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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 Jun 2014

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 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.


Regulating Ethics Committees In Health Care Institutions - Is It Time?, Diane E. Hoffmann Oct 2011

Regulating Ethics Committees In Health Care Institutions - Is It Time?, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.


The Dangers Of Directives Or The False Security Of Forms, Diane E. Hoffmann, Sheryl Itkin Zimmerman, Catherine J. Tompkins Oct 2011

The Dangers Of Directives Or The False Security Of Forms, Diane E. Hoffmann, Sheryl Itkin Zimmerman, Catherine J. Tompkins

Diane Hoffmann

No abstract provided.


The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian Oct 2011

The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian

Diane Hoffmann

Over a quarter of a century has passed since health care ethics committees (HCECs) in the United States received legal recognition as alternatives to the courts in resolving conflicts related to patient end-of-life care. By the mid to late 1980s HCECs had been established in over half of U.S. hospitals and had received a certain legitimacy in the health care system. Given their age and growth one could characterize them developmentally as emerging from adolescence and establishing themselves in young adult-hood. As a result, we might expect that they would have resolved the identify crisis characterizing the adolescent years. Yet, …


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 …


Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil Oct 2011

Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil

Diane Hoffmann

No abstract provided.


Evaluating Ethics Committees: A View From The Outside, Diane E. Hoffmann Oct 2011

Evaluating Ethics Committees: A View From The Outside, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.


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.


Mediating Bioethical Disputes, Diane E. Hoffmann, Naomi Karp Oct 2011

Mediating Bioethical Disputes, Diane E. Hoffmann, Naomi Karp

Diane Hoffmann

No abstract provided.


Mediating Life And Death Decisions, Diane E. Hoffmann Oct 2011

Mediating Life And Death Decisions, Diane E. Hoffmann

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.