Biobanking, Bioethics & The

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Biobanking, Bioethics & The Law September 26th, 2008 Stanford Law School 9:15 Welcome and Introduction 9:30 - 10:45 The Scientific Promise of Biobanks Russ Altman, Professor of Bioengineering, Genetics, and Medicine; Director, Biomedical Informatics Training Program, Stanford University Rex Chisholm, Adam and Richard T. Lind Professor of Medical Genetics; Dean for Research, Feinberg School of Medicine, Northwestern University Douglas Levinson, Walter E. Nichols, M.D. Professor in the School of Medicine, Stanford University Scott VandenBerg, Professor of Pathology and Neurosurgery; Director, Brain Tumor Research Center Tissue Core; Director, Neuropathology Biomarkers Laboratory, University of California San Francisco 10:45 - 11:00 Coffee Break 11:00 - 1:00 The Administration of Biobanks and Review of Research Mariana Bledsoe, National Institute of Health Elena Grigorenko, Child Study Center; Department of Psychology; Department of Epidemiology & Public Health, Yale University Julie Kaneshiro, Policy Team Leader, Office for Human Research Protections Elizabeth Peloso, Director of Compliance; Adjunct Professor of Psychology, University of Delaware Susan Stayn, Senior University Counsel, Office of General Counsel, Stanford University 1:00 – 1:30 Break 1:30 - 2:30 Lunch and Keynote Address: Hakon Hakonarson, Director, Center for Applied Genomics, The Children’s’ Hospital of Philadelphia; Associate Professor, Department of Pediatrics, University of Pennsylvania School of Medicine 2:30 - 4:00 Legal and Ethical Issues Related to Biobanks Kelly Ormond, MS, CGC, Associate Professor Department of Genetics & Director, MS in Genetics and Genetic Counseling, Stanford University David Resnik, JD,PhD, Bioethcist, NIEHS/NIH Ellen Wright Clayton, Rosalind E. Franklin Professor of Genetics and Health Policy; Professor of Pediatrics; Professor of Law; Director, Center for Biomedical Ethics and Society, Vanderbilt University Robert Cook-Deegan, Director, Center for Genome Ethics, Law, and Policy, Institute for Genome Sciences & Policy, Duke University Christina deHayes, General Counsel, Asterand 4:00 - 4:15 Coffee 4:15 - 5:00 Reflections on Lessons Learned and Best Practices 5:00 Reception .

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FALL 2004 DEAN Alex M
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BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Ellen Wright Clayton, J.D., M.D. Professor of Pediatrics Professor of Law eRA COMMONS USER NAME Co-Director, Center for Biomedical Ethics and claytoew Society EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE INSTITUTION AND LOCATION YEAR(s) FIELD OF STUDY (if applicable) Duke University, Durham, North Carolina B.S. 1970-1974 Zoology Stanford University, Stanford, California M.S. 1974-1976 Biology Yale Law School, New Haven, Connecticut J.D. 1976-1979 Law Harvard Medical School, Boston, Massachusetts M.D. 1981-1985 Medicine A. Positions and Honors 1985 Visiting Assistant Professor (Spring Semester), Law School and Program in Medical Ethics, University of Wisconsin, Madison, WI 1985-1988 Resident, Department of Pediatrics, University of Wisconsin Hospital and Clinics, and Lecturer, Program in Medical Ethics, Madison, WI 1988-1996 Assistant Professor of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, Assistant Professor of Law, Vanderbilt University School of Law, Nashville, TN 1996-1999 Associate Professor of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN 1996-1999 Associate Professor of Law, Vanderbilt University School of Law, Nashville, TN 1989-1995 Member, Committee on Bioethics, American Academy of Pediatrics 1995-1998 Member, National Advisory Council, National Human Genome Research Institute 1997-2000 Member, ELSI Research Program & Evaluation Group, Nat’l Human Genome Research Institute 1997-2001 Editor-in-Chief, Journal of Law, Medicine and Ethics 1999-Pres Professor of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN 1999-Pres.
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Contact PD/PI: Clayton, Ellen W BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: Ellen Wright Clayton eRA COMMONS USER NAME (credential, e.g., agency login):claytoew POSITION TITLE: Craig-Weaver Chair and Professor of Pediatrics, Professor of Law, Co-Founder, Center for Biomedical Ethics and Society EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) DEGREE Completion (if Date FIELD OF STUDY INSTITUTION AND LOCATION applicable) MM/YYYY Duke University, Durham, North Carolina BS 05/1974 Zoology Stanford University, Stanford, California MS 06/1976 Biology Yale Law School, New Haven, Connecticut JD 05/1979 Law Harvard Medical School, Boston, Massachusetts MD 05/1985 Medicine A. Personal Statement My work focuses on the appropriate conduct of genomics research, addressing issues ranging from the roles of consent and governance, and the implementation of its fruits into clinical care, including developing criteria and defining the roles of various decision makers, including patients, physicians, family members, professional organizations, and regulators. I use a variety of methodologies in these studies: legal analysis, normative ethical analysis, and qualitative and quantitative research assessing the views of patients, and research participants, most recently regarding pharmacogenomic testing and in the eMERGE consortium’s large population-based survey of opinions about broad consent for research use and data sharing. I have had the opportunity to address many of these critical policy issues in real time, having served as Co-Chair of the ELSI Working Group of the International HapMap Project, as well as playing a leadership role in developing and guiding Vanderbilt’s innovative BioVU resource.
