bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Irregular Terrain of Human Subjects Research Regulations
Authors: Forster David , Nelson Daniel K. , Borasky David , Botkin Jeffrey R. 
Published: October 2014

AbstractThe overlap and differences between the parallel regulatory systems for research create ample room for confusion and missteps, as discussed by Barbara Bierer and Mark Barnes in their report in this supplement. In practice, beyond the inherent differences in the two systems of regulations themselves, there are many issues that further complicate the application of these regulations. These include the variation in size of the institutions receiving PHS funding, the increased prevalence of multisite research, the allocation of research conduct and oversight to external organizations, and the variability in assignment of human subject protection roles between the IRB and the institution.
Parallel Processes at the NIH
Authors: Rockey Sally J. , Patterson Amy P. 
Published: October 2014

AbstractThe report by Barbara Bierer and Mark Barnes highlights the complexities experienced by institutions that conduct Public Health Service‐funded research involving human subjects and that need to negotiate the requirements of two sets of federal regulations: 45 C.F.R. 46, covering protections for human research subjects, and 42 C.F.R. 93, the PHS policies on research misconduct. As the nation's single largest sponsor of biomedical and behavioral research, the National Institutes of Health seeks to exemplify and promote human research protections and the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. The NIH is committed to protecting the rights and welfare of research participants and to upholding integrity standards for research supported with public funds. However, human subjects protections must always take priority.
Emerging Ethical Issues in Reproductive Medicine: Are Bioethics Educators Ready?
Authors: Farrell Ruth M. , Metcalfe Jonathan S. , McGowan Michelle L. , Weise Kathryn L. , Agatisa Patricia K. , Berg Jessica 
Published: October 2014

AbstractAdvocates for the professionalization of clinical bioethics argue that bioethics professionals play an important role in contemporary medicine and patient care, especially when addressing complex ethical questions that arise in the delivery of reproductive medicine. For bioethics consultants to serve effectively, they need adequate training in the medical and ethical issues that patients and clinicians will face, and they need skills to facilitate effective dialog among all parties. Because clinical ethics consultation is a “high‐stakes endeavor” that can acutely affect patient care, efforts are under way to ensure that bioethics consultants have the competence to provide such guidance. Yet to date, no studies have examined whether the training of bioethics consultants meets the needs of health care professionals who are on the front lines of such issues. In fact, limited information is available on the reproductive health issues that bioethics training programs address or the degree to which these programs meet the needs of patients confronting reproductive health decisions and their clinicians. It is therefore important to answer this key question: What are the primary ethical issues encountered in reproductive medicine that currently affect patient care? Equally important, are bioethics training programs prepared to address those issues?To begin to answer these questions, we conducted parallel surveys of directors of graduate bioethics training programs and obstetrician‐gynecologists. The goal of this project is to lay the groundwork to establish a working partnership between bioethics educators and reproductive medicine practitioners to address the often troubling and frequently complex ethical issues in reproductive medicine.
Surgeons, Intensivists, and Discretion to Refuse Requested Treatments
Authors: Wicclair Mark R. , White Douglas B. 
Published: October 2014

AbstractPhysicians are expected to engage patients as partners in identifying the possible benefits and harms associated with treatment options and selecting from among medically appropriate treatment options, rather than simply dictating what treatments patients will and will not receive. This collaborative model reflects the recognition that citizens in multicultural societies have diverse values and are likely to have different views about whether the possible benefits of a medical intervention outweigh the possible harms. However, there are circumstances in which the collaborative process breaks down due to irresolvable disagreement. Especially challenging are cases in which patients are expected to die if they do not receive a treatment and either the patients or their surrogates insist on the treatment despite the physician's belief that providing it is ill advised. The source of disagreement is often differing appraisals of the risks and potential benefits. In such cases, physicians generally judge that there is insufficient likelihood or magnitude of benefit to justify the burdens or expense of treatment, while patients or surrogates believe that the small chance of preventing the patient's death is sufficient to justify the costs and potential burdens to the patient.There is a perception that surgeons enjoy considerable discretion in deciding when the risks of a procedure outweigh the expected benefits. An important contrast can be drawn between surgeons and intensivists—physicians who specialize in the medical management of critically ill patients. We will argue that there are good reasons for subjecting the decisions of both surgeons and intensivists to some oversight. We begin by showing that, for many cases, major professional society guidelines for intensivists recommend oversight via a procedural mechanism rather than unilateral decision‐making by individual clinicians. Next, we present reasons for adopting a procedural approach to dispute resolution, and we argue that these reasons apply to situations in which intensivists believe that patients or surrogates are requesting inappropriate life support as well as to many disagreements between surgeons and surrogates. Finally, we present and respond to several objections.
“Pregnancy Is Not a Disease”
Authors: Brudney Daniel 
Published: October 2014

