Annual Research Ethics Conference — Major Changes in Research Rules & Oversight: Making Progress or Creating New Problems?

8:30am
Welcome
(moderator: Susan M. Wolf, JD, McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; Chair, Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota)

• Christopher J. Cramer, PhD, Vice President for Research; Distinguished McKnight University Professor, Department of Chemistry, University of Minnesota 

8:45am
Changing Oversight of Emerging Technology – Challenges for Researchers, Institutional Biosafety Committees (IBCs), and the Community
(moderator: Jakub Tolar, MD, PhD, Dean of the Medical School; Vice President for Clinical Affairs; McKnight University Distinguished Professor of Pediatrics; Director, Stem Cell Institute, University of Minnesota)

• Carrie D. Wolinetz, PhD, Associate Director for Science Policy, National Institutes of Health (NIH)  

Q/A

9:45am
Changing the Common Rule for Research with Human Participants – Challenges for Investigators, IRBs, and Participants
(moderator: Michelle Biros, MD, Professor, Interim Department Head, and Research Director of the Department of Emergency Medicine; Deputy Institutional Official, University of Minnesota Biomedical Research; Vulnerable Populations Advisor, University of Minnesota Medical School Institutional Review Board; and Past Editor-in-Chief, Academic Emergency Medicine) 

• P. Pearl O’Rourke, MD, Director of Human Research Affairs, Partners HealthCare Systems, Boston; Associate Professor of Pediatrics, Harvard Medical School; Member, Working Group of the Advisory Committee to the Director, All of Us Research Program

Q/A

10:45am
Changing the Definition of Clinical Trials – Challenges for Basic and Social Scientists
(moderator: Megan Gunnar, PhD, Regents Professor; Distinguished McKnight University Professor; Department Chair, Institute of Child Development, University of Minnesota)

• Jeremy M. Wolfe, PhD, Professor of Ophthalmology and Radiology, Harvard Medical School; Director, Visual Attention Lab, Department of Surgery, Brigham and Women’s Hospital; former President, Federation of Associations of Behavioral and Brain Sciences (FABBS)

Q/A

11:45am
Break (with distribution of box lunches)

Noon
Panel Discussion
(moderator: Douglas Yee, MD, John H. Kersey Chair in Cancer Research; Professor, Medicine and Pharmacology; Director, Masonic Cancer Center, University of Minnesota)
The morning speakers and moderators will participate in a panel discussion and take questions from the audience. The following panelists will give brief remarks before all join in the discussion.

• Sue Abderholden, MPH, Executive Director, NAMI (National Alliance on Mental Illness) Minnesota; Member, Community Oversight Board, Office of the Vice President for Research, University of Minnesota 
• Zubin Master, PhD, Associate Professor of Biomedical Ethics, Biomedical Ethics Research Program and Center for Regenerative Medicine, Mayo Clinic
• John E. Wagner, Jr., MD, McKnight Presidential Chair in Childhood Cancer Research; Children’s Cancer Research Fund/Hageboeck Family Endowed Chair in Pediatric Oncology; Scientific Director of Clinical Research, Stem Cell Institute, University of Minnesota

1:25pm
Closing remarks

• Susan M. Wolf, JD, Chair, Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota

1:30 pm
Adjourn

Sue Abderholden, MPH, is the Executive Director of NAMI (National Alliance on Mental Illness) Minnesota, where she focuses on ending the discrimination faced by children and adults with mental illnesses and their families. Over the past nearly 40 years, Ms. Abderholden has successfully fought for community and family support and for laws that enable people with disabilities to fully participate in society. She has held positions with The Arc Minnesota, US Senator Paul D. Wellstone, and the PACER Center (Minnesota’s Parent Training and Information Center) and has received numerous awards for her advocacy.

 

 

Michelle H. Biros, MD, MS, is Professor and  Interim Department Chair   of the Department of Emergency Medicine; Deputy Institutional Official, University of Minnesota Biomedical Research; Vulnerable Populations Advisor, University of Minnesota Medical School Institutional Review Board; and Past Editor-in-Chief, Academic Emergency Medicine. She is an elected member of the National Academy of Medicine (NAM), and is currently Principal Investigator for the University of Minnesota Hub of the National Institutes of Medicine Funded Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) .  

