bluuebunny/crossref_metadata_2025 huggingface dataset:
Genetic Exceptionalism vs. Paradigm Shift: Lessons from HIV
Authors: Ross Lainie Friedman
Published: January 2007

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus (HIV) different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk.
What Lessons Can We Learn from the Exceptionalism Debate (Finally)?
Authors: Lazzarini Zita
Published: January 2007

How we integrate the astounding advances that genetics makes possible into our language, our conceptions of health and disease, and our systems to collect, control, and protect health-related information is a key question facing health law and policy-makers this decade.

For example, the prospect that all of us may harbor the genetic seeds of our own demise forces us to confront the blurring of the lines between “health,” “predisposition,” and “disease.” How will we modify our conceptions of health and disease in response to this new distinction?

That these questions must be answered using, at least in part, new approaches seems unassailable. Yet, we run the risk of becoming mired in an old debate—exceptionalism—in which we haggle over the precise nature and scope of the similarities and differences between genetic information and all other health-related information.
DNA Patents and Human Dignity
Authors: Resnik David B.
Published: January 2007

Those objecting to human DNA patenting frequently do so on the grounds that the practice violates or threatens human dignity. For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health's (NIH) bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples and violate their cultural values. NIH eventually dropped one of its patent applications.

On May 18, 1995, 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable commodities. In his recent book,The Biotech Century,Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeal.
The Case for Caution — Being Protective of Human Dignity in the Face of Corporate Forces Taking Title to Our DNA
Authors: Brown Barry
Published: January 2007

Thirteen years ago, commenting on the treatment of the human body and its cell lines as patentable commodities, Mary Taylor Danforth wrote:

Research with human cells that results in significant economic gain for the researcher and no gain for the patient offends the traditional mores of our society in a manner impossible to quantify Such research tends to treat the human body as a commodity — a means to a profitable end. The dignity and sanctity with which we regard the human whole, body as well as mind and soul, are absent when we allow researchers to further their own interests without the patient's participation by using a patient's cells as the basis for a marketable product.

In his insightful article, David Resnik would have us travel further down the path of allowing the patenting of DNA in order to advance scientific research and the welfare of humankind. Dr. Resnik suggests that that the acquisition of such proprietary rights in DNA research must proceed cautiously
Just What the Patient Ordered: The Case for Result-Based Compensation Arrangements
Authors: Hyman David A. , Silver Charles
Published: January 2007

For more than twenty years, Opinion 6.01 of the American Medical Association's (AMA) Code of Medical Ethics has specified that “a physician's fee for medical services should be based on the value of the service provided by the physician to the patient.” In 1994, the AMA amended Opinion 6.01, adding a new statement that “a physician's fee should not be made contingent on the successful outcome of medical treatment.”

We believe that the amendment is wholly indefensible. Therefore, in this essay, we argue that the AMA should lift this prohibition and encourage the use of result-based compensation for medical services in appropriate circumstances.

The 1994 amendment dramatically changed the significance and scope of Opinion 6.01. Result-based compensation arrangements clearly satisfy the original version of Opinion 6.01 because they base compensation on the “value of the services provided … to the patient.” Yet, it is equally clear that result-based compensation arrangements violate the amended version of Opinion 6.01 because they necessarily make compensation “contingent on the successful outcome of medical treatment.”
Result-Based Compensation in Health Care: A Good, but Limited, Idea
Authors: Morreim E. Haavi
Published: January 2007

David Hyman and Charles Silver are quite right. Opinion 6.01 in the American Medical Association's (AMA) Code of Medical Ethics is difficult to defend. Ties between compensation and outcomes need not mislead patients into thinking that results are guaranteed; they are widely used in other fields with considerable success, even if they have some disadvantages; they can potentially bring patients more actively into decision-making about whether and from whom to purchase which medical care; and, if carefully tuned, they can promote quality by aligning providers’ welfare more closely with patients’.

