent reported they had experienced at least one parental refusal, and 64.4 percent reported that they did not seek permission to perform an evaluation. Pediatric neurologists, careproviders who had less experience doing evaluations, and careproviders who had experienced parental refusal of an evaluation were more likely to obtain permission from parents. Most (80.8 percent) of respondents reported that their institution had a DNC policy. We found variability in many aspects of DNC evaluations and declarations, as well as the handling of refusals. Lack of consistency may make it more difficult for careproviders and families. Greater understanding of parental refusal of DNC evaluation is essential to inform efforts to increase consistency. (shrink)

The definition of death was clearer one hundred years ago than it is today. People were declared dead if diagnosed with permanent cessation of both cardio‐circulatory function and respiratory function. But the definition has been muddled by the development of new technologies and interventions—first by cardiopulmonary resuscitation and ventilators, which were introduced in the mid‐twentieth century, and now by extracorporeal membrane oxygenation, which creates the ability to keep oxygenated blood circulating, with or without a beating heart or functioning lungs. In (...) Defining Death: The Case for Choice, Robert Veatch and I argue that the definition of death should focus on “what change in a human being is so fundamental that we can say the individual is no longer with us as a member of the human community bearing rights such as the right not to be killed.” We assert that this decision is a normative issue about which different stakeholders may believe that different changes are fundamental, and we therefore propose that the optimal policy solution may be to allow stakeholders to choose their own definition within a reasonable range of options. There are three caveats that need to be highlighted regarding this approach. (shrink)

In August 2000, Arthur Matas and his colleagues de scribed a protocol in which their institution began to accept as potential donors, individuals who came to the University of Minnesota hospital offering to donate a kidney to any patient on the waiting list. Matas and his colleagues refer to these donors as nondirected donors by which is meant that the donors are altruistic and that they give their organs to an unspecified pool of recipients with whom they have no emotional (...) relationship. This paper represents an ethical and policy critique of the nondirected donation protocol that was implemented at the University of Minnesota in August 1999. Specifically, I address the ethical questions: Whether altruistic living solid organ donations by strangers should be permitted? And if so, What are appropriate ethical guidelines for such donations? (shrink)

The traditional living donor was very healthy. However, as the supply-demand gap continues to expand, transplant programs have become more accepting of less healthy donors. This paper focuses on the other extreme, asking whether and when individuals who have life-limiting conditions should be considered for living organ donation. We discuss ethical issues raised by 1) donation by individuals with progressive severe debilitating disease for whom there is no ameliorative therapy; and 2) donation by individuals who are imminently dying or would (...) die by the donation process itself. (shrink)

Introduction Biobank-based research is growing in importance. A major controversy exists about the return of aggregate and individual research results. Methods The authors used a mixed-method approach in order to study parents' attitudes towards the return of research results regarding themselves and their children. Participants attended four 2-h, deliberative-engagement sessions held on two consecutive Saturdays. Each session consisted of an educational presentation followed by focus-group discussions with structured questions and prompts. This manuscript examines discussions from the second Saturday which focused (...) on the benefits and risks of returning aggregate and individual research results regarding both adults (morning session) and children (afternoon session). Attitudes were assessed in pre-engagement and post-engagement surveys. Results The authors recruited 45 African-American adults whose children received medical care at two healthcare facilities on the South Side of Chicago that serve different socioeconomic communities. Three dominant themes were identified. First, most participants stated that they would enrol themselves and their children in a biobank, although there was a vocal minority opposed to enrolling children, particularly children unable to participate in the consent process. Second, participants did not distinguish between the results they wanted to receive regarding themselves and their children. Supplemental survey data found no attitudinal changes pre-engagement and post-engagement. Third, participants believed that children should be allowed access to their health information, but they wanted to be involved in deciding when and how the information was shared. Discussion Participant attitudes are in tension with current biobank policies. An intensive educational effort had no effect on their attitudes. (shrink)

In “The Harm Principle Cannot Replace the Best Interest Standard: Problems With Using the Harm Principle for Medical Decision Making for Children,” Bester argues that conceptual and normative diffi...

The "best interest of the child" standard is central to both pediatric bioethics and the child rights community. In pediatric bioethics in the United States, the best interest of the child standard is cited as the guidance principle for parental decision-making.1 Likewise, in the child rights community, the best interest of the child standard is "of paramount consideration" ). Both approaches also recognize parental rights and responsibilities and support a role for the maturing child in the decision-making process. Why, then, (...) do members of the pediatric bioethics community and the child rights communities not speak the same language?This article was developed out of... (shrink)

In a recent paper, Doernberg and Truog identify that physicians must routinely navigate a set of distinct “moral spheres”—clinical care, research, population health and the market.1 While the conce...