AbstractIn many American states, a health care worker has a legal right to immunity from employer sanction if she refuses to perform actions at odds with her conscience: she has a legal right to accommodation of her conscientious beliefs. A number of arguments have been advanced to defend or reject this right. These have tended to focus on the possibly conflicting interests of the health care worker and the patient. Recently, however, a new argument has been proposed to justify immunity from employer sanction. This argument rests on the premise that the scope of the very concepts of medicine and disease circumscribes the scope of proper medical practice. Procedures and activities that fall outside the scope of medicine and disease are not properly within the brief of health care personnel.This argument is important because, in principle, it stands outside the balancing of interests. Its central claim is nonsectarian—namely, that a person ought to do her job but need not do what is not her job. This claim avoids taking any stand in the culture wars. It is merely a claim about the logic of the concept “professional.” The medical professional who refuses to perform a procedure is not asking for special treatment. On the contrary, she is asking to be treated normally—in accordance with the normal contours of her job.Of course, other arguments also seek to justify health care providers’ immunity from employer sanction. Ultimately, these different arguments need to be prized apart and scrutinized one by one. This essay focuses on the argument from the concepts of medicine and disease, as a down payment on that larger project.
Neuroscience and Morality
Authors: Gert Bernard 
Published: October 2014

AbstractIn 2009 I participated in a symposium, “Toward a Common Morality,” held at the United Nations Building in New York, that reflected the growing interest among scientists and philosophers in showing that science—particularly neuroscience—provides a foundation, not only for understanding morality, but also for improving it. In this essay I shall examine three books that are part of this trend: Experiments in Ethics, by Kwame Anthony Appiah; The Moral Landscape: How Science Can Determine Human Values, by Sam Harris; and Braintrust: What Neuroscience Tells Us about Morality, by Patricia S. Churchland. These three books put forward quite different perspectives about the relationship between science and morality, which suggests that neuroscience has nothing to add to our understanding of morality as a code of conduct that everyone should follow. However, neuroscience may help explain why some people behave as they do in situations that call for moral decisions or judgments.
Affordable Access to Care for the Undocumented
Authors: Rosen Dennis 
Published: October 2014

AbstractHow do you tell a sick kid that nobody cares if he gets better? That's an exaggeration, of course, but it is the fundamental message our society sends when we tell him that, because he and his family are undocumented immigrants, we are unwilling to extend them access to affordable and reliable health insurance.One major shortcoming of the Affordable Care Act is its specific exclusion of the almost twelve million undocumented immigrants—including millions of children—in this country from access to the state and federal insurance exchanges where coverage can be purchased. It is true that providing undocumented immigrants access to the exchanges and subsidies mandated by the ACA would require additional funding. However, a recent analysis in California has found that the costs of expanding state‐supported care to include undocumented immigrants would largely be offset by the increased state sales tax revenue paid by managed care organizations and by reduced spending at the county level on emergency‐room and hospital care of the uninsured.
Ethical Issues Raised by the Treatment of Gender‐Variant Prepubescent Children
Authors: Drescher Jack , Pula Jack 
Published: October 2014