The purpose of this commentary is thus not to disagree with the fundamental thesis that result-based compensation arrangements (RBCAs) can be appropriate and useful in the health-care setting. Rather, the objective is to “cut the next swath,” so to speak. While Hyman and Silver are right that RBCAs have potential to do good, they may be overly optimistic about benefits, while underestimating the potential limitations and hazards.
Twenty-Five Years afterQuinlan: A Review of the Jurisprudence of Death and Dying
Authors: Cantor Norman L.
Published: January 2007

Ever since the 1960s, when medical science became capable of prolonging the dying process beyond bounds that many patients would find acceptable, people have sought “death with dignity,” or “a natural death,” or “a good death.” Once debilitation from a fatal affliction has reached a personally intolerable point, dying patients have sought to control the manner and timing of death via diverse techniques. Some sought the disconnection of life-sustaining medical interventions, such as respirators and dialysis machines. Beyond freedom from unwelcome interventions, some patients intent on avoiding suffering sought access to pain relief medication—even in dosages posing some risk (perhaps even a certainty) of hastening death. Other dying patients sought access to deep sedation, even knowing that they would never emerge from the resultant unconsciousness. Still other patients voluntarily refused to eat or drink or to accept artificial nutrition and hydration.
Frozen Embryo Disputes Revisited: A Trilogy of Procreation-Avoidance Approaches
Authors: Daar Judith F.
Published: January 2007

In recent years, courts have increasingly found them-selves arbiters of disputes in the emotionally charged area of assisted reproductive technologies. Legal disputes are hardly surprising in the world of infertility medicine, where millions of patients spend billions of dollars in efforts to have a child. Increasingly, these efforts produce embryos that are frozen for later use, at once maximizing a couple's chances for success and minimizing the medical intrusiveness that necessarily accompanies most forms of assisted reproductive technologies. But with over 100,000 embryos in frozen storage in the United States and a divorce rate of 40 to 50 percent, it is not surprising that disputes over the disposition of these embryos are arising, causing the legal landscape surrounding these technologies to continue to expand.
Managed Care Takes to the Highway: Implications for Insureds
Authors: Gilchrist Barbara J.
Published: January 2007

Automobile insurance companies are joining the move to managed care in the hopes of reducing health-care expenditures arising out of automobile accidents. Industry interest is strong enough that large managed care organizations, such as Concentra Managed Care, Inc., and HNC Insurance Solutions, are beginning to offer their existing network of providers to persons seeking medical care for automobile accident injuries and their evaluation software to insurers.

While insurance companies have successfully pressed four state legislatures and one commissioner of insurance for authorization to offer consumers a managed care option in automobile insurance policies, these efforts have not gone unchallenged. Vocal opponents, primarily lawyer and chiropractic organizations, question whether persons injured in accidents will receive care when needed (especially if the accident occurs when the policyholder is away from home), what the quality of care received will be, and whether any savings will be passed on to consumers.
Currents in Contemporary Ethics
Authors: Anderlik Mary R. , Elster Nanette
Published: January 2007

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards (IREs) and their members may be pulled more and more into the legal fray.

On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency (OTC), a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system.
Patient Injury and Liability: Why Worry?
Authors: Furrow Barry R.
Published: January 2007

We live in an anxious world, riddled with unpredictable threats to our safety and unexpected hatreds directed toward us. It is easy to obsess on the terrors around us, about which we can do little, and lose perspective on the real and sometimes devastating risks that we encounter in our daily lives. These everyday risks need to be regularly revisited — to remind ourselves that they can be reduced with the application of sharp minds, careful scholarship, and political will.

Medical errors in the American health-care system are just such a problem. The risk of death or serious injury at the hands of the American health-care system is not trivial, as we have learned over the past few years as the health-care establishment has acknowledged the level of iatrogenic injury in the system. If, as the Institute of Medicine reported in To Err Is Human, as many as 100,000 people every year are dying in hospitals, clinics, and doctors’ offices as the result of actions or omissions that could have been avoided, then this is a social problem of great magnitude and one that the law must try to correct.
Slouching Toward Managed Care Liability: Reflections on Doctrinal Boundaries, Paradigm Shifts, and Incremental Reform
Authors: Mariner Wendy K.
Published: January 2007

