Should We Return Individual Research Results and Incidental Findings from Genomic Biobanks & Archives?

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May 19, 2011 - 8:30am to 4:45pm
Conference Center, Bethesda North Marriott Hotel, Bethesda, MD

This conference presented recommendations and analysis on managing incidental findings and individual research results in genomic research using biobanks and large archives. In order to understand the genetic contribution to a host of diseases and conditions of great importance to public health, scientists are increasingly assembling large biobanks, archiving many individuals' DNA and health information for scientific reanalysis over time. This project brings leading experts on bioethics, genomics, biobanking, and law to recommend policies and practices on return of both incidental findings and individual research results that may have importance for the donor. 

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Agenda and Videos

8:00am
Introductory Remarks
Susan M. Wolf, JD, University of Minnesota View Online

Welcome
Kathy Hudson, PhD, National Institutes of Health (NIH) View Online

8:15am
Keynotes: Genomic Biobanks & Archives Face the Problem of Incidental Findings and Return of Research Results
Moderator: Jeffrey P. Kahn, PhD, MPH, University of Minnesota

Leslie Biesecker, MD, National Institutes of Health (NIH) View Online
Isaac Kohane, MD, PhD, Harvard Medical School View Online

9:30am
Managing Incidental Findings and Return of Research Results in Genomic Biobanks and Archives: Analysis & Policy Recommendations View Online
Moderator: Susan M. Wolf, JD, University of Minnesota

Brian Van Ness, PhD, University of Minnesota
Frances Lawrenz, PhD, University of Minnesota

Q and A View Online

10:15am
Publically Available Guidance on Managing Incidental Findings and Return of Research Results in Genomic Biobanks and Archives: Empirical Findings & Analysis

Frances Lawrenz, PhD, University of Minnesota View Online

10:30am
Break

10:45am
Panel — Reaction to Recommendations
Moderator: Brian Van Ness, PhD, University of Minnesota

Panelists:
Laura Lyman Rodriguez, PhD, NHGRI, NIH View Online
Nicole C. Lockhart, PhD, National Cancer Institute (NCI), NIH View Online
Marianna Bledsoe, MA, Department of Veterans Affairs View Online
Jerry Menikoff, MD, JD, MPP, Office for Human Research Protections (OHRP), U.S. Department of Health & Human Services View Online
Penny Keller, BS, MP(ASCP), Centers for Medicare & Medicaid Services, CMSO/SCG/Division of Laboratory Services View Online
Christopher O'Donnell, MD, MPH, National Heart, Lung & Blood Institute, NIH and Harvard Medical School View Online
P. Pearl O'Rourke, MD, Partners HealthCare System and Public Responsibility in Medicine and Research (PRIM&R) View Online

Q and A View Online

12:15pm
Networking Lunch

1:00pm
Concurrent Workshops

Session A1: Biobank Structure and Governance: Coping with Incidental Findings & Return of Individual Research Results
Moderator: Brian Van Ness, PhD, University of Minnesota 

Panelists:
Brian Van Ness, PhD, University of Minnesota, on “Coping with Incidental Findings and Individual Research Results in a Cancer Biobank & Cooperative Oncology Group” View Online
Scott Jewell, PhD, Van Andel Research Institute and International Society for Biological and Environmental Repositories (ISBER), on “ISBER Perspectives on Biorepository Return of Results & Incidental Findings” View Online
Michael F. Christman, PhD, Coriell Institute for Medical Research, on “Return of Genetic Results in the Era of Personalized Medicine” View Online
William McGeveran, JD, University of Minnesota, on “Impact of Data Privacy Regulation on Incidental Findings and Return of Individual Results” View Online
Gloria Petersen, PhD, Mayo College of Medicine, on “Institutional Governance of Incidental Findings: The Mayo Clinic Experience” View Online
Karen Maschke, PhD, Associate for Ethics and Science Policy, The Hastings Center, on “Retrofitting No-Results Biobanks and Biobanks in Development to Manage Individual Results and Incidental Findings” View Online

