bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ethical Oversight of Research on Patient Care
Authors: Solomon Mildred Z. , Bonham Ann C. 
Published: October 2014

AbstractThe Institute of Medicine has called on health care leaders to transform their health systems into “learning health care systems,” capable of studying and continuously improving their practices. Learning health care systems commit to carrying out numerous kinds of investigations, ranging from clinical effectiveness studies to quality improvement research and implementation science. There has been progress in realizing the IOM's vision, but also many challenges. One of these challenges has been lingering uncertainty about whether the data collection and monitoring central to learning health care systems is actually research and if so, what kind of ethical oversight it should have. This is not a new question. Yet so far, there has been no foundational analysis of the fit between the existing human subjects protection framework in use in the United States and the new kinds of data collection activities that are being, and increasingly will be, undertaken by learning health care systems. Two companion feature articles in this volume, by a team at Johns Hopkins, fill this void.
The Unbelievable Rightness of Being in Clinical Trials
Authors: Menikoff Jerry 
Published: October 2014

AbstractMuch of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials.
Making the Transition to a Learning Health Care System
Authors: Grady Christine , Wendler David 
Published: October 2014

AbstractThe authors of the two main articles in this supplement recognize the enormous potential of learning health care systems. Their first article argues that the development of these systems calls into question existing guidelines and practices that treat clinical care and clinical research as distinct activities. Their second article proposes to replace this traditional approach with a new framework, one intended to promote two important goals: support the transformation to a learning health care system and help to ensure the ethical appropriateness of the activities carried out within such a system. To promote these goals, the authors propose a framework consisting of seven obligations. The authors are aware that their framework does not provide much guidance for promoting their second goal. At first glance, the seven obligations also might appear to offer little in the way of promoting the first goal. In what way, then, is the proposed framework novel and transformative, as the authors claim? The answer appears to lie largely in how the authors interpret the sixth obligation in the framework—the obligation to conduct learning activities.
Reform within the Common Rule?
Authors: Puglisi Tom 
Published: October 2014

AbstractIn their papers in this supplement, Ruth Faden and colleagues conclude that research ethics and regulation must change to accommodate a changed and changing health care environment. The reality, however, is that the widely understood and accepted ethical framework embedded in the regulatory requirements known as the Common Rule, and recent proposals to modify the Common Rule have become stalled, at least for the foreseeable future, if not permanently. Meaningful systemic modernization of the Common Rule is not likely to occur any time soon. All the same, modernization of the Common Rule is desperately needed. In the short term, the agencies responsible for implementing it must be willing to develop practical guidance for implementing the current regulatory requirements in a way that promotes clarity and understanding and allocates human and fiscal resources based on the level of risk to subjects. To this end, the Veterans Health Administration recently implemented policy to address the research‐practice distinction—a distinction that is especially relevant to VHA's current challenges and that the authors of the “ethical framework” articles have identified as particularly outmoded.
Advances in the Research Enterprise
Authors: Kupersmith Joel 
Published: October 2014

AbstractThe clinical research enterprise is changing in fundamental ways. The bright line that separates research and clinical care is beginning to fade, as both “research” and “nonresearch” converge into and are embodied by the concept of the learning health care system. Here, data about care and operations are translated into practice improvement. VA has been a leader in this area, and based on its use of electronic health records and other inputs, has formed large databases and a data‐driven health care system. These changes raise questions about the traditional approach to “research subject” protection.
Living morally, and happily
Authors: Scheinerman Naomi 
Published: October 2014

AbstractSociety's distribution of goods is not always just: there is a significant lack of jobs and resources accessible to even the hardest of workers, and even the most motivated can have trouble discovering that fulfilling calling. Furthermore, the most needed jobs may, for many, not be the most fulfilling ones, while the most fulfilling jobs may not always better society. Amidst such observations, I find myself reflecting on my own life choices. Working at The Hastings Center is an exceedingly rare opportunity for which I am extremely grateful: it allows me to combine my life passion and my hopes for a moral society with allocating my time in ways that are both fulfilling momentarily and hopefully contribute to a future career in the field.
Information Ethics
Authors: Kaebnick Gregory E. 
Published: October 2014

