Annual Research Ethics Day Conference - Conducting Research in the COVID-19 Pandemic: Ethics in an Emergency

res ethics
March 3, 2021 - 9:00am to 1:30pm
Online - Zoom - Central time

Hear from top national experts on how the COVID-19 pandemic is changing research ethics. Experts will discuss how to advance ethics and equity when conducting pandemic research, how to reconcile the need for research with the clinical imperative to save lives, and how the pandemic is affecting research design. As a large, public, land-grant research university, we aim to explore these vital issues with our faculty, staff, trainees, students, and community, as well as a national audience.

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Conference Agenda

Annual Research Ethics Day Conference - Conducting Research in the COVID-19 Pandemic: Ethics in an Emergency Agenda

9:00 a.m.       

Welcome

 

Moderator: Susan M. Wolf, JD, Distinguished McKnight Professor, 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

Jakub Tolar, MD, PhD Vice President for Clinical Affairs, Dean of the Medical School, Distinguished McKnight Professor, University of Minnesota

9:15 a.m.

Conducting research in a pandemic: Advancing ethics and equity

 

Moderator: Michael T. Osterholm, PhD, MPH, Regents Professor; McKnight Presidential Endowed Chair in Public Health; Director, Center for Infectious Disease Research & Policy, University of Minnesota

Stephen B. Thomas, PhD, Professor of Health Policy & Management, University of Maryland; Director of the Maryland Center for Health Equity; and Principal Investigator (with Dr. Sandra Quinn) for the NIH-NIMHD Center of Excellence in Race, Ethnicity & Health Disparities Research

Abigail Echo-Hawk, MA, Director, Urban Indian Health Institute; Chief Research Officer, Seattle Indian Health Board 

10:15 a.m.                         

Moving fast: Should we think differently about research design and levels of evidence in a pandemic?

 

Moderator: James D. Neaton, PhD, Professor of Biostatistics, University of Minnesota

Christine Grady, MSN, PhD, Chief, Department of Bioethics; Head, Section on Human Subjects Research, NIH Clinical Center 

Derek C. Angus, MD, MPH, FRCP, Chief Healthcare Innovation Officer, Distinguished Professor and Mitchell P. Fink Endowed Chair, Department of Critical Care Medicine, University of Pittsburgh and UPMC Health System; Section Editor, Caring for the Critically Ill, JAMA 

11:15 a.m.                        

Break  

11:30 a.m.   

Learning while saving lives: How should we reconcile research and clinical care in the pandemic?

 

Moderator: Susan Kline, MD, MPH, Professor of Medicine, Co-Director of the General Infectious Disease service, and Physician Director of Antimicrobial Management, Division of Infectious Diseases and International Medicine, University of Minnesota

Arturo Casadevall, MD, PhD, Alfred & Jill Sommer Professor and Chair, Molecular Microbiology & Immunology; Bloomberg Distinguished Professor, Johns Hopkins Bloomberg School of Public Health

Jason V. Baker, MD, MS, FIDSA, Chief, Infectious Diseases, Hennepin Healthcare; Associate Professor of Medicine, Department of Medicine & Institute for Molecular Virology, University of Minnesota 

12:30 p.m.                              

Panel discussion – “Is COVID changing research ethics?”

 

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

Mary J. Owen, MD, Assistant Professor, Department of Family Medicine and BioBehavioral Health; Director, Center of American Indian and Minority Health, University of Minnesota Medical School

Douglas Yee, MD, John H. Kersey Chair in Cancer Research; Professor, Medicine and Pharmacology; Director, Masonic Cancer Center, University of Minnesota 

Nneka O. Sederstrom, PhD, MPH, MA, FCCP, FCCM, Chief Health Equity Officer, Hennepin Healthcare

Sarah Lim, MBBCh, Medical Specialist 2, Division of Infectious Disease Epidemiology, Prevention and Control, Minnesota Department of Health 

J. Michael Oakes, PhD, Professor, Division of Epidemiology and Community Health, School of Public Health; Associate Vice President for Research, University of Minnesota

Richard R. Sharp, PhD, Director, Biomedical Ethics Program, Center for Individualized Medicine Bioethics Program, and the Clinical and Translational Research Ethics Program, Mayo Clinic

1:25 p.m.     

