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Full-Text Articles in Law
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz
Diane Hoffmann
In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …
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
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.
Physicians Who Break The Law, Diane E. Hoffmann
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
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
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
Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg
Diane Hoffmann
No abstract provided.