Research with Human Participants: The National Debates

Human Particpants
December 2, 2015 - 8:30am to 5:00pm
Coffman Theater, Coffman Union

Sponsored by the Office of the Vice President for Research 

This conference brought together experts to discuss the national debates on research with human participants and current thinking on best practices. Researchers, policymakers, bioethicists, patient advocates, and other stakeholders explored research oversight, informed consent when research participants have diminished or fluctuating capacity to consent, community roles, conflicts of interest and industry sponsorship, and research with vulnerable individuals.
 

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    Agenda and Videos

    Research with Human Participants: The National Debates

    Wednesday, December 2, 2015
    Coffman Theater, Coffman Union

    University of Minnesota East Bank Campus, Minneapolis


    8:30am

    Welcome    View Video 

    Moderator: Susan M. Wolf, JD, McKnight Presidential Professor of Law, Medicine & Public Policy, Chair, Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota 


    8:45am

    The National Debates on Research with Human Participants: Issues & Choices   View Video

    • Jeffrey R. Botkin, MD, MPH, Chief, Division of Medical Ethics & Humanities, Associate Vice President for Research Integrity, University of Utah; Chair, Secretary’s Advisory Committee on Human Research Protections (SACHRP), U.S. Department of Health and Human Services; member, FDA’s Pediatric Ethics Advisory Committee

    Q&A

    9:45am

    Break

    10:00am

    Consent to Research When Participants Have Diminished or Fluctuating Decisional Capacity   View Video 

    Moderator: Steven H. Miles, MD, Professor and Maas Family Endowed Chair in Bioethics, University of Minnesota 

    • Scott Y. H. Kim, MD, PhD, Senior Investigator, Department of Bioethics, National Institutes of Health (NIH) Clinical Center; Professor of Psychiatry, University of Michigan 

    Q&A with Drs. Botkin and Kim  View Video  

    11:00am 

    Panel: Multiple Perspectives on the National Debates & Consent Challenges   View Video

    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 

    • Sue Abderholden, MPH, Executive Director, NAMI Minnesota (National Alliance on Mental Illness)
    • Barbara E. Bierer, MD, Professor, Harvard Medical School and Brigham and Women’s Hospital; Director, Regulatory Foundations, Ethics and the Law Program, Harvard Catalyst; Faculty Co-director, Multi-Regional Clinical Trials (MRCT) Center; former-Chair, Secretary’s Advisory Committee on Human Research Protections (SACHRP), U.S. Department of Health and Human Services 
    • Carl Elliott, MD, PhD, Professor, Center for Bioethics and Department of Pediatrics; Affiliate Faculty Member, Department of Philosophy and School of Journalism and Mass Communications, University of Minnesota 
    • Richard Sharp, PhD, Professor and Director, Biomedical Ethics Program, Center for Individualized Medicine Bioethics Program, and Clinical and Translational Research Ethics Program, Mayo Clinic

    Q&A

    12:30pm
    Lunch with Speaker: Community Roles in Research    View Video
    Moderator: Kolawole Okuyemi, MD, MPH, Professor, Department of Family Medicine and Community Health; Director, Program in Health Disparities Research, University of Minnesota

    • Vanessa Northington Gamble, MD, PhD, University Professor of Medical Humanities, Professor of American Studies, George Washington University; former-Chair, Tuskegee Syphilis Study Legacy Committee

    Q&A


    1:45pm

    Panel: Conflicts of Interest & Industry Sponsorship   View Video
    Moderator: Douglas Yee, MD, Director, Masonic Cancer Center;  John H. Kersey Chair in Cancer Research, University of Minnesota 

    • Eric G. Campbell, PhD, Director of Research, Mongan Institute for Health Policy; Professor of Medicine, Harvard Medical School 
    • Bernard Lo, MD, President & CEO, The Greenwall Foundation; Professor of Medicine Emeritus and Director Emeritus of the Program in Medical Ethics, University of California, San Francisco (UCSF)
    • Thomas Morgan, MD, FACMG, Head, Human Disease Genetics, Novartis Institutes for BioMedical Research
    • Paul Haluska, Jr., MD, PhD, Global Director of Scientific Affairs, Oncology, Merck
    • Robert Steinbrook, MD, Editor-at-large and Viewpoints Editor at JAMA Internal Medicine; Professor Adjunct of Internal Medicine, Yale University School of Medicine

