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NEW DIRECTIONS: The Ethics of Synthetic Biology and Emerging PDF

192 Pages·2010·3.96 MB·English
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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. ii 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 iii 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 202 -233 -3960 FAX 202 -233 -3990 WWW.BIOETHICS .GOV v 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 vii 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. viii

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