Q and A View Online

Session A2: What Findings and Results Should Be Returned and How?
Moderator: Susan M. Wolf, JD, University of Minnesota

Panelists:
Bartha Knoppers, JD, PhD, McGill University and Genome Québec Innovation Centre, on “International Normative Perspectives on Return of Individual Results and Incidental Findings in Genomic Biobanks” View Online
Wendy Wolf, PhD, Children's Hospital Boston, on “Managing Incidental Findings and Individual Research Results in Genotype/Phenotype Research Using Electronic Medical Records” View Online
Ingrid Holm, MD, MPH, Children's Hospital Boston, on “The Informed Cohort Oversight Board (ICOB): From Values to Architecture” (paper with Patrick Taylor, JD) View Online
Ellen Wright Clayton, MD, JD, Vanderbilt University, on “Critique of Current Proposals for Addressing Return of Research Results & Incidental Findings” View Online
Isaac Kohane, MD, PhD, Harvard Medical School, on “Quantifying and Managing the Incidentalome: How Many Incidental Findings Will Genomic Research Yield and With What Implications?” View Online
Stephanie Malia Fullerton, DPhil, University of Washington School of Medicine, on “Offering Aggregate Results to Participants in Genomic Biobanks and Archives” (paper with Laura Beskow, MPH, PhD; Wylie Burke, MD, PhD; Richard R. Sharp, PhD) View Online

Q and A View Online

2:30pm
Break

2:45pm
Session B1: Returning Findings from Secondary Research and Reanalysis: Current Practices, Issues & Policy Solutions
Moderator: Leili Fatehi, JD, University of Minnesota

Panelists:
Joseph Thakuria, MD, Harvard University, on “Informed Consent, Biobanking, and Data Distribution in the Personal Genome Project” View Online
Amy McGuire, JD, PhD, Baylor College of Medicine, on “Ethical and Policy Considerations in Disclosing from Downstream Users” View Online
Henry S. Richardson, JD, MPP, PhD, Georgetown University, and Mildred K. Cho, PhD, Stanford University, on “Secondary Researchers’ Duties to Return Incidental Findings and Individual Research Results: A Partial-Entrustment Account” View Online

Q and A View Online
 
Session B2: Engagement with Specific Populations on Management of Incidental Findings & Research Results in Genomic Biobanks & Archives
Moderator: Jeffrey P. Kahn, PhD, MPH, University of Minnesota

Panelists:
Rebecca Fisher, MLIS, on “A Closer Look Revisited: Are We Subjects or Are We Donors?” View Online
Francine C. Gachupin, PhD, MPH, University of New Mexico, on “Engagement with American Indian/Alaska Native Populations on Genomic Findings & Results” View Online
Alan R. Shuldiner, MD, University of Maryland, on “Addressing Incidental Findings and Return of Individual Research Results in Genetic Research Involving the Old Order Amish” View Online
Judy Illes, PhD, University of British Columbia, on “Individual or Community Consent? A Vexing Challenge for Incidental Findings” View Online
Benjamin S. Wilfond, MD, University of Washington School of Medicine, on “Pediatric Assent in Genetic Research: Addressing Incidental Findings and Individual Research Results” View Online
Jeffrey P. Kahn, PhD, MPH, University of Minnesota, on “The Role of Community Engagement and Consultation in Managing Return of Incidental Findings and Individual and Aggregate Research Results” View Online

Q and A View Online

Session B3: Empirical Assessment and Outcomes of Returning IFs & IRRs, Including Stakeholder Preferences
Moderator: Frances Lawrenz, PhD, University of Minnesota

