Bioethics and Medical Ethics Commons^™

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …

Public Health Emergencies: What Counts?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccines and drugs to prevent and treat Ebola Virus Disease that have never been tested in humans, and in scarce supply raise profound ethical challenges. What if good evidence emerged demonstrating safety and efficacy of drugs? What would be an ethical method of allocating scarce beneficial resources? The apparent preference given to foreign aid workers over West Africans provoked a firestorm. In addition to discussing the ethical allocation of scarce drugs, this article also asks a more fundamental question: Why did it take nearly 40 years after the first Ebola outbreak in 1976 to launch clinical trials?

Mid-Atlantic Ethics Committee Newsletter, Fall 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Spring 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Tobacco Endgame Strategies: Challenges In Ethics And Law, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

There are complex legal and ethical tradeoffs involved in using intensified regulation to bring smoking prevalence to near-zero levels. The authors explore these tradeoffs through a lens of health justice, paying particular attention to the potential impact on vulnerable populations. The ethical tradeoffs explored include the charge that heavy regulation is paternalistic; the potentially regressive impact of heavily taxing a product consumed disproportionately by the poor; the simple loss of enjoyment to heavily addicted smokers; the health risks posed by, for example, regulating nicotine content in cigarettes—where doing so leads to increased consumption. Turning to legalistic concerns, the authors explore …

Carrots, Sticks And False Carrots: How High Should Weight Control Wellness Incentives Be? Findings From A Population-Level Experiment, Harald Schmidt

Frontiers in Public Health Services and Systems Research

Employers are increasingly using wellness incentives, including penalties for unhealthy behavior. Survey data suggests that people are willing to accept the principle of penalizing those perceived to take health risks, but the equally relevant question of the magnitude of acceptable penalties is unclear.

While the principle of penalizing overweight and obese people has some support, findings from a population-level experiment (n=1,000) suggest that the acceptable size of penalties is comparatively small, around $50: more than 10-fold below levels favored by advocates. Reward-based incentives are favored over penalty-based ones by a factor of 4. Of two different ways of framing penalty …

Mid-Atlantic Ethics Committee Newsletter, Winter 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Enhancing Communication Between Scientists, Government Officials, And The Lay Public: Advancing Science And Protecting The Public's Welfare Through Better Multi-Stakeholder Interfacing, Clark J. Lee, Patrick P. Rose, Earl Stoddard Iii

Homeland Security Publications

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 …

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 …

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 …

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 …

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 …

Mid-Atlantic Ethics Committee Newsletter, Spring 2012

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Cosmetic Neurology: Enhancement Of The Mind And Attention Deficit Hyperactive Disorder Medication Abuse Among College Students, Mary M. Huff

Senior Honors Theses

Cosmetic neurology is becoming increasingly popular, and it is not just sleep deprived, over worked college students who are interested. People are beginning to seek off-label prescriptions for medications that are typically used to treat disorders such as attention deficit hyperactive disorder (ADHD) or narcolepsy, while researchers are trying to create drugs used solely for mind enhancement purposes. Along with these drugs come many legal and ethical quandaries relating to the regulation of current use as well as the what ifs of future possibilities. A survey was conducted among college students regarding the diagnosis of ADHD, the abuse of ADHD …

It’S My Body: The Biomedical Ethics Of Cell And Organ Harvest, Christina Perri

Common Reading Essay Contest Winners

First Place

Manipulating Fate: Medical Innovations, Ethical Implications, Theatrical Illuminations, Karen H. Rothenberg, Lynn W. Bush

Faculty Scholarship

Transformative innovations in medicine and their ethical complexities create frequent confusion and misinterpretation that color the imagination. Placed in historical context, theatre provides a framework to reflect upon how the ethical, legal, and social implications of emerging technologies evolve over time and how attempts to control fate through medical science have shaped -- and been shaped by -- personal and professional relationships. The drama of these human interactions is powerful and has the potential to generate fear, create hope, transform identity, and inspire empathy -- a vivid source to observe the complex implications of translating research into clinical practice through …

Guantánamo Bodies: Law, Media, And Biopower, Cary H. Federman, Dave Holmes

Department of Justice Studies Faculty Scholarship and Creative Works

The idea of the Guantánamo detainee as a Muselmann, the lowest order of concentration camp inmates, contains within it important implications for the new understanding of sovereignty in the era of Guantánamo, in an age of exception. The purpose of this article is to explain the status of those who are detained at Guantánamo Bay. Stated broadly, in assessing that status, we will emphasize the connection between the altered meaning of sovereignty that has accompanied the placing of prisoners in an American penal colony in Cuba and the biopolitical status of the prisoners who reside there. More particularly, we …

Mid-Atlantic Ethics Committee Newsletter, Fall 2011-Winter 2012

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Placebos: Ethical Research Or Unethical Deceit, Tawnya Schirmeister, Sabrina Crilley

Festival of Communities: UG Symposium (Posters)

There is an ongoing debate between whether or not it is ethical for researchers to use placebos while studying terminal illnesses. Within this debate there are two parties, the party that believes that it is ethical and the party that believes that it is not. Both parties have many valid points and have very detailed arguments against one another. When determining whether or not the use of placebos is ethical or not, you must first understand what a placebo is, and what the different types are. This paper goes over what a placebo is, what the different types are, and …

Using Placebos In Research Involving Terminal Illnesses, Mark Day, Ryan Hicks

Festival of Communities: UG Symposium (Posters)

Placebos are medical interventions that falsely lead patients to believe that they are receiving treatment and that their condition is being changed, when truly no specific treatment is being administered. Using placebos in research involving terminal illnesses has become debatable. While a placebo could potentially give way to new treatments, through testing alongside a specific drug in a clinical trial, the placebo itself may fail and the patient is not cured leading to possible fatality. It has been found that using placebos in research, like performing surgeries, can aid in medical or clinical research and could help our society financially …

Mid-Atlantic Ethics Committee Newsletter, Spring-Summer 2011

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Bad News About Bad News: The Disclosure Of Risks To Insurability In Research Consent Processes, Victoria Smith Apold, Jocelyn Downie

Articles, Book Chapters, & Popular Press

One of the phenomena associated with research is “incidental findings,” that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of …

Mid-Atlantic Ethics Committee Newsletter, Winter 2011

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Biobanking Newborn Bloodspots For Genetic Research Without Consent, Sandra J. Carnahan

Journal of Health Care Law and Policy

No abstract provided.

Researchers Without Borders?: Limiting Obligations Of Ancillary Care Through The Rescue Model, Michael R. Ulrich

Student Articles and Papers

With the expansion of clinical research in developing countries, there is a need to explain obligations that researchers have to their subjects beyond those required by the study protocol. This paper outlines a model founded on the duty to rescue that provides ethical clarification of the obligations of ancillary care.

Refractory Pain, Existential Suffering, And Palliative Care: Releasing An Unbearable Lightness Of Being, George P. Smith Ii

Scholarly Articles

Since the beginning of the hospice movement in 1967, “total pain management” has been the declared goal of hospice care. Palliating the whole person’s physical, psycho-social, and spiritual states or conditions is central to managing the pain which induces suffering. At the end-stage of life, an inextricable component of the ethics of adjusted care requires recognition of a fundamental right to avoid cruel and unusual suffering from terminal illness. This Article urges wider consideration and use of terminal sedation, or sedation until death, as an efficacious palliative treatment and as a reasonable medical procedure in order to safeguard the “right” …