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SERCEB logo Southeast Regional Center of Excellence for Emerging Infections and Biodefense
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Core Services

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  
Public Health Ethics in a Pandemic
Confronting ethical dilemmas for the public's health in the event of a infectious disease crisis.
Bioethics & Biodefense
Unique 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.
Codes of Conduct for Bioscientists
Guidelines and codes intended to reinforce the professional and ethical obligations of life scientists.
Biological and Toxin Weapons Convention (BWC)
Historical, current, and potential future implications of the BWC for biodefense and emerging infectious disease research.
Institutional Biosafety Committees (IBCs)  
The role of and resources for IBC members in reviewing research with dual-use potential.
Intellectual Property
Ensuring access to health products for resource-poor countries.  
Human Subjects Research Oversight
Review 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 Planning
The 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 Research
Unique 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 Epistemology
Considering 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

Advisory Committee

Ruth Berkelman, MD
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
Center for Biomedical Ethics and Society
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 
 
Jim Thomas, PhD, MPH
Associate Professor of Epidemiology
Director, Program in Public Health Ethics
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
 
Rebecca Walker, Ph.D.
Assistant Professor 
Department of Social Medicine
University of North Carolina at Chapel Hill

Staff

Senior Program Coordinator, SERCEB Policy, Ethics and Law Core 
Duke University Medical Center 
 
E. Megan Davidson
Research Analyst, SERCEB Policy, Ethics and Law Core
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
 
 
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