
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.
Conference Agenda
Annual Research Ethics Day Conference - Conducting Research in the COVID-19 Pandemic: Ethics in an Emergency Agenda
9:00 a.m. |
Welcome |
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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 |
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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? |
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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? |
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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?” |
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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 |
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1:30 p.m. |
Adjourn |
Speaker Biographies

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 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, 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).

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.

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.
Advisory Committee
2021 Research Ethics Day Conference Advisory Committee
Resources
Background articles and websites that may be useful for this webinar include:
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Angus DC. Optimizing the trade-off between learning and doing in a pandemic. JAMA 2020;323(19):1895-96.
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Angus DC, Gordon AC, Bauchner H. Emerging lessons from COVID-19 for the US clinical research enterprise. JAMA 2021 Feb 26; online doi:10.1001/jama.2021.3284.
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Anthes, E. Clinical Trials Are Moving Out of the Lab and Into People’s Homes. New York Times 2021 Feb 19; (A)4.
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Arrazola J, Masiello MM, Joshi S, Dominguez AE, Poel A et al. COVID-19 mortality among American Indian and Alaska Native persons: 14 states, January-June 2020. Morb Mortal Wkly Rep 2020 Dec 11;69(49):1853-56.
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Berman G. Ethical considerations for evidence generation involving children on the COVID-19 pandemic. UNICEF. 2020-21. https://www.unicef-irc.org/publications/1086-ethical-considerations-for-evidence-generation-involving-children-on-the-covid-19.html.
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Block Jr R, Berg A, Lennon RP, Miller EL, Nunez-Smith M. African American adherence to COVID-19 public health recommendations. Health Literacy Res Pract 2020;4(3):e166-70.
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Calia C, Reid C, Guerra C, Oshodi A-G, Marley C et al. Ethical challenges in the COVID-19 research context: A toolkit for supporting analysis and resolution. Ethics & Behavior 2021;31(1):60-75.
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Collins FS, Stoffels P. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): An unprecedented partnership for unprecedented times. JAMA 2020;323(24):2455-57.
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Cook DJ, Marshall JC, Fowler RA. Critical illness in patients with COVID-19: Mounting an effective clinical and research response. JAMA 2020;323(16):1559-60.
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Fleming TR, Labriola D, Wittes J. Conducting clinical research during the COVID-19 pandemic: Protecting scrientific integrity. JAMA 2020;324(1):33-34.
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Flores LE, Frontera WR, Andrasik MP. Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA 2021;4(2):e2037640. doi:10.1001/jamanetworkopen.2020.37640.
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Gross CP, Essien UR, Pasha S, Gross JR, Wang S, Nunez-Smith M. Racial and ethnic disparities in population-level Covid-19 mortality. J Gen Intern Med 2020;35:3097-99.
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Hatcher SM, Agnew-Brune C, Anderson M, Zambrano LD, Rose CE et al. COVID-19 among American Indian and Alaska Native persons: 23 states, January 31-July 3, 2020. Morb Mortal Wkly Rep 2020 Aug 28;69(34):1166-69.
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Hooper MW, Nápoles AM, Pérez-Stable EJ. COVID-19 and racial/ethnic disparities. JAMA 2020;323(24):2466-67.
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Janiaud P, Axfors C, Schmitt AM et al. Association of convalescent plasma treatment with clinical outcomes in patients with COVID-19: A systematic review and meta-analysis. JAMA 2021 Feb 26: doi:10.1001/jama.2021.2747
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Joyner MJ, Carter RE, Senefeld JW, Klassen SA, Mills JR et al. Convalescent plasma antibody levels and the risk of death from Covid-19. New Engl J Med 2021 Jan 13; DOI: 10.1056/NEJMoa2031893.
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Kalil AC. Treating COVID-19: Off-label drug use, compassionate use, and randomized clinical trials during pandemics. JAMA 2020;323(19):1897-98.