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Appendix C Acknowledgments OTA thanks the many individuals and organizations that generously supplied information for this study. In addition, OTA acknowledges the following individuals for their review of drafts of this background paper: J.G.M Aartsen S.R. Benatar Health Council of the Netherlands University of Cape Town The Hague, The Netherlands Cape Town, South Africa Duane F. Alexander Bela Blasszauer National Institute of Child Health Medical University of Pees and Human Development Pecs, Hungary Bethesda, MD Dan W. Brock Margaret A. Anderson Brown University American Public Health Association Providence, RI Washington, DC Christian Byk Paul W. Armstrong Paris, France Bridgewater, NJ Daniel Callahan Christian Bardoux The Hastings Center Commission of the European Communities Briarcliff Manor, NY Brussels, Belgium Alastair V. Campbell Nora K. Bell University of Otago University of South Carolina Dunedin, New Zealand Columbia, SC 84 Appendix C-Acknowledgments I 85 Arthur L. Caplan John 1, Fleming University of Minnesota Southern Cross Bioethics Institute Minneapolis, MN Plympton, Australia Peter Carpenter John C. Fletcher Stanford University University of Virginia Atherton, CA Charlottesville, VA Max Charlesworth S.S. Fluss North Carlton, Australia World Health Organization Geneva, Switzerland R. Alta Charo University of Wisconsin Law School Patricia Anne Flynn Madison, WI St. Mary’s College of California Moraga, CA James Childress Heman L. Fuenzalida University of Virginia Pan American Health Organization Charlottesville, VA Washington, DC Ellen Wright Clayton K.W.M. Fulford The Vanderbilt Clinic University of Oxford Nashville, TN Oxford, United Kingdom Robert M. Cook-Deegan Bradford H. Gray Institute of Medicine Yale University Washington, DC New Haven, CI’ Jean Davies Jiri F.
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TRANSCRIPT Current Issues in Genetics Ellen Wright Clayton, J.D., M.D. Craig-Weaver Professor of Pediatrics; Professor of Law; Director, Center for Biomedical Ethics and Society; Vanderbilt University Susan Wolf, J.D. McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre & Benson Professor of Law; Professor of Medicine; Faculty Member, Center for Bioethics; University of Minnesota Erik Parens, Ph.D. Senior Research Scholar, The Hastings Center Meeting 4, Session 4 February 28, 2011 Washington, D.C. DR. WAGNER: Okay, since our other Commissioners have the privilege of having your bios in their briefings, I’ll go ahead and introduce you to the rest of the room. We welcome today, Ellen Clayton, who is the Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt. She has advised the National Institutes of Health and other Federal and international bodies on topics ranging from children’s health to the ethical conduct of research. She received the William G. Bartholomew Award for Ethical Excellence from the American Academy of Pediatrics Section of Bioethics, and maybe the thing to do, a few of us have already spun up, Ellen, rather than introduce all three of you, I’ll let Ellen go ahead and make her presentation. DR. CLAYTON: Well, let me begin first by thanking you for inviting me to make a presentation to you. I want to make three quick comments, in response to Hank, and then I’m going to proceed to the purpose of my talk. With regard to his final comments about data, I would suggest that there are three major problems.
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Ellen Wright Clayton CURRICULUM VITAE February, 2020 Name
Ellen Wright Clayton CURRICULUM VITAE February, 2020 Name: Ellen Wright Clayton Addresses: Center for Biomedical Ethics and Society 2525 West End Ave., Suite 400 Nashville, TN 37203 (615) 322-1186 Vanderbilt University School of Law Nashville, TN 37240 (615) 322-1186 E-mail: ELLEN. [email protected] Date of Birth: June 22, 1952 Place of Birth : Houston, TX Home Address : 504 Fairfax Avenue Nashville, TN 37212 (615) 385-3779 Education: 1970-74: B.S., Duke University, Zoology 1974-76: M.S., Stanford University, Biology 1976-79: J.D., Yale Law School 1981-85: M.D., Harvard Medical School Postgraduate Training: 1985-88: Resident, Department of Pediatrics, University of Wisconsin Hospital and Clinics, and Lecturer, Program in Medical Ethics Licensure and Certification: 1988- : License to Practice Medicine, Tennessee #MD0000018825 1989- : Certification, American Board of Pediatrics #211033 1991- : Fellow, American Academy of Pediatrics #140172001 1988- : Inactive Member, State Bar of Texas Academic Appointments: Ellen Wright Clayton 1982-83: Research Assistant, Professor Jay Katz, Yale University, worked on his book, The Silent World of Doctor and Patient, Free Press, 1985 1985: Visiting Assistant Professor (Spring Semester), Law School and Program in Medical Ethics, University of Wisconsin 1988-96: Assistant Professor of Pediatrics, Vanderbilt University Medical School Assistant Professor of Law, Vanderbilt University School of Law Fellow, Vanderbilt Institute for Public Policy Studies, Center for Health Policy 1993: Visiting Professor of Law, University of Houston Law Center, Health Law and Policy Institute 1996-99: Associate Professor of Pediatrics with tenure, Vanderbilt University Medical School Associate Professor of Law, Vanderbilt University School of Law Faculty Member, Vanderbilt Program in Human Genetics Senior Fellow, Vanderbilt Institute for Public Policy Studies, Center for Health Policy Associate, Center for Clinical and Research Ethics 1999-05: Director, Center for Genetics and Health Policy 1999-2010: Rosalind E.
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Ethical Issues in Newborn Sequencing Research: the Case Study of Babyseq Lainie Friedman Ross, MD, Phd,A Ellen Wright Clayton, MD, Jdb
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