AbstractThe use of information raises a perplexing new set of questions in bioethics. One familiar subset of these has to do with the goal of improving medical practice by collecting information about it, in effect integrating practice and research. This topic was discussed in the January‐February 2013 issue of the Report and in this issue is taken up again in Policy and Politics, where Michelle Meyer connects the issue to the evidence‐based medicine movement.A somewhat less familiar set has to do with potentially dangerous information. In the lead article in this issue, David Resnik discusses the publication last year of two articles that described how researchers had developed new and more dangerous forms of H5N1, also known as bird flu, which has produced an extraordinary death rate when it has infected people but has not so far evolved into a form that can be easily transmitted from one person to another.Yet another set has to do with sharing clinical medical information using newly developed tools such as electronic health records. In an essay in this issue, Kyle Galbraith argues that these technologies also need to be usable for patients, but that “those who have the most to gain from increased access to their health information are often unlikely to be able to decipher that information and respond in a meaningful way.”
“Ever Vigilant” in “Ethically Impossible”
Authors: Galarneau Charlene 
Published: October 2014

AbstractThe report from the Presidential Commission for the Study of Bioethical Issues is clear that the public health services research conducted in Guatemala mid‐century was wrong, but its focus on individual responsibilities is inadequate for the structural and institutional factors at the root of that research.Ethically Impossible”: STD Research in Guatemala from 1946 to 1948, released in September 2011 by the Presidential Commission for the Study of Bioethical Issues, 1 responds to President Obama's request for a “thorough fact‐finding investigation” into research carried out by the U.S. Public Health Service in Guatemala from 1946 to 1948. “Ethically Impossible” offers a detailed narrative of what happened in Guatemala and a self‐described “unvarnished ethical analysis.” I argue, however, that being “ever vigilant” to prevent exploitation, as well as learning as a society from this past and honoring the memory of Guatemalan victims, requires a more complex ethical analysis than the commission offers in this report. Specifically, we need to identify the structural injustices that innervated the social relations and the institutions fundamental to the moral landscape of this 1940s research, and we need to expand our understandings of moral responsibility accordingly. The report posits three “longstanding and widely accepted moral principles” as the framework for evaluating this research: (1) to treat persons fairly and with respect, (2) not to harm (or risk harming) persons unless the risk is reasonable and the benefit proportional, and (3) not to treat persons as means to others’ ends. As critically important as the three principles are to research ethics writ large, they alone are unfitting tools for addressing the kind of structural and institutional moral factors that are so important in these PHS studies.
Exchanges on Obesity and Smoking
Authors: Kaebnick Gregory E. 
Published: October 2014

AbstractThe January‐February issue of the Report introduced a number of new features designed to provide opportunities for further give‐and‐take in our pages. In this issue, we put to use our revamped letters to the editor, Exchange, with a set of commentaries on another of the January‐February articles, Daniel Callahan's “Obesity: Chasing an Elusive Epidemic.” Commentaries in Other Voices and special reports are planned and solicited, in consultation with scholars in the field and with the guest editors of the special reports, but our hope is that Exchange will provide an opportunity for unsolicited voices in the Report. Of course, Callahan's controversial article is all too good for drumming up unsolicited commentary: Callahan argued that the rise in obesity requires an aggressive public health campaign that employs some stigmatization of obesity.
Patient and Trainee: Learning When to Step In
Authors: Cummings Christy L. 
Published: October 2014

AbstractWith advancing rank in medical training comes increased academic and clinical responsibility, including education and supervision of trainees and junior staff. When I became a senior postdoctoral fellow sub‐specializing in neonatology, I assumed the role of co‐attending in the neonatal intensive care unit. At that point in my training, I felt well prepared for the challenging task. I would be in charge, make decisions independently with the team, and supervise, as well as teach, the junior fellows, residents, and practitioners. In short, I would assume full responsibility for the care of the patients, their families, and the medical team. My mentor, an experienced attending, would discuss every patient with me each day, but would otherwise stand in the shadows, available for help and guidance when needed.On the very first day, one of the smaller premature babies on our service started having difficulty breathing, and it was soon clear that she would need to have her endotracheal tube reinserted.
Voluntary Sterilization for Childfree Women
Authors: Richie Cristina 
Published: October 2014