    Q&A

    3:15 pm
    Break

    3:30 pm
    Panel: Research with Vulnerable & Underrepresented Populations   View Video
    Moderator: John E. Wagner, Jr., MD, Professor, Department of Pediatrics; Director, Blood and Marrow Transplantation, Department of Pediatrics; Scientific Director of Clinical Research, Stem Cell Institute; Co-Director, Center for Translational Medicine; Children’s Cancer Research Fund/Hageboeck Family Endowed Chair in Pediatric Oncology; McKnight Presidential Chair in Childhood Cancer Research, University of Minnesota

    • Amy Frohnmayer, MA, Graduate Student, Oregon State University Cascades; Patient Representative, FDA
    • James M. DuBois, DSc, PhD, Bander Professor of Medical Ethics and Professionalism; Professor of Psychology; Director, Center for Clinical Research Ethics, Washington University, St. Louis; American Psychological Association’s Committee on Human Research
    • Raegan W. Durant, MD, MPH, Associate Professor, Division of Preventive Medicine, University of Alabama at Birmingham School of Medicine
    • Steven Joffe, MD, MPH, Vice Chair of Medical Ethics, Emanuel and Robert Hart Associate Professor, Department of Medical Ethics and Health Policy, University of Pennsylvania

    Q&A

    4:45 pm

    Closing remarks   View Video 

    Susan M. Wolf, JD, McKnight Presidential Professor of Law, Medicine & Public Policy, Chair, Consortium on Law and Values

    5:00 pm

    Adjourn

    5:00-6:30 pm

    Reception
    Great Hall, Coffman Union

    Speaker Biographies

    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.

     

    Sue Abderholden, MPH, is the Executive Director of NAMI Minnesota (National Alliance on Mental Illness). She has devoted her career to changing laws and attitudes that affect people with disabilities and their families. At NAMI Minnesota she has focused on the stigma surrounding mental illness and the broken system of care for children and adults with mental illnesses. Over the past twenty-five years, Ms. Abderholden has successfully fought for community and family supports and for laws that enable people with disabilities to fully participate in society. She was on the White House lawn when the Americans with Disabilities Act was signed into law, and has held positions with The Arc Minnesota, U.S. Senator Paul D. Wellstone, and the PACER Center (Minnesota’s Parent Training and Information Center).

     

    Barbara E. Bierer, MD, is a Professor at Harvard Medical School; Senior Vice President of Research at Brigham and Women’s Hospital; Director of Regulatory Foundations, Ethics and the Law at Harvard Catalyst; Faculty Co-Director, Multi-Regional Clinical Trials (MRCT) Center; and former-Chair, Secretary’s Advisory Committee on Human Research Protections (SACHRP), Department of Health and Human Services. In addition, Dr. Bierer is Co-chair of the Partners HealthCare Committee on Conflict of Interest. In addition to her academic responsibilities, Dr. Bierer was elected to the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), serving as its President from 2003-07, and was on the Board of Directors of the Federation of American Societies for Experimental Biology (FASEB). She was a member of the Medical and Scientific Advisory Board and, later, the Board of Directors of ViaCell, Inc. Dr. Bierer is currently a member of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Clinical Research and a member of the National Academy of Sciences Committee on Science, Technology and the Law.

    Jeffrey R. Botkin, MD, MPH, is Chief of the Division of Medical Ethics & Humanities, Associate Vice President for Research Integrity, and Professor of Pediatrics at the University of Utah. He serves as the Chair of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), U.S. Department of Health and Human Services (DHHS), and is a member of the FDA’s Pediatric Ethics Advisory Committee. He also serves on the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children at DHHS. Prof. Botkin was formerly Chair of the Committee on Bioethics for the American Academy of Pediatrics.   

     

     

    Eric G. Campbell, PhD, is Director of the Mongan Institute for Health Policy (MIHP) and a Professor at Harvard Medical School. A sociologist with expertise in survey science, Prof. Campbell conducts research relating to physician conflicts of interest and professionalism. He has received funding from organizations including the Office for Research Integrity in the U.S. Department of Health and Human Services, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Institute for Medicine.

