Medicine and Health Sciences Commons^™

An Evaluation Of The Us High Production Volume (Hpv) Chemical-Testing Programme: A Study In (Ir)Relevance, Redundancy And Retro Thinking, Andrew Nicholson, Jessica Sandler, Troy Seidle

Troy Seidle, PhD

Under the US Environmental Protection Agency (EPA) High Production Volume (HPV) Challenge Programme, chemical companies have volunteered to conduct screening-level toxicity tests on approximately 2800 widely-used industrial chemicals. Participating companies are committed to providing available toxicity information to the EPA and presenting testing proposals for review by the EPA and posting on the EPA Web site as public information. People for the Ethical Treatment of Animals (PETA) and a coalition of animal protection organisations have reviewed all the test plans submitted by the participating chemical companies for compliance with the original HPV framework, as well as with animal welfare guidelines …

A Modular One-Generation Reproduction Study As A Flexible Testing System For Regulatory Safety Assessment, Richard Vogel, Troy Seidle, Horst Spielmann

Troy Seidle, PhD

The European Union’s Registration, Evaluation and Authorisation of Chemicals (REACH) legislation mandates testing and evaluation of approximately 30,000 existing substances within a short period of time, beginning with the most widely used “high production volume” (HPV) chemicals. REACH testing requirements for the roughly 3000 HPV chemicals specify three separate tests for reproductive toxicity: two developmental toxicity studies on different animal species (OECD Test Guideline 414) and a two-generation reproduction toxicity study (OECD TG 416). These studies are highly costly in both economic and animal welfare terms. OECD TG 416 is a fertility study intended to evaluate reproductive performance of animals …

Brain And Law: An Eeg Study Of How We Decide Or Not To Implement A Law, Armando Rocha, Eduardo Massad, Fábio Rocha, Marcelo Buratini

Armando F Rocha

Brazil has introduced a referendum regarding the prohibition of firearm commerce and propaganda arguments has invoked socially and personally driven issues in the promotion of voting in favor of and against firearm control, respectively. Here, we used different techniques to study the brain activity associated with a voter’s perception of the truthfulness of these arguments and their influence on voting decisions. Low Resolution Tomography was used to identify the possible different sets of neurons activated in the analysis of the different types of propaganda. Linear correlation was used to calculate the amount information provided by different electrodes about how these …

What Future Democracy?, Aziz Rana

Aziz Rana

The threat posed by Aids to the development of democracy in Africa plays no part in current discussions of the impact of the disease.

Expert Testimony In Capital Sentencing: Juror Responses, John H. Montgomery, J. Richard Ciccone, Stephen P. Garvey, Theodore Eisenberg

Stephen P. Garvey

The U.S. Supreme Court, in Furman v. Georgia (1972), held that the death penalty is constitutional only when applied on an individualized basis. The resultant changes in the laws in death penalty states fostered the involvement of psychiatric and psychologic expert witnesses at the sentencing phase of the trial, to testify on two major issues: (1) the mitigating factor of a defendant’s abnormal mental state and (2) the aggravating factor of a defendant’s potential for future violence. This study was an exploration of the responses of capital jurors to psychiatric/psychologic expert testimony during capital sentencing. The Capital Jury Project is …

Outpatient Commitment: A Competency Based Justification, Albert J. Grudzinskas, Jeffrey L. Geller, Jonathan C. Clayfield, William H. Fisher

Jeffrey L. Geller

A recent survey of state statutes for outpatient commitment (Torrey and Kaplan, 1995) indicates that while thirty-five states and the District of Columbia have laws permitting outpatient commitment, Massachusetts is not one of them. Rather, Massachusetts uses a competency-based, substituted-decision-making model for the involuntary administration of medication in the community. To appreciate the Massachusetts model, it is important to understand how this court-ordered involuntary outpatient treatment fits into the overall scheme of outpatient commitment and how it is structured. A review of involuntary outpatient treatment (IOT) literature indicates that it is prudent to distinguish between outpatient commitment, conditional release, and …

Addressing The Ethical, Legal, And Social Issues Raised By Voting By Persons With Dementia, Jason H. Karlawish, Richard J. Bonnie, Paul S. Appelbaum, Constantine Lyketsos, Bryan James, David Knopman, Christopher Patusky, Rosalie A. Kane, Pamela S. Karlan

Jason Karlawish

This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance …

Keynote Speaker Presentations: 5th Annual Umass Center For Clinical And Translational Research Retreat (Video), Robert H. Brown Jr., Thomas Grisso

Thomas Grisso

This video features the full keynote presentations from the 5th Annual UMass Center for Clinical and Translational Science Research Retreat at the University of Massachusetts Medical School (UMMS) in Worcester, MA, on May 20, 2014.