AbstractApproximately 47 percent of women ages fifteen to forty‐four are currently without children, and slightly more than 20 percent of white women in America will never bear children, the highest percentage in modern history. Many fertile women who are childless are voluntarily so. Although any competent person twenty‐one years or older is legally eligible for voluntary sterilization, many doctors refuse to sterilize childfree women. This essay explores various reasons a woman would want to continue in her childfree lifestyle, evaluates the accessibility of sterilization for women who are childfree by examining the reported reasons for denial of sterilization—both from the woman's and the physician's perspective—and assesses the legal status of voluntary sterilization for nonparous women. The essay also urges physicians to follow recommended guidelines for counseling women who, regardless of parity, desire sterilization and to provide this contraception if, after careful consideration, there are no outstanding health or other reasons that the procedure should not be performed.
New Life to the Debate about Death
Authors: Kaebnick Gregory E. 
Published: October 2014

AbstractThis issue of the Report is far ranging, with essays on the nature of the U.S. government's responsibility toward Indian tribes, a medical school's commitment toward applicants who are immigrants, the difficulty of developing a transparent national registry of clinical trials, and the ethical problems embedded in the topic of global health. Two items in the issue revolve around physicians’ role in upholding the value placed on reproduction. Another small set of pieces within this issue of the Report examines the intractability of the debate over how to define death.
Autonomy or Exploitation?
Authors: Esau Darren , Hickey Catherine 
Published: October 2014

AbstractAn eighty‐six–year‐old woman has had lifelong obsessive‐compulsive disorder. At times, it has been so severe that she has lost touch with reality and been psychotic. She is actively followed by a community mental health nurse. Since she is physically frail, the nurse visits her at home and liaises with the attending psychiatrist, who adjusts medications as needed. Currently, the patient is stable, and there is no evidence of psychosis.The patient's home deteriorates, and several repairs are needed. The nurse questions the patient about this, and the patient agrees to have her nephew arrange for the repairs and pay for them out of her bank account. The nurse asks how the nephew has access to the account. The patient mentions that he has power of attorney, but when asked to supply the document giving him this authority, she becomes confused and supplies a number of bank statements instead. The nurse is surprised to see several withdrawals for over ten thousand dollars each. When she questions the patient about these, the patient simply suggests that her nephew must have “needed the money” for something. The nurse questions her repeatedly about this matter, but she refuses to give further details. The patient becomes quite upset whenever the nurse brings it up and states, “This is my money, and he wouldn't take it unless he needed it to help me.”Should the nurse challenge the patient's right to make her own financial decisions in order to avoid a risk of exploitation by her family members? Does the patient have the right to refuse a capacity assessment, which could determine her decision‐making abilities in this area?
Banking on Infertility: Medical Ethics and the Marketing of Fertility Loans
Authors: von Hagel Alisa 
Published: October 2014

AbstractIn 2012, a number of news headlines captured a growing trend in fertility medicine—the increased presence of lenders specializing in fertility loans, often promoted or featured by fertility clinics and physicians. Streamlining the financing of assisted reproduction connects patients with loan company representatives either on‐site or through a clinic's webpage. While medical professionals and clinics do not receive a commission for product promotion, this recent spate of news reports identified investment opportunities for physicians in private lending firms and some of the physicians involved in such investments. In facilitating the process to obtain credit and, in some instances, benefiting financially through equity ownership in private lending firms, participating physicians declare this a “win‐win situation” with no clear conflict of interest. The emergence of these specialty lenders seems a natural development in the current fertility market, but the growing use of private fertility loans suggests the need for further inquiry.
On Noncongruence between the Concept and Determination of Death
Authors: Bernat James L. 
Published: October 2014

AbstractA combination of emerging life support technologies and entrenched organ donation practices are complicating the physician's task of determining death. On the one hand, technologies that support or replace ventilation and circulation may render the diagnosis of death ambiguous. On the other, transplantation of vital organs requires timely and accurate declaration of death of the donor to keep the organs as healthy as possible. These two factors have led to disagreements among physicians and scholars on the precise moment of death. In this article, I suggest that the debate about exactly when a person dies can benefit from distinguishing the strict biological concept of death from the medical standards for determining human death, and I show how an appreciation of the difference between the permanent and irreversible cessation of circulation is helpful in understanding the reasons for the two approaches to determining when death should be declared.
Execution by Lethal Injection: Illegal Research?
Authors: Philpott Sean 
Published: October 2014

AbstractSeveral states systematically collect data to assess whether the anesthesia administered was sufficient—the same data used by researchers to show that the concentration of sodium thiopental in the blood of executed prisoners was not enough to ensure loss of consciousness and that these inadequate levels of anesthesia were not the result of pharmacokinetic changes after death. This activity could constitute human subjects research under existing law.
The Third‐Party Notification Dilemma
Authors: Adams Ann K. 
Published: October 2014