Closing Remarks 

 

  Susan M. Wolf, JD

1:30 p.m. 

Adjourn

Speaker Biographies

Derek Angus

Derek C. Angus, MD, MPH, FRCP (UK), is Chief Healthcare Innovation Officer, Associate Vice Chancellor for Healthcare Innovation, University of Pittsburgh Schools of the Health Sciences and UPMC Healthcare System. At the University, he is a Distinguished Professor and the Mitchell P. Fink Endowed Chair in Critical Care Medicine with secondary appointments in Medicine, Health Policy and Management, and Clinical and Translational Science. Dr. Angus directs the CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illnesses) Center. He also co-directs the UPMC ICU Service Center, responsible for the provision of ICU services across the 20-plus hospital system. Dr. Angus is Section Editor on Caring for the Critically Ill in JAMA.

 

Jason Baker

Jason V. Baker, MD, MS, FIDSA, is Chief of Infectious Diseases at Hennepin Healthcare and an Associate Professor of Medicine at the University of Minnesota. Dr. Baker’s research program at HCMC involves translational clinical studies emphasizing persistent immune depletion, inflammation, and coagulation abnormalities among HIV+ patients. He focuses on mechanisms and treatment strategies targeting aging complications, such as cardiovascular disease, through both pathogenesis-oriented studies and multi-center trials and cohorts. Dr. Baker also holds leadership positions and directs studies within the NIH/NIAID-funded INSIGHT network (International Network for Strategic Initiative in Global HIV Trials), which recently conducted the SMART and START trials. Dr. Baker serves as a member of the NIH COVID-19 Treatment Guidelines Panel.

 

Arturo Casadevall

Arturo Casadevall, MD, PhD, is the Alfred & Jill Sommer Professor and Chair of Molecular Microbiology & Immunology as well as a Bloomberg Distinguished Professor at the Johns Hopkins School of Medicine. He holds a joint appointment in molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health. His research focuses on how microbes cause disease and how the immune system defends itself. Dr. Casadevall’s work has been recognized with numerous awards, including the American Society for Microbiology Founders Distinguished Service Award, the National Institutes of Health Merit Award, and the Rhoda Benham Award from Medical Mycology Society of America. Dr. Casadevall is an elected member of the National Academy of Medicine and the American Academy of Arts and Sciences. 

 

Christopher J. Cramer, PhD, is Vice President for Research at the University of Minnesota and a Distinguished McKnight and University Teaching Professor in the College of Science and Engineering. Prior to his appointment as Vice President, he served as Associate Dean for Research and Planning, and Academic Affairs, in the University’s College of Science and Engineering. Prof. Cramer served as the Editor-in-Chief of Theoretical Chemistry Accounts and as an Associate Editor for the Journal of Physical Organic Chemistry. He is a Fellow by the American Chemical Society, the Alfred P. Sloan Foundation and John Simon Guggenheim Foundation, and his recent research has been supported by the U.S. Department of Energy, the National Science Foundation, and the Defense Threat Reduction Agency. 

 

Abigail Echo-Hawk, MA (Pawnee), is the Director of the Urban Indian Health Institute, and the Chief Research Officer at the Seattle Indian Health Board. Urban Indian Health Institute is a Tribal Epidemiology Center that serves tribal people currently living off tribal lands nationwide. In addition, in UIHI’s role as the National Coordinating Center for Good Health and Wellness in Indian Country, she also works with approximately 100 tribal nations. Ms. Echo-Hawk also works with American Indian and Alaska Native tribes and organizations to identify health research priorities and with health researchers to ensure research is done in a manner that respects tribal sovereignty and is culturally appropriate.

 

Christine Grady, MSN, PhD, is a nurse-bioethicist and a senior investigator who serves as the Chief of the Department of Bioethics at the National Institutes of Health Clinical Center. Her research is both conceptual and empirical and primarily in the ethics of clinical research, including informed consent, vulnerability, study design, recruitment, and international research ethics, as well as ethical issues faced by nurses and other health care providers. She is an elected fellow of The Hastings Center and the American Academy of Nursing, a senior fellow at the Kennedy Institute of Ethics, and an elected member of the National Academy of Medicine. 

