Bioethics and Medical Ethics Commons^™

Rethinking The Ethics Of Research Involving Nonhuman Animals: Introduction, Tom L. Beauchamp, Hope Ferdowsian, John P. Gluck

Experimentation Collection

No abstract provided.

State-Of-The-Art Of 3d Cultures (Organs-On-A-Chip) In Safety Testing And Pathophysiology, Natalie Alépée, Anthony Bahinski, Mardas Daneshian, Bart De Wever, Alan Goldberg, Jan Hansmann, Thomas Hartung, John Haycock, Helena T. Hogberg, Lisa Hoelting, Jens M. Kelm, Suzanne Kadereit, Emily Mcvey, Robert Landsiedel, Marcel Leist, Marc Lübberstedt, Fozia Noor, Christian Pellevoisin, Dirk Petersohn, Uwe Pfannenbecker, Kerstin Reisinger, Tzutzuy Ramirez, Barbara Rothen-Rutishauser, Monika Schäfer-Korting, Katrin Zeilinger, Marie-Gabriele Zurich

in Vitro Research Models Collection

Integrated approaches using different in vitro methods in combination with bioinformatics can (i) increase the success rate and speed of drug development; (ii) improve the accuracy of toxicological risk assessment; and (iii) increase our understanding of disease. Three-dimensional (3D) cell culture models are important building blocks of this strategy which has emerged during the last years. The majority of these models are organotypic, i.e., they aim to reproduce major functions of an organ or organ system. This implies in many cases that more than one cell type forms the 3D structure, and often matrix elements play an important role. This …

Ethical Decision-Making Aid For Patients With Diminished Capacity, Nicholas J. Kockler, John Tuohey, Marian O. Hodges

Articles, Abstracts, and Reports

Many patients, especially the elderly and those with mental illness, have diminished or no capacity to participate in decision-making. Consider, for example, the patient who influenced by her paranoid schizophrenia refuses to allow her aortic stenosis to be managed by catheritization with valvuloplasty even though her prognosis is excellent if she does so and poor if she does not. Another example is the patient without any next of kin who has dementia, diabetes, and osteomyelitis with gangrene who needs an amputation of his foot and rehabilitation but who refuses. A last example is the medically fragile young adult with severe …

Inferences & Connections, Tamara Kneese

Media Studies

Data-oriented systems are inferring relationships between people based on genetic material, behavioral patterns (e.g., shared geography imputed by phone carriers), and performed associations (e.g., "friends" online or shared photographs). What responsibilities do entities who collect data that imputes connections have to those who are implicated by association? For example, as DNA and other biological materials are collected outside of medicine (e.g., at point of arrest, by informatics services like 23andme, for scientific inquiry), what rights do relatives (living, dead, and not-yet-born) have? In what contexts is it acceptable to act based on inferred associations and in which contexts is it …

Clinical Trials And Late-Stage Drug Development In Alzheimer’S Disease: An Appraisal From 1984 To 2014, L. S. Schneider, F. Mangialasche, S. Andreasen, H. Feldman, E. Giacobini, R. Jones, V. Mantua, P. Mecocci, L. Pani, B. Winblad, M. Kivipelto

Human Clinical Trials Collection

The modern era of drug development for Alzheimer's disease began with the proposal of the cholinergic hypothesis of memory impairment and the 1984 research criteria for Alzheimer's disease. Since then, despite the evaluation of numerous potential treatments in clinical trials, only four cholinesterase inhibitors and memantine have shown sufficient safety and efficacy to allow marketing approval at an international level. Although this is probably because the other drugs tested were ineffective, inadequate clinical development methods have also been blamed for the failures. Here, we review the development of treatments for Alzheimer's disease during the past 30 years, considering the drugs, …

Tripartite Conflicts Of Interest And High Stakes Patent Extensions In The Dsm-5, Lisa Cosgrove, Sheldon Krimsky, Emily E. Wheeler, Jenesse Kaitz, Scott B. Greenspan, Nicole L. Dipentima

Counseling, School Psychology & Sport Faculty Publication Series

Background: The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators (PIs) of clinical trials for new DSM-5 diagnoses, and drug companies.

