Law Commons^™

Reimagining Icarus: Ethics, Law And Policy Considerations For Commercial Human Spaceflight, Sara M. Langston

Sara Langston

Commercial human spaceflight presents an area for engaging novel human activity and objectives, to include space exploration, entertainment, transportation and extraterrestrial resource acquisition. The inherent dangers and lack of scientific and medical certainty involved however raise interrelated questions of ethics, bioethics, law and public policy. This is particularly the case with spaceflight participant (SFP) screening, selection, and commercial human spaceflight activities where regulations are currently silent or lacking. In the absence of established law, ethics can play an important role by informing industry standards, policies and best practices. Understanding the fundamental ethical values at stake in the application of new …

Organizations As Evil Structures, Cary Federman, Dave Holmes

Cary Federman

Nursing practice in forensic psychiatry opens new horizons in nursing. This complex, professional, nursing practice involves the coupling of two contradictory socioprofessional mandates: to punish and to provide care. The purpose of this chapter is to present nursing practice in a disciplinary setting as a problem of governance. A Foucauldian perspective allows us to understand the way forensic psychiatric nursing is involved in the governance of mentally ill criminals through a vast array of power techniques (sovereign, disciplinary, and pastoral), which posit nurses as “subjects of power.” These nurses are also “objects of power” in that nursing practice is constrained …

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

Cary Federman

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 …

Usa: Millions Of Cats Killed, Millions Of Cats Declawed; The Culture Of Convenience And The Lack Of Respect For Life, Alev Dudek

Alev Dudek

Biting The Hands That Feed “The Alligators”: A Case Study In Morbid Obesity Extremes, End-Of-Life Care, And Prohibitions On Harming And Accelerating The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Obesity, recognized as a disease in the U.S. and at times as a terminal illness due to associated medical complications, is an American epidemic according to the Centers for Disease Control and Prevention (“CDC”), American Heart Association (“AHA”), and other authorities. More than one third of Americans (39.8% of adults and 18.5% of children) are medically obese. This article focuses on cases of “extreme morbid obesity” (“EMO”)—situations in which death is imminent without aggressive medical interventions, and bariatric surgery is the only treatment option with a realistic possibility of success. Bariatric surgeries themselves are very high risk for EMO patients. …

Application Of Default Rules To Address Financial Conflicts Of Interest In Academic Medical Centers, Joanna K. Sax

Joanna K Sax

A recent report issued from the Institute of Medicine contains an extensive analysis of financial conflicts of interest (FCOIs) in biomedical science. In brief, an FCOI exists when a profit-seeking motive either unduly influences or appears to influence an academic scientist’s primary obligations. The cornerstone of current policy to address FCOIs at academic medical centers (AMCs) is disclosure; however, disclosure does not appear to appropriately regulate, manage, or eliminate FCOIs.

Although the relationships between intramural scientists and industry and extramural scientists and industry may be structurally different, they both can lead to FCOIs that threaten scientific integrity. Overall, the NIH …

The Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch

Martin Stephens, PhD

No abstract provided.

Addressing The Ethical, Legal, And Social Issues Raised By Voting By Persons With Dementia, Jason H. Karlawish, Richard J. Bonnie, Paul S. Appelbaum, Constantine Lyketsos, Bryan James, David Knopman, Christopher Patusky, Rosalie A. Kane, Pamela S. Karlan

Bryan G Kane MD

This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance …

Self-Harm In Laboratory-Housed Primates: Where Is The Evidence That The Animal Welfare Act Amendment Has Worked?, Jonathan Balcombe, Hope Ferdowsian, Debra Durham

Jonathan Balcombe, PhD

The 1985 amendment to the United States Animal Welfare Act (AWA) to promote psychological well being of primates in the laboratory represents an acknowledgment of an important welfare problem concerning nonhuman animals. How effective has this amendment been? Perhaps the best-known contributor to psychological distress in primates in the laboratory is nonsocial housing; yet, available analyses suggest that little progress has been made in avoiding single-caging of these animals. Another way to assess psychological well being is to examine rates of self-abusive behavior in laboratory primates. If the AWA has been effective, then post-AWA self-harm rates might be lower than …

Self-Harm In Laboratory-Housed Primates: Where Is The Evidence That The Animal Welfare Act Amendment Has Worked?, Jonathan Balcombe, Hope Ferdowsian, Debra Durham

