Bioethics and Medical Ethics Commons^™

Food For Thought … Mechanistic Validation, Thomas Hartung, Sebastian Hoffman, Martin Stephens

Experimentation Collection

Validation of new approaches in regulatory toxicology is commonly defined as the independent assessment of the reproducibility and relevance (the scientific basis and predictive capacity) of a test for a particular purpose. In large ring trials, the emphasis to date has been mainly on reproducibility and predictive capacity (comparison to the traditional test) with less attention given to the scientific or mechanistic basis. Assessing predictive capacity is difficult for novel approaches (which are based on mechanism), such as pathways of toxicity or the complex networks within the organism (systems toxicology). This is highly relevant for implementing Toxicology for the 21st …

History Of The 3rs In Toxicity Testing: From Russell And Burch To 21st Century Toxicology, Martin L. Stephens, Nina S. Mak

Humane Science Movement Collection

Toxicity testing is a key part of the process of assessing the hazards, safety, or risk that chemicals and other substances pose to humans, animals, or the environment. Standardized methods for such testing, typically involving animals, began to emerge during the first half of the 20th century. In 1959, British scientists William Russell and Rex Burch proposed a framework for reducing, refining, or replacing animal use in toxicology and other forms of biomedical experimentation. This “3Rs” or “alternatives” approach emerged at a time of growing sensitivity to the use of animals in experimentation, and progress in its implementation has been …

Psychologists And Medications In The Era Of Interprofessional Care: Collaboration Is Less Problematic And Costly Than Prescribing, William N. Robiner, Tim R. Tumlin, Tanya Tompkins

Faculty Publications

Increasing emphasis on interprofessionalism and teamwork in healthcare renders psychologists’ collaborations critical and invites reexamination of psychologists’ roles related to medications. The Collaboration Level outlined by the APA’s Ad Hoc Task Force is more achievable and in synch with health reform than prescription privileges (RxP). RxP remains controversial due to training and safety concerns, lacking support from health professionals, psychologists, and consumers. Differences in educational preparation of psychologists relative to prescribing professionals are discussed. Enactment of only three of 170 RxP initiatives reveals RxP to be a costly, ineffectual agenda. Alternatives (e.g., integrated care, collaboration, telehealth) increase access without risks …

In Memoriam: Edmund D. Pellegrino, George P. Smith Ii

Scholarly Articles

No abstract provided.

Gently Into The Good Night: Toward A Compassionate Response To End-Stage Illness, George P. Smith Ii

Scholarly Articles

End-of-life decision making by health care providers must respect individual patient values. Indeed, these values must always be viewed as the baseline for developing and pursuing patient-centered palliative care for those with terminal illness. Co-ordinate with this fundamental bioethics principle is that of beneficence or, in other words, respect for conduct which benefits the dying patient by alleviating end-stage suffering — be it physical or existential. Compassion, charity, agape and/or just common sense, should be a part of setting normative standards and of legislative and judicial responses to the task of managing death. Aided by the principles of medical futility, …

Astrue V. Capato: Forcing A Shoe That Doesn't Fit, Courtney Hannon

Journal of Health Care Law and Policy

No abstract provided.

Applying Bioethics In The 21st Century: Principlism Or Situationism?, George P. Smith Ii

Scholarly Articles

After an examination of the four cardinal bioethical principles which define Principlism — autonomy, beneficence, non maleficence and justice — an explication of Joseph Fletcher’s theory of Situationism is undertaken.

The conclusion of this Article is that when an ethical dilemma arises and is “tested” as to its moral efficacy, rather than judge the acts in question in order to determine whether they are in conformance with one of the four bioethical principles, it is more humane and practical to determine the ethical propriety of questioned conduct by use of a situation ethic which in fact is more sensitive. This …

The Duty To Rescue In Genomic Research, Michael Ulrich

Student Articles and Papers

No abstract provided.

George P. Smith, Ii's Law And Bioethics - Intersections Along The Mortal Ciol, Michael Donald Kirby The Honourable

Indiana Journal of Global Legal Studies

No abstract provided.