Methods: Financial conflicts of interest (FCOI) of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found …

Harassment: A Challenge At Workplace, Muhammad Younas, Salma Rattani

School of Nursing & Midwifery

Health care professionals are deeply involved in caring for the human life and during this process, they come in a close contact with the care recipients. This, at times, positions the health care professionals in a vulnerable situation including workplace harassment which is an offensive verbal or physical act and comprises of an unwanted behavior or advancement or demand for sexual and other favors. This conduct creates an intimidating, unfriendly, and offensive work environment (Sigal, 2006). Consequently, it impacts on care providers' performance, quality care and their retention in the system. Hence, it is important that the health care personnel …

Legal And Ethical Responsibilities Following Brain Death: The Mcmath And Muñoz Cases, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

What are the legal and ethical implications of continuing to treat a brain dead patient? And may a hospital refuse to provide such treatment? These ethical and legal problems are raised in two recent cases. In the first Marlise Muñoz, a pregnant woman declared brain dead, was kept on life support against her family’s wishes due to the treating hospital’s interpretation of a Texas fetal protection law. In the other a hospital refused to treat Jahi McMath, a brain dead girl, despite her family's entreaties. The cases, at first, appear similar because in each case the hospital was refusing to …

Conscientious Objection To Harmful Animal Use Within Veterinary And Other Biomedical Education, Andrew Knight

Science Education and Alternative Methods Collection

Laboratory classes in which animals are seriously harmed or killed, or which use cadavers or body parts from ethically debatable sources, are controversial within veterinary and other biomedical curricula. Along with the development of more humane teaching methods, this has increasingly led to objections to participation in harmful animal use. Such cases raise a host of issues of importance to universities, including those pertaining to curricular design and course accreditation, and compliance with applicable animal welfare and antidiscrimination legislation. Accordingly, after detailed investigation, some universities have implemented formal policies to guide faculty responses to such cases, and to ensure that …

Finding Fault?: Exploring Legal Duties To Return Incidental Findings In Genomic Research, Elizabeth R. Pike, Karen H. Rothenberg, Benjamin E. Berkman

Faculty Scholarship

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must …

Setting The Stage: Enhancing Understanding Of Bioethical Challenges With Theatre, Karen H. Rothenberg

Faculty Scholarship

Theatre provides a dynamic platform to reflect upon the ethical, legal, and social implications of medical innovations and the powerful impact on personal and professional relationships. This article explores the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities, to aid in the understanding of the bioethical challenges we face today and to place them in an historical and societal context. Four plays are discussed that reflect the ethical and legal context of their eras and reveal significant ethical challenges for us to consider.

Mid-Atlantic Ethics Committee Newsletter, Winter 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Review Of Manon Parry, Broadcasting Birth Control: Mass Media And Family Planning, Rose Holz

Women's and Gender Studies Program: Faculty Publications

As Manon Parry explains in her interesting new book, ‘Many of the women who wrote [to the Birth Control Review] noted that they had read about [Margaret] Sanger’s work in the press, confirming the important role of the mass media in publicizing and building support for the movement’ (p. 13). Therein lies the crux of Parry’s project: the use of publicity was central to the family planning movement and a sustained analysis of its use over time is long overdue. To that end, she challenges several long-standing historiographic assumptions and unearths more than a few fascinating stories. For example, …

Is The Current State Of Medical Ethics Education Having An Impact On Medical Students?, Lauren Saltzburg

Journal of Health Ethics

Medical education prepares medical students as they transition from the classroom to clinical setting in caring for patients through education in the sciences, pharmacology, and medicine basics—but does it leave room for the courses that lack scientific basis, such as medical ethics? Current research has shown that medical students do not place much emphasis on medical ethics. This leads to skepticism and wariness for medical students to speak up about their concerns if faced with an ethical situation. The “hidden curriculum” that is seen in many medical schools has a large impact on medical students’ impressions of how to deal …