Debra Durham, PhD

The 1985 amendment to the United States Animal Welfare Act (AWA) to promote psychological well being of primates in the laboratory represents an acknowledgment of an important welfare problem concerning nonhuman animals. How effective has this amendment been? Perhaps the best-known contributor to psychological distress in primates in the laboratory is nonsocial housing; yet, available analyses suggest that little progress has been made in avoiding single-caging of these animals. Another way to assess psychological well being is to examine rates of self-abusive behavior in laboratory primates. If the AWA has been effective, then post-AWA self-harm rates might be lower than …

The Pedagogical Significance Of The Bush Stem Cell Policy: A Window Into Bioethical Regulation In The United States (President George W. Bush, Fifth Anniversary Essay Collection), O. Carter Snead

O. Carter Snead

The enormous significance of the Bush stem cell funding policy has been evident since its inception. The announcement of the policy on August 9, 2001 marked the first time a U.S. president had ever taken up a matter of bioethical import as the sole subject of a major national policy address. Indeed, the August 9th speech was the President's first nationally televised policy address of any kind. Since then, the policy has been a constant focus of attention and discussion by political commentators, the print and broadcast media, advocacy organizations, scientists, elected officials, and candidates for all levels of office …

Law And Social Change: Bioethics: 2001, Richard Haigh

Richard Haigh

Course number 2750C

Allowing Patients To Waive The Right To Sue For Medical Malpractice: A Response To Thaler And Sunstein, Tom Baker, Timothy D. Lytton

Timothy D. Lytton

This essay critically evaluates Richard Thaler and Cass Sunstein’s proposal to allow patients to prospectively waive their rights to bring a malpractice claim, presented in their recent, much acclaimed book, Nudge: Improving Decisions about Health, Wealth and Happiness. We show that the behavioral insights that undergird Nudge do not support the waiver proposal. In addition, we demonstrate that Thaler and Sunstein have not provided a persuasive cost-benefit justification for the proposal. Finally, we argue that their liberty-based defense of waivers rests on misleading analogies and polemical rhetoric that ignore the liberty and other interests served by patients’ tort law rights. …

The Class B Dealer: Down And Out?, Bernard Unti

Bernard Unti, PhD

The supply of dogs and cats to laboratories by Class B animal dealers has been a contentious matter for decades. The subject engenders heated debate whenever it surfaces, most recently in September 2005 when Senator Daniel Akaka (D-HI) proposed an amendment to the FY 2006 agriculture funding bill to withhold federal monies to research institutions that purchase animals from Class B dealers.

Human Genetics Studies: The Case For Group Rights, Laura S. Underkuffler

Laura S. Underkuffler

No abstract provided.

Addressing The Ethical, Legal, And Social Issues Raised By Voting By Persons With Dementia, Jason H. Karlawish, Richard J. Bonnie, Paul S. Appelbaum, Constantine Lyketsos, Bryan James, David Knopman, Christopher Patusky, Rosalie A. Kane, Pamela S. Karlan

Jason Karlawish

This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance …

Regulating The Placebo Effect In Clinical Practice, Tracey Chan

Tracey E Chan

Recent research and ethical analysis have forced a clinical and ethical reappraisal of the utility of placebos in medical practice. The main concern of ethics and law is that using placebos in health care involves deception, which is antithetical to patient autonomy and trust in the physician-patient relationship. This paper reviews the various, more nuanced scientific conceptions of the placebo effect, and evaluates the ethical and legal objections to deploying placebos in clinical practice. It argues that the placebo effect may be legitimately accommodated on the basis that it does not engage the requirement for material or quasi-fiduciary disclosures of …

The Separation Of Politics And Science, Joanna K. Sax

Joanna K Sax

This article proposes that scientific inquiry regarding questions of fact should have an autonomous zone that is protected from politics. Although many scholars promote the idea that science is politicized, little empirical data exists to support this conclusion. This article contains an empirical study that demonstrates that the public received inaccurate information in the debate over a highly politicized and controversial area of scientific inquiry, embryonic stem cell research. This article utilizes the data from the empirical study and public choice theory to explain that there are process defects; this economic model can help explain, but cannot be used to …

Evaluation Of Academic Scientists’ Responses To Situations That Pose A Conflict Of Interest, Joanna K. Sax