 

 

Christopher J. Cramer, PhD, is Vice President for Research at the University of Minnesota. Prior to joining the Office of the Vice President for Research (OVPR), Prof. Cramer was a Distinguished McKnight and University Teaching Professor in the College of Science and Engineering, where he also served as Associate Dean for Research and Planning and for Academic Affairs. Prof. Cramer served as the Editor-in-Chief of Theoretical Chemistry Accounts for 15 years and as an Associate Editor for the Journal of Physical Organic Chemistry for 20. He has been recognized as a Fellow by the American Chemical Society, as well as by the Alfred P. Sloan and John Simon Guggenheim foundations, and his recent research has been supported by the Department of Energy, the National Science Foundation, and the Defense Threat Reduction Agency. 

 

Megan Gunnar, PhD, is Regents Professor; Distinguished McKnight University Professor; Director (Department Chair) of the Institute of Child Development; and Associate Director, Center for Neurobehavioral Development, all at the University of Minnesota. Her research focuses on how children and adolescents regulate stress physiology and emotions and the impact of early life stress on brain and behavioral development.

 

 

Zubin Master, PhD, is an Associate Professor of Biomedical Ethics, Biomedical Ethics Research Program and Center for Regenerative Medicine at Mayo Clinic. After earning his PhD at the University of Toronto, Dr. Master completed post-doctoral fellowships at Dalhousie University in Nova Scotia and the University of British Columbia, as well as serving as Guest Researcher at the National Institute of Environmental Health Sciences, National Institutes of Health and as Affiliate Investigator at the Sprott Centre of Stem Cell Research and the Ottawa Hospital Research Institute, University of Ottawa. Prior to his return to academia, Dr. Master was a Senior Policy Advisor at Health Canada, where he was responsible for developing regulations on assisted human reproduction and embryo research and subsequently led the development of the Health Canada Scientific Integrity Framework. 

 

P. Pearl O’Rourke, MD, is Director of Human Research Affairs at Partners HealthCare Systems, Boston; Associate Professor of Pediatrics at Harvard Medical School; and a member of the Advisory Committee to the Director at the All of Us Research Program. Dr. O’Rourke has worked as a Pediatric Critical Care Physician at Children's Hospital, Boston and at the Children’s Hospital at the University of Washington in Seattle, where she was the Director of the Pediatric Intensive Care Unit. She has undertaken clinical research in extracorporeal membrane oxygenation, liquid ventilation, high frequency ventilation, and pediatric resuscitation. In Seattle she served many years as a member of the Institutional Review Board. Dr. O'Rourke is currently a member and past Chair of the Public Responsibility in Medicine and Research (PRIM&R) Board. 

 

Kristine Rhodes, MPH, Chief Executive Officer, American Indian Cancer Foundation (AICAF). Prior to joining AICAF, she was a Research Project Coordinator at the University of Minnesota School of Public Health, where she worked on numerous community research efforts. She began her career as the Community Health Educator for her tribal community at the Fond du Lac Reservation.

 

 

 

Jakub Tolar, MD, PhD, is the Dean of the University of Minnesota Medical School; Vice President for Clinical Affairs; a Distinguished McKnight Professor in the Department of Pediatrics, Blood and Marrow Transplantation; and Director of the Stem Cell Institute at the University of Minnesota. He is also Board Chair for University of Minnesota Physicians and co-leader of M Health Fairview, the Joint Clinical Enterprise between the University of Minnesota Medical School, University of Minnesota Physicians and Fairview Health Services. An internationally recognized physician and researcher, Dr. Tolar is known for his care of patients with recessive dystrophic epidermolysis bullosa. His research is focused on using hematopoietic stem cell transplant as a treatment for rare genetic disorders. 

 

John E. Wagner, Jr., MD, is McKnight Presidential Chair in Childhood Cancer Research; Children's Cancer Research Fund/Hageboeck Family Endowed Chair in Pediatric Oncology; Professor and Director of Blood and Marrow Transplantation in the Department of Pediatrics; Scientific Director of Clinical Research at the Stem Cell Institute; and Co-Director of the Center for Translational Medicine at the University of Minnesota.  Prof. Wagner has led the University of Minnesota's Cord Blood Transplantation Program in the treatment of adults and children and is responsible for its international prominence, having first pioneered its use in 1990 in leukemia.