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Lim S, DeBruin DA, Leider JP, Sederstrom N, Lynfield R et al. Developing an ethics framework for allocating remdesivir in the COVID-19 pandemic. Mayo Clin Proc 2020;95(9):1946-54.
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London AJ, Kimmelman J. Against pandemic research exceptionalism: Crises are no excuse for lowering scientific standards. Science 2020;368(6490):476-77.
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Meagher KM, Cummins NW, Bharucha AE, Badley AD, Chlan LL, Wright RS. COVID-19 ethics and research. Mayo Clin Proc 2020;95(6):1119-23.
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Murray DD, Babiker AG, Baker JV, Barkauskas CE, Brown SM et al. Design and implementation of the multi-arm, multi-stage Therapeutics for Inpatients with COVID-19 (TICO) platform master protocol: An Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV) initiative. medRxiv Preprint 2020 Nov 12 [revised 2020 Nov 13]. doi: 10.1101/2020.11.08.20227876.
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National Academies of Sciences, Engineering, and Medicine. Framework for equitable allocation of COVID-19 vaccine. Washington, DC: National Academies Press. 2020.
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National Academies of Sciences, Engineering, and Medicine. Integrating clinical research into epidemic response: The Ebola experience. Washington, DC: National Academies Press. 2017.
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NIH. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/.
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Nuffield Council on Bioethics. Research in global health emergencies: Ethical issues. 2020.
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Rau AK, Aberg J, Baker J, Belperio PS, Coopersmith C et al. Convalescent plasma for the treatment of COVID-19: Perspectives of the National Institutes of Health COVID-19 Treatment Guidelines Panel. Ann Intern Med 2021 Jan; https://doi.org/10.7326/M20-6448.
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Retraction Watch. Retracted coronavirus (COVID-19) papers. https://retractionwatch.com/retracted-coronavirus-covid-19-papers/.
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Rubin A. The price of success -- how to evaluate COVID-19 vaccines when they’re available outside of clinical trials. JAMA 2021 Feb 18; doi:10.1001/jama.2021.0641.
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Shuman AG, Pentz RD. Cancer research ethics and COVID-19. Oncologist 2020;25(6):458-59.
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Strassle C, Jardas E, Ochoa J, Berkman BE, Danis M et al. Covid-19 vaccine trials and incarcerated people: The ethics of inclusion. New Engl J Med 2020;383:1897-99.
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Thomas SB. Racial and ethnic disparities as a public health ethics issue. In The Oxford Handbook of Public Health Ethics (AC Mastroianni, JP Kahn, NE Kass, eds.) 2019: 277-89.
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Thomas SB, Casper E. The burdens of race and history on Black people’s health 400 years after Jamestown. Am J Pub Health 2019;109(10):1346-47.
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Urban Indian Health Institute. Best practices for American Indian and Alaska Native data collection. 2020.
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Urban Indian Health Institute. Data genocide of American Indians and Alaska Natives in COVID-19 data. 2021.
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Wendler D, Ochoa J, Millum J, Grady C, Taylor HA. COVID-19 vaccine trial ethics once we have efficacious vaccines. Science 2020;370(6522):1277-79.
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White DB, Angus DC. A proposed lottery system to allocate scarce COVID-19 medications: Promoting fairness and generating knowledge. JAMA 2020;324(4):329-30.
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The White House. President Biden Announces Members of the Biden-Harris Administration COVID-19 Health Equity Task Force. February 10, 2021. https://www.whitehouse.gov/briefing-room/press-briefings/2021/02/10/president-biden-announces-members-of-the-biden-harris-administration-covid-19-health-equity-task-force/
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World Health Organization (WHO) Working Group on Ethics & COVID-19. Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D. WHO reference number: WHO/RFH/20.1. 2020.
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World Health Organization (WHO). “Solidarity” clinical trial for COVID-19 treatments. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments.
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Zdravkovic M, Berger-Estilita J, Zdravkovic B, Berger D. Scientific quality of COVID-19 and SARS CoV-2 publications in the highest impact medical journals during the early phase of the pandemic: A case control study. PLoS One 2020;15(11):e0241826.
Presented by the Office of the Vice President for Research; Consortium on Law and Values in Health, Environment & the Life Sciences; Masonic 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.