Panelists:
Lisa Parker, PhD, University of Pittsburgh, on “Returning Individual Research Results: What Role Should People’s Preferences Play?” View Online
Robert C. Green, MD, MPH, Harvard Medical School, on “How Do Participants in a Genetics Disclosure Study Respond to the Return of Unexpected Results?” View Online
Joan A. Scott, MS, CGC, National Coalition for Health Professional Education in Genetics, on “Return of Research Results: What Do People Really Want and Why?” View Online
Barbara Koenig, PhD, Mayo College of Medicine, on “Patient Perspectives on Return of Results in Biorepositories for Life-Threatening Illness” View Online
Bonnie S. LeRoy, MS, CGC, University of Minnesota, on “Genetic Counseling: What is the Experience of Providing Test Results and the Lessons for Return of Research Results?” 
Moira Keane, MA, CIP, University of Minnesota, on “The IRB Experience in Overseeing Return of Results and Incidental Findings” 

Q and A View Online

Breakout Wrap-Up View Online

4:15pm

Reports from Concurrent Workshops & Next Steps
Moderator: Susan M. Wolf, JD, University of Minnesota

Jeffrey P. Kahn, PhD, MPH, University of Minnesota
Brian Van Ness, PhD, University of Minnesota
Frances Lawrenz, PhD, University of Minnesota

4:45pm
Reception

Speaker Biographies

Leslie G. Biesecker, MD, is Chief and Senior Investigator, Genetic Disease Research Branch, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). Dr. Biesecker’s research focuses on understanding the relationship of genomic variation to health and disease. Currently, his laboratory is engaged in studies in two main areas: classic genotype-phenotype studies of genetic disorders of development and growth, and new approaches to hypothesis-generating clinical genomics research.

 

 

Marianna J. Bledsoe, MA, is Senior Program Manager for Biorepositories and Biobanking at the Department of Veterans Affairs, Office of Research and Development. She provides strategic direction and oversight of the VA’s tissue banking activities. Prior to this position, she was Deputy Associate Director of the Clinical Research Policy Analysis and Coordination Program in the Office of Science Policy, Office of the Director, National Institutes of Health (NIH).

 

 

 

Mildred K. Cho, PhD, is Associate Professor of Pediatrics and Genetics; Associate Director, Center for Biomedical Ethics; and PI, Center for Integration of Research on Genetics & Ethics (CIRGE), Stanford University. Dr. Cho’s major areas of interest include: ethical and social issues in genetic research, stem cell research, bioweapons and microbial genome research, the effects of gene patenting on clinical genetic testing and research, and the impacts of academic-industry ties on biomedical research.

 

 

Michael F. Christman, PhD, is President and CEO, Coriell Institute for Medical Research. Under Dr. Christman’s leadership, Coriell has established a state-of-the-art genotyping and microarray center and formed partnerships with several hospitals to enroll volunteer study participants into the Coriell Personalized Medicine Collaborative (CPMC).

 

 

 

Ellen Wright Clayton, MD, JD, is Craig-Weaver Professor of Pediatrics, Professor of Law, and Director of the Center for Biomedical Ethics and Society, Vanderbilt University. She is the 2010 recipient of the William G. Bartholeme Award for Ethical Excellence, through which the American Academic of Pediatrics’ Section on Bioethics recognizes an individual each year who has had a significant impact on public discussion of ethical issues in pediatric medicine.

 

 

 

Leili Fatehi, JD, is Associate Director of Research & Education, Consortium on Law and Values in Health, Environment & the Life Sciences; Adjunct Associate Professor of Law; and Faculty Managing Editor, Minnesota Journal of Law, Science & Technology, University of Minnesota.

 

 

 

Rebecca Fisher, MLIS, is a Medical Librarian and Patient Advocate. Ms. Fisher has worked extensively in the areas of health privacy and improving health outcomes. She serves on several national committees, including the Secretary for Health and Human Services’ American Health Information Community (AHIC) Personalized Health Care Working Group; the AHIC Confidentiality, Privacy, and Security Working Group; the NIH Advisory Committee to the Director’s Working Group on Participant and Data Protection for the Genetic Association Information Network; and the Johns Hopkins Genetics and Public Policy Citizens Advisory Panel. She currently works as a Writer and Researcher, Center for the Study of Intelligence, U.S. Central Intelligence Agency.

