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Contents - JLME - 2014 Volume 42: 3
Table of Contents
  1. Table Of Contents
Letter From The Editor
  1. Letter From The Editor
Introduction
  1. Introduction
Symposium Articles
  1. Foreword
  2. Where Do We Go from Here? An Inside Look into the Development of Georgia's Youth Concussion Law
  3. State Experiences Implementing Youth Sports Concussion Laws: Challenges, Successes, and Lessons for Evaluating Impact
  4. Requiring Athletes to Acknowledge Receipt of Concussion-Related Information and Responsibility to Report Symptoms: A Study of the Prevalence, Variation, and Possible Improvements
  5. Perceived Coach Support and Concussion Symptom-Reporting: Differences between Freshmen and Non- Freshmen College Football Players
  6. Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey
  7. Loss of Possession: Concussions, Informed Consent, and Autonomy
Independent Articles
  1. The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations
  2. The Pan American Health Organization and the Mainstreaming of Human Rights in Regional Health Governance
  3. Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials
  4. A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity
Columns
  1. Currents in Contemporary Bioethics: What Is an Epidemic?
  2. Teaching Health Law Laying the Foundation for an Interprofessional, Comparative Health Law Clinic
Calendar
  1. Calendar
Table of Contents
Table Of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

In the increasingly fractured world of American cultural life, it is becoming more and more difficult to find entertainment and pastimes that are enjoyed and experienced by the broadest selection of people. Films, for instance, which were once a hallmark of family entertainment, are now marketed to specific age groups and genders. Television used to consist of three network stations, and the entire family would gather to watch their favorite shows. Today there are hundreds of stations supplying entertainment to cover nearly every interest. If viewers still don't find something they like, they can go online to find (often instantly) whatever form of entertainment they might fancy.
Introductions
Introduction
David Orentlicher - [PDF]

While it has become clear that concussion is a serious problem for football and other sports, it is not clear how best to respond to the problem. When athletes suffer concussions - or injuries that might be a concussion - what steps should be taken? Experts generally agree that the athletes should immediately stop play after a possible concussion, but how long should they rest before resuming practice or competition? What kind of testing should be used to diagnose the injury and how should a concussion be treated? To what degree should guidelines and rules vary depending on the age of the athlete?
Symposium Articles
Foreword
Alan Schwarz - [PDF]

The Journal of Law, Medicine & Ethics has asked me to write this foreword on concussions in sports because, I am told, I'm the reporter who thrust concussions onto the national stage. So forgive me when I say that, in my mind, my 120 articles in The New York Times were never about law, medicine nor ethics. They were about making sense.
Where Do We Go from Here? An Inside Look into the Development of Georgia's Youth Concussion Law
Amanda Cook, Harold King, and John A. Polikandriotis - [PDF]

Concussion is a form of mild traumatic brain injury (mTBI) that can occur as a result of contact to the head or other parts of the body that causes a rapid acceleration-deceleration force to the brain that may cause a functional disturbance in an individual's ability to concentrate or learn new information. Contrary to popular belief, it is not a bruise to the brain, and there is usually nothing detectable on standard imaging such as a computed tomography or magnetic resonance imaging. Symptoms and signs are therefore important to detect and include decreased levels of consciousness, headache, nausea, difficulty concentrating, memory loss, and poor coordination. These signs and symptoms usually occur within minutes after the injury but may also appear several hours or even days later.
State Experiences Implementing Youth Sports Concussion Laws: Challenges, Successes, and Lessons for Evaluating Impact
Kerri McGowan Lowrey and Stephanie R. Morain - [PDF]