     

     

    James M. DuBois, DSc, PhD, is Steven J. Bander Professor of Medical Ethics and Professionalism, Professor of Psychology, and Director of the Center for Clinical Research Ethics at Washington University School of Medicine in St. Louis. He is an Adjunct Professor in the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, where he was the inaugural Hubert Mäder Professor of Health Care Ethics and Director of the Bander Center for Medical Business Ethics.  Prof. DuBois directs the NIH-funded Professionalism and Integrity in Research Program (PI Program).

     

     

     

    Raegan W. Durant, MD, MPH, is Associate Professor of Medicine in the Division of Preventive Medicine at the University of Alabama at Birmingham. Dr. Durant’s research is focused on the relationships among social support, self-management behaviors, and hospital use for heart failure, with an eye toward developing community-based interventions to eliminate racial disparities in heart failure hospitalization rates.  He also studies multi-level barriers to the recruitment of minorities into clinical trials, as possible targets for system and behavioral interventions to increase diversity in research study populations. In addition to his research, Dr. Durant serves as Medical Director at Cooper Green Mercy Health Services, a multi-specialty, publicly funded, safety-net ambulatory care center.  

     

    Carl Elliott, MD, PhD, is Professor in the Center for Bioethics and the Department of Pediatrics, and an Affiliate Faculty Member in the Department of Philosophy and the School of Journalism and Mass Communications at the University of Minnesota. He is the author or editor of seven books, including White Coat, Black Hat: Adventures on the Dark Side of Medicine (Beacon, 2010) and Better than Well: American Medicine Meets the American Dream (Norton, 2003). His articles have appeared in The New YorkerAtlantic MonthlyLondon Review of Books, Mother JonesNew York Times, and New England Journal of Medicine. In 2011 the Austen Riggs Center awarded him its Erikson Prize for Excellence in Mental Health Media.

     

    Amy Frohnmayer, MA, received her graduate degree in health psychology from Stanford University and has conducted research within the Fanconi anemia (FA) population, with a concentration on psychosocial challenges, coping strategies, and quality of life in adults with this disease. She has also worked for the Adolescent and Young Adult Oncology Program at Oregon Health and Sciences University and has collaborated with investigators at the National Institutes of Health to evaluate the role of uncertainty in decision-making related to bone marrow transplantation in families dealing with FA. She is currently pursuing a Master’s degree in counseling from Oregon State University–Cascades. She serves as a Patient Representative at the Food and Drug Administration.

     

    Vanessa Northington Gamble MD, PhD is University Professor of Medical Humanities and Professor of Health Policy and American Studies at the George Washington University. She is the first woman and African American to hold this prestigious, endowed faculty position. She is also Professor of Health Policy in the Milken Institute School of Public Health and Professor of American Studies in the Columbian College of Arts and Sciences. Dr. Gamble is Adjunct Professor of Nursing at the University of Pennsylvania School of Nursing. Throughout her career she has worked to promote equity and justice in medicine and public health. A physician, scholar, and activist, Dr. Gamble is an internationally recognized expert on the history of American medicine, racial and ethnic disparities in health and health care, public health ethics, and bioethics. She is the author of several widely acclaimed publications on the history of race and racism in American medicine and bioethics. Public service has been a hallmark of her career. She has serviced on many boards and chaired the committee that took the lead role in the successful campaign to obtain an apology in 1997 from President Clinton for the United States Public Health Syphilis Study at Tuskegee. She is a member of the National Academy of Medicine (formerly the Institute of Medicine) and a Fellow of the Hastings Center. A proud native of West Philadelphia, Dr. Gamble received her B.A. from Hampshire College and her MD and PhD in the history and sociology of science from the University of Pennsylvania.

    Paul Haluska, Jr., MD, PhD, is a medical oncologist and Global Director of Scientific Affairs, Oncology at Merck. Previously, Dr. Haluska worked at Mayo Clinic for 15 years, where his lab developed one of the largest existing collections of ovarian patient-derived xenograft (PDX) models, referred to as “Avatars.” The long-term goal of that research is to use a translational approach to develop and improve therapies in breast and ovarian cancers based on the best treatment for each patient, using her own tumor as a guide to the optimal individualized therapy. He also was the Director of the Phase I Program. Currently, he runs the investigator-initiated trials program (MISP) for Merck’s oncology franchise. Consequently, Dr. Haluska has both academic and industry perspectives on conducting research on patients and using patient tissue.