Personhood, Ethics, And Animal Cognition: Situating Animals In Hare’S Two-Level Utilitarianism, By Gary E. Varner / The Philosophy Of Animal Minds, Edited By Robert W. Lurz., Kristin Andrews

Sentience Collection

It seems to be a widely held belief that we should not try to trap, kill, and eat any creature that can relate the story of its close call. While this turns out to be a good rule from the perspective of R. M. Hare’s version of utilitarianism, other intuitive-level rules about the proper treatment of sentient beings require revision, or so Gary Varner argues in his recent book Personhood, Ethics, and Animal Cognition. After defending Hare’s two-level utilitarianism in the first section, Varner turns to the question of the kinds of beings who worthy of kinds of concern, and …

Consensus Report On The Future Of Animal-Free Systemic Toxicity Testing, Marcel Leist, Nina Hasiwa, Costanza Rovida, Mardas Daneshian, David Basketter, Ian Kimber, Harvey Clewell, Tilman Gocht, Alan Goldberg, Francois Busquet, Anna-Maria Rossi, Michael Schwarz, Martin Stephens, Rob Taalman, Thomas B. Knudsen, James Mckim, Georgina Harris, David Pamies, Thomas Hartung

Experimentation Collection

Since March 2013, animal use for cosmetics testing for the European market has been banned. This requires a renewed view on risk assessment in this field. However, in other fields as well, traditional animal experimentation does not always satisfy requirements in safety testing, as the need for human-relevant information is ever increasing. A general strategy for animal-free test approaches was outlined by the US National Research Council’s vision document for Toxicity Testing in the 21st Century in 2007. It is now possible to provide a more defined roadmap on how to implement this vision for the four principal areas of …

Measuring Humaneness: Can It Be Done, And What Does It Mean If It Can?, John Hadidian, Bernard Unti, John Griffin

Humane Treatment of Animals Collection

Differences over what constitutes humaneness in the control of wildlife have traditionally presented a roadblock to understanding, not to mention agreement, between animal welfare and wildlife damage management professionals. Complaints that a proposed action or given program is not humane can refer to everything from specific techniques to broader administrative justifications. A number of concepts have been used to describe welfare standards and measurements, and different assessment metrics have been developed in attempts to bring objectivity to what might prove, in the end, to be an intractably subjective domain. Some of the most widely used and serviceable of the concepts …

Lost In Translation: Animal Models And Clinical Trials In Cancer Treatment, Isabella W.Y. Mak, Nathan Evaniew, Michelle Ghert

Human Clinical Trials Collection

Due to practical and ethical concerns associated with human experimentation, animal models have been essential in cancer research. However, the average rate of successful translation from animal models to clinical cancer trials is less than 8%. Animal models are limited in their ability to mimic the extremely complex process of human carcinogenesis, physiology and progression. Therefore the safety and efficacy identified in animal studies is generally not translated to human trials. Animal models can serve as an important source of in vivo information, but alternative translational approaches have emerged that may eventually replace the link between in vitro studies and …

Confidentiality And Mental Health/Chaplaincy Collaboration, Denise Bulling, Mark Dekraai, Tarik Abdel-Monem, Jason A. Nieuwsma, William C. Cantrell, Keith Ethridge, Keith Meador

University of Nebraska Public Policy Center: Publications

Confidentiality can both facilitate and inhibit working relationships of chaplains and mental health professionals addressing the needs of service members and veterans in the United States. Researchers conducted this study to examine opportunities for improving integration of care within the Department of Defense (DoD) and Department of Veterans Affairs (VA). Interviews were conducted with 198 chaplains and 201 mental health professionals in 33 DoD and VA facilities. Using a blended qualitative research approach, researchers identified several themes from the interviews, including recognition that integration can improve services; chaplaincy confidentiality can facilitate help seeking behavior; and mental health and chaplain confidentiality …