Following the seemingly endless debate over managed care liability, I cannot suppress thoughts of Yeats’s poem, “The Second Coming.” It is not the wellknown phrase, “Things fall apart; the centre cannot hold,” that comes to mind; although that could describe the feeling of a health-care system unraveling. The poem’s depiction of lost innocence — “The best lack all conviction, while the worst/Are full of passionate intensity” — does not allude to the legislature, the industry, the public, or the medical or legal profession. What resonates is the poem’s evocation of humanity’s cyclical history of expectation and disappointment, with ideas as grand as justice and occupations as pedestrian as managed care. Writing in 1919, Yeats described the end of an era with images of war’s destructive forces. The poem expresses a universal desire for some miraculous rebirth or resolution of all problems: “Surely some revelation is at hand.” But instead, the brutish Sphinx-like creature emerges, possibly the Antichrist. New gods displace old gods in the cycle of civilization, and man must muddle on.
The Role of the Courts in Shaping Health Policy: An Empirical Analysis
Authors: Jacobson Peter D. , Selvin Elizabeth , Pomfret Scott D.
Published: January 2007

The transformation of health-care delivery from fee-for-service medicine to managed care represents a fundamental philosophical shift away from the prevailing medical ethos that the needs of the individual patient take precedence over competing social values, such as reducing health-care costs. In managed care, financial incentives to reduce health-care utilization may result in denying an individual’s claim for medical services.

Litigation challenging managed care’s resource allocation decisions often presents the need to resolve conflicting social policy goals, such as the tension between an individual patient’s access to health care and a managed care organization’s (MCO’s) need to restrain costs. Conflicts may arise when a patient’s desire for unconstrained health care clashes with a provider’s and an insurer’s cost containment strategies. In turn, cost containment strategies may raise questions about restrictions on physician autonomy and conflicts among stakeholders for control over resource allocation decisions.
Managing Care in the New Era of “Systems-Think”: The Implications for Managed Care Organizational Liability and Patient Safety
Authors: Noble Alice A. , Brennan Troyen A.
Published: January 2007

Three major trends in American health policy are intersecting in a fascinating way. First, managed care has grown to become the most dominant form of health-care delivery, leading to reductions in health-care costs as insurers are able to influence health-care providers with financial incentives. Second, the present growth of managed care has slowed, almost to a standstill, largely on account of consumers questioning what effects these financial incentives are having on the care of patients — questioning that has been expressed in particular through lawsuits against managed care companies.

Third, we are experiencing a renewed interest in the existence of medical error and how it may be reduced as a result of the Institute of Medicine’s (IOM) report,To Err Is Human: Building a Safer Health System. The most important aspect of this renaissance in error reduction has been its emphasis on health care as a system that can be made better through system-oriented change. The most frustrating aspect is that the IOM did not endorse change in malpractice liability, which consistently puts the impetus for reducing medical error on the individual provider rather than the system as a whole.
Quality Control, Enterprise Liability, and Disintermediation in Managed Care
Authors: Jacobi John V. , Huberfeld Nicole
Published: January 2007

The Institute of Medicine (IOM) has returned the problem of medical error to the top of the health-care agenda. Its report that 44,000 to 98,000 patients die each year as a result of medical errors in American hospitals has renewed scholarly interest in health system quality control. InTo Err Is Human, the IOM provides a vivid picture of a health-care system riven with serious quality problems. It calls for systems-based error-reduction methods borrowed from other high-risk industries and forcefully argues against the traditional tendency to assign accountability primarily to individual physicians. Most errors, the IOM argues, can be successfully addressed by engineering systemic fail-safe protections against the inevitable failings of human actors.
The Brave New World of Medical Standards of Care
Authors: Kinney Eleanor D.
Published: January 2007

There have always been medical standards of care in the American health-care sector. However, never before have they been so deeply incorporated in the delivery of health care as they are today. With the increased delivery of care through integrated delivery systems, as well as the development of the computerized patient record, medical standards of care are now used in innovative ways by providers and health plans in delivering health care to individual patients. There is great potential for even more innovative uses of medical standards of care in the future.

This article first presents a taxonomy of the medical standards of care that are involved in health-care delivery today Next, the article traces the historical evolution of medical standards of care since the early 1980s. Included in this discussion are the origins of the standard-setting movement as well as the developments that led to the way standards of care are currently used by large institutional providers and managed care plans to improve the quality of their health-care services. The article concludes with a brief analysis of the key legal issues that affect how standards of care can be used to improve the health care of patients.
Tort Claims Analysis in the Veterans Health Administration for Quality Improvement
Authors: Weeks William B. , Foster Tina , Wallace Amy E. , Stalhandske Erik
Published: January 2007

Tort claims have been studied for various reasons. Several studies have found that most tort claims are not related to negligent adverse events and most negligent adverse events do not result in tort claims. Several studies have examined the disposition of tort claims to understand the likelihood of payment once a claim has been made. Still others have proposed that tort-claims trend analysis may help administrators target their quality-improvement efforts and identify problems with quality that would not otherwise be captured.

