The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

The first book on the ethical, legal, and social concerns raised by human microbiome research.
Calls for research ethics reform, including relaxed consent requirements.
Addresses the need for thoughtful policies and procedures to guide the use of the large number of biobanked human samples required for advancing this new domain of human microbiome research.
Relates to a number of ongoing debates and controversies, including regulation of human subject research and epidemic preparedness.

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Description

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

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Acknowledgements
Introduction: Looking Back and Looking Forward
Rosamond Rhodes
The Project Collaborators
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
Introduction: Microbes and Microbiology
The Role of Microorganisms in the Environment
The Use of Microorganism in Industry and Food Production
The History of Microorganisms in Human Health and Disease
The Human Microbiome
Human Microbiome Project and the National Institute of Health
Research Tools and Methods
Acquisition of the Microbiome
Interactions between the Microbiome and the Host Genome
Manipulating the Microbiome for Medical Purposes
Conclusions

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
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
Henrietta Lacks and HeLa Cells
John Moore's Leukemia Cells
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
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 on Probiotics
Conclusions
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
Federal Regulations Applied to Biobanks
Risks and Human Microbiome Biobanks
Benefits and Human Microbiome Biobanks
Obtaining Consent from Human Microbiome Biobank Donors
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 Improvement, Quality Assurance 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 by William J. Earle
Policy Recommendations

Glossary
Index

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Author Information

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.

Contributors:

Rosamond Rhodes, PhD, Mount Sinai School of Medicine
Jody Azzouni, PhD, Tufts University
Mary Ann Baily, PhD, Hastings Center Fellow
Stefan Bernard Baumrin, PhD, JD, The Graduate Center, CUNY
Keith Benkov, MD, Mount Sinai School of Medicine
Martin J. Blaser, MD, New York University Medical School
Barbara Brenner, PhD, Mount Sinai School of Medicine
Joseph W. Dauben, PhD, The Graduate Center, CUNY
William J. Earle, PhD, The Graduate Center, CUNY
Lily Frank, MPhil, The Graduate Center, CUNY
Nada Gligorov, PhD, Mount Sinai School of Medicine
Joseph Goldfarb, PhD, Mount Sinai School of Medicine
Kurt Hirschhorn, MD, Mount Sinai School of Medicine
Rochelle Hirschhorn, MD, New York University Medical School
Ian Holzman, MD, Mount Sinai School of Medicine
Debbie Indyk, PhD, Mount Sinai School of Medicine
Ethylin Wang Jabs, MD, Mount Sinai School of Medicine
Douglas P. Lackey, PhD, The Graduate Center, CUNY
Daniel A. Moros, MD, Mount Sinai School of Medicine
Sean Philpott, PhD, Union Graduate College
Matthew E. Rhodes, PhD, National Jewish Health, Denver, Colorado
Lynne D. Richardson, MD, Mount Sinai School of Medicine
Henry S. Sacks, MD, Mount Sinai School of Medicine
Abraham Schwab, PhD, Indiana University, Purdue
Rhoda Sperling, MD, Mount Sinai School of Medicine
Brett Trusko, PhD, Mount Sinai School of Medicine
Arnulf Zweig, PhD, University of Oregon (emeritus)

The Human Microbiome

Ethical, Legal and Social Concerns

Edited by Rosamond Rhodes, Nada Gligorov, and Abraham Paul Schwab

Reviews and Awards

"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, CHOICE

This 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