Acute Lung Injury And Acute Respiratory Distress Syndrome Requiring Tracheal Intubation And Mechanical Ventilation In The Intensive Care Unit: Impact On Managing Uncertainty For Patient-Centered Communication, Robert F. Johnson Jr., Jillian Gustin

Peer Reviewed Articles

A 56 year-old male presented with symptoms of pneumonia and findings consistent with acute lung injury (ALI). Deterioration of respiratory function occurred over the first 24 hours of hospitalization leading to placement in an intensive care unit (ICU) followed by tracheal intubation and mechanical ventilation (ETMV). At that time criteria defining acute respiratory distress syndrome (ARDS) were present. The palliative medicine service was asked to address concerns expressed by the patient’s spouse reflecting uncertainty regarding outcome expectations.

When interacting with families of incapacitated critically ill patients, clinicians are advised to employ a patient-centered communication process to alleviate family distress and …

Introduction, Peter J. Strauss

NYLS Law Review

No abstract provided.

Death Panels And The Rhetoric Of Rationing, Elizabeth Weeks Leonard

Scholarly Works

This essay offers an explanation for the United States' continued resistance to universal health care as grounded in two taboos: taxation and rationing. Even we were willing to pay more in taxes to directly subsidize the cost of medical care for those in need, rather than our current system of indirect subsidization through private insurance risk-pooling and cost-shifting, we still would face the unavoidable reality of resource limitations. Attempts to limit resource consumption, however, have been strongly opposed, as evidenced by the "death panels" controversy. Governor Palin's grossly erroneous characterization of the Patient Protection and Affordable Care Act (ACA) rendered …

A Distinction Without A Moral Difference? An Essay On The Difference Between Palliative Sedation And Physician-Assisted Death, Patrick T. Smith

Wayne State University Dissertations

Professionals engaged in palliative care have a responsibility to treat their patients by aggressively managing pain and certain kinds of suffering within legal and professional ethical boundaries. Many medical professionals and ethicists, rightly or wrongly, have considered the practices of euthanasia and physician-assisted suicide, which can be categorized as instances of physician-assisted death (PAD), to be beyond the scope of ethically appropriate health care. Many of these same individuals who oppose PAD, and the professional organizations they sometimes represent, often embrace, at the same time, the practice of palliative/terminal sedation at the end of life. Palliative sedation is thought to …

Tuskegee Redux: Evolution Of Legal Mandates For Human Experimentation, Robert S. Levine, Jamila C. Williams, Barbara A. Kilbourne, Paul D. Juarez

Sociology Faculty Research

Human health experiments systematically expose people to conditions beyond the boundaries of medical evidence. Such experiments have included legal-medical collaboration, exemplified in the U.S. by the Public Health Service (PHS) Syphilis Study (Tuskegee). That medical experiment was legal, conforming to segregationist protocols and specific legislative authorization which excluded a selected group of African Americans from any medical protection from syphilis. Subsequent corrective action outlawed unethical medical experiments but did not address other forms of collaboration, including PHS submission to laws which may have placed African American women at increased risk from AIDS and breast cancer. Today, anti-lobbying law makes it …

The Moral Status Of Invasive Animal Research, Bernard E. Rollin

Experimentation Collection

No abstract provided.

The Ethics Of Abortion: Women's Rights, Human Life, And The Question Of Justice, Christopher Kaczor

Faculty Pub Night

No abstract provided.

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

Mid-Atlantic Ethics Committee Newsletter, Fall 2012

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Opinion: Bias Is Unavoidable, Lisa Cosgrove

Counseling, School Psychology & Sport Faculty Publication Series

It is part of the human condition to have implicit biases—and remain blissfully ignorant of them. Academic researchers, scientists, and clinicians are no exception; they are as marvelously flawed as everyone else. But it is not the cognitive bias that’s the problem. Rather, the denial that there is a problem is where the issues arise. Indeed, our capacity for self-deception was beautifully captured in the title of a recent book addressing researchers’ self-justificatory strategies, Mistakes Were Made (But Not by Me).

Ethical Challenges Of Preexposure Prophylaxis For Hiv, Jonathan S. Jay, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution …