bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Research‐Treatment Distinction:A Problematic Approach for Determining Which Activities Should Have Ethical Oversight
Authors: Kass Nancy E. , Faden Ruth R. , Goodman Steven N. , Pronovost Peter , Tunis Sean , Beauchamp Tom L. 
Published: October 2014

AbstractThe rise of quality improvement research and comparative effectiveness research in health care settings constitutes progress toward the goal of what the Institute of Medicine has called a “learning healthcare system,” in which we are “drawing research closer to clinical practice by building knowledge development and application into each stage of the healthcare delivery process.” As clinical research and clinical practice move closer to a deliberately integrated system, the distinction between the two is increasingly blurred, although the sharp distinction in U.S. regulations and research ethics literature remains in place. In the 1970s and for two decades thereafter, this distinction was helpful: for some forms of research, it sheds light on which activities require ethical oversight. Research that is closely integrated with health care—notably, health delivery research—was then uncommon, however. That is no longer the case, and regulations and research ethics need to change to accommodate the new landscape.In this paper, we argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice. We start with the history of the research‐practice distinction in the reports of a U.S. national commission and in U.S. federal regulations, and then offer a critical assessment of five characterizations of research that have been used in policy documents and the scholarly literature to try to make a sharp distinction between research and practice. We challenge the clarity and the tenability of these characterizations as a way of distinguishing research from practice. We argue that the received view of the research‐practice distinction leads to overprotection of the rights and interests of patients in some cases and to underprotection in others. We contend that a new ethical foundation needs to be developed that facilitates both care and research likely to benefit patients, and that provides oversight that, rather than being based on a distinction between research and practice, is commensurate with risk and burden in both realms.
A Prescription for Ethical Learning
Authors: Largent Emily A. , Miller Franklin G. , Joffe Steven 
Published: October 2014

AbstractWe argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems.
Evaluation as Part of Operations: Reconciling the Common Rule and Continuous Improvement
Authors: Platt Richard , Grossmann Claudia , Selker Harry P. 
Published: October 2014

AbstractUnderstanding the components of clinical care that work best is a cornerstone of improving health care. And yet, the more we improve the quality of quality improvement and move to continuous learning about clinical care more broadly, the more we find ourselves in a regulatory environment that makes evaluation more difficult, expensive, and, in some situations, impossible. In their paper on the ethical underpinnings of the distinction between research and treatment, Ruth Faden and colleagues raise important implications for a wide array of situations. These points give reason to rethink the definition of routine clinical operations to include evaluation of the processes and outcomes of care and dissemination of findings. We concur with the assertion by Faden and colleagues, and with previous work from The Hastings Center, that conducting continuous improvement activities such as these is an obligation of health systems and clinicians. We believe that rigorous, systematic evaluation should be considered part of normal, expected operations, rather than exceptional behavior that requires extraordinary regulatory control.
Should We Call It Fraud?
Authors: CAULFIELD TIMOTHY 
Published: October 2014

AbstractI recently had the opportunity to chair an interdisciplinary workshop on stem cell tourism—the practice, that is, of marketing unproven stem cell therapies for a wide range of diseases and disabilities, drawing patients from around the world. The goal of the event was to produce a statement to educate Canadian family physicians about this troubling and exploitative phenomenon. We wanted to keep the statement basic and straightforward. “Let's simply call stem cell tourism what it is. It is fraud,” someone suggested. I wrote the word “fraud” on the flipchart at the front of the room, and everyone seemed comfortable with this frank declaration. But when I went to write up the first draft of our statement, I hesitated.
Medicine's Metaphysics
Authors: Dugdale Lydia S. 
Published: October 2014

AbstractThe scenario could not have been more grim. Mrs. Carr had been fitted with a breathing tube for surgery, but the doctors were unable to wean her from the ventilator due to recurrent episodes of life‐threatening infection. She could not eat because of the ventilator, so she received nutrition through a tube in her stomach. At some point, her kidneys shut down and she started dialysis treatments. Between recurrent infection and dialysis, her blood pressure bottomed out, and the medical team frequently jump‐started her heart with intravenous adrenaline‐type medications. Without aggressive support of her lungs, kidneys, nutrition, and cardiovascular system, Mrs. Carr would be dead. “What is going on here?” Anna wondered aloud. “Is this life?”Philosopher and physician Jeffrey Bishop might argue that this is not life. Rather, medicine has created a body in perpetual motion. Contemporary medicine, he contends, has redefined human life as human function; doctors simply replace the broken or dead parts of the human machine with other machines—a ventilator for the lungs, dialysis for the kidneys, and so forth—and the body stays in motion indefinitely. Bishop argues that the discipline of medicine needs to reexamine its metaphysical assumptions—its current approach is detrimental to human flourishing. Should a metaphysics of efficient causation be replaced with a more expansive metaphysics of final causes?
From Evidence‐Based Medicine to Evidence‐Based Practice
Authors: Meyer Michelle N. 
Published: October 2014

AbstractAs a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human research guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice.The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality.
Whose Bed?
Authors: Tong Bonnie , Lipman Hannah I. 
Published: October 2014

AbstractRichard, a sixty‐seven‐year‐old man, has been admitted to Midtown University Center for difficulty breathing. He has a significant medical history that includes pulmonary fibrosis and subsequent heart failure, and he depends on supplemental oxygen to breathe. Upon admission and after discussing his prognosis with his family and doctors, Richard decided to sign a do‐not‐resuscitate order stating that if his heart stops or he stops breathing, he does not want to undergo cardiopulmonary resuscitation or other life‐sustaining measures.On his third day in the hospital, the nurse practitioner who is caring for Richard notices that his breathing is becoming more labored and that his blood pressure is steadily dropping. She thinks he requires closer observation and treatment in the cardiac intensive care unit. Dr. P, the physician in the intensive care unit at the time, Dr. P does not want to accept Richard into the CICU because of his prognosis and his DNR order. He believes that Richard should be cared for on a regular hospital floor, and that the last bed in the CICU should be held for its intended user—a patient suffering a life‐threatening heart attack who requires intensive care.Should Richard be admitted to the CICU?
Why We Should All Pay for Fertility Treatment: An Argument from Ethics and Policy
Authors: Johnston Josephine , Gusmano Michael K. 
Published: October 2014

AbstractSince 1980, the number of twin births in the United States has increased 76 percent, and the number of triplets or higher‐order multiples has increased over 400 percent. These increases are due in part to increased maternal age, which is associated with spontaneous twinning. But the primary reason for these increases is that more and more people are undergoing fertility treatment. Despite an emerging (but not absolute) consensus in the medical literature that multiples, including twins, should be a far less frequent outcome of fertility treatment, American clinicians currently practice fertility medicine in ways likely to result in twins and, occasionally, triplets—often, they tell us, at the request of their patients. At first blush, one might conclude that these practice patterns show that patients and their doctors have weighed the risks associated with twins against the benefits of swiftly completing their families and decided that the risks are worth taking. That is, their requests for twins must represent their free and informed choices. But there are reasons to be skeptical of this interpretation, including that the preferences of many patients seem to be very strongly shaped, if not sometimes completely constrained, by concerns about costs—costs that mainly result from the routine exclusion of in vitro fertilization from health insurance coverage. It is quite possible, we believe, that these cost concerns actually undermine the autonomy of fertility patients, pushing many of them to take risks with their health and the health of their hoped‐for future children.
The Increasingly Compelling Moral Responsibilities of Life Scientists
Authors: Relman David A. 
Published: October 2014

AbstractAs a member of the National Science Advisory Board for Biosecurity, I was involved in early deliberations about the appropriateness of publishing this avian influenza research when manuscripts were referred to us from two scientific journals during their review process, via the U.S. government. As described by David Resnik in this issue, we grappled with benefits and risks, and in our initial, unanimous decision recommended limited publication, alerting the world to the possibility of evolved transmissibility in these viruses but with redaction of the exact genetic mutations that would enable anyone skilled in the art to synthesize these potentially dangerous viruses. However, after additional discussion, both internal and external to the board, we were asked to reconsider the situation, and this time a majority voted in favor of full publication. I was one of the minority that opposed full publication.Resnik points to the difficulties of performing a formal risk‐benefit assessment without the means of quantifying these two terms and suggests application of reasoning based on the precautionary principle instead. This makes sense. But there are three other issues that should be highlighted.
H5N1 and the Politics of Truth
Authors: Bennett Gaymon 
Published: October 2014

