Human microbiome research has revealed that legions of bacteria, viruses, and fungi live on our skin and within the cavities of our bodies. New knowledge from these recent studies shows that humans are superorganisms and that the microbiome is indispensible to our lives and our health. This volume explores some of the science on the human microbiome and considers the ethical, legal, and social concerns that are raised by this research.

The human microbiome is the bacteria, viruses, and fungi that cover our skin, line our intestines, and flourish in our body cavities. Work on the human microbiome is new, but it is quickly becoming a leading area of biomedical research. What scientists are learning about humans and our microbiomes could change medical practice by introducing new treatment modalities. This new knowledge redefines us as superorganisms comprised of the human body and the collection of microbes that inhabit it and reveals how (...) much we are a part of our environment. The understanding that microbes are not only beneficial but sometimes necessary for survival recasts our interaction with microbes from adversarial to neighborly. This volume explores some of the science that makes human microbiome research possible. It then considers ethical, legal, and social concerns raised by microbiome research. Chapters explore issues related to personal identity, property rights, and privacy. The authors reflect on how human microbiome research challenges reigning views on public health and research ethics. They also address the need for thoughtful policies and procedures to guide the use of the biobanked human samples required for advancing this new domain of research. In the course of these explorations, they introduce examples from the history of biomedical science and recent legal cases that shed light on the issues and inform the policy recommendations they offer at the end of each topic's discussion.This volume is the product of an NIH Human Microbiome Project grant. It represents three years of conversations focused on consensus formation by the twenty-seven members of the interdisciplinary Microbiome Working Group. (shrink)

In this article the authors reflect on regulations which have been developed to protect research subjects and data in research which uses human subjects. They suggest that regulations related to informed consent and privacy protection are burdensome in research which uses human subjects. They argue that a new category of research risk must be established which informs research subjects of the level of risk that they will be exposed to by participating in the research.

From the beginning, a code of ethics for bioethicists has been conceived of as part of a movement to professionalise the field. In advocating for such a code, Baker repeatedly identifies 'having a code of ethics' with 'professionalization'. The American Society of Bioethics and Humanities echoes this view in their code of ethics for healthcare ethics consultants 1 and the subsequent publication in the American Journal of Bioethics.2 Taking for granted that a code of ethics could be a valuable asset (...) for HCECs, this essay has two aims. First, there are good reasons to doubt that the label 'profession' has significant meaning for HCECs. Attempts to accurately conceive of a profession fall into two broad camps: substantive and formal. Substantive conceptions should be rejected. Specifically, substantive conceptions beg the question about what it means to be a profession, which produces devastating problems for practical application. Formal conceptions of profession avoid begging the question, but do so at the cost of identifying the responsibilities of a profession. Using the term 'professional responsibilities', then, requires additional explication and classifying HCECs as professionals requires the identification of their role-specific responsibilities.i Second, this essay will critique the ASBH code of ethics for HCECs as a first articulation of these responsibilities. As written, this code of ethics has limited value for HCECs because most of the responsibilities identified in this code do not identify HCEC-specific responsibilities. In closing, some important strategies to improve upon this initial attempt to define the responsibilities of HCECs are identified. (shrink)

Active shooter incidents have unfortunately become a common occurrence the world over. There is no country, city, or venue that is safe from these tragedies, and healthcare institutions are no exception. Healthcare facilities have been the targets of active shooters over the last several decades, with increasing incidents occurring over the last decade. People who work in healthcare have a professional and moral obligation to help patients. As concerns about the possibility of such incidents increase, how should healthcare institutions and (...) healthcare professionals understand their responsibilities in preparation for and during ASI? (shrink)

The American Journal of Bioethics, Volume 11, Issue 11, Page 44-45, November 2011.

Conflicts of interest represent one of the defining problems of our time, and yet a clear definition of what constitutes a conflict of interest remains elusive. To move us closer to resolving this problem, this article first reviews and critiques attempts to define conflicts of interest, and, second, uses these critiques to ground a more conceptually consistent and practically useful definition. This definition builds on, but also breaks away from Michael Davis’s definition of conflicts of interest. Specifically, it articulates and (...) defends defining conflicts of interest in terms of their threat to good judgment but does so in the broadest terms. Defining it in this way expands the domain of conflicts of interest, but also avoids unnecessary conceptual distractions and practical difficulties. (shrink)

Using four examples of cost-effectiveness analyses, I argue that discussions of and research on cost-effectiveness in medical practice should clearly delineate between protocol and practice cost-effectiveness analyses. Failure to do so risks confusing conclusions that warrant substantial confidence and limited applicability with conclusions with broader applicability but more limited confidence. Further, these different types of analyses incorporate different sets of values. I argue that some favor should be shown for those analyses that include a wider array of values.

This paper is split into two parts. The first half analyzes conflicts of interests’ effects on judgment, the harms these effects threaten, and our current policies and practices for handling conflicts of interest. This analysis relies on scholarship in several fields, most prominently psychology, all of which have reasons to worry about conflicts of interest. This analysis will show that our current classifications of conflicts of interest and our current strategies for handling conflicts of interest are confusing, of dubious benefit, (...) or both. The second half provides some tools for helping us to limit or avoid the harms of conflicts of interest. These simple tools focus on how we think about and classify conflicts of interest. Specifically, I recommend beginning to classify conflicts of interest in a new way: as either severable or systemic. These new classifications are not intended to be heavy conceptual machinery, but simple and valuable tools. These new classifications, even though they are not meant to be exhaustive or comprehensive, help delineate tractable strategies and help determine the distribution of responsibilities for addressing specific conflicts of interest. (shrink)

The article reviews the article "The Pitfalls of Deducing Ethics From Behavioral Economics: Why the Association of American Medical Colleges Is Wrong About Pharmaceutical Detailing," by T. S. Huddle in the January 1, 2010 issue of "American Journal of Bioethics.".

1The opinions contained in this article are those of the authors and should not be construed as policies of the American Medical Association.