 

Susan M. Wolf, JD, is Chair of the conference planning committee. She is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. Prof. Wolf is Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences. She is an elected member of the National Academy of Medicine (NAM) and a Fellow of the American Association for the Advancement of Science.  Prof. Wolf's research has been supported by the National Institutes of Health (NIH) and National Science Foundation (NSF) as well as private foundations including the Robert Wood Johnson Foundation and The Greenwall Foundation.

 

 

Jeremy M. Wolfe, PhD, is Professor of Ophthalmology and Professor of Radiology at Harvard Medical School and Director of the Visual Attention Lab at Brigham and Women's Hospital. Prof. Wolfe is Editor of the journal Cognitive Research: Principles and Implications and immediate past-Editor of the journal, Attention, Perception and Psychophysics. He is former-President of the Federation of Associations of Behavioral and Brain Sciences (FABBS), is on the Governing Board of the Vision Sciences Society, and is a Fellow of the AAAS, the American Psychological Assocation (Div. 1, 3, 6, & 21), and the American Psychological Society, and a member of the Society for Experimental Psychologists.

 

Carrie D. Wolinetz, PhD, is Associate Director for Science Policy, National Institutes of Health (NIH). Prior to joining the NIH, she was Deputy Vice President for Federal Relations with the Association of American Universities (AAU) and Director of Scientific Affairs and Public Relations at the Federation of American Societies for Experimental Biology (FASEB). Dr. Wolinetz has served as President of United for Medical Research, a leading coalition of universities, patient groups, and private sector companies advocating for sustainable funding for the NIH. In addition, she is an Adjunct Assistant Professor at Georgetown University in the School of Foreign Service’s program on Science, Technology & International Affairs, as well as past-Chair of the Advocacy Committee for the Association for Women in Science (AWIS). 

 

Douglas Yee, MD, is Director of the Masonic Cancer Center, Professor of Medicine and Pharmacology, and John H. Kersey Chair in Cancer Research at the University of Minnesota. As Director of the Cancer Center, he serves as the point person for all cancer research at the University. He also treats patients with breast cancer and conducts research to improve cancer therapies.

Susan M. Wolf, JD, is Chair of the conference planning committee. She is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. Prof. Wolf is Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences. She is an elected member of the National Academy of Medicine (NAM) and a Fellow of the American Association for the Advancement of Science.  Prof. Wolf's research has been supported by the National Institutes of Health (NIH) and National Science Foundation (NSF) as well as private foundations including the Robert Wood Johnson Foundation and The Greenwall Foundation.

 

William Arnold, PhD, is Distinguished McKnight University Professor, Joseph T. and Rose S. Ling Professor, and Associate Department Head in the Department of Civil, Environmental, and Geo-Engineering at the University of Minnesota. His research focuses on water pollutants, and seeks to understand how organic pollutants (like industrial solvents, pesticides, and pharmaceuticals) behave in natural systems (such as lakes and rivers) and engineered systems (like drinking water pipes and wastewater treatment technologies).

 

 

Gregory Cuomo, PhD, is Associate Dean for Research and Graduate Programs in the University of Minnesota's College of Food, Agriculture and Natural Resource Sciences (CFANS). He is a Professor in the Department of Agronomy and Plant Genetics, Deputy Director of the Minnesota Agricultural Experiment Station (MAES), and Division Head of CFAN's 10 outstate research and outreach centers.

 

 

 

Milton "Mickey" Eder, PhD, is Assistant Professor in the Department of Family Medicine and Community Health. His research interests include quality and safety within primary care office systems and engaging diverse communities in all aspects of research with the goal of translating knowledge into improved health outcomes. He is Associate Director of the U of M Clinical and Translational Science Institute (CTSI) and Director of the Office of Community Engagement to Advance Research and Community Health. He has chaired and served on AHC biomedical review boards.  Previous research and program evaluation regarding patient safety, health literacy, and health disparities, helped improve patient outcomes within a Federally Qualified Health Center network.