AbstractTransgender issues and transgender rights have become increasingly a matter of media attention and public policy debates. Reflecting changes in psychiatric perspectives, the diagnosis of “trans‐sexualism” first appeared in the International Statistical Classification of Diseases and Related Health Problems in 1975 and shortly thereafter, in 1980, in the Diagnostic and Statistical Manual of Mental Disorders. Since that time, international standards of care have been developed, and today those standards are followed by clinicians across diverse cultures. In many instances, treatment of older adolescents and adults is covered by national health care systems and, in some cases, by private health insurance. Most recently, the Medicare ban on coverage for gender reassignment surgery was lifted in 2014.In contrast to the relative lack of controversy about treating adolescents and adults, there is no expert clinical consensus regarding the treatment of prepubescent children who meet diagnostic criteria for what was referred to in both DSM‐IV‐TR and ICD‐10 as gender identity disorder in children and now in DSM‐5 as gender dysphoria. One reason for the differing attitudes has to do with the pervasive nature of gender dysphoria in older adolescents and adults: it rarely desists, and so the treatment of choice is gender or sex reassignment. On the subject of treating children, however, as the World Professional Association for Transgender Health notes in their latest Standards of Care, gender dysphoria in childhood does not inevitably continue into adulthood, and only 6 to 23 percent of boys and 12 to 27 percent of girls treated in gender clinics showed persistence of their gender dysphoria into adulthood. Further, most of the boys’ gender dysphoria desisted, and in adulthood, they identified as gay rather than as transgender.In an effort to clarify best treatment practices for transgender individuals, a recent American Psychiatric Association Task Force on the Treatment of Gender Identity outlined three differing approaches to treating prepubescent gender dysphoric children.
Reducing Health Disparities and Enhancing the Responsible Conduct of Research Involving LGBT Youth
Authors: Fisher Celia B. , Mustanski Brian 
Published: October 2014

AbstractAlthough there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence to support treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research.
Legal and Ethical Concerns about Sexual Orientation Change Efforts
Authors: Powell Tia , Stein Edward 
Published: October 2014

AbstractThe United States has recently made significant and positive civil rights gains for LGB people, including expanded recognition of marriages between people of the same sex. Among the central tropes that have emerged in the struggle for the rights of LGB people are that they are “born that way,” that sexual orientations cannot change, and that one's sexual orientation is not affected by choice. Writer Andrew Sullivan put it this way: “[H]omosexuality is an essentially involuntary condition that can neither be denied nor permanently repressed.… [S]o long as homosexual adults as citizens insist on the involuntary nature of their condition, it becomes politically impossible to deny or ignore the fact of homosexuality.… [The strategy for obtaining LGB rights is to] seek full public equality for those who, through no fault of their own, happen to be homosexual.”This idea of linking LGB rights to empirical claims about sexual orientations has become so central that casting doubt on these claims is, in many circles, tantamount to opposing LGB rights. Nonetheless, claims about innateness, immutability, and lack of choice about sexual orientation should not be the primary basis for LGB rights.
Moral Progress in the Public Safety Net: Access for Transgender and LGB Patients
Authors: Davis Stephan , Berlinger Nancy 
Published: October 2014

AbstractAs a population, people who self‐identify as lesbian, gay, bisexual, or transgender face significant risks to health and difficulty in obtaining medical and behavioral health care, relative to the general public. These issues are especially challenging in safety‐net health care institutions, which serve a range of vulnerable populations with limited access, limited options, and significant health disparities. Safety‐net hospitals, particularly public hospitals with fewer resources than academic medical centers and other nonprofit hospitals that also serve as safety nets, are under immense financial pressures. However, with the introduction in 2011 of standards for LGBT inclusion by The Joint Commission, showing progress on LGBT health care has become a compliance issue for hospitals. And because the health care community itself has contributed to LGBT health disparities through prejudice, disrespect, or inadequate knowledge that have made it difficult for LGB and especially T people to seek care or to obtain the care they need, there is a moral case for allocating scarce resources to this population: we owe them some investment in righting wrongs that the health care system itself has produced.So, where to begin in the typical safety‐net hospital or clinic? Beyond staff training, which is essential and for which good models now exist, what does justice demand from a service‐utilization perspective? Given the range of health care services that an LGBT person in the safety net may need or want, how should we set priorities? And what can't we promise to do for this member of our community?
Ensuring Appropriate Care for LGBT Veterans in the Veterans Health Administration
Authors: Sharpe Virginia Ashby , Uchendu Uchenna S. 
Published: October 2014