Over the past decade, a flurry of media stories devoted to sports-related concussions have drawn attention to the previously "silent epidemic" of traumatic brain injury (TBI) in athletes. From 2001 to 2009, the annual number of sports-related TBI emergency department visits in individuals age 19 and under climbed from 153,375 to 248,414, an increase of increase of 62 percent. Multiple head injuries place youth athletes at risk for serious health conditions, including cerebral swelling, brain herniation, and even death - postconcussive conditions that have collectively (and controversially) been referred to as "second impact syndrome." Studies have shown that children and teens - and girls, in particular - are more likely to sustain a concussion and have a longer recovery time than adults. Recent research also suggests that even subconcussive hits in children and adolescents may result in longer-term health effects such as decreased cognitive functioning, increased rates of depression, memory problems, and mild cognitive impairment (a pre-Alzheimer's condition).
Requiring Athletes to Acknowledge Receipt of Concussion-Related Information and Responsibility to Report Symptoms: A Study of the Prevalence, Variation, and Possible Improvements
Christine M. Baugh, Emily Kroshus, Alexandra P. Bourlas, and Kaitlyn I. Perry - [PDF]

Scientific evidence increasingly confirms that concussions from contact sports and other sources can lead to a myriad of negative biomedical, social, and behavioral outcomes. In the days and weeks after injury, concussions have been linked to cognitive deficits, sleep disturbances, depression, irritability, difficulty concentrating, difficulty remembering, and in some cases suicidal thoughts or behaviors. Studies have shown that exposure to head impacts, even without a recognized concussion, can result in changes in the blood brain barrier, structural changes in the brain's white matter, and functional impairment, Additional long-term deficits resulting from repetitive concussions and subconcussive hits include cognitive dysfunction, depression, and executive dysfunction. Perhaps most troublingly, repetitive head impacts, including those sustained in high school, college, and professional sports, have been linked to neurodegenerative diseases, including chronic traumatic encephalopathy.
Perceived Coach Support and Concussion Symptom-Reporting: Differences between Freshmen and Non- Freshmen College Football Players
Christine M. Baugh, Emily Kroshus, Daniel H. Daneshvar, and Robert A. Stern - [PDF]

Concussion is a form of traumatic brain injury that has been defined as a "trauma-induced alteration in mental status that may or may not involve loss of consciousness." Terms such as getting a "ding" or getting your "bell rung" are sometimes used as colloquialisms for concussion, but inappropriately downplay the seriousness of the injury. It is estimated that between 1.6 and 3.8 million concussions occur annually in the United States as a result of participation in sports or recreational activities. To date, there are no objective, biological markers for concussion; rather, the current diagnosis of concussion is dependent upon symptom reporting by the athlete. In the acute phase, concussions can result in a broad spectrum of symptoms that can be transient or last for days, weeks, or even months. Symptom prolongation is generally referred to as post-concussion syndrome. Variation in symptom duration is not well understood, but it is thought that cognitive and physical rest after the initial injury is critical. Repetitive concussive injuries are thought to lead to a later-life neurodegenerative disease called chronic traumatic encephalopathy, in some people. Given the incidence, prevalence, and possible shortterm and long-term health consequences, concussions have been increasingly seen as a public health priority.
Youth Sports & Public Health: Framing Risks of Mild Traumatic Brain Injury in American Football and Ice Hockey
Kathleen E. Bachynski and Daniel S. Goldberg - [PDF]

Children in North America, some as young as eleven or twelve, routinely don helmets and pads and are trained to move at high-speed for the purpose of engaging in repeated full-body collisions with each other. The evidence suggests that the forces generated by such impacts are sufficient to cause traumatic brain injury (TBI) among children. Moreover, there is only limited evidence supporting the efficacy of interventions typically used to reduce the risks of such hazards. What kind of risk assessment enables such activities to be a relatively common feature of childhood in Canadian and American society?
Loss of Possession: Concussions, Informed Consent, and Autonomy
Richard Robeson and Nancy M. P. King - [PDF]

The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called "consenting" them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent process. Too often, the sharing of information has been replaced by the mere acquisition of agreement with the authority ostensibly offering a choice
Independent Articles
The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations
Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon-Ho Yu, and Paul S. Appelbaum - [PDF]