 

Sarah E. Gollust, PhD, is an Associate Professor of Health Policy and Management in the School of Public Health, University of Minnesota. Prof. Gollust is a social scientist examining the processes through which health information is presented in the media, shapes public attitudes and opinions, and influences the health policy process. She has applied this research approach in studying obesity, health disparities, the Affordable Care Act, and cancer screening and prevention. She is a past Robert Wood Johnson Foundation Health & Society Scholar at the University of Pennsylvania and Bioethics Fellow at NIH.

 

 

Megan Gunnar, PhD, is Regents Professor; Distinguished McKnight University Professor; Director (Department Chair) of the Institute of Child Development; and Associate Director, Center for Neurobehavioral Development, all at the University of Minnesota. Her research focuses on how children and adolescents regulate stress physiology and emotions and the impact of early life stress on brain and behavioral development.

 

 

Brian Herman, PhD, is Professor of BioMedical Engineering in the College of Science and Engineering, and previously served as the Vice President for Research, at the University of Minnesota. Before coming to Minnesota, Dr. Herman was Professor and Chair of the Department of Cellular and Structural Biology, and then Vice President for Research, at the University of Texas Health Science Center at San Antonio. He is a past recipient of an American Cancer Society Faculty Research Award (1991-1995) and two NIH National Institute on Aging “Method to Extend Research in Time” (MERIT) Awards (1994-2004, 2005-2015).

 

 

David H. Ingbar, MD, is Professor of Medicine in the Division of Pulmonary, Allergy, Critical Care and Sleep Medicine; Division Director, Department of Medicine; and Director, Research Education, Training, and Career Development (CTSI-Ed), Clinical and Translational Science Institute (CTSI), all at the University of Minnesota. His clinical interests are acute lung injury/ARDS, respiratory failure, pulmonary embolism, hemoptysis, critical care, and pulmonary edema. Prof. Ingbar is past-President of the American Thoracic Society.

 

 

Amy Kircher, DrPH, is Director of the Food Protection and Defense Institute, a Department of Homeland Security Center of Excellence, and Assistant Professor in the University of Minnesota's College of Veterinary Medicine. Prof. Kircher coordinates a research consortium dedicated to protecting the food system. Her current research includes identification and warning of food disruptions through data fusion and analysis. Prior to coming to the University of Minnesota, Dr. Kircher held epidemiologist positions at NORAD – US Northern Command and with the United States Air Force.

 

 

Frances Lawrenz, PhD, is Associate Vice President for Research and Wallace Professor of Teaching and Learning in the Department of Educational Psychology, which is part of the College of Education and Human Development, University of Minnesota. Her research focuses on science and mathematics program evaluation, utilizing a variety of techniques and usually involving mixed methodologies. She was recognized by the American Educational Research Association, receiving the 2016 Research on Evaluation SIG Distinguished Scholar Award and by the National Association for Research in Science Teaching, with the Distinguished Contributions to Science Education through Research Award in 2014.

 

 

Tucker LeBien, PhD, is a Professor of Laboratory Medicine & Pathology; Director of the Office of Discovery and Translation in the Clinical and Translational Science Institute (CTSI); and Senior Advisor for Research Operations in the Office of Academic Clinical Affairs, all at the University of Minnesota. In addition to his administrative, research advocacy and oversight roles, Prof. LeBien serves as the University's liaison to the University of Minnesota-Mayo Partnership in Biotechnology and Medical Genomics. That innovative collaboration is focused on positioning the state of Minnesota as a world leader in biotechnology and biomedical research. Since its founding in 2003, the Partnership has attracted more than $160 million in new grant funding from the National Institutes of Health.  

 

Michael T. Osterholm, PhD, MPH, is Regents Professor; McKnight Presidential Endowed Chair in Public Health; the Director of the Center for Infectious Disease Research and Policy (CIDRAP); and Distinguished Teaching Professor in the Division of Environmental Health Sciences, School of Public Health at the University of Minnesota. He is also a Professor in the Technological Leadership Institute, College of Science and Engineering, and an Adjunct Professor in the Medical School. Prof. Osterholm is a member of the National Academy of Medicine (NAM) and the Council on Foreign Relations, and is currently serving as one of the US Department of State's international Science Envoys. He has previously served as a high-level advisor on issues related to bioterrorism, public health preparedness, and infectious diseases.