In this article, we conduct a tort-claims analysis to explore areas for quality improvement, specifically for patient safety, in the Veterans Health Administration (VHA). Patient safety is an increasingly highlighted aspect of health-care delivery. Failure to assure patient safety can result in bad clinical outcomes, additional costs of care, and a negative organizational image. Filing a tort claim is one way for an individual to express concern about an organization. For our analysis, we draw from resolved tort claims in the Veterans Health Administration from fiscal years 1989 to 2000.
The Adverse Event of Unaddressed Medical Error: Identifying and Filling the Holes in the Health-Care and Legal Systems
Authors: Liang Bryan A.
Published: January 2007

Patient safety has assumed a prominent role on the policy agenda since the Institute of Medicine reportTo Err Is Humanwas released in November 1999. The report maintained that medical error is the predominant mechanism by which patients in the United States and around the world are injured. This finding, along with the report’s recommendation for a “systems” approach to reducing medical error, provided an extremely important insight into the operation of our medical delivery system. Clearly, while advances in medical technology, diagnostic techniques, and knowledge provide the foundation for saving lives, medical error has resulted in their loss. However, recognition that medical error is a primary cause of these avoidable patient injuries and deaths is a key one and may result in improvements within our system of health-care delivery as well as minimization of the emotional and financial toll that iatrogenic injury causes.
The Problem of Medical Misadventures: A Review of E. Haavi Morreim'sHolding Health Care Accountable
Authors: Furrow Barry R.
Published: January 2007

Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as anin terroremdevice that drives disclosure of medical errors into hiding?
The Artificial Heart: How Close are We, and Do We Want to Get There?
Authors: Simmons Paul D.
Published: January 2007

On July 2, 2001, a medical milestone was reached when Robert Tools received a total artificial heart implant at Jewish Hospital in Louisville, Kentucky. Tools was implanted with an AbioCor artificial heart, one of several brands of new-generation artificial hearts that has been approved by the U.S. Food and Drug Administration (FDA) for clinical trial. The AbioCor heart was developed by Abiomed of Danvers, Massachusetts.

Following the surgery, physicians were guardedly enthusiastic about the device and optimistic about the patient’s future. Tools, 59, has had a history of numerous heart attacks and by-pass surgery, as well as diabetes and kidney problems. He met the requirements of the AbioCor protocol because he was not a candidate for transplant, death was otherwise probable within thirty days, and other interventions were deemed ineffective. Researchers hope that strengthening his heart function will result in increased function of his other vital organs, thus prolonging the patient's life and increasing his energy. But because the device is experimental, nothing can be promised.
Public Health Law: A Renaissance
Authors: Gostin Lawrence O.
Published: January 2007

This symposium issue of the Journal of Law, Medicine & Ethics is about public health law, not health-care law. There is a difference. Most scholarly writing has examined the rich and textured field of health-care law or law and medicine. This field revolves around several broad themes related to the health-care system: delivery, financing, and research and innovation.

In studying health-care delivery, scholars have examined everything from the physician/patient relationship (e.g., consent and privacy) to systems of care (e.g., hospitals and managed care organizations). In studying financing, scholars have examined theories of competition and justice to ensure cost-efficient access to care. And in studying research and innovation, scholars have studied everything from human subject protection to intellectual property.
Rethinking the Meaning of Public Health
Authors: Rothstein Mark A.
Published: January 2007

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public health and the distinctions, for example, between public health and clinical care, and public health and health promotion.

In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities.
A Globalized Theory of Public Health Law
Authors: Fidler David P.
Published: January 2007

This symposium issue of theJournal of Law, Medicine & Ethicsindicates that interest in public health law in the United States is enjoying a renaissance. The focus of the articles reflects this renaissance, as they explore the state of public health law in various contexts within the United States. Additionally, all but one of the symposium authors plies his or her trade at a university, institution, or government agency in the United States. My task here is different: I focus on public health law within the context of international relations.