 

Stephanie Malia Fullerton, DPhil, is Assistant Professor in the Department of Bioethics & Humanities, University of Washington School of Medicine. Her work explores researcher and participant perspectives on data-sharing, research use, and result return in the context of genome-wide association studies and related forms of genetic research, especially as it involves the use of electronic health records and/or clinical specimens. She holds adjunct positions in the UW Departments of Genome Sciences and Epidemiology, is an affiliate investigator with the Public Health Sciences division of the Fred Hutchinson Cancer Research Center, and serves as a member of the Regulatory Support and Bioethics Core of the UW Institute of Translational Health Sciences CTSA.

 

Francine C. Gachupin, PhD, MPH, is Associate Member, Population Sciences Program, University of New Mexico Cancer Center and Manager, Research Protections Operations, University of New Mexico School of Medicine Human Research Protections. Dr. Gachupin has extensive experience working with American Indian tribal communities as an Epidemiologist focusing primarily on chronic disease surveillance, public health practice, and research. Dr. Gachupin obtained her doctorate from the University of New Mexico and her Masters of Public Health from the University of Washington in Seattle.

 

 

Robert C. Green, MD, MPH, is Associate Director, Harvard-Partners Center for Personalized Genetic Medicine, Division of Genetics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School. Since 1999, Dr. Green has directed the NHGRI-funded REVEAL Study. Dr. Green is also PI (with Scott Roberts) of a new NHGRI-funded study to prospectively examine the impact of consumer-based personal genomics services.

 

 

 

Ingrid Holm, MD, MPH, is Director, Phenotyping Core, Program in Genomics, Children’s Hospital Boston. Prof. Holm’s research focuses on the genetics of bone disorders. She has performed research in the role of mutations in the PHEX gene in hypophosphatemic rickets.

 

 

 

Kathy Hudson, PhD, is Deputy Director for Science, Outreach, and Policy, National Institutes of Health (NIH). Prior to this appointment, Dr. Hudson served as the Chief of Staff to the NIH Director. Dr. Hudson oversees and coordinates the work of the Office of Communications & Public Liaison, the Office of Legislative Policy and Analysis, and the Office of Science Policy within the Office of the Director. Before joining the NIH, she was the founder and Director of the Genetics and Public Policy Center and an Associate Professor in the Berman Institute of Bioethics, Institute of Genetic Medicine, and the Department of Pediatrics at Johns Hopkins University.

 

 

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

 

 

 

Scott Jewell, PhD, is Deputy Director for Research Resources, Professor and Director, Program for Biospecimen Science, Van Andel Research Institute and Current President, International Society for Biological and Environmental Repositories (ISBER).

 

 

 

 

Jeffrey P. Kahn, PhD, MPH, is Director of the Center for Bioethics and the Maas Family Chair in Bioethics; Professor, Department of Medicine, University of Minnesota Medical School; Division of Health Services Research and Policy, School of Public Health; Department of Philosophy, University of Minnesota. Dr. Kahn works in a variety of areas of bioethics, exploring the intersection of ethics and public health policy, including research ethics, ethics and genetics, and ethical issues in public health. Dr. Kahn is a Co-Investigator on the NIH/NHGRI grant on “Managing Incidental Findings and Research Results in Genomic Biobanks & Archives.”

 

 

Moira Keane, MA, CIP, is Director of the Research Subjects’ Protection Programs (RSPP) which includes the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC), University of Minnesota. She is actively involved in subjects’ protections and serves as Co-Chair of the Association for Accreditation of Human Research Programs (AAHRPP) Council on Accreditation. She serves as Vice Chair of the Council on Certified IRB Professionals (CCIP), is a member of the Secretary’s Advisory Committee on Human Subjects Protection (SACHRP) Subpart A Sub Committee, and on the Board of Public Responsibility in Medicine and Research (PRIM&R).

 

Penny Keller, BS, MP (ASCP), is with the Centers for Medicare & Medicaid Services, CMSO/SCG/Division of Laboratory Services.

