bluuebunny/crossref_metadata_2025_split huggingface dataset:
Litigation in Clinical Research: Malpractice Doctrines versus Research Realities
Authors: Morreim E. Haavi 
Published: January 2007

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.
Governing the Globalization of Public Health
Authors: Taylor Allyn L. 
Published: January 2007

The number and the scale of transboundary public health concerns are increasing. Infectious and non-communicable diseases, international trade in tobacco, alcohol, and other dangerous products as well as the control of the safety of health services, pharmaceuticals, and food are merely a few examples of contemporary transnationalization of health concerns. The rapid development and diffusion of scientific and technological developments across national borders are creating new realms of international health concern, such as aspects of biomedical science, including human reproductive cloning, germ-line therapy, and xenotransplantation, as well as environmental health problems, including climate change, biodiversity loss, and depletion of the ozone layer. Growth in international trade and travel, in combination with population growth, has served to increase the frequency and intensity of health concerns bypassing or spilling over sovereign boundaries.Although health has traditionally been seen an area of limited multilateral cooperation, there is growing awareness that contemporary globalization has led to the proliferation of cross border determinants of health status and is undermining the capacity of nation states to protect health through domestic action alone.
Tobacco Control Legislation: Tools for Public Health Improvement
Authors: Hodge James G. , Eber Gabriel B. 
Published: January 2007

Government’s responsibility to safeguard the public’s health through law has been part of the social contract since ancient times. Cicero declaredsalus populi suprema lex esto- “the safety of the people is the supreme law”. Disraeli proclaimed that protecting the public’s health is the first duty of the statesman. Of the ten most important public health achievements of the 20th century in the US., seven are directly related to legal interventions, including legislative interventions. As new and existing risks to health risks emerge internationally, governments have consistently used the law as a tool to define the goals of public health, direct public health authorities to accomplish these goals, and equip them with the power and resources to do so.Tobacco control represents a salient example of how law can be used to ensure health. Like other public health laws, tobacco control laws have historic grounds. Government and other policymakers have enacted laws to control tobacco use for hundreds of years. The Russian church forbade tobacco use as an “abomination.”
The Production of Criminal Violence in America: Is Strict Gun Control the Solution?
Authors: Stell Lance K. 
Published: January 2007

“Strict gun control”(SCG) has no clear meaning,so it is necessary to clarify it.I define SGC as an array of legally sanctioned restrictions designed to impose firearm scarcity on the general population. SGC’s public policy goal, gun scarcity, commonly rests on the predicates that “dangerous criminal control” is not the central problem for reducing the problem of criminal gun violence but rather that it is the social prevalence of the distinctively-lethal instruments (guns) by which both supposedly “good citizens” as well as violent criminals inflict a staggeringly high percentage of injury and death.Professor Zimring (who also has an essay published in this issue) is one SGC’s most distinguished, prolific and comprehensive theorists. He has advocated for handgun scarcity among the general population since at least 1969.
Controlling Communications That Teach or Demonstrate Violence: “The Movie Made Them Do It”
Authors: BeVier Lillian R. 
Published: January 2007

Violence sells, Americans have what sometimes seems to be an insatiable appetite for it. Depictions and descriptions of violence saturate our culture. songs urge us to rape women, kill police officers, and commit suicide. Movies portray-indeed they glorifyviolence as an intrinsic element of every imaginable plot line.Despite substantial evidence that an individual’s repeated exposure to portrayals of violence is associated with significantly increased likelihood that the individual will commit aggressive acts against others, no legal regime currently regulates such portrayals either on television, in music, in movies, or in video games. Neither Congress, the Federal Communications Commission, the Federal Trade Commission, nor any state legislature has yet mustered the political will to impose substantial or systematic legal constraints upon producers or purveyors of violent images. Official censorship is rightly to be feared, but unreflective invocations of our commitment to freedom of speech provide incomplete justification for our legal regime’s apparent indifference to the possibility that media-induced violence may impose substantial costs on innocent victims.
Why Not Retribution? The Particularized Imagination and Justice for Pregnant Addicts
Authors: Eckenwiler Lisa 
Published: January 2007

The Law is a grim, unsmiling thing, Not Justice, though. Justice is witty and whimsical and kind and caring.Rohinton Misuy, A Fine Balance;When the South Carolina Supreme Court upheld the conviction and twelve-year sentence of Regina McKnight, it affirmed that state 's commitment to bring the full force of the law to the punishment of pregnant women who use drugs. Prosecutors linked the delivery of Ms.McKnight 's stillborn baby to her use of cocaine, and argued successfully for a finding of homicide by child abuse. The McKnight judgment follows the South Carolina Supreme Court decision in the case of Cornelia Whitner. Whitner was sentenced to prison for illegal drug use during pregnancy on the grounds that the viable fetus is a child under the state s criminal child endangerment statute.On the basis of constitutional concerns such as due process and privacy, worries that criminal prosecutions may thwart public policy goals such as keeping families together and promoting the health of women and children, and findings that legislatures did not intend to include the fetus in the scope of drug laws or child abuse and neglect laws, criminal prosecution has been resisted in most jurisdictions.
Ending Concerns about Undue Inducement
Authors: Emanuel Ezekiel J. 
Published: January 2007