Analyzing public health law with an international perspective proves no easy assignment. Examining the role of public health law in the proverbial global village takes the analysis out of the familiar territory of law operating within a single sovereign state. The analysis could take two forms. One could compare different national systems of public health law on specific issues. Such a comparative law approach would be interested in, for example, how the public health laws of the United States and South Africa differ in connection with regulating tobacco consumption.
Public Health Ethics: Mapping the Terrain
Authors: Childress James F. , Faden Ruth R. , Gaare Ruth D. , Gostin Lawrence O. , Kahn Jeffrey , Bonnie Richard J. , Kass Nancy E. , Mastroianni Anna C. , Moreno Jonathan D. , Nieburg Phillip
Published: January 2007

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.

Public health is primarily concerned with the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions.
Disease Stigma in U.S. Public Health Law
Authors: Burris Scott
Published: January 2007

Stigma has become an important concept in public health law. It is widely accepted that certain diseases are disfavored in society, leading to discrimination against people identified with them, which in turn has the tendency to drive an epidemic underground—i.e., to make it more difficult for voluntary public health programs to reach and succeed among populations bent on concealing their disease or risk status. The need to reduce stigma and its effects has been used to justify the passage of privacy and antidiscrimination law to protect people with HIV. More recently, stigma has been part of the arsenal of justification for special genetic antidiscrimination and privacy law. Despite its importance, however, there is no single widely accepted definition of stigma in social science, and its relationship to law has been generally under-theorized and unsupported by data, reducing our ability to effectively deploy law and other tools in the anti-stigma cause.
Managed Care and Public Health: Conflict and Collaboration
Authors: Rosenbaum Sara , Kamoie Brian
Published: January 2007

This article reviews the relationship between managed care and public health. Managed care, with its seemingly infinite structural and organizational variation, dominates the modern American health-care system for the non-elderly U.S. population. Through its emphasis on standarhzed practice norms and performance measurement, coupled with industrial purchasing techniques, prepayment, risk downstreaming, and incentives-based compensation, managed care has the potential to exert considerable influence over the manner in which the health-care system is organized and functions. Given the degree to which the attainment of the basic public health goal of protecting the public against population health threats for which there are known and effective medical interventions depends on the successful interaction between public health policy and the medical care system, the importance of a viable working relationship between public health and managed care is difficult to overstate.

The potential for conflict between public health and medical care is nothing new; indeed, delineating the boundaries of public health to shape and influence medical practice has occupied the energies of policymakers and the medical industry for well over a century.
After September 11: Rethinking Public Health Federalism
Authors: Parmet Wendy E.
Published: January 2007

In the fall of 2001, the need for a vigorous and effective public health system became more apparent than it had been for many decades. With the advent of the first widescale bioterrorist attack on the United States, the government's obligation to respond and take steps to protect the public health became self-evident.

Also obvious was the need for of an effective partnership between federal, state, and local officials. Local officials are almost always on the front lines of the struggle against bioterrorism. They are the first to recognize a suspicious case and to provide testing and treatment for the affected population. At the same time, state officials are needed to support and coordinate local efforts, providing an expertise that may be lacking in many communities, especially smaller ones.

But few would doubt that the federal government has a key role to play. The Centers for Disease Control and Prevention (CDC) is expected to lead the epidemiological investigation and provide expertise on how to cope with diseases that remain unfamiliar to most physicians.
Administrative Law and the Public's Health
Authors: Kinney Eleanor D.
Published: January 2007

Today, public health regulation at all levels faces unprecedented challenges both at home and abroad. The September 11, 2001 attacks on New York and Washington, D.C., by the Al Qaeda terrorist network and the anthrax bioterrorism that followed shortly thereafter have put public health regulation at the forefront of homeland security. The anthrax scare, in particular, has greatly tested the American public health system, calling into question whether the United States and its component states and localities are prepared to handle a major outbreak of infectious disease, such as smallpox, in a future bioterrorist action. While the response of public health agencies was commendable, especially in light of the magnitude of the assaults, it is manifestly clear that the American public health system will be hard pressed to meet similar challenges that may lie ahead.