Beginning at 12:40

1st Keynote Speaker: Robert H. Brown, Jr., MD, D.Phil, Chair, Department of Neurology, UMMS. “Lou Gehrig Disease: From Mapping to Medicines”

Beginning at 1:22:19

2nd Keynote Speaker: Thomas Grisso, PhD, Director, Law and Psychiatry Program and Professor, Department of Psychiatry, UMMS. Recipient, Chancellor’s Medal for Distinguished Scholarship. “Translational Research in Law and Psychiatry”

Also included is a brief introductory presentation with updates …

39. Young Children’S Difficulty With Indirect Speech Acts: Implications For Questioning Child Witnesses, Angela D. Evans, Stacia N. Stolzenberg, Kang Lee, Thomas D. Lyon

Thomas D. Lyon

Forensic Training And Practice, Ira Packer, Randy Borum

Ira K Packer

The recognition by the American Psychological Association (APA) of Forensic Psychology as a Specialty is a significant landmark for the field. This recognition has resulted from the development of a substantial body of professional literature and specialized knowledge. The foundation for these advances was laid in the decades of the 1970s, with the establishment of the American Psychology-Law Society (later recognized as Division 41 by APA) and the American Board of Forensic Psychology (which subsequently became a specialty board of the American Board of Professional Psychology). This chapter describes the state of the field in terms of both practice and …

Introduction: Obstacles To The Development And Use Of Pharmacotherapies For Addiction, Richard C. Boldt

Richard C. Boldt

No abstract provided.

Regulating The Placebo Effect In Clinical Practice, Tracey Chan

Tracey E Chan

Recent research and ethical analysis have forced a clinical and ethical reappraisal of the utility of placebos in medical practice. The main concern of ethics and law is that using placebos in health care involves deception, which is antithetical to patient autonomy and trust in the physician-patient relationship. This paper reviews the various, more nuanced scientific conceptions of the placebo effect, and evaluates the ethical and legal objections to deploying placebos in clinical practice. It argues that the placebo effect may be legitimately accommodated on the basis that it does not engage the requirement for material or quasi-fiduciary disclosures of …

Insurance Mandates: Colorectal Cancer Screening Utilization And Racial/Ethnic Disparities, Michael Preston

Michael Preston

Colorectal Cancer is the third most common cancer found in men and women in the United states. In 2014, the American Cancer Society estimates over 136,000 new cases of colorectal cancer and approximately 50,000 deaths. Although the overall death rate for colorectal cancer has decreased over the past 20 years, disparities remain among medically underserved populations.

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The Separation Of Politics And Science, Joanna K. Sax

Joanna K Sax

This article proposes that scientific inquiry regarding questions of fact should have an autonomous zone that is protected from politics. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains an empirical study that demonstrates that the public received inaccurate information in the debate over a highly politicized and controversial area of scientific inquiry, embryonic stem cell research. This article utilizes the data from the empirical study and public choice theory to explain that there are process defects; this economic model can help explain, but cannot be used to …

Medicare: The Perpetual Balance Between Performance And Preservation, Craig B. Garner

Craig B. Garner

Passed by Congress and signed by President Lyndon Johnson into law in 1965, Medicare has weathered storms from all directions, growing to be the preeminent standard for health insurance in the United States. The idea of losing Medicare as a vital public benefit still remains the single greatest fear with which each passing generation of Americans must contend, and yet, these challenges over the past fifty years, designed to fortify Medicare’s foundation and ensure its longevity, continue to take a toll on the program. The most recent climate of reform includes changes implemented by the Patient Protection and Affordable Care …

Evaluation Of Academic Scientists’ Responses To Situations That Pose A Conflict Of Interest, Joanna K. Sax

Joanna K Sax

The industry-academy relationship has many benefits, but it also has potential drawbacks, including potential conflicts of interest (e.g., when the profit motives of a private company unduly influence academic responsibilities). To date, policies intended to regulate or manage financial conflicts of interest appear to be unsatisfying and inadequate. The present study examined predictors of the responses of academic scientists and clinicians to hypothetical situations in which financial and other conflicts of interest may arise. Academic scientists and clinicians at five medical schools completed an anonymous survey that included vignettes that posed a potential conflict of interest. Participants indicated the likelihood …

Financial Conflicts Of Interest In Science, Joanna K. Sax

Joanna K Sax

This article proposes that an analysis of behavior may be utilized to create an effective policy addressing financial conflicts of interest. Importantly, this article focuses on the academics that conduct basic science. An understanding of the background of the public-private interaction is critical to fully appreciate the rise of the financial conflicts of interest in biomedical science. Part II of this Article describes the rise of financial conflicts of interest and the types of harms that can occur in the absence of effective policy to regulate financial conflicts of interest. Part III describes the current system addressing conflicts of interest, …

Access To Prescription Drugs: A Normative Economic Approach To Pharmacist Conscience Clause Legislation, Joanna K. Sax