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges.
Natural Settings Trials — Improving the Introduction of Clinical Genetic Tests
Authors: Freund Carol L. , Clayton Ellen W. , Wilfond Benjamin S. 
Published: January 2007

Many new genetic tests are used in clinical practice, and the number of available tests is growing. Two important health policy questions arise as these genetic tests become available. The first question, whether a new test should be made available, has been the focus of much recent discussion. The second question concerns defining the appropriate standards surrounding the use of these tests, including patient selection, education, informed consent, test interpretation and counseling.Genetic tests currently move from the research arena, where strategies are put in place to minimize risks,into the clinical context where the practice of medicine is more variable and the risks to patients less understood. In the research setting, risks can be minimized through safeguards including education, consent, and counseling. The frequency and magnitude of psychosocial and clinical risks canbe assessed. In the clinical setting, however, these safeguards may not be used consistently, creating unknown risksfor patients (see table).
Research Ethics and Misguided Moral Intuition
Authors: Miller Franklin G. 
Published: January 2007

The term therapeutic misconception was coined
by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.
Evaluation of the Condom Distribution Program in New South Wales Prisons, Australia
Authors: Dolan Kate , Lowe David , Shearer James 
Published: January 2007

Male to male unprotected anal sex is the main route of HIV transmission in Australia. The Australian Study of Health and Relationships, a large, representative population survey of sexual health behaviors, found that six percent of males in the general population have engaged in homosexual activity. These findings were consistent with studies in Europeand North America. Condoms have been shown to reduce the transmission of HIV in the community. Barriers to the use of condoms include access,stigma,and cost? Nevertheless, increased condom use has been reported among homosexual males, sex workers and injecting drug users although recent declines in condom use among homosexuals has presented new challenges in HIV prevention.The prevalence of male to male sexual activity may be higher in prison than in the general population. Sexual activity in prison can be consensual and non-consensual involving both homosexual / bisexual and heterosexual men.
Benign Neglect or Neglected Abuse: Drug and Alcohol Withdrawal in U.S. Jails
Authors: Fiscella Kevin , Pless Naomi , Meldrum Sean , Fiscella Paul 
Published: January 2007

Two days following her arrest, a forty-four-year-old woman died in jail from aspiration pneumonia secondary to Untreated opiate withdrawal. The New York State Commission of Corrections concluded in its final report that had adequate medical evaluation and treatment been afforded, her death would have been prevented. A forty-six-year-old male with a history of alcohol dependence was arrested for trespassing and held in the county jail. Three days later he became agitated and aggressive. Following physician orders, deputies placed him in restraints. He subsequently vomited and seized. Fifteen minutes later, he experienced respiratory arrest and died.These cases highlight a serious, but neglected problem in jails across the country: inadequate assessment and treatment of drug and alcohol withdrawal among arrestees. In this article, we show that untreated drug or alcohol withdrawal is associated with adverse outcomes including needless pain and suffering, medical morbidity, and in some instances, death.
Legal Barriers to Implementing Recommendations for Universal, Routine Prenatal HIV Testing
Authors: Wolf Leslie E. , Lo Bernard , Gostin Lawrence O. 
Published: January 2007

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission (MTCT). However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves.
Bioethics and the National Security State
Authors: Moreno Jonathan D. 
Published: January 2007

it is mandatory that in building up our strength, we enlarge upon our technical superiority by an accelerated exploitation of the scientific potential of the United States and our allies. National Security Council, NSC-G8: United States Objectives and Program for National Security April 14, 1950 Innovation within the armed forces will rest on experimentation with new approaches to warfare, strengthening joint operations, exploiting U.S. intelligence advantages, and takingfull advantage of science and technology. George W Bush, The National Security Strategy of the United States of America, September 17,2002
Does Ethical Theory Have a Future in Bioethics?
Authors: Beauchamp Tom L. 
Published: January 2007

The last twenty-five years of published literature and curriculum development in bioethics suggest that the field enjoys a successful and stable marriage to philosophical ethical theory. However, the next twenty-five years could be very different. I believe the marriage is troubled. Divorce is conceivable and perhaps likely. The most philosophical parts of bioethics may retreat to philosophy departments, while bioethics continues on its current course toward a more interdisciplinary and practical field.I make no presumption that bioethics is integrally linked to philosophical ethical theory. Indeed, I assume that the connection is contingent and fragile. Many individuals in law, theological ethics, political theory, the social and behavioral sciences, and the health professions carefully address mainstream issues of bioethics without finding ethical theory essential or breathtakingly attractive. This is not surprising. Moral philosophers have traditionally formulated theories of the right, the good, and the virtuous in the most general terms.
Bioethics: A Field in Transition
Authors: Faden Ruth R. 
Published: January 2007