The events of fall 2001 follow a period of major challenges for public health. The AIDS pandemic has killed millions of people throughout the globe, especially in Africa and other parts of the developing world.
Evaluating the Impact of Criminal Laws on HIV Risk Behavior
Authors: Lazzarini Zita , Bray Sarah , Burris Scott
Published: January 2007

Criminal law is one of the regulatory tools being used in the United States to influence risk behavior by people who have HIV/AIDS. Several different types of laws have been or could be used in this way These include:

HIV-specific exposure and transmission laws — i.e., laws that explicitly mention and exclusively apply to conduct by people with HIV;

public health statutes prohibiting conduct that would expose others to communicable diseases and/or sexually transmitted diseases (STDs); and

general criminal laws governing attempted murder and assault.
Bioterrorism Law and Policy: Critical Choices in Public Health
Authors: Hodge James G.
Published: January 2007

There is perhaps no duty more fundamental to American government than the protection of the public's health, safety, and welfare. On September 11, 2001, this governmental duty was severely tested through a series of terrorist acts. The destruction of the World Trade Towers in New York City and a portion of the Pentagon in Washington, D.C., presented many Americans with a new, visible reality of the potential harms that terrorists can cause. The staggering loss of lives (estimated from 2,600 to 2,900) damaged the national psyche in ways far exceeding the physical scars to American institutions.

As horrific as the images of destruction and loss of human lives may be, events that unfolded after September 11 revealed another dreaded, and potentially more catastrophic, threat to Americans sense of security and public health: bioterrorism. Unlike terrorists that use bombs, explosives, or other tools for mass destruction, a bioterrorist's weapon is an infectious agent.
Injury as a Field of Public Health: Achievements and Controversies
Authors: Bonnie Richard J. , Guyer Bernard
Published: January 2007

The mission of public health is to assure the conditions in which people can be healthy and to reduce the occurrence of death and disability attributable to disease and injury. From the distinctive perspective of public health, the target is the health of the population as a whole, with a particular concern for vulnerable populations within the whole. Although public health is grounded in science, the mission and perspective of the field are shaped by the ever-evolving values of the society. Ethics and law are therefore constituent disciplines of public health policy and practice. One of the major challenges confronting contemporary practitioners of public health is the need to broaden and deepen their understanding of legal and ethical aspects of their work. This special issue of theJoumal of Law, Medicine & Ethicsresponds to this challenge. This article describes how the mission of public health has come to encompass the prevention and treatment of injury and highlights some of the political and ethical controversies now confronting the field.
Regulating Tobacco: The Need for a Public Health Judicial Decision-Making Canon
Authors: Daynard Richard A.
Published: January 2007

Cigarette smoke is by far the leading preventable cause of death and disease in the United States. It has been estimated to kill between 419,000 and 589,000 smokers and up to 65,000 non-smokers each year. This premier status is hardly a new development, having been true for most of the last century, and known to be true at least since the first Surgeon General’s Report in 1964.

Why then are tobacco products exempt from any significant federal oversight or control? Why do cigarette advertisements, pitched to young smokers and non-smokers, continue to be plastered on every available surface inside and outside many convenience stores and to adorn the pages of popular magazines? Why, decades since the makers of far less dangerous products began to be held accountable in tort law, was the first payment by a cigarette company on a products liability judgment not made until 2001?
Other Branches of Science are Necessary to Form a Lawyer: Teaching Public Health Law in Law School
Authors: Goodman Richard A. , Lazzarini Zita , Moulton Anthony D. , Burris Scott , Elster Nanette R. , Locke Paul A. , Gostin Lawrence O.
Published: January 2007

Over two hundred years ago, Thomas Jefferson suggested the need for a broader legal curriculum. As the twenty-first century begins, the practice of law will increasingly demand interdisciplinary knowledge and collaboration — between those trained in law and a broad range of scientific and technical fields, including engineering, biology, genetics, ethics, and the social sciences. The practice of public health law provides a model for both the substantive integration of law with science, and for the way its practitioners work. In addition, public health law also provides a model for interdisciphuy and integrative teaching.
A Rightful Place for Public Health in American Law
Authors: Parmet Wendy E. , Robbins Anthony
Published: January 2007