     

    Steven Joffe, MD, MPH, is Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy at the University of Pennsylvania, Perelman School of Medicine. A pediatric oncologist and bioethicist, he is also Director of the Penn Fellowship in Advanced Biomedical Ethics. Dr. Joffe has led NIH and foundation grants to study the roles and responsibilities of principal investigators in multicenter randomized trials, accountability in the clinical research enterprise, children’s capacity to engage in research decisions, return of individual genetic results to participants in epidemiologic cohort studies, and the integration of whole-exome sequencing technologies into the clinical care of cancer patients. He currently chairs the Children’s Oncology Group Bioethics Committee, and serves as a member of the FDA’s Pediatrics Ethics Subcommittee.

     

    Eric W. Kaler, PhD, took office as President of the University of Minnesota in 2011. Before coming to the University, he served as Provost and Senior Vice President for Academic Affairs at Stony Brook University in New York. Pres. Kaler received his PhD in chemical engineering from the University of Minnesota and went on to become one of the nation's foremost experts in "complex fluids," which have applications in drug delivery, food processing, pharmaceuticals, and manufacturing.  He is an elected member of the American Academy of Arts and Sciences and National Academy of Engineering.

     

     

    Scott Y. H. Kim, MD, PhD, is a Senior Investigator in the Department of Bioethics at the National Institutes of Health Clinical Center. Dr. Kim studies research ethics, especially the ethics of involving decisionally impaired persons in research, the ethics of high-risk research, and methodological issues in empirical bioethics research. Dr. Kim is Professor of Psychiatry at the University of Michigan and has served as Co-Director of the Center for Bioethics and Social Sciences in Medicine. His work has been supported by the NIH, the American Association for Geriatric Psychiatry, the Michael J. Fox Foundation, and The Greenwall Foundation Faculty Scholars Award in Bioethics.

     

     

    Bernard Lo, MD, is President and CEO of The Greenwall Foundation. He is also Professor of Medicine Emeritus and Director Emeritus of the Program in Medical Ethics at the University of California, San Francisco (UCSF). Dr. Lo chaired the Institute of Medicine Committee on Conflict of Interest in Medical Research, Education and Practice, whose report was published in 2009. He currently serves as Co-chair of the Standards Working Group of the California Institute of Regenerative Medicine, which recommends regulations for stem cell research funded by the state of California. At the National Institutes of Health (NIH), he serves on data and safety monitoring committees for HIV vaccine trials and the Long-term Oxygen Treatment Trial. Dr. Lo serves on the Board of Directors of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and on the Medical Advisory Panel of Blue Cross/Blue Shield.

     

    Steven H. Miles, MD, is Professor of Medicine and Bioethics and Maas Family Endowed Chair in Bioethics at the University of Minnesota. He is an Affiliate Faculty member for the Law School's Concentration in Health Law and Bioethics. He is board certified in internal medicine. Dr. Miles has served as President of the American Society for Bioethics & Humanities and received its Distinguished Service Award. Among his other awards is the National Council of Teachers of English George Orwell Award for Distinguished Contribution to Honesty and Clarity in Public Language; American Bar Association, Section of Individual Rights and Responsibilities, Human Rights Hero; and the Sullivan-Ballou Fund Award for Human Rights.

     

     

    Thomas Morgan, MD, FACMG, is Head of Human Disease Genetics at the Novartis Institutes for BioMedical Research within the Division of Biomarker Development, in which capacity he serves as a member of the Novartis Ethics Advisory Group and has exposure to clinical trial and investigator-initiated trial ethics. He has been cross-trained in clinical epidemiology, family medicine, clinical genetics, and medical biochemical genetics. As a Robert Wood Johnson Clinical Scholar at Yale, Dr. Morgan received advanced training in clinical epidemiology and health care systems and policy. He has authored over 50 publications pertaining to complex genetics research. He also served as a voting member of the Institutional Review Board at Vanderbilt University. In 2013, he was selected as Vanderbilt’s representative at the Advancing Ethical Research Conference of the Public Responsibility in Medicine & Research (PRIM&R), and he delivered the 2014 Gheen’s Foundation Visiting Scholar in Humanism in Medicine Lecture at the University of Louisville on the history of ethics in genetic research.

