Lainie Ross

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 ..

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.

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

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 ..

: There is a general consensus in the medical and medical ethics communities against predictive genetic testing of children for late onset conditions, but minimal consideration is given to predictive testing of asymptomatic children for disorders that present later in childhood when presymptomatic treatment cannot influence the course of the disease. In this paper, I examine the question of whether it is ethical to perform predictive testing and screening of newborns and young children for conditions that present later in childhood. I consider the risks and benefits of (1) predictive testing of children from high-risk families; (2) predictive population screening for conditions that are untreatable; and (3) predictive population screening for conditions in which the efficacy of presymptomatic treatment is equivocal. I conclude in favor of parental discretion for predictive genetic testing, but against state-sponsored predictive screening for conditions that do not fulfill public health screening criteria

In a recent article in this journal, we argued that living organ donation from a parent to a child should be described as a beneficent rather than an altruistic act. Emotional relationships can generate an obligation of beneficence to help those with whom we have these relationships. This may involve an obligation for a parent to donate an organ to a child, even though it entails some risk to the parent. The parent's donation is not altruistic because altruistic acts are not obligatory but optional, and they are motivated solely or primarily by other-regarding concerns. In contrast, donor parents' other-regarding concerns are inseparable from their own self-regarding concerns. An individual who donates to a stranger is acting altruistically. She may choose to help others to whom she is not emotionally related for a variety of reasons—sympathy, compassion, generosity, or a desire to give something back to humanity. But she does not have an obligation to do so. Although she may benefit as a consequence of donating, this is not her reason for donating. Instead, her action is motivated by a concern for the recipient's own sake. This is what makes the donation altruistic, and it can be justified without any expectation of benefit to the donor. However, although the potential competent donor decides whether the donation is in her best interests, physicians have the right to refuse to perform a transplant if the risks to the donor are too great or the potential benefits to the recipient are too small

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

Background: The American Medical Association, the British Medical Association and the Canadian Medical Association have guidelines that specifically discourage physicians from self-prescribing or prescribing to family members, but only the BMA addresses informal prescription requests between colleagues. Objective: To examine the practices of paediatric providers regarding self-prescribing, curbsiding colleagues, and prescribing and refusing to prescribe to friends and family. Methods: 1086 paediatricians listed from the American Academy of Paediatrics 2007 web-based directory were surveyed. Results: 44% of eligible survey respondents returned usable surveys. Almost half of respondents had prescribed for themselves. An equal number had informally requested a prescription from a colleague. Three-quarters stated they had been asked to prescribe a prescription drug for a first-degree or second-degree relative, and 51% had been asked by their spouse. Eighty-six per cent stated that they had refused to write a prescription on at least one occasion for a friend or family member. The following reasons “strongly influenced” their decision to refuse a prescription request: outside of provider’s expertise ; patient’s need for his or her own physician ; not medically indicated ; need for a physical examination. Conclusion: These data confirm that most physicians have engaged in self-prescribing or curbside requests for prescriptions. It can be argued that curbsiding is more morally problematic than self-prescribing because it implicates a third party, and should be discouraged regardless of whether the requester is a colleague, family member or friend

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.

Van Rensselaer Potter was an American biochemist who worked in the McArdle Laboratory for Cancer Research at the University of Wisconsin at Madison. In 1970, in an article in this journal, Potter coined the term bioethics to combine a new discipline that combines biological knowledge with ethics. Potter wrote, “Ethical values cannot be separated from biological facts” (p. 127). His conception was broad-ranging: “We are in great need of a land ethic, a wild-life ethic, a population ethic, a consumption ethic, an urban ethic, an international ethic, a geriatric ethic, and so on. All of these problems call for actions that are based on values and biological facts. All of them involve bioethics, and survival of the ..

: 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

There are approximately one million cases oftype 1 diabetes in the US, and the incidenceis increasing worldwide. Given that two-thirdsof cases present in childhood, it is criticalthat prediction and prevention research involvechildren. In this article, I examine whethercurrent research methodologies conform to theethical guidelines enumerated by the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research, andadopted into the federal regulations thatprotect research subjects. I then offer twopolicy recommendations to help researchersdesign studies that conform to these ethicalrequirements.

ABSTRACTI argue that parents ought to be allowed to authorize their child's participation as an organ donor for another family member. I introduce a model of decisionmaking for children in intimate families which I call Constrained Parental Autonomy. This model permits wide parental discretion which is constrained absolutely by a broadly defined principle of respect for persons. In general, parental authorization alone is sufficient but I argue that the respect for persons constraint prevents certain donations and requires the child's assent for other donations. I also consider two controversial implications of the application of this model: the objection that the model does not respect the child's right to bodily integrity, and the objection that the model does not and is unable to address intrafamilial disgreement

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.

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.

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

: 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

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...

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

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.

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..

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.