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Bioethics and Medical Ethics

Selected Works

Selected Works

Health Law and Policy

Articles 1 - 9 of 9

Full-Text Articles in Law

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 Jul 2013

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 Jul 2013

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 Jul 2013

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 Mar 2012

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 Mar 2012

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.


Physicians Who Break The Law, Diane E. Hoffmann Oct 2011

Physicians Who Break The Law, Diane E. Hoffmann

Diane Hoffmann

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …


Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz Oct 2011

Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz

Diane Hoffmann

No abstract provided.


The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian Oct 2011

The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian

Diane Hoffmann

In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?


Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg Oct 2011

Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg

Diane Hoffmann

No abstract provided.