Faculty Bibliography
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Vaccine refusal is a serious public health problem, especially in the context of diseases with potential to spark global pandemics, such as Ebola virus disease in the Democratic Republic of the Congo. This article examines whether and when compelling vaccination through mandates and criminalization, for example, are appropriate. It argues that some legal approaches are ethical when they preserve social stability, trust in government, therapeutic research opportunities, or when they diminish disease severity.
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This Introduction summarizes the contributions of the chapters and introduces the main themes of the edited volume Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, Barbara J. Evans, eds., Cambridge University Press 2019). It also provides the front matter for the volume, including its table of contents.
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The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parameters around how offers of payment may be advertised to prospective participants? This article seeks to answer this question, focusing on the ethical and practical issues associated with disclosing information about payment, and payment amounts in particular, in recruitment materials. We argue that it is permissible—and indeed typically ethically desirable—for recruitment materials to disclose the amount that participants will be paid. Further, we seek to clarify the regulatory guidance on “emphasizing” payment in a way that can facilitate design and review of recruitment materials.
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This term the Supreme Court will decide whether states can require all health insurers – including employers who self-insure – to submit health care claims data to the state’s All-Payer Claims Database (APCD). Because of the importance of the data compiled in APCDs, this case, Gobeille v. Liberty Mutual Insurance Company , could have serious ramifications for health services research.
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In order for the Food and Drug Administration (FDA) to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter (OTC) status for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved.
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The New Jersey Supreme Court has continually avoided making moral judgments about the value of life and emphasized that such decision making should be the province of the potential parents. Recently, in Acuna v. Turkish, the court elaborated on the limitations of the decision-making right of the potential parents, and its decision demonstrated that New Jersey courts were only willing to require physicians to disclose all relevant medical information, and not moral statements that had not been agreed upon by the state's medical community, people, or legislature. Acuna might be read as a departure from the trend displayed by New Jersey courts in “wrongful birth” and “wrongful life” actions toward empowering potential parents to decide if they want to bring the pregnancy to term. However, the decision actually fits squarely within this trend in that the reluctance to expand the information to which potential parents are entitled from their physicians can be directly tied to the reluctance of the New Jersey Supreme Court to weigh in on the value of life in wrongful birth and wrongful life suits.
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In May of 2006, the Abigail Alliance for Better Access to Development Drugs (Abigail) appeared to have won a victory when a divided panel of the Court of Appeals for the District of Columbia Circuit (D.C. Circuit) ruled that “terminally ill, mentally competent adult patients” had a constitutionally protected right to access investigational medications. This victory was short lived, however. On August 7, 2007, the D.C. Circuit sitting en banc reversed this earlier decision, marking a setback in Abigail's campaign for removal of the regulatory barriers that currently prevent terminally ill patients from gaining early access to investigational drugs (i.e., experimental drugs). This loss represents a big blow for Abigail's cause, because there is no guarantee that they will have another day in court, and attaining their goal through other branches of the government remains uncertain.