The Human Microbiome: Ethical, Legal and Social Concerns

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 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

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.

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