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Policy, Ethics and Law Core
Research, clinical care, and public health interventions related to emerging infections and biodefense raise critically important ethical, legal, and social issues. The Policy, Ethics and Law (PEL) Core is part of the Southeast Regional Center of Excellence for Biodefense and Emerging Infections (SERCEB), one of 10 regional centers established by the National Institute of Allergy and Infectious Diseases (NIAID) to develop new vaccines, therapies, and diagnostics for emerging infections and biodefense threats. The PEL Core functions under the direction of a multi-disciplinary Advisory Committee. Committee members consult with researchers, clinicians, public health and government officials, experts in biosecurity and health policy, epidemiologists, bioethicists, and the senior scientists serving as SERCEB investigators. For more information please contact Bob Cook-Deegan (PEL Core PI) or Allison Chamberlain (PEL Core Senior Program Coordinator).
Topics of interest, publications, and projects include:
The Dual Use Dilemma in Biological Research
- NEW! We have revised our online dual use educational module! Click here for more information and to take the module: ONLINE EDUCATIONAL MODULE
- Our dual use EDUCATIONAL PACKET provides information on the history and current activities surrounding the dual use dilemma in the U.S., as well as information on some of the entities involved in biosecurity and dual use policy.
- Davidson EM, Frothingham R, Cook-Deegan R. Policy Forum: Practical Experiences in Dual-Use Review. Science v316 n5830 (8 June 2007): 1432-1433.
- Kelley M. Infectious Disease Research and Dual Use Risk
. Virtual Mentor v8 n4 (April 2006): 230-234.
- Dual Use Research and Publication
Public Health Ethics in a PandemicConfronting ethical dilemmas for the public's health in the event of a infectious disease crisis.
- Thomas JC. Ethical Concerns in Pandemic Influenza Planning and Responses
. White Paper commissioned by the SERCEB Policy, Ethics and Law Core. May 2007.
- Thomas JC, Dasgupta N, Martinot A. Ethics in a Pandemic: A Survey of the State Pandemic Influenza Plans. American Journal of Public Health v7 nS1 (Apr 2007): S26-31.
Bioethics & BiodefenseUnique ethical questions that arise in the conduct of scientific research undertaken for biodefense objectives.Balancing Biosecurity
Analyzing how contemporary bioscience research, public health, and national security communities relate in the post-2001 environment.
- Fischer JE. Stewardship or Censorship? Balancing Biosecurity, The Public's Health, and The Benefits of Scientific Openness. White Paper commissioned by the SERCEB Policy, Ethics and Law Core. Published by the Henry L. Stimson Center. May 2006.
Codes of Conduct for BioscientistsGuidelines and codes intended to reinforce the professional and ethical obligations of life scientists.
- Anestidou L et al. Letter regarding National Science Advisory Board for Biosecurity (NSABB) Codes of Conduct Working Group Progress and Draft Document
. 7 September 2006.
- NSABB Codes of Conduct Working Group Progress Report
& Draft Considerations in Developing a Code of Conduct for Dual Use Research in the Life Sciences
. 13 July 2006. National Institutes of Health: Bethesda, Maryland.
- OECD Biosecurity Codes website
Biological and Toxin Weapons Convention (BWC)
Historical, current, and potential future implications of the BWC for biodefense and emerging infectious disease research.
- Gronvall GK. Biological and Toxin Weapons Convention
. White Paper commissioned by the SERCEB Policy, Ethics and Law Core. April 2006.
- Gronvall GK. A new role for scientists in the Biological Weapons Convention
. Nature Biotechnology v23 n10 (10 Oct 2005): 1213-16.
Institutional Biosafety Committees (IBCs)The role of and resources for IBC members in reviewing research with dual-use potential.
- Cook-Deegan RM, et al. Letter: Issues in Biosecurity and Biosafety. Science v308 n5730 (24 Jun 2005): 1867-8.
Intellectual PropertyEnsuring access to health products for resource-poor countries.Human Subjects Research OversightReview mechanisms for research responding to an imminent threat or rapidly emerging infectious disease.
- Kelley M, Tilden SJ. Ethical and Legal Oversight of Human Subjects Research in Emerging Infections and Biodefense Research: A Review of Recent Changes and Call for Policy Reform. Houston Journal of Health Law & Policy. v8 n1 (Fall 2007): 1 - 45.
- Jester PM, Tilden SJ, Li Y, Whitley RJ, Sullender WM. Regulatory challenges: Lessons learned from recent West Nile virus trials in the US. Contemporary Clinical Trials v27 n3 (Jun 2006): 254-9.
Emergency Response PlanningThe interface between state and local public health institutions, recently enacted state and federal emergency response legislation, and the basic science research community.Ethical Use of Animals in Biodefense ResearchUnique questions that arise when utilizing animal subjects for such research, previous related experiences, and utilizing such information when proposing future studies with animal subjects.Social Moral EpistemologyConsidering social and cultural relationships in reducing the risks of research misuse and laboratory accidents while maintaining openness and transparency.
Principal Investigator
Robert Cook-Deegan, MD
Director, Center for Genome Ethics, Law and Policy
Institute for Genome Sciences and Policy
Duke University
Director, Center for Genome Ethics, Law and Policy
Institute for Genome Sciences and Policy
Duke University
Advisory Committee
Ruth Berkelman, MD
Professor of Epidemiology
Professor of Epidemiology
Director, Center for Public Health Preparedness
Rollins School of Public Health
Emory University
Biosafety Officer
Vanderbilt University
Distinguished Visiting Professor, United States Air Force Academy (2007-8)
Senior Lecturer in Biology
Director, Emory College Program in Science and Society
Emory University
Professor of Molecular Genetics and Microbiology
University of Florida
Elizabeth Heitman, PhD
Associate Professor of Medical Ethics
Associate Professor of Medical Ethics
Center for Biomedical Ethics and Society
Vanderbilt University
Vanderbilt University
Professor of Social Sciences and Health Policy
Director, Program in Bioethics, Health and Society
Wake Forest University School of Medicine
Director, Trent Center for Bioethics, Humanities & History of Medicine
Professor of Pediatric Infectious Diseases
Duke University Medical Center
Associate Professor of Epidemiology
Director, Program in Public Health Ethics
School of Public Health
School of Public Health
University of North Carolina at Chapel Hill
Deputy Provost for Human Subjects Research
Research Compliance Officer
Professor of Pediatrics
University of Alabama at Birmingham
University of Alabama at Birmingham
Rebecca Walker, Ph.D.
Assistant Professor
Assistant Professor
Department of Social Medicine
University of North Carolina at Chapel Hill
Staff
Duke University Medical Center
Nikki M. Vangsnes
Project Director, SERCEB Policy, Ethics and Law Core
Associate Director, Trent Center for Bioethics, Humanities and History of Medicine
Duke University Medical Center
Project Director, SERCEB Policy, Ethics and Law Core
Associate Director, Trent Center for Bioethics, Humanities and History of Medicine
Duke University Medical Center



. Virtual Mentor v8 n4 (April 2006): 230-234.
. White Paper commissioned by the SERCEB Policy, Ethics and Law Core. May 2007. 

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