 

 

Susan Kline, MD, MPH, is Professor of Medicine, Co-Director of the General Infectious Disease service, and Physician Director of Antimicrobial Management, Division of Infectious Diseases and International Medicine, University of Minnesota Medical School, and Medical Director for Infection Control at the University of Minnesota Medical Center. She helped establish the Antibiotic Management Team at the University of Minnesota Medical Center in 2007. She currently is the Co-Director of the General Infectious Disease service and the Physician Director of Antimicrobial Management for the ID Division. She also is Co-Director of the HIV Family Clinic in the Delaware Street Clinic and Hospital Epidemiologist for the University of Minnesota Medical Center.

 

Sarah Lim, MBBCh, is a board-certified infectious disease physician who was previously an Assistant Professor in the Department of Infectious Diseases at the University of Vermont. She is now a Medical Specialist at the Minnesota Department of Health working on the COVID-19 response. Her areas of interest include MIS-C/MIS-A, COVID-19 therapies, and the allocation of scarce resources during the COVID-19 pandemic.

 

 

James D. Neaton, PhD, is Professor of Biostatistics in the School of Public Health at the University of Minnesota. He leads a large network called INSIGHT, which conducts international trials of HIV and influenza treatments and conducts observational studies of C. difficile infection and influenza. He also leads research on Ebola in West Africa that includes clinical trials of vaccines and treatments, and a large cohort study of Ebola survivors and their close contacts. Dr. Neaton has served on several national committees and advisory panels, including the U.S. Public Health Service Panel on Clinical Practices for the Treatment of HIV Infection, the Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee, and the Panel on Handling Missing Data in Clinical Trials of the Committee on National Statistics of the National Academy of Sciences.

 

J. Michael Oakes, PhD, is Professor, Division of Epidemiology and Community Health in the School of Public Health and Associate Vice President for Research at the University of Minnesota. Associate Vice President Oakes has regulatory and compliance responsibilities associated with the Human Research Protection Program (HRPP), Institutional Review Board (IRB), the Research Compliance Office (RCO), and several academic centers and institutes in the Office of the Vice President for Research (OVPR). He co-founded and directs the Interdisciplinary Research Leaders (IRL), a nationwide research leadership program supported by the Robert Wood Johnson Foundation.

 

Michael T. Osterholm, PhD, MPH, is Regents Professor; McKnight Presidential Endowed Chair in Public Health; Director of the Center for Infectious Disease Research and Policy (CIDRAP); Distinguished Teaching Professor in the Division of Environmental Health Sciences, School of Public Health; and an Adjunct Professor in the Medical School at the University of Minnesota. In November 2020, Dr. Osterholm was appointed to President-elect Joe Biden's 13-member Transition COVID-19 Advisory Board. From June 2018 through May 2019, he served as a Science Envoy for Health Security on behalf of the U.S. Department of State. Dr. Osterholm is a member of the National Academy of Medicine and the Council on Foreign Relations.

 

Mary J. Owen, MD, is Director of the Center of American Indian and Minority Health (CAIMH) and Assistant Professor, Department of Family Medicine and BioBehavioral Health at the University of Minnesota. She has developed and managed programs that increase the numbers of American Indian and Alaska Native (AIAN) students entering medical careers, done outreach to local and national Native leaders to ensure that CAIMH and the University of Minnesota Medical School remain in tune with AIAN health care and education needs, developed an AIAN track for all students interested in providing healthcare to AIAN communities, and developed research efforts to address AIAN health disparities. She continues to provide clinical care at the Center of American Indian Resources in Duluth.

 

Nneka Sederstrom, PhD, MPH, MA, FCCP, FCCM, is Chief Health Equity Officer at Hennepin Healthcare. Dr. Sederstrom leads the work to assess, build, and execute strategies across the system to cultivate a culture of diversity, equity, and inclusion and transform how care is delivered for our community. Dr. Sederstrom has served as Director of the Clinical Ethics Department at Children’s Minnesota and Director of the Center for Ethics at MedStar Washington Hospital Center in Washington, DC, where she also led the Spiritual Care Department and was the creator and Executive Director of the Journal of Hospital Ethics. She is a Fellow of the American College of Chest Physicians and the American College of Critical Care Medicine and an affiliate faculty member of the University of Minnesota Center for Bioethics.