 

 

 

 

Bartha Maria Knoppers, JD, PhD, is Canada Research Chair in Law and Medicine; Director, Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University. She held the Chair d’excellence Pierre Fermat and was named Distinguished Visiting Scientist at the Netherlands Genomics Initiative. She is Chair of the Ethics Working Party of the International Stem Cell Forum, Co-Chair of the Sampling/ELSI Committee of the 1000 Genomes Project, and a member of the Scientific Steering Committee of the International Cancer Genome Consortium (ICGC).

 

 

Barbara Koenig, PhD, is an anthropologist who studies contemporary biomedicine, Professor of Medicine,Mayo Clinic College of Medicine, and Faculty Associate at the Center for Bioethics, University of Minnesota. Her research focuses on two areas: end-of-life care and the ethical, social, and political implications of new biomedical technologies, particularly those within the genomic sciences. Prof. Koenig has served on the Department of Health and Human Services Secretary’s Advisory Committee on Genetic Testing. Her ongoing NIH-funded research examines the ethical and policy implications of emerging knowledge in genetics and neurobiology of addiction.

 

 

Isaac Kohane, MD, PhD, is Director of the Children’s Hospital Informatics Program, Children’s Hospital Boston; Henderson Professor of Pediatrics and Health Sciences and Technology, Harvard Medical School (HMS); Co-Director of the HMS Center for Biomedical Informatics; and Director, HMS Countway Library of Medicine. Dr. Kohane leads multiple collaborations at Harvard Medical School and its hospital affiliates in the use of genomics and computer science to study diseases (particularly cancer and autism) through the perspective of biological development.

 

 

Lawrenz

Frances Lawrenz, PhD, is Associate Vice President for Research and Professor of Educational Psychology, University of Minnesota. Her major research focus is science and mathematics program evaluation. Prof. Lawrenz is currently working on evaluation of several national science and mathematics programs. She is also interested in instrument development and in distinguishing among various types of assessments those that are most appropriate for a given situation. Prof. Lawrenz is a Co-Investigator on the NIH/NHGRI grant on “Managing Incidental Findings and Research Results in Genomic Biobanks & Archives.”

 

 

Bonnie S. LeRoy, MS, CGC, is Associate Professor and Director of the Graduate Program in Genetic Counseling, University of Minnesota. The primary focus of her work is on fully preparing graduate students to enter the profession of genetic counseling. Her major area of research interest involves the ethical and social challenges associated with the genetic counseling profession. Prof. LeRoy served as the President of the American Board of Genetic Counseling from 2001-03.

 

 

 

Nicole C. Lockhart, PhD, is Biospecimen Technology Program Specialist, Office of Biorepositories and Biospecimen Research (OBBR), National Cancer Institute (NCI), National Institutes of Health (NIH). Dr. Lockhart works on ethical issues and biospecimen resource evaluation. Her dissertation research investigated contractionraction- induced skeletal muscle injury and the cellular processes necessary to reduce injury. Prior to joining OBBR, Dr. Lockhart was a Mirzayan Science and Technology Policy Graduate Fellow at the National Academies of Science.

 

 

Karen Maschke, PhD, is Associate for Ethics and Science Policy, The Hastings Center and Editor of IRB: Ethics & Human Research. Dr. Maschke has been active in research and public policy involving the ethical, legal, and social implications of human genetic research. She was the Co-Chair of the ELSI Subcommittee for the NCI’s Cancer Human Biobank (calHUB) and was a participant in the NCI Data Release Workshop on Biospecimen Access and Ethical, Legal, and Policy Issues, the NCI/NHGRI Data Release Worskshop for The Cancer Genome Atlas (TCGA), and the NCI Workshop on Release of Research Results to Participants in Biospecimen Studies.

 

William McGeveran, JD, is Associate Professor at the University of Minnesota Law School. Prof. McGeveran specializes in information law, including intellectual property, data privacy, communications and technology, and free speech. His current research focuses on digital identity and data privacy, disclosure rules and norms in areas such as open records laws, and fair use and the public domain in trademark and copyright law.

