Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight

nanodiagnostics & nanotherapeutics
September 26, 2011 - 8:30am to 4:45pm
Cowles Auditorium, Hubert H. Humphrey Center

This conference presented the first systematic and comprehensive recommendations and analysis on protecting human participants in research on nanomedicine products, including drugs, devices, and gene therapy using nano-vectors. Nanomedicine research in human subjects is at the forefront of new challenges to research ethics and oversight posed by advanced technologies. This research raises significant questions about how to protect human subjects, especially in first-in-human (FIH) trials. But the challenges are even bigger — how to protect researchers, lab workers, the environment, and bystanders who may be exposed to nanomaterials in the course of research. This conference brought together the top experts in the country to address cutting-edge questions, including:

  • Does some nanomedicine research pose unique risks? When are risk and uncertainty low enough to justify initiating nanomedicine research in humans?
  • What are the special challenges in obtaining informed consent for nanomedicine research?
  • How should occupational, bystander, and environmental risks be considered in deciding whether to authorize nanomedicine human subjects research?
  • What innovations in the oversight of human subjects research are needed for nanomedicine research?

Read about the conference in an article in Nature

Expand all

Agenda and Videos

8:30am
Opening Remarks
Susan M. Wolf, JD, University of Minnesota
View video

Welcome
Mihail C. Roco, PhD, National Science Foundation (NSF)
View video

8:45am
Translation of Nanotherapeutics and Nanodiagnostics to Clinical Practice: Overview and Examples
Moderator: Susan M. Wolf, JD, University of Minnesota
Samuel Wickline, MD, Washington University in St. Louis 
View video

9:15am
The Challenges Posed by Nanomedicine Research in Human Beings
Andrew Maynard, PhD, University of Michigan 
View video

9:45am
Discussion 
View video

10:00am
Break

10:15am
Ethical Conduct and Oversight of Human Subjects Research in Nanomedicine: Project Analysis & Recommendations 

Susan M. Wolf, JD, University of Minnesota
Leili Fatehi, JD, University of Minnesota
Frances P. Lawrenz, PhD, University of Minnesota
Jeffrey McCullough, MD, University of Minnesota Medical School
Jeffrey P. Kahn, PhD, MPH, University of Minnesota
Ralph Hall, JD, University of Minnesota Law School
View video 

10:45am
Panel—Reaction to Recommendations 
Moderator: Frances Lawrenz, PhD, University of Minnesota

Panelists:
Mihail C. Roco, PhD, National Science Foundation (NSF)
John Howard, MD, MPH, JD, LLM, National Institute for Occupational Safety and Health (NIOSH)
Jerry Menikoff, MD, JD, MPP, U.S. Department of Health & Human Services
Jeffrey A. Schloss, PhD, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)
R. Alta Charo, JD, University of Wisconsin-Madison
Warren Lux, MD, U.S. Environmental Protection Agency (EPA)
View video

12:15pm
Networking Lunch

1:00pm
Concurrent Workshops

Session A: Defining the Problem & Core Risks
Moderator: Jeffrey McCullough, MD, University of Minnesota

Panelists:
Jeffrey McCullough, MD, and Michael Etheridge, MSME and MS candidate, University of Minnesota, on “Mapping the Nanomedicine Landscape”

Ron Siegel, ScD, University of Minnesota, on “What Is Unique About Nanomedicine? The Significance of the Meso-Scale”
View video

Andrew Maynard, PhD, University of Michigan, on “Proposals for Governance of Nanomedicine Research”
View video

Christy Haynes, PhD, Professor of Chemistry, University of Minnesota, (paper with Melissa Mauer-Jones, PhD candidate, Chemistry, University of Minnesota) on “Discrepancies in In Vivo and In Vitro Nanotoxicology Studies”
View video

Robert Hoerr, MD, PhD, Nanocopoeia, Inc., on “Collaborative Governance of Nanomedicine in the Face of Uncertainty”
View video

Q&A 
View video

Session B: First-in Human Research
Moderator: Jeffrey P. Kahn, PhD, MPH, and Ralph Hall, JD, University of Minnesota

Panelists:
Jerry Menikoff, MD, JD, MPP, OHRP, U.S. Department of Health & Human Services, on “Nanomedicine First-in-Human Research: OHRP Oversight”
View video

Rebecca Dresser, JD, Washington University in St. Louis, on “Building an Ethical Foundation for First-in-Human Nanotrials”
View video

Efrosini Kokkoli, PhD, University of Minnesota, on “What Does Pre-Clinical Research Tell Us About Moving Into Humans” 
View video

Nancy M.P. King, PhD, Wake Forest University School of Medicine, on “Nanomedicine First-in-Human Research: Challenges to Informed Consent”
View video