Joanna K Sax

The industry-academy relationship has many benefits, but it also has potential drawbacks, including potential conflicts of interest (e.g., when the profit motives of a private company unduly influence academic responsibilities). To date, policies intended to regulate or manage financial conflicts of interest appear to be unsatisfying and inadequate. The present study examined predictors of the responses of academic scientists and clinicians to hypothetical situations in which financial and other conflicts of interest may arise. Academic scientists and clinicians at five medical schools completed an anonymous survey that included vignettes that posed a potential conflict of interest. Participants indicated the likelihood …

Financial Conflicts Of Interest In Science, Joanna K. Sax

Joanna K Sax

This article proposes that an analysis of behavior may be utilized to create an effective policy addressing financial conflicts of interest. Importantly, this article focuses on the academics that conduct basic science. An understanding of the background of the public-private interaction is critical to fully appreciate the rise of the financial conflicts of interest in biomedical science. Part II of this Article describes the rise of financial conflicts of interest and the types of harms that can occur in the absence of effective policy to regulate financial conflicts of interest. Part III describes the current system addressing conflicts of interest, …

Access To Prescription Drugs: A Normative Economic Approach To Pharmacist Conscience Clause Legislation, Joanna K. Sax

Joanna K Sax

The goals of this Article are two-fold: (1) to explain that pharmacist conscience clause legislation may be expanded to areas concerning controversial biomedical research; and (2) to demonstrate that welfare economics can be applied to analyze pharmacist conscience clause legislation. Regarding the first goal, the broad language of existing and proposed conscience clause legislation creates an umbrella that allows a pharmacist to escape liability for refusing to fill a prescription for almost any type of medication. With respect to the second goal, this Article applies welfare economics to demonstrate that pharmacist conscience clauses are a part of tort law and …

Informed Consent, Psychotropic Medications, And A Prescribing Physician's Duty To Disclose Safer Alternative Treatments, Rita F. Barnett

Rita Barnett-Rose

The use of psychotropic medication to treat any presumed mental health disorder always involves serious risks of harm. Accordingly, before prescribing psychotropic medication to control the behaviors associated with a presumed mental health disorder, prescribing physicians are required, under various medical ethical guidelines and informed consent laws, to first disclose information regarding available alternative treatment options, and the risks and benefits of such alternative treatment options. Indeed, because psychotropic medications are themselves experimental treatments due to the concededly unknown etiology of most mental health disorders, disclosing safer alternative treatments would seem to be a particularly critical aspect of a prescribing …

La Loi, N° 85, Du 27 Novembre 2013 Sur La Médecine Régénérative, Matthieu Forlodou

Matthieu Forlodou

Le document fournit une proposition de traduction en français de la loi japonaise n° 85, du 27 novembre 2013, visant à garantir l'innocuité de la médecine régénérative.

Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel

Diane Hoffmann

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry

Leslie Meltzer Henry

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the …

Revising The Common Rule: Prospects And Challenges, Leslie Henry

Leslie Meltzer Henry

The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address "Human Subjects Research Regulations: Proposals for Reform." This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule.

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Maxwell L. Stearns

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Leslie Meltzer Henry

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

Ethical Issues In Open Adoption, Frederic Reamer, Deborah Siegel

Deborah H Siegel

Total secrecy and confidentiality no longer typify adoption in the United States. Today, most adoptions involve an exchange of information or some form of contact between the birth family and adoptive family - so-called open adoptions. This article provides a comprehensive overview of ethical issues associated with various forms of open adoption, including issues of privacy, confidentiality, self-determination, paternalism, conflicts of interest, deception, and truthtelling.We present guidelines for social work practice in open adoptions, based on current ethical theory and ethical standards in social work.

Patently Ours? Constitutional Challenges To Dna Patents, Vincent Ling

Vincent Y. Ling

This Comment analyzes constitutional issues raised by gene patenting and details how the issues apply to various types of DNA patents. In Association for Molecular Pathology v. U.S. Patent & Trademark Office, the Federal Circuit recently held that genes and DNA sequences are patentable under the federal statute for patent eligible subject matter, 35 U.S.C. § 101, but courts have thus far avoided addressing the constitutional challenges raised by plaintiffs. This Comment confronts those constitutional issues and makes a determination as to their strengths and weaknesses. Moreover, it explores additional constitutional issues that may become more salient over time. Ultimately, …