The practice of law has changed greatly since the days when judges based decisions on the maxim salus populi suprema lex, and Oliver Wendell Holmes disagreed, noting that “experience” has been the “life of the law.” In the intervening years, the profession has followed Holmes and the legal realists in recognizing that the law does not exist in a vacuum. It is a human endeavor, molded by experiences and filled with human consequences. Today, lawyers, jurists, and legal scholars everywhere on the political spectrum recognize the importance of social context, history, and a variety of non-legal disciplines, and non-legal insights to the intelligent practice of the law Unfortunately, in rejecting the old maxims, the legal profession also lost sight of the fundamental truth of salus populi suprema lex, Latin for “the health of the people is the highest law” - namely, it has lost sight of the truth that a population’s health is a critical part of law’s social context. One of the consequences of this is that the profession has failed to include public health - the study of the causes and prevention of disease, disability, and death in populations - among the non-legal disciplines regularly incorporated into legal analysis and routinely taught to all would-be lawyers. It is time to correct this oversight.
Conflicts of Interest in Clinical Research: Addressing the Issue of Physician Remuneration
Authors: Caulfield Timothy , Griener Glenn
Published: January 2007

In the past few years, there have been a number of high profile incidents that have emphasized the issues associated with financial conflicts of interest. As a result, commentators and policy-makers throughout the world have been directing their attention to how financial conflicts should be addressed. Despite such activity, however, there are few policies that provide specific guidance addressing one of the most common forms of financial conflict-the provision of generous remuneration packages to clinical investigators.

In this column, we explore the conflict of interest issues that flow from the pharmaceutical industry paying community physicians to be investigators in clinical drug trials. In particular, we are interested in the challenges associated with the management of this complex issue by local research ethics boards. We suggest the need for more research on this topic and specific guidelines to empower these boards to address this growing concern. We recognize that this is one of many current conflict issues faced by policy-makers today.
HIPAA Compliance: Lessons from the Repeal of Hawaii's Patient Privacy Law
Authors: Kelly Curly
Published: January 2007

In 1996, Congress passed the Health Insurance Portability and Accountability Act (HIPAA), which required the enactment of new regulations to protect confidential patient health information. In December 2000, the U.S. Department of Health and Human Services (DHHS) published the agency's final rule on patient privacy and the proper use of privileged health information. The HIPAA privacy regulations cover all health-care providers that handle medical records or other identifiable patient health information. Most health-care organizations have until April 14,2003, to comply with HIPPA.
Symposium on Human Subjects Research: Redux
Authors: Goldner Jesse A.
Published: January 2007

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.
The Podium
Authors: Folkman Judah
Published: January 2007

Thank you very much, Ladies and Gentleman. I am very honored by the invitation to give a keynote address at this very informative, national meeting, before such a distinguished audience.

If you made a list of the hundreds of different activities that go on during the day in a major medical center and tried to rank order them in terms of degree of difficulty, or judgment required, or risk of error, or damage that can result from an error of omission or an error of commission, at the top of the list one might consider the teaching of a surgical resident at the operating table by a senior experienced surgeon, hours on end, often emotionally draining.
RAC Oversight of Gene Transfer Research: A Model Worth Extending?
Authors: King Nancy M. P.
Published: January 2007

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.

Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board (IRB) whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration (FDA).
Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts
Authors: Barnes Mark , Florencio Patrik S.
Published: January 2007

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition ofTimemagazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and Johns Hopkins University.

At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board (IRB) — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration (FDA) a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center.
Universality and its Limits: When Research Ethics Can Reflect Local Circumstances
Authors: Orentlicher David
Published: January 2007

Studies in several developing countries for treatmen to prevent HIV-transmission from mother to child generated considerable controversy in 1997. Critics of the studies argued that basic principles of research ethics were violated. According to the critics, researchers subjected women in developing countries to studies that would have been unethical in the United States (and other developed countries) and that the researchers were therefore engaged in unethical exploitation ofcitizens of the developing countries in which the studies were conducted.

While the critics agreed that unethical exploitation had occurred, they differed on the exact nature of the exploitation. Some observers condemned the researchers for employing a double standard — because the researchers were applying a standard of care that would have been unacceptable in their own country. In the view of these critics, researchers should have been comparing the experimental treatment to established therapy rather than to placebo, as would have been required in the United States or other developed countries.
The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection
Authors: Davis Arlene M. , Hull Sara Chandros , Grady Christine , Wilfond Benjamin S. , Henderson Gail E.
Published: January 2007

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board (IRB) review, data monitoring, and informed consent forms. However, the protection of human subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research.