Bioethics is clearly a field in transition, if not confusion. Bioethics began as a scholarly, reflective, academic enterprise. Increasingly, however, some in bioethics are not as interested in producing scholarship as they are in practicing bioethics by providing services to institutions and clients.Bioethics also began as an interdisciplinary line of inquiry, with its major contributors all trained in some established discipline. We were and for the most part still are a field composed of theologians, philosophers, lawyers, physicians, nurses, and social scientists who work in bioethics. Today, however, some young people actually aspire to be bioethicists. Increasingly, they have the option of being trained directly in bioethics, without any other disciplinary background.We are not the first field to find itself engaged in these kinds of transitions. In this short piece, I consider very briefly how two fields--health psychology and epidemiology- have approached similar branch points.
Law & Bioethics: From Values to Violence
Authors: Wolf Susan M. 
Published: January 2007

Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the fields imposition of broad fiduciary responsibilities on health care professionals and researchers.In addition to debating how to properly describe laws historical relationship to bioethics, commentators have argued over whether laws influence in bioethics is now good or bad.
Passing on the Right: Conservative Bioethics is Closer Than it Appears
Authors: Charo R. Alta 
Published: January 2007

In August 2001,just after President Bush announced his stem cell funding policy and the creation of a new Presidents Council on Bioethics PCB), the new chair of the PCB, Leon Kass, set out his philosophy for constructing public bioethics bodies: There are several ways of running commissions, he said. One is to stack it with your people, make them homogenous, and force a consensus. Another is to make them heterogeneous, so that you can only come to the lowest common denominator. We re not going to adopt either . We are going to allow the debate to be developed and heard.Now, three years, sixteen meetings, and five reports later, there are nagging questions about whether this council indeed has allowed the debate to be developed and heard. And the charge of politicizing public bioethics to a degree heretofore unknown and stifling the voices of dissenting members comes not from the political left but from President Bushs own appointees, including one scientist who was dismissed from further service.
Pain, Impairment, and Disability in the AMA Guides
Authors: Robinson James P. , Turk Dennis C. , Loeser John D. 
Published: January 2007

Back injuries have a bad reputation. The workman looks upon them with apprehension, the insurance company with doubt, the medical examiner with suspicion, the lawyer with uncertainty. The medical examiner is faced with the difficulty of estimating the true value of the subjective symptoms in the comparative absence of physical signs. His suspicion is born of the frequent disparity between these two.This prophetic statement made almost 100 years ago highlights an ongoing problem - how people who are incapacitated by painful conditions such as chronic low back pain can be evaluated consistently and equitably for purposes of disability compensation. We confronted this vexing problem when we participated in writing the chapter devoted to impairment associated with pain (Chapter 18) of the American Medical Association sGuides to the Evaluation of Permanent Impairment, 5thedition AMA Guides 5thOur purposes in this essay are to clarify several important conceptual issues associated with the assessment of pain among disability applicants, and to articulate reasons why pain should be considered in impairment and disability ratings.
Cyberbanks and Other Virtual Research Repositories
Authors: Majumder Mary Anderlik 
Published: January 2007

Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to (1) constructing a repository by forming a network among institutions; (2) using the Internet or the World Wide Web to solicit specimens and information; (3) integrating web-based technology into the operation of the bank; (4) using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and (5) digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank.
Is Obtaining an Arrestee's DNA a Valid Special Needs Search Under the Fourth Amendment? What Should (and Will) the Supreme Court Do?
Authors: Maclin Tracey 
Published: January 2007

In the past twenty years, advances in forensic DNA technology have revolutionized the American criminal justice system. The use of forensic DNA testing in America began in 1987, and its demonstrated scientific accuracy quickly led jurisdictions to accept expert testimony regarding DNA matches between suspects and crime scene evidence. Wielding the power to exonerate the innocent and apprehend the guilty, the use of DNA identification technology has become an indispensable resource for prosecutors and law enforcement officials, as well as for defense lawyers representing persons falsely accused or wrongfully convicted of crimes they did not commit. As states began to compile DNA profiles from convicted offenders, the need for a repository for these profiles resulted in the DNA database.Originally, DNA databases included only “those classes of offenders with a high recidivism rate, such as sex offenders and violent felons.” Recognizing the crime-solving potential of this technology, state legislatures soon began to expand the scope of DNA database statutes to include broader classes of offenders.
The Ethical Health Lawyer
Authors: Griffin Leslie 
Published: January 2007

“There's a new whistleblower in Washington,” according to CNN News. He is Food and Drug Administration scientist David Graham, who claims that the FDA failed to warn the public about certain drugs' dangerous side effects and pressured him to change his research's conclusion that the arthritis drug Vioxx caused heart attacks. Another Washington whistleblower, Dr. Jonathan Fishbein of the National Institutes of Health, alleged that he was fired because “he had raised concerns about sloppy practices that might endanger patient safety” in a study of the AIDS drug nevirapine.Graham and Fishbein thus joined the ranks of whistleblowers who have gained some prominence in recent years for their reporting of corporate or institutional misconduct. The best-known whistleblowers—the FBI's Coleen Rowley, Enron's Sherron Watkins, and WorldCom's Cynthia Cooper, who together receivedTime magazine'sWhistleblower Person of the Year Award in 20024 - focused public attention on the reform of corporate accounting and legal practices.