AbstractIn their report in this supplement on research regulatory systems, Barbara Bierer and Mark Barnes note that, when research misconduct has been detected but not yet proven, the individual with institutional responsibility for oversight of research misconduct investigations “may determine that notification of relevant journals or professional societies and correction or full retraction of implicated papers or presentations is appropriate. In those cases, even when a finding of research misconduct per se has not been made or has not been explicitly stated, the journal, professional society, and their readers or members may draw their own conclusions as to what led to the retraction or correction.” This statement highlights an aspect of the reviewed regulatory schemes that creates vulnerability for institutions of higher education subject to the regulations: while, as the authors suggest, it may be “appropriate” to notify third parties (that is, journals, professional societies, and other academic institutions) of suspected research misconduct, there is no regulatory obligation to provide such a notification, and, in fact, providing early (or any) notification is contrary to the confidentiality provisions of the research misconduct regulations. Moreover, the institution—and individuals acting on behalf of the institution—may face legal exposure for notifying outside entities.
The Woman Question in Medicine: An Update
Authors: Lindemann Hilde 
Published: October 2014

AbstractThe Women's Movement has greatly benefitted women in the workplace. What about in their encounters with medicine? This paper reviews the history of physicians’ attitudes toward women and then considers three contemporary areas of medicine in particular: health research relevant to women, health policies, and women's success at working their way into the medical profession. The picture that emerges is somewhat less than rosy. The androcentrism that has been so glaring in the history of medicine has not entirely gone away. Women and their concerns are still considered less important than men's, and women are valued more for what they provide than for who they are themselves.These problems are mostly not the fault of specific physicians or other individuals; they are, rather, systemic problems—the result of social practices and institutions that work together quite impersonally to favor the interests of men over women. Correcting them requires listening to women's voices better than medicine, or bioethics, has so far managed to do.
The Time Is Now: Bioethics and LGBT Issues
Authors: Powell Tia , Foglia Mary Beth 
Published: October 2014

AbstractOur goal in producing this special issue is to encourage our colleagues to incorporate topics related to LGBT populations into bioethics curricula and scholarship. Bioethics has only rarely examined the ways in which law and medicine have defined, regulated, and often oppressed sexual minorities. This is an error on the part of bioethics. Medicine and law have served in the past as society's enforcement arm toward sexual minorities, in ways that robbed many people of their dignity. We feel that bioethics has an obligation to discuss that history and to help us as a society take responsibility for it.We can address only a small number of topics in this special issue of the Hastings Center Report, and we selected topics we believe will stimulate discourse. Andrew Solomon offers an elegant overview of the challenges that bioethics faces in articulating a solid basis for LGBT rights. Timothy F. Murphy asks whether bioethics still faces issues related to lesbian, gay, and bisexual people, given the deletion of homosexuality as a disease and the progress toward same‐sex marriage. Jamie Lindemann Nelson's essay addresses the search for identity for transgender persons and the role of science in that search. Two articles, those by Brendan S. Abel and by Jack Drescher and Jack Pula, take up the complex issue of medical treatment for children who reject their assigned birth gender. Celia B. Fisher and Brian Mustanski address the special challenges of engaging LGBT youth in research, balancing the need for better information about this vulnerable group against the existing restrictions on research involving children. Tia Powell and Edward Stein consider the merits of legal bans on psychotherapies intended to change sexual orientation, particularly in the light of current research on orientation. Mary Beth Foglia and Karen I. Fredricksen‐Goldsen highlight health disparities and resilience among LGBT older adults and then discuss the role of nonconscious bias in perpetuating disparities. Stephan Davis and Nancy Berlinger assess the challenges of access to care and health policy for transgender persons. Edward J. Callahan et al. tackle the ways in which diverse aspects of medicine should change to better incorporate the needs of LGBT patients, including through use of the electronic medical record, education of health professionals, and recruitment efforts for LGBT health professionals. Virginia Ashby Sharpe and Uchenna S. Uchendu describe multifaceted efforts within Veterans Administration facilities to create change for LGBT veterans across the largest integrated health care network in the United States. Lance Wahlert and Autumn Fiester find a mixed record in the use of case studies in teaching about LGBT issues