AbstractWithin health care systems, negative perceptions of lesbian, gay, bisexual, and transgender persons have often translated into denial of services, denial of visitation rights to same‐sex partners, reluctance on the part of LGBT patients to share personal information, and failure of workers to assess and recognize the unique health care needs of these patients. Other bureaucratic forms of exclusion have included documents, forms, and policies that fail to acknowledge a patient's valued relationships because of, for example, a narrow definition of “spouse,” “parent,” or “family.” Bureaucratic exclusion has taken a particularly prominent form in the U.S. military. Until its repeal and termination in 2011, the “Don't Ask, Don't Tell” policy had for eighteen years barred openly gay men and lesbians from serving in the military. Among the effects of DADT is a dearth of information about the number and needs of LGBT service members who transition to the Veterans Health Administration for health care at the end of their military service. The long‐standing social stigma against LGBT persons, the silence mandated by DADT, and the often unrecognized bias built into the fabric of bureaucratic systems make the task of creating a welcoming culture in the VHA urgent and challenging.The VHA has accepted a commitment to that task. Its Strategic Plan for fiscal years 2013 through 2018 stipulates that “[v]eterans will receive timely, high quality, personalized, safe, effective and equitable health care irrespective of geography, gender, race, age, culture or sexual orientation.” To achieve this goal, the VHA undertook a number of coordinated initiatives to create an environment and culture that is informed, welcoming, positive, and empowering for the LGBT veterans and families whom the agency serves.
Comfort Care as Denial of Personhood
Authors: Peace William J. 
Published: October 2014

AbstractIt is 2 a.m. I am very sick. I am not sure how long I have been hospitalized. The last two or three days have been a blur, a parade of procedures and people. I had a bloody debridement for a severe, large, and grossly infected stage four wound‐the first wound I have had since I was paralyzed in 1978. I know the next six months or longer are going to be exceedingly difficult. I will be bedbound for months, dependent upon others for the first time in my adult life. As these thoughts are coursing through my mind, a physician I have never met and the registered nurse on duty appear at my door. As they put on their gowns I am weary but hopeful. Surely there is something that can be done to stop the vomiting. The physician examines me with the nurse's help. Like many other hospitalists that have examined me, he is coldly efficient. At some point, he asks the nurse to get a new medication.What transpired after the nurse exited the room has haunted me. Paralyzed me with fear. The hospitalist asked me if I understood the gravity of my condition. He grimly told me I would be bedbound for at least six months and most likely a year or more. That there was a good chance the wound would never heal. If this happened, I would never sit in my wheelchair. I would never be able to work again. Not close to done, he told me I was looking at a life of complete and utter dependence. He went on to tell me I was on powerful antibiotics that could cause significant organ damage. He informed me I had the right to forego any medication, including the lifesaving antibiotics. If I chose not to continue with the current therapy, I could be made very comfortable. I would feel no pain or discomfort at all. Although not explicitly stated, the message was loud and clear. I can help you die peacefully.
The Influenza Controversy: Should Limits Be Placed on Science?
Authors: Gostin Lawrence O. 
Published: October 2014

AbstractShould government have the power to place limits on a scientific pursuit that holds the potential for both good and harm—on what is called “dual‐use research”? That is the highly charged question surrounding research to genetically modify influenza A (H5N1) to render it more easily transmissible from human to human. There is seldom a “right” answer to dual‐use research, but a fair, inclusive, and transparent process—building on the NSABB model—should improve decision‐making. A local institutional panel should evaluate dual‐use research based on the following structured ethical framework.
Whither the Affordable Care Act?
Authors: Latham Stephen R. 
Published: October 2014

AbstractThe U.S. Supreme Court has likely already decided how much, if any, of President Obama's signature Affordable Care Act it is going to strike down as unconstitutional; its holding will be published this summer. No matter what the Court decides, though, it will send state and federal legislators scrambling—either to implement the law or to deal with the consequences of its alteration. There are various decisions the Court might make, but it is still most apt either to leave the ACA standing, or to selectively invalidate some of its mandate‐related provisions. In either case, there will be exchanges to design and manage, subsidies to allocate, transparency standards to design and enforce. The Court's decision will thus mark the beginning, not the end, of health reform.