August 2016
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The Summer issue marks the second published with SAGE Publications, and we are thrilled to once again be working with guest editor Robert M. Sade. The symposium, titled Ethical and Legal Issues in Pediatrics, consists of papers presented at the 20th Annual Thomas A. Pitts Memorial Lectureship held in October 2013. In the symposium, Sade and his co-authors focus on the ethical considerations in pediatric surrogate decision-making. The issue addresses concerns on newborn screening, preventive surgery, and circumcision, and each topic is presented for differing viewpoints. Be sure to check out the table of contents below!

Table of Contents (Free Download)

Introduction: Ethical and Legal Issues in Pediatrics

Symposium Articles

Screening of Newborns for Disorders with High Benefit-Risk Ratios Should Be Mandatory
Nicole Kelly, Dalia Chehayeb Makarem, and Melissa P. Wasserstein

Newborn screening was initiated due to its potential to prevent severe disabilities; it has the ability to save lives through early diagnosis and treatment. Today, over 98% of the 4 million newborns born annually in the United States are tested for more than 30 treatable genetic, metabolic, endocrine, and infectious diseases within the first week of life. The emergence of new technologies and the ability to screen for increasing numbers of disorders have led to a broad expansion of disorders on newborn screening panels. While many disorders on expanded panels adhere to traditional screening guidelines, which recommend screening for disorders that are serious or life-threatening, treatable, and have well-understood stages of disease (Table 1), others do not. Inclusion of "non-traditional" disorders has raised the important question about the role of parental consent in newborn screening.

Informed Consent Should Be a Required Element for Newborn Screening, Even for Disorders with High Benefit-Risk Ratios
Norman Fost

Reducing complicated questions to binary formulations can lead to misleading answers. The famous example, "Have you stopped beating your wife?," comes to mind. I am also reminded of the great naturalist, Louis Agassiz, who was asked the standard question when applying for US citizenship: "Do you advocate the overthrow of the United States Government by force or violence?" After thinking carefully about it for a few moments, Agassiz replied, "By force."

Newborn Male Circumcision with Parental Consent, as Stated in the AAP Circumcision Policy Statement, Is Both Legal and Ethical
Michael T. Brady

Circumcision is a surgical procedure that removes the foreskin (prepuce) of the penis. While it is a minor surgical procedure, it has generated considerable controversy. There are zealous proponents and opponents of this medical practice. The medical and lay literature has numerous articles and opinion pieces discussing the risks and benefits of circumcision. Opponents of male circumcision have called it "child abuse" and a "human rights violation," while proponents feel that the health benefits derived from removal of the foreskin make circumcision a "biomedical imperative" and a "cost effective prevention strategy." Given this tremendous dichotomy of opinion and the polarization of opponents and proponents, it is unlikely that any rational discussion will sway those who hold extreme views. For that reason, any decision about the role of newborn male circumcision in the delivery of optimal healthcare to children should not be high jacked by those who have emotional or subjective beliefs about this procedure. Rather, determination about whether newborn male circumcision is an appropriate medical option should be based on non-biased review of the evidence relating to the health risks and health benefits of newborn male circumcision.

Circumcision Is Unethical and Unlawful
J. Steven Svoboda, Peter W. Adler, and Robert S. Van Howe

The foreskin is a complex structure that protects and moisturizes the head of the penis, and, being the most densely innervated and sensitive portion of the penis, is essential to providing the complete sexual response. Circumcision-the removal of this structure-is non-therapeutic, painful, irreversible surgery that also risks serious physical injury, psychological sequelae, and death. Men rarely volunteer for it, and increasingly circumcised men are expressing their resentment about it.

Cardiac Surgical Repair Should Be Offered to Infants with Trisomy 18, Interrupted Aortic Arch and Ventricular Septal Defect
Minoo N. Kavarana

The management of children born with trisomy 18 is controversial, and both providers and parents often have differing opinions. Many parents choose to terminate the pregnancy while others go forward, making decisions based on their beliefs, understanding, and physician recommendations. Physicians are similarly divided regarding treatment of these children, as some feel that aggressive treatments are futile while others defer to the parents' wishes.

Infants with Trisomy 18 and Complex Congenital Heart Defects Should Not Undergo Open Heart Surgery
Eric M. Graham

Trisomy 18 is a common autosomal trisomy, second only to trisomy 21, with a birth prevalence of approximately 1 in 3,000 to 1 in 8,000. This is one of the few chromosomal abnormalities for which we have extensive outcome data confirming a universally poor outcome for these children, and as such this is often termed a lethal anomaly. In pediatrics, "lethal anomalies" is a term usually reserved for a variety of conditions that have 2 key features. First, these conditions result in structural anomalies or neurologic impairment that if left untreated, will likely result in death. Second, children with these conditions who survive exhibit profound intellectual impairments, and their behavior is not likely to develop beyond that of a one- or two- year old. Recently some have rejected this term for trisomy 18, citing the few survivors and the lack of aggressive medical and surgical management contribute to the lethal prognosis becoming a self-fulfilling prophesy. Although it is correct that some children with trisomy 18 survive childhood, the intellectual impairments remain profound and are unlikely to be significantly improved by aggressive medical and surgical management.