 

 

 

Amy L. McGuire, JD, PhD, is Associate Director for Research in the Center for Medical Ethics and Health Policy and Associate Professor of Medicine and Medical Ethics, Baylor College of Medicine. Prof. McGuire’s research focuses on legal and ethical issues in genetics and genomics, with a particular interest in genetic research and personalized genomic medicine. She is currently studying participant attitudes toward broad data-sharing in genome-wide association studies, ethical issues in human microbiome research, and consumer expectations regarding the clinical integration of direct-to-consumer personal genome testing services.

 

 

Jerry Menikoff, MD, JD, MPP, is Director, Office for Human Research Protections (OHRP), U.S. Department of Health & Human Services. Prior to his current role, he was in charge of the human subjects protections program at the National Institutes of Health (NIH). Dr. Menikoff was also Associate Professor of Law, Ethics & Medicine at the University of Kansas School of Medicine. He has been a Faculty Fellow at the MacLean Center for Clinical Medical Ethics at the University of Chicago, and at the Center for Ethics and the Professions at Harvard University. He also has been on the faculty of the University of Chicago School of Law and other law schools.

 

 

Christopher O’Donnell, MD, MPH, is Associate Director and Scientific Director of the SHARe Project, Framingham Heart Study, National Heart, Lung and Blood Institute at NIH; and Assistant Professor, Harvard Medical School. Dr. O’Donnell’s major research focus is on the epidemiology and genetic epidemiology of clinical and subclinical cardiovascular disease, and he directs numerous large-scale imaging studies using cardiac CT scanning, cardiac magnetic resonance imaging, and other subclinical atherosclerosis modalities.

 

 

 

P. Pearl O’Rourke, MD, is Director of Human Research Affairs, Partners HealthCare System and Chair, Board of Directors, Public Responsibility in Medicine and Research (PRIM&R). Dr. O’Rourke has been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-96, she completed a Robert Wood Johnson Health Policy fellowship and worked for Senator Edward Kennedy (Democrat-MA) as a member of the Labor Committee Staff.

 

 

Pilar Ossorio, JD, PhD, is Associate Professor of Law and Bioethics and Program Faculty in the Graduate Program of Population Health, University of Wisconsin–Madison. Prof. Ossorio is a Fellow of the American Association for the Advancement of Science (AAAS), a member of the editorial board of the American Journal of Bioethics, chair of an NHGRI advisory group on ethical issues in large-scale sequencing, and a member of University of Wisconsin’s Institutional Review Board for health sciences research.

 

 

 

Lisa S. Parker, PhD, is Associate Professor of Human Genetics and Behavioral and Community Health Sciences in the Graduate School of Public Health; Affiliated Faculty Member, Department of Philosophy; Member of the Steering Committee of the Women’s Studies Program; Fellow of the Center for Philosophy of Science; and Director of Graduate Education for the Center for Bioethics and Health Law, University of Pittsburgh.

 

 

Gloria Petersen, PhD, is Professor of Epidemiology and Purvis and Roberta Tabor Professor, College of Medicine, Mayo Clinic. She is also certified by the American Board of Medical Genetics as a PhD Medical Geneticist; is a founding member of the American College of Medical Genetics; and directs one of the largest and most comprehensive patient registry and biobank resources for the study of pancreatic cancer.

 

 

 

Henry S. Richardson, JD, MPP, PhD, is Professor of Philosophy, Georgetown University. Dr. Richardson has worked on the question of what obligations medical researchers have to provide the care that their research subjects need but that is not required to carry out research studies soundly or safely.

 

 

 

 

Laura Lyman Rodriguez, PhD, is Acting Director, Office of Policy, Communications and Education (OPCE); and Senior Advisor to the Director for Research Policy, NHGRI, NIH. Dr. Rodriguez works to develop and implement policy for research initiatives at the NHGRI, as well as trans-NIH programs. Among other activities, Dr. Rodriguez has provided leadership for many of the policy development activities pertaining to genomic data-sharing and the creation of the database for Genotypes and Phenotypes (dbGaP) at the NIH.