AbstractThe social fact of disease means the ethical dimensions of H5N1 research are not only fraught but empirical. Any account of the reality of research that leaves out its ethical dimensions leaves out reality. For this reason alone—and quite apart from his carefully reasoned analysis—David Resnik deserves our thanks: his attention in this issue to the ethics of knowledge focuses our attention on the fact that the possible harms and benefits of H5N1 turn as much on the “politics of truth”—how work is conducted and talked about—as the biology itself. Sufficient discussion of this ethical dimension, as Resnik points out, requires attending to all stages of research, its premises and its ramifications. Resnik focuses on questions of publication and risk, offering philosophical, legal, and political insight. For my part, I would like to bolster (if complicate) Resnik's assessment by offering a few anthropological notes.
Preventing Sin: The Ethics of Vaccines Against Smoking
Authors: Lieber Sarah R. , Millum Joseph 
Published: October 2014

AbstractThe alarming rates of smoking, obesity, and substance abuse pose an enormous challenge for parents and public health officials: how do we prevent children and adolescents from adopting unhealthy behaviors? One new option that may soon be available is the use of nicotine vaccines. Immunological therapies to help smokers stop smoking have shown promise in phase I and II trials; similar therapies could combat smoking addiction before it starts. Nicotine vaccines are distinctive because they confer protection not against infection—the normal target for vaccines—but against enticing pleasures that lead to unhealthy behaviors. As a result, using them preventively in children would be likely to arouse some novel ethical concerns that should be addressed before the vaccines become commonly available and their off‐label use as a preventive measure becomes a real option.In this paper, we consider whether it would be ethical for parents to vaccinate their children against smoking if a nicotine vaccine were to be proven effective as a preventive intervention for children or adolescents. We begin by explaining the current state of nicotine vaccine science and suggesting some likely ethical concerns about allowing parents to have their children receive a vaccine. We then present a preliminary argument for making vaccination permissible, at least if nicotine vaccination substantially reduces the probability that someone subsequently becomes a smoker. We consider a series of possible ethical objections, which are useful for identifying the conditions under which it would be ethical for parents to vaccinate their children against smoking. We conclude that it would be permissible for parents to give their child a nicotine vaccine if the following conditions were met: the vaccine is expected to result in a net benefit to each individual vaccinated, the expected harms from the side effects of the vaccine are lower than the nonvoluntary harms caused by smoking, and there are no other, less manipulative methods available that are as effective at preventing smoking initiation.
Health Reform and the Uninsured: The New Requirements of the Old Ethics
Authors: Tunzi Marc 
Published: October 2014

AbstractU.S. health reform will raise many familiar ethical issues over the next several years‐old issues in new forms. One of these is the fate of individuals who will still be uninsured after implementation of the Patient Protection and Affordable Care Act. One way to think about meeting their needs is to appeal to the "social contract" around which the American Medical Association was originally formed. The AMA Code of Medical Ethics directs physicians to promote "access to medical care for all people" and to "share in providing care to the indigent." I propose that a minimum standard of public service activities be defined and required by all U.S. medical specialties in order to maintain board certification and/or professional society membership.
PEPFAR's Antiprostitution “Loyalty Oath”: Politicizing Public Health
Authors: Gostin Lawrence O. 
Published: October 2014

AbstractCan Congress require AIDS service organizations to pledge fidelity to the government's view opposing prostitution as a condition of receiving funding? This term, the Supreme Court will decide whether the First Amendment permits such censorship in USAID v. Alliance for Open Society International (AOSI).The 2008 legislation reauthorizing the President's Emergency Plan for AIDS Relief (PEPFAR) requires host countries to support “activities promoting abstinence, delay of sexual début, monogamy, and fidelity.” PEPFAR's “conscience clause” allows organizations with a moral or religious objection to opt out of providing services to patients with a sexual orientation of which they disapprove. In addition, the law requires grantees to adopt “a policy explicitly opposing prostitution” and to refrain from any speech or activities the government deems “inconsistent” with that policy. The antiprostitution pledge extends not only to what a recipient says or does with PEPFAR funds, but even to what it says or does with its own private funds. The government, however, has not enforced the pledge against U.S.‐based nongovernmental organizations partly because of a preliminary injunction granted by the lower courts. That injunction is now at risk if the Supreme Court upholds the loyalty oath.
“Yet the Body Is His Book”: Plastinated Bodies and the Book of Common Bioethics
Authors: Nelson James Lindemann 
Published: October 2014