Large-scale sequencing tests, including wholeexome and whole-genome sequencing (WES/WGS), are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI) have funded studies on clinical and research sequencing under the Clinical Sequencing Exploratory Research (CSER) program as well as studies on return of results (RoR). Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing, whether to return results, and the role of patient/ participant preferences - controversy fueled by publication of the American College of Medical Genetics and Genomics (ACMG) recommendations for clinical sequencing in 2012 and management of incidental findings in 2013, with ensuing commentaries. Indeed, debate over the ACMG recommendations on incidental findings prompted a recent amendment of those recommendations.
The Pan American Health Organization and the Mainstreaming of Human Rights in Regional Health Governance
Benjamin Mason Meier and Ana S. Ayala - [PDF]

In the development of a rights-based approach to global health governance, international organizations have looked to human rights under international law as a basis for public health. Operationalizing human rights law through global health policy, the World Health Organization (WHO) has faced obstacles in efforts to mainstream human rights across the WHO Secretariat. Without centralized human rights leadership in an increasingly fragmented global health policy landscape, regional health offices have sought to advance human rights in health governance and support states in realizing a rights-based approach to health. Examining the efforts of the Pan American Health Organization (PAHO), this article explores the evolution of human rights in PAHO policy, assesses the mainstreaming of human rights in the Pan American Sanitary Bureau (Bureau or PASB), and analyzes the future of the rights-based approach through regional health governance.
Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials
Megan S. Wright and Christopher T. Robertson - [PDF]

The payment of human subjects is an area where Institutional Review Boards (IRBs) have wide discretion. Although the "Common Rule" requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation (NSF) cautions that high payments for risky research "may induce a needy participant to take a risk that they normally would prefer not to take." For research under its purview, the Food and Drug Administration (FDA) guidance provides that "[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type." One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized.
A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity
Valerie Gutmann Koch - [PDF]

Despite existing federal and state law and regulation, new human subjects research (HSR) scandals involving "vulnerable" populations continue to surface. Although existing oversight mechanisms were enacted to ensure voluntary informed consent for participants and institutional review board (IRB) oversight of HSR, these laws and regulations do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults. The absence of rules to ensure consistently ethical conduct of research involving adults who lack consent capacity may either lead to exploitation of this vulnerable population or the dearth of important research into the broad range of diseases that impair cognition. In other words, while some institutions and investigators are conducting research with this group without guidance, others are taking an extremely conservative approach and are excluding these individuals from research. Without safeguards that are adequate and robust but not overly burdensome, conducting research involving this population is ethically and legally challenging.
Columns
Currents in Contemporary Bioethics: What Is an Epidemic?
Jonny Anomaly - [PDF]

Misuse of the word "epidemic" has become an epidemic. In this note I examine several accounts of what it means to be an epidemic, explore what I take to be the motivation for over-extending the term, and explain why I think we should use it in a more careful way.
Teaching Health Law Laying the Foundation for an Interprofessional, Comparative Health Law Clinic
Diane E. Hoffmann, Chikosa Banda, and Kassim Amuli - [PDF]

In June 2013, faculty from the University of Maryland Carey School of Law, along with students from the law school and several health professional schools at the University of Maryland, Baltimore, visited Malawi, in southeast Africa. While there, they met with faculty and students at the University of Malawi Chancellor College to discuss the possibility of establishing an ongoing collaboration between the two universities' law schools. The starting point for our discussion was the potential establishment of a multi-professional, comparative health law clinic that would focus on serving individuals living with HIV and AIDS (PLWHA). This goal would serve two objectives of the Law & Health Care Program (L&HCP) at Maryland: to increase interprofessional education (IPE) opportunities and to expose law students to more global health law issues. Establishing this clinic would also be consistent with two strategic objectives of the University of Malawi Faculty of Law: to establish links with other law schools providing clinical legal education, and to contribute to Malawi's efforts to solve HIV/AIDS-related problems.
Calendar
Calendar
ASLME - [PDF]