    Kolawole Okuyemi, MD, MPH, is a Professor in the Department of Family Medicine and Community Health and Director of the Program in Health Disparities Research at the University of Minnesota. Dr. Okuyemi has devoted his career to improving the health of minorities and eliminating health disparities using pharmacological and culturally tailored behavioral interventions. He has received funding for research and educational programs from NIH and private foundations totaling $28 million, and has mentored a large number of faculty, postdoctoral fellows, and graduate and undergraduate students.

     

     

    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. He is a member of the National Academy of Medicine (NAM) and the Council on Foreign Relations. He has served as a high-level advisor on issues related to bioterrorism, public health preparedness, and infectious diseases.

     

     

    Richard Sharp, PhD, is Professor and 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 has studied a variety of topics in biomedical ethics, including the integration of genetic technologies into patient care, best practices for clinical ethics consultation, financial conflicts of interest, and ethical dimensions of patient advocacy. Prof. Sharp 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. 

     

     

    Robert Steinbrook, MD, is Editor-at-large and Viewpoints Editor at JAMA Internal Medicine, a contributing writer for JAMA, and Professor Adjunct of Internal Medicine at the Yale University School of Medicine. Previously, he was a Deputy Editor and national correspondent for The New England Journal of Medicine, and a medical writer for the Los Angeles Times.  He is a general internist and trained in internal medicine at the University of California, San Francisco.

     

     

     

    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 Marrow Transplantation in the 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. Dr. 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. Dr. Wagner also specializes in Fanconi anemia and the use of stem cells in severe forms of a rare skin disease called epidermolysis bullosa, or EB.

     

    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 also treats patients with breast cancer and conducts research to improve cancer therapies.

    Planning Committee

    These faculty members at the University of Minnesota collaborated in planning the conference, striving to recruit top experts and key stakeholders, who could present diverse points of view and engage in dialogue with conference participants. 

     

    Susan M. Wolf, JD, Planning Committee Chair, is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine. 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.

     

    Bruce Blazar, MD, is Regents Professor of Pediatrics, and Chief of the Pediatric Blood and Marrow Transplantation Program.  He has directed preclinical basic and translational immunology and stem cell research and early phase clinical studies for more than 25 years, with particular emphasis on the blood and marrow transplantation immunobiology.  Prof. Blazar is the Associate Vice President for Clinical and Translational Science and the Director of the University of Minnesota's Clinical and Translational Science Institute.  He is an elected member of the National Academy of Medicine (NAM). 

     

     

    Kathleen Thiede Call, PhD, is a Professor of Health Policy and Management in the School of Public Health. She received the University of Minnesota President's Community-Engaged Scholar Award and is Faculty Liaison for the Clinical and Translational Science Institute. Prof. Call's research interests include disparities in access to health insurance and developing community-engaged research projects focusing on equitable access to health care.

     

     

     

    Gary Gardner, PhD, is a Professor in the Department of Horticultural Science. He is on the executive committee of the Consortium on Law and Values in Health, Environment & the Life Sciences and serves as an Advisory Board Member of the Healthy Foods, Healthy Lives Institute and as a Faculty Legislative Liaison.

     

     

     

    Apostolos P. Georgopoulos, MD, PhD, is Regents Professor of Neuroscience; McKnight Presidential Chair in Cognitive Neuroscience; American Legion Brain Sciences Chair; Director of the Brain Sciences Center for Cognitive Sciences; and Professor of Neuroscience, Neurology, and Psychiatry. He is also Director of the Brain Sciences Center at the Veterans Affairs Medical Center, Minneapolis. He is an elected member of the National Academy of Medicine (NAM) and American Academy of Arts and Sciences.

     

     

     

    Sarah E. Gollust, PhD, is an Assistant Professor of Health Policy & Management and McKnight Land-Grant Professor in the School of Public Health. 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 R. Gunnar, PhD, is Regents Professor; Distinguished McKnight University Professor; Department Chair and Director of the Institute of Child Development; and Associate Director of the Center for Neurobehavioral Development.  Her research focuses on how children and adolescents regulate stress and emotions, the effects of early adverse care on brain and behavioral development, and stress neurobiology and development.  Prof. Gunnar is the principal investigator for the Minnesota International Adoption Project and the Stress, Social Buffering and Fear Learning Research Network.