Independent Articles

Raising Genomic Citizens: Adolescents and the Return of Secondary Genomic Findings
Maya Sabatello and Paul S. Appelbaum

Whole genome and exome sequencing (WGS/WES) techniques raise hope for a new scale of diagnosis, prevention, and prediction of genetic conditions, and improved care for children. For these hopes to materialize, extensive genomic research with children will be needed. However, the use of WGS/WES in pediatric research settings raises considerable challenges for families, researchers, and policy development. In particular, the possibility that these techniques will generate genetic findings unrelated to the primary goal of sequencing has stirred intense debate about whether, which, how, and when these secondary or incidental findings (SFs) should be returned to parents and minors. The debate is even more pronounced when the subjects are adolescents, for whom decisions about return of SFs may have particular implications. In this paper, we consider the rise of "genomic citizenship" and the main challenges that arise for these stakeholders: adolescents' involvement in decisions relating to return of genomic SFs, the types of SFs that should be offered, privacy protections, and communication between researchers and adolescents about SFs. We argue that adolescents' involvement in genomic SF-related decisions acknowledges their status as valuable stakeholders without detracting from broader familial interests, and promotes more informed genomic citizens.

Ethical and Legal Challenges Associated with Public Molecular Autopsies
Quianta L. Moore, Mary A. Majumder, Lindsey K. Rutherford, and Amy L. McGuire

There is a national movement supporting the retention and use of bio-specimens from deceased individuals for the purpose of genetic testing. Studies have identified mutations that scientists believe can cause sudden unexpected death, and funding for a national registry for sudden death in the young (SDY) has been granted to several states to promote investigation into the causes of and risk factors for SDY. Medico-legal death investigators, particularly Medical Examiners (ME), are being called upon to develop systematic protocols to collect and retain bio-specimens for future use, and some ME offices are going further by performing postmortem genetic testing themselves.


Individual Responsibility for Promoting Global Health: The Case for a New Kind of Socially Conscious Consumption
Nicole Hassoun

The problems of global health are truly terrible. Millions suffer and die from diseases like tuberculosis, HIV/AIDS, and malaria. One way of addressing these problems is via a Global Health Impact labeling campaign (http://globalhealth- impact.org/). If even a small percentage of consumers promote global health by purchasing Global Health Impact products, the incentive to use this label will be substantial. One might wonder, however, whether consumers are morally obligation to purchase any these goods or whether doing so is even morally permissible. This paper suggests that if the proposal is implemented, purchasing Global Health Impact labelled goods is at least morally permissible, if not morally required. Its argument should, moreover, be of much more general interest to those considering different kinds of ethical consumption.

Kings to Cowards: One-Punch Assaults
Jason Schreiber, Angela Williams, and David Ranson

Methodology: Literature Review and medico-legal commentary. Results: Fatal one-punch assaults have been reported extensively in the media. This article provides a commentary on recent policy developments and legislative amendments in Australia regarding so called 'one-punch' assaults. Comparisons are made with the situation in other jurisdictions including the UK, US, and Europe. The clinical forensic medical aspect of fist strikes to the head and face is examined in the context of the recent media attention and public interest these cases have attracted. The increased recognition of the risk of harm and death inherent in these types of assaultive behavior is reflected in the policy and legislative changes that have taken place in some jurisdictions. Conclusion: One punch strikes may result in a range of injuries that can include permanent neurological impairment and death. Recent media and community concern regarding these cases and the need for stronger deterrence has resulted in a change in public policy and consequent legislative amendments.

Biobank Regulation in South Korea
Won Bok Lee

Like many other countries, South Korea has recognized the importance of biobanks as a tool for medical research and has engaged in two very important tasks to foster biobanking infrastructure: funding biobanks and setting up rules to protect the integrity of biobanks that share potentially sensitive personal information. As a result of the government's efforts, one government-run central biobank and 61 government-approved biobanks are in operation in Korea as of 2015. Many more biospecimen repositories that do not require government approval and thus are not officially tallied are also in operation. The government- approved biobanks alone collectively house over 983,000 blood/serum/plasma samples, over 75,000 DNA samples, and over 157,000 tissue samples, which are not a meagre sum by any international standards. The biobanking regulation has kept its pace with the sprawling biobanks in Korea too, which has been embedded in linchpin legislation in the human research sphere: the Bioethics and Biosafety Act.

Columns

Currents in Contemporary Bioethics: The End of the HIPAA Privacy Rule?
Mark A. Rothstein

The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.
   

Public Health Law: Taxing Sugar-Sweetened Beverages to Lower Childhood Obesity
Sarah A. Wetter and James G. Hodge, Jr.

Consumption of sugar-sweetened beverages (SSBs) contributes to multiple health problems including obesity, diabetes, and tooth decay, especially among children. Excise taxation has been proven efficacious in changing purchasing behaviors related to tobacco use with resulting improvements in public health outcomes. Similar taxes applied to SSBs are starting to take hold internationally and domestically. SSB taxes have been proposed in over 30 U.S. jurisdictions since 2009, but only Berkeley (CA) has passed and implemented one to date. Given empirical evidence of their effectiveness, governments should consider implementation of SSB excise taxes based on uniform definitions of SSBs and other factors.

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