AbstractJohn Donne, poet laureate of the human body, was much troubled by its fate. Scorning Plato's picture of the body as the soul's prison, Donne imagined souls as leaving their bodies reluctantly and as yearning to return to the very one from which they had departed. In poems like “The Ecstasy,” he depicts the union of lovers’ souls, hints at a similar love of souls for bodies, and suggests that it is through the body—“his book”—that the lover comes to know love's spiritual mysteries. John Lantos also thinks bodies important, and that some among their possible fates, anyway, can be troubling.A review of Controversial Bodies: Thoughts on the Public Display of Plastinated Corpses, edited by John D. Lantos.
Ethical Challenges in Refugee Health: A Global Public Health Concern
Authors: Aaron Eliana 
Published: October 2014

AbstractMedications of choice, necessary supplies, and evidence‐based health care now seem like luxuries. The contrast between my experience at a well‐funded health unit and the Lev El Lev (“heart to heart”) African Refugee Clinic in Tel Aviv, Israel, is staggering. The complex personal, social, health, psychological, educational, and economic difficulties create a unique ethical environment for the health care provider.
Great Challenges
Authors: Gilbert Susan 
Published: October 2014

AbstractWe first got to know TEDMED, a partner of TED (known for its entertaining talks on important ideas), in November 2011, when Jay Walker, its ebullient curator and chairman, visited The Hastings Center to discuss our common interests. What took place was an energizing conversation with Hastings Center staff and several members of the center's board of directors about some of the most intractable health care problems. Jay sketched his vision of marshaling creative and motivated leaders from business, public policy, and medicine to address them. He imagined these people drawing on their areas of expertise to make unforeseen connections—perhaps some insight from business would spark a new idea for combatting childhood obesity or eliminating medical errors. They would use their influence to put the best ideas into practice. Soon after, Walker's colleagues were back in touch with a plan for launching his movement: The Great Challenges of Health and Medicine program.
A Win‐Win?
Authors: Kaebnick Gregory E. 
Published: October 2014

AbstractThere is widespread agreement that medical care offered at the end of a life ought to accord with the preferences of the person whose life it is, at least if the care requested would not be futile. There is considerable evidence, too, that making care more “patient‐centered” in this way would tend to lower the cost of care, for the simple reason that people in those straits often prefer to avoid the most intrusive and therefore most expensive care. So patient‐centered care could be a win‐win of sorts: there could be a collective benefit of lowering costs along with the individual benefit of conforming care better to what the patient wants. But to what degree should the collective benefit be an express goal of health reform, in light of the fact that a given patient might want whatever intrusive, aggressive interventions stand a chance of prolonging life? This question animates several items in this issue of the Report.
There Oughta Be a Law
Authors: Hall Mark A. 
Published: October 2014

Abstract“Unconscionable.” “Outrageous.” “Indefensible.” These are just some of the tamer descriptions for the billing practices of most hospitals, and also many physicians, that have recently come to the public's attention. Earlier this year, Time magazine published an extraordinary 24,000‐word exposé—the longest article it has ever published—detailing how even charitable hospitals routinely price‐gouge their patients.1 With characteristic flare for telling details, journalist Steven Brill documented ten‐fold markups of charges over costs at some prominent hospitals for common services like X rays and lab tests, and one‐hundred‐fold mark‐ups on mundane supplies such as gauze pads and generic aspirin. Just as the buzz from Brill's article was abating, the Centers for Medicare & Medicaid Services released a comprehensive data set in May that galvanized local and national media across the country.This news tsunami caught hospital managers flat‐footed and tongue‐tied. Typical responses conceded that hospitals’ pricing practices are based neither on actual cost structures nor rational marketplace dynamics. Instead, hospitals attempted to deflect blame by noting that hardly anyone actually pays list prices, and they characterized their indefensible pricing as a symptom of a broken system that is beyond them to fix.There are two glaring faults in these standard defenses.