Bioethics and Medical Ethics Commons^™

Improving Nurse Education On Research Informed Consent, Tina Rasooli

Master's Projects and Capstones

As the number of human participants in clinical trials continues to grow, it is increasingly imperative that research nurses are educated about valid research informed consent to improve patient outcomes. As patient advocates, nurses must be aware of the components and principles of valid informed consent in order to protect the rights, safety, and wellbeing of their patients as human subjects. The research nurse must also be aware of their available resources and who to contact if they suspect a problem or a lack of patient comprehension of the study. In order to address these needs, an evidence-based performance improvement …

The Ethics Of Animal Research: A Survey Of Pediatric Health Care Workers, Ari Joffe, Meredith Bara, Natalie Anton, Nathan Nobis

Experimentation Collection

Introduction: Pediatric health care workers (HCW) often perform, promote, and advocate use of public funds for animal research (AR). We aim to determine whether HCW consider common arguments (and counterarguments) in support (or not) of AR convincing.

Design: After development and validation, an e-mail survey was sent to all pediatricians and pediatric intensive care unit nurses and respiratory therapists (RTs) affiliated with a Canadian University. We presented questions about demographics, support for AR, and common arguments (with their counterarguments) to justify the moral permissibility (or not) of AR. Responses are reported using standard tabulations. Responses of pediatricians and nurses/RTs were …

Anorexia/Bulimia, Transcendence, And The Potential Impact Of Romanticized/Sexualized Death Imagery, Heather D. Schild

Center for the Study of Ethics in Society Papers

Presented November 10, 2014. Papers presented for the Center for the Study of Ethics in Society Western Michigan University

Mid-Atlantic Ethics Committee Newsletter, Fall 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Documenting Mass Rape: Medical Evidence Collection Techniques As Humanitarian Technology, Jaimie Morse

Genocide Studies and Prevention: An International Journal

Aim: Emerging global networks of human rights activists, doctors, and nurses have advocated for increased collection of medical evidence in conflict-affected countries to corroborate allegations of sexual violence and facilitate prosecution in international and domestic courts. Such initiatives are part of broader shifts in human rights advocacy to document human rights violations using rigorous, standardized methodologies. In this paper, I consider three principal forms of medical evidence to document sexual violence and their use in these settings: the patient medical record, the medical certificate, and the sexual assault medical forensic exam (commonly known as the “rape kit”).

Methods: Combining archival …

Considering A New Paradigm For Alzheimer’S Disease Research, Gillian R. Langley

Experimentation Collection

Using Alzheimer’s disease as a case study, this review argues that it might be time to consider a new paradigm in medical research and drug discovery. The existing framework is overly dependent on often unvalidated animal models, particularly transgenic mice. Translational success remains elusive and costly late-stage drug failure is common. The conventional paradigm tends to overlook species differences and assumes that animal-based findings are generally applicable to humans. Could pathways-based research using advanced human-specific models probed with new tools, including those of systems biology, take centre stage? The current transition in chemical toxicology to a 21st-century paradigm could be …

An Efficient Standardized Method Of Maintaining Quality Assurance In Therapeutic Treatment Record Keeping, Kelsey Michael Bradshaw

UNLV Theses, Dissertations, Professional Papers, and Capstones

Quality assurance (QA) within the field of mental health is the practice of monitoring and reviewing services to ensure adherence to specified standards of care. Agents within State governments and various organizations influence record keeping procedures through ethical guidelines and law. For instance, client records must be maintained for all clients receiving mental health services, including informed consent, releases of information, treatment plans, and progress notes. Accurate and timely record keeping procedures assure quality mental health services. However, professionals sometimes err in the maintenance of client records, which can have a negative impact on services, clients, and practitioners. To assist …

Strategic Focus On 3r Principles Reveals Major Reductions In The Use Of Animals In Pharmaceutical Toxicity Testing, Elin Törnqvist, Anita Annas, Britta Granath, Elisabeth Jalkesten, Ian Cotgreave, Mattias Öberg

Application of Alternative Methods Collection

The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order to safeguard animal welfare. In the present study we have studied the systematic application of 3R principles to toxicological research in the pharmaceutical industry, with particular focus on achieving reductions in animal numbers used in regulatory and investigatory in vivo studies. The work also details major factors influencing these reductions including the conception of ideas, cross-departmental working and acceptance into the work process. Data from 36 reduction projects were collected retrospectively from work between 2006 and 2010. …

Review Of "Truly Human Enhancement: A Philosophical Defense Of Limits ", James Mcbain

Faculty Submissions

Review of "Truly Human Enhancement: A Philosophical Defense of Limits" by Nicholas Agar.

