NEW DIRECTIONS: The Ethics of Synthetic Biology and Emerging

192 Pages·2010·3.96 MB·English

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and Emerging Technologies 182 183 184 185 186 187 188 189
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NEW DIRECTIONS e Ethics of Synthetic Biology and Emerging Technologies Presidential Commission for the Study of Bioethical Issues December 2010
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NEW DIRECTIONS
e Ethics of Synthetic Biology
and Emerging Technologies
Presidential Commission
for the Study of Bioethical Issues
Washington, D.C.
December 2010
www.bioethics.gov
NEW DIRECTIONS Te Ethics of Synthetic Biology and Emerging Technologies
ABOuT ThE PRESIDENTIAl COmmISSION fOR
ThE STuDy Of BIOEThICAl ISSuES
Te Presidential Commission for the Study of Bioethical Issues (PCSBI) is
an advisory panel of the nation’s leaders in medicine, science, ethics, religion,
law, and engineering. PCSBI advises the President on bioethical issues arising
from advances in biomedicine and related areas of science and technology.
Te Commission seeks to identify and promote policies and practices that
ensure scientifc research, health care delivery, and technological innovation
are conducted in a socially and ethically responsible manner.
for more information about PCSBI, please see www.bioethics.gov.
On the front cover: Portion of the genome map of M. mycoides JCVI-syn1.0. From Gibson, D.G., et al. (2010).
Creation of a bacterial cell controlled by a chemically synthesized genome. Science 329(5987):52-56.
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CONTENTS
letter of Transmittal to the President ...........................................................................v
letter from the President to the Commission ...........................................................vi
members of the Commission ........................................................................................vii
Commission Staf ............................................................................................................viii
Acknowledgements ............................................................................................................ix
Executive Summary ...........................................................................................................1
ChAPTER 1 Introduction ..........................................................................................19
ChAPTER 2 Science of Synthetic Biology .............................................................35
ChAPTER 3 Applications, Benefts, and Risks ....................................................55
ChAPTER 4 Oversight................................................................................................79
ChAPTER 5 Analysis and Recommendations ................................................... 111
Public Benefcence .............................................................................113
Responsible Stewardship .................................................................123
Intellectual freedom and Responsibility ....................................141
Democratic Deliberation ................................................................. 151
Justice and fairness ...........................................................................161
Appendix: Guest Speakers ............................................................................................175
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NEW DIRECTIONS Te Ethics of Synthetic Biology and Emerging Technologies
iv
PRESIDENTIAL COMMISSION FOR THE STUDY OF BIOETHICAL ISSUES

President Barack Obama
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20500

Dear Mr. President:

We are pleased to present to you this report, New Directions: The Ethics of Synthetic Biology and Emerging
Technologies. In response to your request of May 20, 2010, this first report of the Presidential Commission for
the Study of Bioethical Issues (PCSBI) examines the implications of the emerging science of synthetic biology,
including the announcement in May of the successful creation of a self-replicating bacterial cell with a
completely synthetically-replicated genome. It offers recommendations to ensure that America reaps the benefits
of this developing field within appropriate ethical boundaries.
PCSBI approached this task through inclusive and deliberative engagement with ethicists, scientists, engineers,
and individuals in faith, business, and non-profit communities. We held three public meetings, both in and
outside of Washington, D.C., created an open forum for dialogue, and heard many diverse voices.
The Commission found that synthetic biology offers extraordinary promise to create new products for clean
energy, pollution control, and medicine, to revolutionize chemical production and manufacturing, and to create
new economic opportunities. With this promise comes a duty to attend carefully to potential risks, be
responsible stewards, and consider thoughtfully the implications for humans, other species, nature, and the
environment.
PCSBI concluded that synthetic biology is capable of significant but limited achievements posing limited risks.
Future developments may raise further objections, but the Commission found no reason to endorse additional
federal regulations or a moratorium on work in this field at this time. Instead, the Commission urges monitoring
and dialogue between the private and public sectors to achieve open communication and cooperation.
The Commission recommends that the government, through a coordinated process or body within the Executive
Office of the President, lead an ongoing review of developments, risks, opportunities, and oversight as this field
grows. This review should be in consultation with relevant scientific, academic, international, and public
communities, and whenever possible its results should be made public. We also recommend that reasonable risk
assessment should precede any field release of synthetic organisms. We suggest support for public engagement,
education, and dialogue to ensure public trust and avoid unnecessary limitations on science and social progress.
You gave the Commission a rare and exceptional opportunity to be proactive and forward looking in this first
study. The Commission is grateful for the opportunity to serve you and the nation in this way. We would be
happy to brief you if you have any questions about our recommendations.
Sincerely,

Amy Gutmann, Ph.D. James Wagner, Ph.D.
Chair Vice-Chair
1425 NEW YORK AVENUE, NW, SUITE C-100 , WASHINGTON, DC 20005
PHONE [phone] FAX [phone] WWW.BIOETHICS .GOV
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NEW DIRECTIONS Te Ethics of Synthetic Biology and Emerging Technologies
vi
PRESIDENTIAl COmmISSION fOR ThE STuDy
Of BIOEThICAl ISSuES
Amy GuTmANN, Ph.D., ChAIR
President and Christopher h. Browne
Distinguished Professor of Political Science, university of Pennsylvania
JAmES W. WAGNER, Ph.D., VICE ChAIR
President, Emory university
yOlANDA AlI ChRISTINE GR ADy, R.N., Ph.D.
michael J. fox foundation Acting Chief of the Department of
founder’s Council; Bioethics, National Institutes of health
Emory Neurosciences Clinical Center
Community Advisory Board
STEPhEN l. hAuSER, m.D.
Robert A. fishman Distinguished
ANITA l. AllEN, J.D., Ph.D.
Professor and Chair of the Department
Deputy Dean for Academic Afairs;
of Neurology, university of California,
henry R. Silverman Professor of law,
San francisco
Professor of Philosophy, university
of Pennsylvania law School
R AJu S. KuChERlAPATI, Ph.D.
Paul C. Cabot Professor, Department
JOhN D. ARR AS, Ph.D.
of Genetics, harvard medical School;
Porterfeld Professor of Biomedical
Professor, Department of medicine,
Ethics, Professor of Philosophy,
Brigham and Women’s hospital
university of Virginia
BARBAR A f. ATKINSON, m.D. NElSON l. mIChAEl, m.D., Ph.D.
Executive Vice Chancellor, Colonel, medical Corps, u.S. Army;
university of Kansas medical Center; Director, Division of Retrovirology;
Executive Dean, university of Walter Reed Army Institute of Research;
Kansas School of medicine u.S. military hIV Research Program
NITA A. fAR AhANy, J.D., Ph.D. DANIEl P. SulmASy, m.D.
Associate Professor of law, Kilbride-Clinton Professor of medicine
Associate Professor of Philosophy, and Ethics, Department of medicine
Vanderbilt university and Divinity School; Associate Director,
maclean Center for Clinical medical
AlEXANDER G. GARZA, m.D., m.P.h.
Ethics, university of Chicago
Assistant Secretary, Ofce of health
Afairs; Chief medical Ofcer,
Department of homeland Security
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NEW DIRECTIONS Te Ethics of Synthetic Biology and Emerging Technologies
PRESIDENTIAl COmmISSION fOR ThE STuDy
Of BIOEThICAl ISSuES
STAff AND CONSulTANTS
Executive Director
Valerie h. Bonham, J.D.
Research Staf
Debbie forrest, m.P.P.
Chris havasy, Sc.B.
holly fernandez lynch, J.D., m. Bioethics
David G. miller, Ph.D.
Anne Pierson, J.D. Candidate, 2011
Jason l. Schwartz, A.m., m. Bioethics
Kayte Spector-Bagdady, J.D., m. Bioethics
Consultants
Burness Communications
Alison Davis, Ph.D.
Kathi E. hanna, m.S., Ph.D.
Administrative Staf
Judith E. Crawford
Esther yoo, B.A.
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