 

 

Joan A. Scott, MS, CGC, is Executive Director of the National Coalition for Health Professional Education in Genetics (NCHPEG). There, she leads the national effort to promote health professional education and access to information about advances in human genetics. Her research interests include studying public and stakeholder attitudes about genomics.

 

 

 

Alan R. Shuldiner, MD, is Associate Dean for Personalized Medicine and John L. Whitehurst Professor of Medicine, University of Maryland School of Medicine. He also serves as Principal Investigator and Director of the NIH-funded Mid-Atlantic Nutrition and Obesity Research Center, and Director and Principal Investigator of the University of Maryland Multidisciplinary Clinical Research (K12) Career Development Program, and is a Core Investigator at the Geriatric Research and Education Clinical Center (GRECC) at the Baltimore Veterans Administration Medical Center.

 

 

Joseph Thakuria, MD, MMSc, is Attending Physician in Chemical and Biochemical Genetics, Massachusetts General Hospital, and Instructor of Medicine, Harvard University. Dr. Thakuria discovered a new syndrome of Wolff-Parkinson-White arrhythmia with developmental delay, along with the causative gene. Since 2005, he has worked as Co-Investigator and Medical Director of the Personal Genome Project (PGP) led by George Church – an HMS IRB-approved study for enrollment of 100,000 participants (and screening of 350,000) for comprehensive sequencing, phenotyping, tissue collection, generation of individualized adult stem cell lines, and biobanking.

 

 

Brian Van Ness, PhD, is Professor of Genetics, Cell Biology & Development; Director of the Division of Medical Genomics; Co-Director of the Institute for Human Genetics, University of Minnesota. His lab focuses on defining genetic deregulation that contributes to lymphoid malignancies, particularly multiple myeloma as well as working with both national and international clinical groups to correlate genetic defects with disease outcome and response to different therapies. Prof. Van Ness is a Co-Investigator on the NIH/NHGRI grant on “Managing Incidental Findings and Research Results in Genomic Biobanks & Archives.

 

 

Benjamin S. Wilfond, MD, is Director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Hospital; Professor and Chief of the Division of Bioethics, University of Washington School of Medicine; and Adjunct Professor in the Department of Bioethics and Humanities, University of Washington. Prof. Wilfond conducts research on ethical and policy issues related to genetic testing, genetic research, and pediatrics research. He has recently worked on issues related to newborn screening, disclosure of genetic research results, and pediatric biobanks.

 

 

Susan M. Wolf, JD, is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre & Benson Professor of Law; Professor of Medicine; and Faculty Member, Center for Bioethics, University of Minnesota. She is also Chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences. Prof. Wolf was PI on the Consortium’s NIH/NIH grant on “Managing Incidental Findings in Human Subjects Research” (Award #1-R01-HG003178) and is PI on the current NIH/NHGRI grant on “Managing Incidental Findings and Research Results in Genomic Biobanks & Archives” (Award #2-R01-HG003178).

 

 

Wendy Wolf, PhD, is Executive Director, Biorepository, Children’s Hospital Boston. She was formerly the Director and Co-Investigator, Center for Genetic Medicine, Northwestern University. Dr. Wolf was co-investigator on a recent Department of Energy-funded ELSI (Ethical, Legal and Social Implications of the Human Genome Project) study on participant perceptions of the informed consent process for NUgene. She is a member of the American Society of Human Genetics and is a Director for Women Advancing Bioscience.

Continuing Medical Education (CME)
This event has been designated by the University of Minnesota's Office of the Vice President for Research to satisfy the Awareness/Discussion component of the Responsible Conduct of Research (RCR) Continuing Education requirement.

This event has been approved for 7.5 AMA PRA Category 1 Credits™.

The University of Minnesota is accredited by the ACCME to provide continuing medical education for physicians.

The conference is sponsored by:
  • A grant from the National Institutes of Health, National Human Genome Research Institute (NIH, NHGRI) Award #2-R01-HG003178
  • The University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences