bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Survey of Physician Training Programs in Risk Management and Communication Skills for Malpractice Prevention
Authors: Lefevre Frank V. , Waters Teresa M. , Budetti Peter P. 
Published: January 2007

Malpractice lawsuits serve as a great source of pain, consternation and loss for physicians and patients alike, usually leaving all parties involved in the process with a sense of betrayal. A significant number of physicians will be sued at least once in their career, especially if they practice in some of the more vulnerable specialties. In addition, there is some evidence that the threat of malpractice lawsuits changes the practice style of many physicians, leading to the practice of “defensive medicine” and raises the total cost of health care. Clearly, the prevention of medical malpractice is an issue that deserves considerable attention from physicians and from those who train them.Empirical evidence suggests that medical negligence may play a relatively minor role in malpractice lawsuits. As demonstrated by Localio, et al., one in thirty-five cases of negligence or incompetence actually results in a lawsuit.
Risks, Benefits, and Conflicts of Interest in Human Research: Ethical Evolution in the Changing World of Science
Authors: Koski Greg 
Published: January 2007

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe.
Defining and Describing Benefit Appropriately in Clinical Trials
Authors: King Nancy M. P. 
Published: January 2007

Institutional review boards (IRBs) and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal.
The Ethics of Clinical Trials: A Child's View
Authors: Rosato Jennifer 
Published: January 2007

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the AIDS epidemic. These social forces have shifted the core ethical question fromwhetherchildren should be research subjects towhenchildren should be research subjects.The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration (FDA) that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults.
The Girl Who Cried Pain: A Bias against Women in the Treatment of Pain
Authors: Hoffmann Diane E. , Tarzian Anita J. 
Published: January 2007

To the woman, God said, “I will greatly multiply your pain in child bearing; in pain you shall bring forth children, yet your desire shall be for your husband, and he shall rule over you.”Genesis 3:16There is now a well-established body of literature documenting the pervasive inadequate treatment of pain in this country. There have also been allegations, and some data, supporting the notion that women are more likely than men to be undertreated or inappropriately diagnosed and treated for their pain.One particularly troublesome study indicated that women are more likely to be given sedatives for their pain and men to be given pain medication. Speculation as to why this difference might exist has included the following: Women complain more than men; women are not accurate reporters of their pain; men are more stoic so that when they do complain of pain, “it's real”; and women are better able to tolerate pain or have better coping skills than men.
Pain Management and Provider Liability: No More Excuses
Authors: Furrow Barry R. 
Published: January 2007

Pain is undertreated in the American health-care system at all levels: physician offices, hospitals, long-term care facilities. The result is needless suffering for patients, complications that cause further injury or death, and added costs in treatment overall. The health-care system's failure to respond to patient pain needs corrective action. Excuses for such shortcomings are simply not acceptable any longer.Physicians have long been accused of poor pain management for their patient. The term “opiophobia” has been coined to describe this remarkable clinical aversion to the proper use of opioids to control pain. If the professional mandate of the health-care professional is to relieve suffering, then physicians are falling far short of their obligations by accepting myths about the use of opioids in the face of evidence to the contrary.
Race, Ethnicity, and Pain Treatment: Striving to Understand the Causes and Solutions to the Disparities in Pain Treatment
Authors: Bonham Vence L. 
Published: January 2007

would like for them to know that I am in pain or this part of my body hurts or the other part hurts — that I am not lying about it. To examine me and to cut down on the pain….And help me out.Patient with Sickle Cell Disease, Focus Group ParticipantPain in the United States is widely recognized to be undertreated; however, the capacity to treat pain has never been greater. The causes of this undertreatment are varied. As we focus on pain and why it is too often ineffectively treated, we also discover that this undertreatment afflicts some more than others. What divides the some from the others isn't limited to one factor, but one particularly disturbing factor is race and ethnicity. Racial and ethnic minority populations are at higher risk for oligoanalgesia, or the ineffective treatment of pain. Only through further study of the differences in pain treatment based on race and ethnicity can we develop strategies to reduce the disparities in care.
From Confrontation to Collaboration: Collegial Accountability and the Expanding Role of Pharmacists in the Management of Chronic Pain
Authors: Brushwood David B. 
Published: January 2007

Federal and state laws create a tightly controlled system for distribution of those drugs that have recognized value in therapy, but also have the potential for abuse. The challenges pharmacists face in keeping controlled substances within the closed system are many and complex. Drug abusers and drug dealers have at times seen pharmacists as easy marks for access to abusable drugs. Unfortunately, pharmacists often find themselves in a game with criminals, who use both sophisticated and dangerous methods of inducing pharmacists to divert controlled substances. The effects of this problem on the health-care system have been judicially noted:The frequency of these crimes has terrorized the community of dispensing pharmacists. Some pharmacists have ceased to carry drugs that are highly desired on the black market, although this interferes with their patients’ ability to obtain necessary medicine. This has a serious potential to impede the delivery of health care in many communities around the nation.
Currents in Contemporary Ethics
Authors: Stone T. Howard 
Published: January 2007

In what is clearly an important development related to research integrity and the protection of human research subjects, the U.S. government has instituted two new training requirements as a condition of receiving federal financial support. First, the National Institutes of Health (NIH) is requiring, as a condition of funding, that key research personnel involved in human subject research complete education “in the protection of human subjects.” Evidence that key personnel have completed this training must be provided in NIH grant applications or contract proposals.The NIH education policy will eventually be superseded by a more broadly applicable instructional policy for the “responsible conduct of research,” which will be promulgated by the Department of Health and Human Service's Office of Research Integrity and the Public Health Service (PHS). The instructional policy will apply to all persons engaged in any research or research training with PHS support. Presently, the only version of the policy is in draft form.
Jonathan Mann's Legacy to the 21st Century: The Human Rights Imperative for Public Health
Authors: Marks Stephen P. 
Published: January 2007

Professor Gostin is a leading authority on health law, whose writing and teaching are among the most authoritative in the United States, as exemplified by his recent work, Public Health Law: Power, Duty, Restraint. Gostin's article in this issue of the Journal of Law, Medicine & Ethics pays homage to Jonathan Mann (1947-1998) by expressing the debt he feels toward this extraordinary doctor and public health official with whom he had collaborated on several projects.As many will remember, Mann held high-level positions at the Centers for Disease Control and worked on AIDS research in Central Africa before setting up the World Health Organization's Global Programme on AIDS, which he ran from 1986 to 1990. Thanks to his profound commitment and consummate communication skills, he achieved the unprecedented feat of raising the budget within two years to almost $100 million from the initial set-up of “himself, a secretary, and one typewriter,” as described by Daniel Tarantola.
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.
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.
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.
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.