 

Michael Sadowsky, PhD, is Director of the BioTechnology Institute; Professor in the BioTechnology Institute and Department of  Soil, Water & Climate; and serves on the faculty of 10 Graduate Programs, all at the University of Minnesota. Prof. Sadowsky is a Fellow of the American Academy of Microbiology and the American Association for the Advancement of Science. He is internationally known and respected for his research work in the area of fecal microbiota transplantation and environmental microbiology.

 

 

John E. Wagner, Jr., MD, is McKnight Presidential Chair in Childhood Cancer Research; Children's Cancer Research Fund/Hageboeck Family Endowed Chair in Pediatric Oncology; Professor and Director of Blood and Marrow Transplantation in the Department of Pediatrics; Scientific Director of Clinical Research at the Stem Cell Institute; and Co-Director of the Center for Translational Medicine at the University of Minnesota.  Prof. Wagner has led the University of Minnesota's Cord Blood Transplantation Program in the treatment of adults and children and is responsible for its international prominence, having first pioneered its use in 1990 in leukemia.

 

 

Sarah Waldemar is Director of the Research Compliance Office, an independent unit that helps ensure that University of Minnesota research complies with relevant laws, rules, policies, and guidelines. She has served the University for more than 37 years, including as Director of Research Education and Oversight; Head of the Office of Oversight, Analysis, and Reporting; and Administrative Director of the Division of Environmental Health Sciences in the School of Public Health. She has coordinated multi-center clinical trials and been a leader in the University’s risk recalibration activities. She holds a B.A. from the University of Minnesota and is a graduate of Minnesota Partnership for Executive Leadership Development.

 

Douglas Yee, MD, is Director of the Masonic Cancer Center, Professor of Medicine and Pharmacology, and John H. Kersey Chair in Cancer Research at the University of Minnesota. As Director of the Cancer Center, he serves as the point person for all cancer research at the University. He also treats patients with breast cancer and conducts research to improve cancer therapies.

 

 

 

Philip David Zelazo, PhD, is the Nancy M. and John E. Lindahl Professor, Department of Psychology, Institute of Child Development at the University of Minnesota. From 1992-2007, he taught at the University of Toronto, where he held the Canada Research Chair in Developmental Neuroscience. Prof. Zelazo's research focus is developmental psychology and neuroscience, with particular attention to executive function (conscious control of thought, action, and emotion).

Background articles and websites that may be useful include: 

• Collins FS, Gottlieb S. The Next Phase of Human Gene-Therapy Oversight. New England Journal of Medicine 2018;379:1393-1395.
• Kaiser J. Some Scientists Hate NIH’s New Definition of a Clinical Trial. Here's Why. Science Magazine 2019;363(6423).
• Lenzi RN, Altevogt BM, Gostin LO, eds. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington DC: National Academies Press 2013.
• National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Federal Register 2018;83(160)41082-41093.
• Nicols L, Brako L, Rivera SM, Tahmassian A, Jones MF, Pierce HH, Bierer BE. What Do Revised US Rules Mean for Human Research? Science Magazine 2017;357(6352):650-651.
• Office of Extramural Research, National Institutes of Health: NIH's Definition of a Clinical Trial
• Office for Human Research Protections, US Department of Health & Human Services: Revised Common Rule
• O'Rourke PP. The Final Rule: When the Rubber Meets the Road. American Journal of Bioethics 2017;17(7):27-33.
• University of Minnesota Board of Regents Policy: Research Involving Human Participants
• University of Minnesota Institutional Review Board: Common Rule Changes
• Wolfe JM, Kanwisher NG. Not Your Parent's NIH Clinical Trial. Nature Human Behavior 2018;2:107-109.
• Wolinetz CD, Collins FS. Single-Minded Research Review: The Common Rule and Single IRB Policy. American Journal of Bioethics 2017;17(7):34-36.