 

 

Richard R. Sharp, PhD, is Director of the Biomedical Ethics Program, the Center for Individualized Medicine Bioethics Program, and the Clinical and Translational Research Ethics Program at the Mayo Clinic. He frequently advises health care organizations on ethical issues and has served on advisory committees for the National Institutes of Health, Institute of Medicine, and U.S. Environmental Protection Agency.

 

 

Stephen B. Thomas, PhD, is Professor of Health Policy & Management, University of Maryland; Director of the Maryland Center for Health Equity; and Principal Investigator (with Dr. Sandra Quinn) for the NIH-NIMHD Center of Excellence in Race, Ethnicity & Health Disparities Research. One of the nation's leading scholars in the effort to eliminate racial and ethnic health disparities, Dr. Thomas has applied his expertise to address a variety of conditions from which minorities generally face far poorer outcomes, including cardiovascular disease, diabetes, obesity and HIV/AIDS. Dr. Thomas has received numerous awards for his professional accomplishments, and over the years, his work has become recognized as one of the scholarly contributions leading to the 1997 Presidential Apology to Survivors of the Syphilis Study Done at Tuskegee. His current research focuses on the translation of evidence-based science on chronic disease into community-based interventions designed to eliminate racial and ethnic disparities in health and health care.

 

Jakub Tolar, MD, PhD, is the Dean of the University of Minnesota Medical School and a Distinguished McKnight Professor in the Department of Pediatrics, Blood and Marrow Transplantation. He is also the Vice President for Clinical Affairs at the University of Minnesota, 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.

 

Susan M. Wolf, JD, 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 and a Fellow of the American Association for the Advancement of Science. Her research has been supported by the National Institutes of Health and National Science Foundation, as well as private foundations including the Robert Wood Johnson Foundation and The Greenwall Foundation. Professor Wolf is co-lead of the Minnesota COVID Ethics Collaborative (MCEC)

 

Yee

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 is a medical oncologist with a specialty in breast cancer. His laboratory has been interested in the regulation of cancer cells by the insulin-like growth factors (IGFs) and insulin. He serves as the site principal investigator on several clinical trials that employ experimental therapies targeted against IGF receptor and the PI3K pathway. He is chair of the Agent Selection Committee and serves on the Executive Committee of the I-SPY2 trail, which is designed to validate investigational therapies in the neoadjuvant treatment of breast cancer.

Planning Committee

Susan M. Wolf, JD, 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 and a Fellow of the American Association for the Advancement of Science. Her research has been supported by the National Institutes of Health and National Science Foundation, as well as private foundations including the Robert Wood Johnson Foundation and The Greenwall Foundation. Professor Wolf is co-lead of the Minnesota COVID Ethics Collaborative (MCEC)

 

Christopher J. Cramer, PhD, is Vice President for Research at the University of Minnesota and a Distinguished McKnight and University Teaching Professor in the College of Science and Engineering. Prior to his appointment as Vice President, he served as Associate Dean for Research and Planning, and Academic Affairs, in the University’s College of Science and Engineering. Prof. Cramer served as the Editor-in-Chief of Theoretical Chemistry Accounts and as an Associate Editor for the Journal of Physical Organic Chemistry. He is a Fellow by the American Chemical Society, the Alfred P. Sloan Foundation and John Simon Guggenheim Foundation, and his recent research has been supported by the U.S. Department of Energy, the National Science Foundation, and the Defense Threat Reduction Agency. 

 

J. Michael Oakes, PhD, is Professor, Division of Epidemiology and Community Health in the School of Public Health and Associate Vice President for Research at the University of Minnesota. Associate Vice President Oakes has regulatory and compliance responsibilities associated with the Human Research Protection Program (HRPP), Institutional Review Board (IRB), the Research Compliance Office (RCO), and several academic centers and institutes in the Office of the Vice President for Research (OVPR). He co-founded and directs the Interdisciplinary Research Leaders (IRL), a nationwide research leadership program supported by the Robert Wood Johnson Foundation.