Q&A 
View video
 

2:30pm
Break
 

2:45pm
Concurrent Workshops

Session C: Human Subjects Protection
Moderator: Susan M. Wolf, JD, University of Minnesota

Panelists:
Ralph Hall, JD, University of Minnesota, on “FDA Approaches to Protecting Human Subjects in Nanomedicine Trials”
View video

Frances Lawrenz, PhD, University of Minnesota, on “Current Approaches to Oversight of Human Subjects Research in Nanomedicine”
View video

Gary Marchant, JD, PhD, MPP, Arizona State University, on “Applying Prudent Precaution to Nanomedicine Clinical Trials” 
View video

Jeffrey P. Kahn, PhD, MPH, University of Minnesota, on “Models of Exceptional Oversight for Nanomedicine”
View video

Susan M. Wolf, JD, and Cortney Jones, JD, University of Minnesota, on “Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies” 
View video

Q&A 
View video
 

Session D: Beyond the Common Rule
Moderator: Moira Keane, MA, University of Minnesota

Panelists:
Jonathan Kimmelman, PhD, McGill University, on “Predicting Ethical and Safety Risks to Bystanders from Nanomedicine Research” 
View video

David Resnik, JD, PhD, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), on “Responsible Conduct in Nanomedicine Research: Concerns Beyond the Common Rule”
View video

Moira Keane, MA, CIP, University of Minnesota, on “Institutional Oversight of Nanomedicine Human Subjects Research: From the IRB to the IBC and Beyond”
View video

Gurumurthy Ramachandran, PhD, University of Minnesota, on “Handling Worker and Third-Party Exposures in Nanomedicine Research”
View video

Arthur Erdman, PhD, University of Minnesota, on “Nanomedicine Commercialization Issues, including Barriers to Start-Up Companies” 
View video

Q&A 
View video

4:15pm
Reports from Concurrent Sessions and Next Steps
Workshop Moderators 
View video

4:45pm
Reception

Conference Speakers

Robert Bullard, PhD, is the Edmund Asa Ware Distinguished Professor of Sociology and Director of the Environmental Justice Resource Center at Clark Atlanta University. He is the author of fourteen books that address sustainable development, environmental racism, urban land use, industrial facility siting, community reinvestment, housing, transportation, climate justice, emergency response, smart growth, and regional equity. He has been described as the "father of environmental justice."

 

 

Arthur L. Caplan, PhD, is the Emanuel and Robert Hart Professor Bioethics, Chair of the Department of Medical Ethics and the Director of the Center for Bioethics at the University of Pennsylvania. He has served on a number of national and international committees including as the Chair National Cancer Institute Biobanking Ethics Working Group and the ethics committee of the American Society of Gene Therapy.

 

 

 

 

R. Alta Charo, JD, is the Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin Law School. Charo serves on several expert advisory boards of organizations with an interest in stem cell research, including CuresNow, the Juvenile Diabetes Research Foundation, the International Society for Stem Cell Research and WiCell, as well as on the advisory board to the Wisconsin Stem Cell Research Program.

 

 

Ellen Clayton, MD, JD, is the Rosalind E. Franklin Professor of Genetics and Health Policy; Professor of Law; Professor of Pediatrics; and Co-Director, Center for Biomedical Ethics and Society at Vanderbilt University. She advises the National Human Genome Research Institute as well as other federal and international bodies on an array of topics ranging from children's health to the ethical conduct of research involving human subjects.

 

 

 

Cary Coglianese, JD, PhD, MPP, is the Associate Dean; Edward B. Shils Professor of Law; Professor of Political Science and Director of the Penn Program on Regulation at the University of Pennsylvania.

 

 

 

 

Glenn Cohen, JD, is an Assistant Professor and former Academic Fellow at the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School.

 

 

 

 

Holly Doremus, JD, PhD, is a Professor of Law at the University of California, Davis and a Member Scholar of the Center for Progressive Reform. She has written extensively about environmental and natural resources law and policy, with particular emphasis on biodiversity conservation and on the interplay of science and policy.

 

 

 

Apostolos P. Georgopoulos, MD, PhD, is a Professor of Neuroscience and Professor of Neurology at the University of Minnesota.

