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The Human Microbiome
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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.
"The microbiome is a relatively new area of medical attention. Ethical issues related to the microbiome have barely been identified, much less carefully analyzed. This volume is an excellent start toward that ethical analysis. Many of the arguments are persuasive and provocative. In particular, some contributors challenge the ethical need for anonymizing microbiome specimens as well as the need for individual informed consent for specific uses of these specimens. I highly recommend this volume for all those interested in the microbiome and in new frontiers in medical ethics." -Leonard M. Fleck, Michigan State University
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Table of Contents

Acknowledgements ; Microbiome Working Group Participants ; Introduction: Looking Back and Looking Forward ; Rosamond Rhodes ; The Project Collaborators ; Our Method ; The Scope of this Volume ; Reading this Book ; 1. The Human Microbiome: Science, History and Research ; Lily E. Frank, Martin J. Blaser, Kurt Hirschhorn, Daniel A. Moros, Matthew E. Rhodes, Sean Philpott, Rhoda Sperling, Keith Benkov ; Introduction ; The Role of Microorganisms in the Environment ; The Use of Microorganisms in Industry and Food Production ; The History of Microorganisms in Human Health and Disease ; The Human Microbiome ; Human Microbiome Project and the National Institutes of Health ; Research Tools and Methods ; Acquisition of the Microbiome ; Interactions between the Microbiome and the Host Genome ; Manipulating the Microbiome for Medical Purposes ; Conclusion ; 2. Personal Identity: Our Microbes, Ourselves ; Nada Gligorov, Jody Azzouni, Douglas P. Lackey, Arnold Zweig ; Introduction ; Personal Identity over Time ; The Human Microbiome and Numerical Identity ; The Human Microbiome and Conceptions of Self ; The Impact of Science on Commonsense Conceptions of Self ; Conclusion ; Policy Recommendations ; 3. Property and Research on the Human Microbiome ; Mary Ann Baily, Abraham P. Schwab, Joseph Goldfarb, Kurt Hirschhorn, Rosamond Rhodes, Brett Trusko ; Four Controversial Cases ; Introduction ; Ownership and Property in Philosophy ; Ownership and Property in the Social Sciences ; Ownership and Property in the Context of Biomedical Research ; Current Property Structures and Research on the Human Microbiome ; Patents ; Copyrights ; Property Rights and Biological Samples ; Conclusion ; Policy Recommendations ; 4. Privacy, Confidentiality, and New Ways of Knowing More ; Nada Gligorov, Lily E. Frank, Abraham P. Schwab, Brett Trusko ; Introduction ; Philosophical Approaches to Privacy ; Confidentiality ; Legislations to Protect Medical and Research Information ; Data Sharing ; Conclusion ; Policy Recommendations ; 5. Research Ethics ; Rosamond Rhodes, Joseph W. Dauben, Lily E. Frank, Daniel A. Moros, Sean Philpott, Martin J. Blaser ; Introduction ; The Landscape of Microbiome Research ; Historical Development of Research Ethics Regulation and Guidelines ; Research Ethics and Human Microbiome Research ; Critical Reflections on the U.S. Framework for Human Subject Research ; Implications for the Conduct of Human Subject Microbiome Research ; Research and Regulation of Probiotics and Phages ; Conclusion ; Policy Recommendations ; 6. Biobanks and the Human Microbiome ; Abraham P. Schwab, Barbara Brenner, Joseph Goldfarb, Rochelle Hirschhorn, Sean Philpott ; Introduction ; What is a Biobank? ; Human Microbiome Biobanks ; Ethical, Legal, and Social Implications (ELSI) of Human Microbiome Biobanks ; International Biobanks ; Community Consultation: A Reasonable Approach to Participatory Research ; Discrimination and Other Issues ; Conclusion ; Policy Recommendations ; 7. Public Health and Research on Populations ; Rosamond Rhodes, Stefan Bernard Baumrin, Martin J. Blaser, William J. Earle, Debbie Indyk, Ethylin Wang Jabs, Daniel A. Moros, Lynne D. Richardson, Henry S. Sacks ; Microbes and Public Health ; Public Health, Liberty, and Privacy ; Public Health Functions ; Public Health Agency Powers ; Public Health Methods ; Research Regulations and Public Health Data Gathering ; Quality Assurance, Quality Improvement and Surveillance ; De Minimis Risk: A Proposal for a New Category of Research Risk ; Additional Factors in the Ethical Conduct of Population Studies ; Prevention and Education ; Cautions for Public Health Policy Makers ; Coda: Further Philosophical Reflections on Public Health and the Microbiome ; Policy Recommendations ; Glossary ; Index

About the Author

Rosamond Rhodes, Ph.D., is Professor of Medical Education and Director of Bioethics Education at Icahn School of Medicine at Mount Sinai, Professor of Philosophy at The Graduate Center, CUNY, and Professor of Bioethics and Associate Director of the Union-Mount Sinai Bioethics Program. She writes on a broad array of issues in bioethics. Nada Gligorov, Ph.D., is Assistant Professor of Medical Education at Icahn School of Medicine at Mount Sinai and Assistant Professor of Bioethics at the Union- Mount Sinai Bioethics Program. She is primarily interested in neuroethics, most specifically determinism and free will as well as the impact of brain imaging technologies on privacy. She has also published on personal identity as it relates to biomedical issues such as advance directives. Abraham Paul Schwab, Ph.D., is Assistant Professor of Philosophy at Indiana University-Purdue University Fort Wayne and an associate faculty member in the Union-Mount Sinai Bioethics Program.

Reviews

"The authors, all members of the Microbiome Working Group, have brought their many years of experience and varied areas of expertise to bear on [social, ethical, and legal aspects of microbiome research], with an eye toward formulating guidelines and public policy recommendations that should prove useful as microbiome research ventures into increasingly uncharted territory in the coming years." -R.K. Harris, William Carey University, CHOICEThis anthology would be very useful for human microbiome researchers with little experience with medical ethics or philosophers with little knowledge of the human microbiome, although as a jumping-off point for further detailed examination of both sides of many issues. This is a solid first look at ethics and the human microbiome. -- The Quarterly Review of Biology"This volume is a fine example of bioethics at its best." --Environmental Philosophy "The authors, all members of the Microbiome Working Group, have brought their many years of experience and varied areas of expertise to bear on [social, ethical, and legal aspects of microbiome research], with an eye toward formulating guidelines and public policy recommendations that should prove useful as microbiome research ventures into increasingly uncharted territory in the coming years." -R.K. Harris, William Carey University, CHOICEThis anthology would be very useful for human microbiome researchers with little experience with medical ethics or philosophers with little knowledge of the human microbiome, although as a jumping-off point for further detailed examination of both sides of many issues. This is a solid first look at ethics and the human microbiome. -- The Quarterly Review of Biology"This volume is a fine example of bioethics at its best." --Environmental Philosophy

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