 

 

Michael T. Osterholm, PhD, MPH, is Regents Professor; McKnight Presidential Endowed Chair in Public Health; Director of the Center for Infectious Disease Research and Policy (CIDRAP); Distinguished Teaching Professor in the Division of Environmental Health Sciences, School of Public Health; and an Adjunct Professor in the Medical School at the University of Minnesota. In November 2020, Dr. Osterholm was appointed to President-elect Joe Biden's 13-member Transition COVID-19 Advisory Board. From June 2018 through May 2019, he served as a Science Envoy for Health Security on behalf of the U.S. Department of State. Dr. Osterholm is a member of the National Academy of Medicine and the Council on Foreign Relations.

 

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.

 

Yee

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 is a medical oncologist with a specialty in breast cancer. His laboratory has been interested in the regulation of cancer cells by the insulin-like growth factors (IGFs) and insulin. He serves as the site principal investigator on several clinical trials that employ experimental therapies targeted against IGF receptor and the PI3K pathway. He is chair of the Agent Selection Committee and serves on the Executive Committee of the I-SPY2 trail, which is designed to validate investigational therapies in the neoadjuvant treatment of breast cancer.

Resources

Background articles and websites that may be useful for this webinar include:

Presented by the Office of the Vice President for ResearchConsortium on Law and Values in Health, Environment & the Life SciencesMasonic Cancer Center; and Clinical and Translational Science Institute, University of Minnesota.

This conference is part of Research Ethics Week (March 1-5, 2021), during which the University of Minnesota focuses on professional development and best practices to ensure safety and integrity in research. A complete list of Research Ethics Week events is available.

Disclosure information is available here.

Agenda update (Feb. 20): Please note that the opening session on “Advancing ethics and equity” will be presented by Stephen B. Thomas, PhD, Director of the Maryland Center for Health Equity and Principal Investigator (with Dr. Sandra Quinn) on the NIH-NIMHD Center of Excellence in Race, Ethnicity & Health Disparities Research, together with Abigail Echo-Hawk, MA, Director of the Urban Indian Health Institute and Chief Research Officer of the Seattle Indian Health Board. We regret that scheduling difficulties will prevent participation by Marcella Nunez-Smith, MD, MHS, and encourage you to follow the work of the Biden-Harris COVID-19 Health Equity Task Force, which she chairs. 

Continuing Education Information: 

Accreditation Statement 
In support of improving patient care, University of Minnesota, Interprofessional Continuing Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Credit Designation Statements

American Medical Association (AMA)
The University of Minnesota, Interprofessional Continuing Education designates this live activity (enduring material) for a maximum of 4.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals
Other healthcare professionals who participate in this CE activity may submit their statement of participation to their appropriate accrediting organizations or state boards for consideration of credit. The participant is responsible for determining whether this activity meets the requirements for acceptable continuing education.

Continuing Legal Education (CLE)
4.25 Continuing Legal Education (CLE) credits have been approved. Event code: 338010
Note: If you plan to request credits, you will need to sign-in upon accessing the webinar via Zoom. Later viewing of this video will not qualify for credit. 

Educational Objectives for this webinar include:

  • Describe the challenges posed by interpreting COVID-19 research on treatments and preventives, understanding the significance of EUA authorization by the FDA, and making ethical treatment decisions under uncertainty.
  • Analyze options in research design and deployment of investigational treatments and preventives. Describe trade-offs, evolving guidance, and best practices.
  • Identify key priorities for advancing ethics and equity in research. Discuss best practices to partner with vulnerable communities, identify research questions, design research, recruit and retain diverse research participants, and promote health equity in the COVID-19 pandemic.

Land Acknowledgment:
The University of Minnesota - Twin Cities is built within the traditional homelands of the Dakota people. It is important to acknowledge the peoples on whose land we live, learn, and work as we seek to improve and strengthen our relations with our tribal nations. We also acknowledge that words are not enough. We must ensure that our institution provides support, resources, and programs that increase access to all aspects of higher education for our American Indian students, staff, faculty, and community members.