: The past decade has witnessed the emergence of novel methods to increase the number of living donors. Although such programs are not likely to yield high volumes of organs, some transplant centers have gone to great lengths to establish one or more of them. I discuss some of the ethical and policy issues raised by five such programs: (1) living-paired and cascade exchanges; (2) unbalanced living-paired exchanges; (3) list-paired exchanges; (4) nondirected donors; and (5) nondirected donors catalyzing cascade exchanges. (...) I argue that living-paired and cascade exchanges are ethically sound, but will lead to only a few additional transplants. Unbalanced exchanges and list-paired exchanges raise ethical issues that should limit their permissibility. Nondirected donations can be ethically sound with adherence to strict eligibility criteria and fair allocation procedures. Nondirected donors catalyzing cascade exchanges can be ethically sound provided that individuals with blood types O and B are not made worse off. (shrink)

: Subpart D of 45 CFR 46 focuses on research involving children. Section 46.407 addresses research that is not otherwise approvable. The research is not otherwise approvable because either (1) it seeks to enroll healthy children, but offers no prospect of direct benefit and entails more than minimal risk; or (2) it seeks to enroll children with a disorder or condition, but offers no prospect of direct benefit and entails more than a minor increase over minimal risk. According to 46.407, (...) such research can be permissible if it is approved by a panel of experts. Prior to 2000, only two 407 panels had been convened, but in 2001, the Office for Human Research Protections received more than 20 protocols for 407 review. The first, entitled "Precursors to Diabetes in Japanese American Youth," serves here as a case study in human subject protections. (shrink)

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to justify (...) the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection. (shrink)

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to justify (...) the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection. (shrink)

Background There is lack of consensus in the bioethics literature regarding the use of cardiopulmonary resuscitation (CPR) for organ-preserving purposes. In this study, we assessed the perspectives of clinicians in critical care settings to better inform donor management policy and practice.Methods An online anonymous survey of members of the Society of Critical Care Medicine that presented various scenarios about CPR for organ preservation.Results The email was sent to 10,340 members. It was opened by 5,416 (52%) of members and 405 members (...) (4%) completed the survey with few missing data. A majority of respondents (81%) answered that donation status should not influence whether CPR is performed on an imminently dying patient. There was very strong agreement (>85%) that 1) CPR should be performed on a registered donor who experiences a cardiac arrest with an unknown code status before death by neurological criteria (DNC) and 2) CPR should be performed if the patient is not a registered donor and experiences cardiac arrest but the surrogate/power of attorney (POA) has not yet been approached regarding code status and donation. When a registered donor with a DNR order experiences cardiac arrest before DNC, 98% of respondents would not perform CPR. However, after DNC, respondents were evenly divided on whether they would (49%) or would not (51%) perform CPR on a registered donor with an undocumented code status. When asked whether consent should be required for CPR for organ-preserving purposes, 39% answered “Yes” when a patient arrests before DNC and 48% answered “Yes” when a patient arrests after DNC (P = 0.2).Conclusions The majority of respondents did not consider donor status relevant to CPR decisions before DNC, and virtually all would respect a DNR order in a registered donor before DNC. Respondents were divided about the need for an affirmative consent for CPR for organ-preserving purposes both before and after DNC. (shrink)

The “best interest standard” is the guidance principle for pediatric healthcare in the United States (US) and the United Kingdom (UK). In the UK, the best interest standard may also be used as an intervention principle when parents make good but non-ideal decisions whereas intervention in the US requires a determination of abuse or neglect. I examine whether and how the different uses of the best interest standard influence predictive genetic testing of children.

The genetic testing and screening of children has been fraught with controversy since Robert Guthrie developed the bacterial inhibition assay to test for phenylketonuria and advocated for rapid uptake of universal newborn screening in the early 1960s. Today with fast and affordable mass screening of the whole genome on the horizon, the debate about when and in what scenarios children should undergo genetic testing and screening has gained renewed attention. United States professional guidelines — both the American College of Medical (...) Genetics /American Society of Human Genetics statement and the American Academy of Pediatrics Statement on the genetic testing of children and the new AAP and ACMG joint policy statement and technical report — as well as the old UK guidelines by the Working Part of the Clinical Genetics Society and the new United Kingdom guidelines by the British Society of Human Genetics all give the same answer: genetic testing and screening should only be done if it is in the child’s best interest. (shrink)

The Common Health problems that plague Americans today are often the result of people’s choices and behaviors: obesity, cigarette smoking, accidental pediatric head trauma owing to failure to properly restrain children, and failure to adhere to medication regimens. For each problem, there is a well-studied effective behavioral intervention: a healthy diet and exercise for obesity, smoking cessation programs to overcome cigarette addiction, appropriate car restraints to prevent accidental head trauma, and direct observation of treatment and simplification of medical regimens to (...) improve drug adherence. Traditionally, the physician defined the problem and told the patient what she needed to do. In the modern era of .. (shrink)

A couple and their five‐year‐old daughter are in a car accident. The parents are not expected to survive. The child is transported to a children's hospital, and urgent treatment decisions must be made. Whom should the attending physician approach to make decisions for the child? When such cases arise in, for example, the hospitals where we work, the social worker or chaplain is instructed to use the Illinois Health Care Surrogacy Act as a guidepost to identify a decision‐maker. But in (...) our state and the country overall, the limitations of such statutes leave hospital workers to make a judgment call among friends, family, and clergy who may come forward. While surrogate decision‐making statutes comprehensively address surrogate decision‐makers for adults, a patchwork of laws—permanency statutes, kinship provider statutes, standby guardianship statutes, and, in some cases, surrogate decision‐making statutes—provide variable decision‐making pathways for children. (shrink)

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.