 

 

 

 

 

Lawrence Gostin

Lawrence O. Gostin, an internationally acclaimed scholar, is Associate Dean (Research and Academic Programs) and the Linda D. and Timothy J. O'Neill Professor of Global Health Law at the Georgetown University Law Center, where he directs the O'Neill Institute for National and Global Health Law. Dean Gostin is also Professor of Public Health at the Johns Hopkins University and Director of the Center for Law & the Public's Health at Johns Hopkins and Georgetown Universities-a Collaborating Center of the World Health Organization and the Centers for Disease Control and Prevention. Dean Gostin is Visiting Professor of Public Health (Faculty of Medical Sciences) and Research Fellow (Centre for Socio-Legal Studies) at Oxford University. He is the Health Law and Ethics Editor, Contributing Writer, and Columnist for the Journal of the American Medical Association. In 2007, the Director General of the World Health Organization appointed Dean Gostin to the International Health Regulations (IHR) Roster of Experts and the Expert Advisory Panel on Mental Health.

Judy Illes, PhD, is a Professor of Neurology and Canada Research Chair in Neuroethics, National Core for Neuroethics at the University of British Columbia. She helped build the research enterprise in imaging sciences in the Department of Radiology at Stanford University. She co-founded the Stanford Brain Research Center (now the Neuroscience Institute at Stanford), and served as its first Executive Director between 1998 and 2001.

 

 

 

Isaac (Zak) Kohane, MD, PhD, is the director of the Children's Hospital Informatics Program and is the Henderson Associate Professor of Pediatrics and Health Sciences and Technology at Harvard Medical School (HMS). He is also co-director of the HMS Center for Biomedical Informatics and Director of the HMS Countway Library of Medicine. Dr. Kohane leads multiple collaborations at Harvard Medical School and its hospital affiliates in the use of genomics and computer science to study cancer and the development of the brain (with emphasis on autism). He has developed several computer systems to allow multiple hospital systems to be used as "living laboratories" to study the genetic basis of disease while preserving patient privacy.

 

Jennifer Kuzma, PhD, is an Associate Professor in the Center for Science, Technology, and Public Policy at the Humphrey Institute of Public Affairs, University of Minnesota. Her current research interests include agrifood nanotechnology risk analysis and regulatory policy, and developing methods for integrated assessment of oversight models for bio and nanotechnology. She also participates on an interdisciplinary team studying full-cost accounting for renewable energy systems.

 

 

 

Gary Marchant, JD, MPP, PhD, is a Professor of Law and Executive Director & Faculty Fellow in the Center for the Study of Law, Science, & Technology, and Lincoln Professor of Emerging Technologies, Law & Ethics at Arizona State University.

 

 

 

Jonathan D. Moreno, PhD, is the David and Lyn Silfen University Professor and Professor of Medical Ethics and of History and Sociology of Science at Penn. He holds a joint appointment in HSS (School of Arts and Sciences) and in medical ethics in the School of Medicine. Moreno is also a Senior Fellow at the Center for American Progress in Washington, DC and a Visiting Professor of Biomedical Ethics at the University of Virginia. He is an elected member of the Institute of Medicine (IOM) of the National Academies and has been a member of numerous National Academies committees. He co-chaired the Committee on Guidelines for Human Embryonic Stem Cell Research. He has served as a senior staff member for two presidential advisory committees and has given invited testimony for both houses of congress. He is an advisor to the Howard Hughes Medical Institute, the Bill and Melinda Gates Foundation, and GlaxoSmithKline. He is also a Faculty Affiliate of the Kennedy Institute of Ethics at Georgetown University, and a Fellow of the Hastings Center and the New York Academy of Medicine.

Stephen J. Morse, PhD, JD, is the Ferdinand Wakeman Hubbell Professor of Law and Professor of Psychology and Law in Psychiatry at the University of Pennsylvania Law School. He is an expert in criminal and mental health law whose work emphasizes individual responsibility in criminal and civil law and the relation of the behavioral and neurosciences to responsibility and social control.

 

 

 

Alan Packer, PhD, is the Senior Editor at Nature Genetics. His graduate and post-doctoral research was in genetics.

 

 

 

 

E. Thomas Sullivan, JD, is the Senior Vice President for Academic Affairs and Provost at the University of Minnesota.

 

 

 

 

Deborah Swackhamer, PhD, is a Professor of Environmental Chemistry in the Division of Environmental health Sciences in the School of Public Health and Co-Director of the Water Resources Center at the University of Minnesota.

 

 

 

 

Susan Wolf

Susan M. Wolf, JD, is the McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre & Benson Professor of Medicine; Faculty Member in the Center for Bioethics; Director of the Joint Degree Program in Law, Health & the Life Sciences; and Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota.

Continuing Legal Education (CLE)

6.75 hours of standard Continuing Legal Education (CLE) credit has been approved. Event code 157975.

Conference sponsored by:
  • A grant from the National Institutes of Health, National Human Genome Research Institute (NIH, NHGRI) Award #1-RC-HG005338-01
  • The University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences
Academic Year