Joanna K Sax

The goals of this Article are two-fold: (1) to explain that pharmacist conscience clause legislation may be expanded to areas concerning controversial biomedical research; and (2) to demonstrate that welfare economics can be applied to analyze pharmacist conscience clause legislation. Regarding the first goal, the broad language of existing and proposed conscience clause legislation creates an umbrella that allows a pharmacist to escape liability for refusing to fill a prescription for almost any type of medication. With respect to the second goal, this Article applies welfare economics to demonstrate that pharmacist conscience clauses are a part of tort law and …

ÜBerschussdaten In Retinabildern: Ein Beitrag Zum Datenschutzfreundlichen Entwurf Biometrischer Systeme, Michael Friedewald, Sebastian Wawrzyniak, Frank Pallas

Michael Friedewald

Die Retina ist wegen ihrer Unterscheidungskraft ein vielversprechendes biometrisches Merkmal, das vor allem für sicherheitsrelevante Systeme genutzt wird. Allerdings manifestieren sich auch zahlreiche Erkrankungen durch entsprechende Veränderungen der Retina. Die Nutzung solcher gesundheitsbezogener und für Zwecke der Authentifizierung unnötiger Daten ist daher unbedingt zu vermeiden. Dieser Beitrag befasst sich mit der Frage, welche gesundheitsrelevanten Informationen aus Retinabildern gewonnen werden können und welche Konsequenzen dies für den Entwurf biometrischer Systeme hat.

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Diane Hoffmann

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Virginia Rowthorn

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Commodification Of The Female Egg: Stem Cell Technology And The Future, Rachel Rose Ostrander

Rachel Rose Ostrander

As the science of stem cell research progresses it is difficult to tell what implications it will have on our society and for women. I will begin this discussion by examining how science has viewed women in the past, and use this as a basis to conjecture about how they will be viewed and treated in the future. Prevalent gender bias in scientific writing should be a cause for concern as the science of stem cell research and commodification of the female egg becomes more of a reality.

The process of egg donation has stirred much debate in the feminist …

Regulation Of Over-The-Counter Derivatives: A Comparative Study Of Proposals In Singapore And Hong Kong, Chao-Hung Christopher Chen

Christopher Chao-hung CHEN

This chapter identifies some of the potential legal and policy issues involved in the future regulation of over-the-counter (OTC) derivatives. First, regulators must be cautious in the regulation and solvency of some mammoth clearing- houses. Second, Singapore and Hong Kong both face challenges in the areas of global regulatory cooperation and extra-territorial regulatory effects. Third, the exact scope of a clearing obligation determines whether there is any regulatory competition or room for regulatory arbitrage in the future. Fourth, there are legal definition problems with the term ‘derivative’ and its sub-categories that must be addressed. Fifth, there are potential privacy and …

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Health Care Reform: Colorectal Cancer Screening Disparities, Before And After The Affordable Care Act (Aca), Michael Preston

Michael Preston

Colorectal Cancer is the third most common cancer found in men and women in the United states. In 2014, the American Cancer Society estimates over 142,000 new cases of colorectal cancer and approximately 50,000 deaths. Although the overall death rate for colorectal cancer has decreased over the past 20 years, disparities remain among medically underserved populations.

Informed Consent, Psychotropic Medications, And A Prescribing Physician's Duty To Disclose Safer Alternative Treatments, Rita F. Barnett

Rita Barnett-Rose

The use of psychotropic medication to treat any presumed mental health disorder always involves serious risks of harm. Accordingly, before prescribing psychotropic medication to control the behaviors associated with a presumed mental health disorder, prescribing physicians are required, under various medical ethical guidelines and informed consent laws, to first disclose information regarding available alternative treatment options, and the risks and benefits of such alternative treatment options. Indeed, because psychotropic medications are themselves experimental treatments due to the concededly unknown etiology of most mental health disorders, disclosing safer alternative treatments would seem to be a particularly critical aspect of a prescribing …

Parenting In The Face Of Prejudice: The Need For Representation For Parents With Mental Illness, Leigh Goodmark

Leigh S. Goodmark

No abstract provided.

Neurotechnologies At The Intersection Of Criminal Procedure And Constitutional Law, Amanda C. Pustilnik

Amanda C Pustilnik

The rapid development of neurotechnologies poses novel constitutional issues for criminal law and criminal procedure. These technologies can identify directly from brain waves whether a person is familiar with a stimulus like a face or a weapon, can model blood flow in the brain to indicate whether a person is lying, and can even interfere with brain processes themselves via high-powered magnets to cause a person to be less likely to lie to an investigator. These technologies implicate the constitutional privilege against compelled, self-incriminating speech under the Fifth Amendment and the right to be free of unreasonable search and seizure …

La Loi, N° 85, Du 27 Novembre 2013 Sur La Médecine Régénérative, Matthieu Forlodou

Matthieu Forlodou

Le document fournit une proposition de traduction en français de la loi japonaise n° 85, du 27 novembre 2013, visant à garantir l'innocuité de la médecine régénérative.