     

     

    Gordon E. Legge, PhD, is Distinguished McKnight University Professor in the Department of Psychology. He heads the Minnesota Laboratory for Low-Vision Research.  Prof. Legge specializes in visual perception with a cognitive-neuroscience perspective and the role of vision in important real-world activities including reading, object recognition, and wayfinding. He is a Fellow of the American Association for the Advancement of Science, the Association for Psychological Science, and  the Association for Research in Vision and Ophthalmology.

     

     

    Steven H. Miles, MD, is Professor of Medicine and Bioethics and Maas Family Endowed Chair in Bioethics at the University of Minnesota. He is an Affiliate Faculty member for the Law School's Concentration in Health Law and Bioethics. He is board certified in internal medicine. Dr. Miles has served as President of the American Society for Bioethics & Humanities and received its Distinguished Service Award. Among his other awards is the National Council of Teachers of English George Orwell Award for Distinguished Contribution to Honesty and Clarity in Public Language; American Bar Association, Section of Individual Rights and Responsibilities, Human Rights Hero; and the Sullivan-Ballou Fund Award for Human Rights.

     

    Kolawole Okuyemi, MD, MPH, is a Professor in the Department of Family Medicine and Community Health and Director of the Program in Health Disparities Research at the University of Minnesota. Prof. Okuyemi has devoted his career to improving the health of minorities and eliminating health disparities using pharmacological and culturally tailored behavioral interventions. He has received funding for research and educational programs from NIH and private foundations totaling $28 million and mentored a large number of faculty, postdoctoral fellows, and graduate and undergraduate students. 

     

     

    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. He is a member of the National Academy of Medicine (NAM) and the Council on Foreign Relations. He has served as a high-level advisor on issues related to bioterrorism, public health preparedness, and infectious diseases.

     

     

    Member Rep

    Michael J. Sadowsky, PhD, is Director of the BioTechnology Institute and Professor in the Department of Soil, Water and Climate. His research focuses on molecular plant-microbe interactions in nitrogen-fixing symbiotic systems; investigation of the use of microorganisms for biodegradation and bioremediation; molecular methods to determine sources and kinds of bacteria in the environment; and the metagenomics of soil, water, and intestinal environments.

     

     

    Jakub Tolar, MD, PhD, is McKnight Professor of Pediatrics; Edmund Wallace Tulloch and Anna Marie Tulloch Chair in Stem Cell Biology, Genetics and Genomics; and Director of the University of Minnesota Stem Cell Institute. Prof. Tolar's research focuses on using hematopoietic stem cell transplant as a treatment for rare genetic disorders including Hurler syndrome and dyskeratosis congenital, and has achieved international recognition for his work in caring for patients with recessive dystrophic epidermolysis bullosa.

     

     

    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. Prof. Wagner also specializes in Fanconi anemia and the use of stem cells in severe forms of a rare skin disease called epidermolysis bullosa, or EB.

     

     

    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 also treats patients with breast cancer and conducts research to improve cancer therapies.

    Registration and fees
    This event was free of charge and open to the public.

    Continuing Education Information

    Continuing Legal Education (CLE)

    The Minnesota Board of Continuing Legal Education (event code 212933) approved this conference for 7.25 standard continuing legal education (CLE) credits for in-person attendance and webcast participation on the day of the conference. Credit is not available for viewing the archival videotape from this website.

    Continuing Medical Education (CME)
    Continuing Medical Education credit is only available for in-person attendance; online viewing does not meet the requirements of our approvers.

    Office of Continuing Professional Development

    The University of Minnesota is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    The University of Minnesota designates this live activity for a maximum of 7.0 AMA PRA Category 1 Credits™. Event code: CM-15-676d.


    Upon completion of this educational activity, the participant should be better able to:

    • Explain the importance of ethical conduct of research with human participants;
    • Describe the national debates on issues such as best practices for research oversight and approaches to research with individuals who have diminished or fluctuating capacity to consent;
    • Articulate the potential roles that community members can play in the conduct and oversight of research with human participants;
    • Discuss approaches to conflicts of interest in research; and
    • Specify ethical challenges in research with vulnerable populations and suggest ways to address those challenges.
    Academic Year