When Harvard Said No To Eugenics: The J. Ewing Mears Bequest, 1927, Paul A. Lombardo

Faculty Publications By Year

James Ewing Mears (1838-1919) was a founding member of the Philadelphia Academy of Surgery. His 1910 book, The Problem of Race Betterment, laid the groundwork for later authors to explore the uses of surgical sterilization as a eugenic measure. Mears left $60,000 in his will to Harvard University to support the teaching of eugenics. Although numerous eugenic activists were on the Harvard faculty, and who of its Presidents were also associated with the eugenics movement, Harvard refused the Mears gift. The bequest was eventually awarded to Jefferson Medical College in Philadelphia. This article explains why Harvard turned its back …

Statement Before The House Of Representatives Subcommittee On Health Of The Committee On Energy And Commerce, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

Statement of Fred David Ledley, M.D.
Director, Center for Integration of Science and Industry
Professor, Natural and Applied Sciences and Management
Bentley University, Waltham, MA

Before the House of Representatives
Subcommittee on Health of the
Committee on Energy and Commerce

Hearing: 21st Century Cures: Examining the Role of Incentives in Advancing Treatments and Cures for Patients

June 11, 2014

A Longitudinal View Of Primate Life In Two American Laboratories, Jonathan Balcombe

Experimentation Collection

If representative of other facilities, our findings uncover serious welfare concerns for the wellbeing of primates kept in American research facilities. These animals face regular or chronic sources of pain and distress including noxious experimental and non‐experimental events and illness and injury; and severe and prolonged social disruptions. Pain relief is meager by comparison to that normally provided to humans, despite legislative requirements to minimize pain and distress and assume similarity to humans in terms of ability to experience pain and distress. Living environments are usually confinement indoors to a metal cage, often alone, and often with a minimum of …

Maximizing Doctor-Patient Communication Of A Positive Hiv/Aids Test Result: A Best Practices Approach, Vikki Yashandra Spann

Dissertations

The purpose of this study was to examine healthcare practitioner (HCP) communication of a positive human immodeficiency syndrome/acquired immunodeficiency syndrome (HIV/AIDS) test result in an effort to find best practices. The population of this study included healthcare practitioners who had to disclose a positive HIV/AIDS status to a patient. Data from specific accounts recalled by the healthcare practitioners were analyzed using grounded theory approach. The first research question was concerned with the strategies used by healthcare practitioners. The results indicated that there are two primary strategies used in HIV/AIDS disclosure: strategic interactive facilitation and strategic interactive force. The second and …

Killing And Letting Die: The Irrelevant Distinction, Sarah Beth Shaw

Honors College Theses

The object of this essay is to explain why the distinctions made in euthanasia between killing vs. letting die and willingness to kill vs. unwillingness to kill are not relevant to real life euthanasia cases. The specific purpose of the research is to isolate the relevant factor for debate when discussing the morality of euthanasia. It begins with a brief examination of some vocabulary that is commonly used when discussing euthanasia. Following this is a quick overview of what the word euthanasia meant in the ancient Greco-Roman world compared to what it means in the modern vernacular. I use an …

Consent For Nondiagnostic Research Biopsies: A Pilot Study Of Participant Recall And Therapeutic Orientation, Roberto Abadie, Jonathan Kimmelman, Josiane Lafleur, Trudo Lemmens,

Department of Sociology: Faculty Publications

A growing number of clinical trials incorporate invasive procedures like nondiagnostic tumor biopsies for biomarker or pharmacodynamic analysis.1 Such invasive research procedures are ethically contentious. Tumor biopsies involve pain and complication risk,2 and at least one procedure-related death has been reported.3 However, nondiagnostic tumor biopsies obtained in the research context generally have no value for managing the participant’s medical condition. Some commentators therefore argue that research biopsies “take” from participants without “giving in return.”4 Because such procedures are conducted contrary to research participants’ medical interests, an ethical framework for enrolling patients in studies that include a research biopsy rides heavily …

An Inevitable Conflict: The Subordination Of Contract Principles To Informed Consent In The Business Of Banking Umbilical Cord Blood, Abigail Norris

William & Mary Business Law Review

This Note explores the business of banking umbilical cord blood for later, and potentially life-saving, use. It discusses the importance of the stem cells found in umbilical cord blood, and the complexities involved in applying business models to its collection, storage, and use. Furthermore, this Note discusses how contracts governing the storage and use of umbilical cord blood can conflict with concepts of human dignity and informed consent. It concludes that in the event umbilical cord blood banking contracts conflict with informed consent, the contract should be subordinated to a person’s understanding, acquired through procedures intended to achieve the patient, …

Mid-Atlantic Ethics Committee Newsletter, Spring 2014

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

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 …