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 
View Online

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?” View Online
Moira Keane, MA, CIP, University of Minnesota, on “The IRB Experience in Overseeing Return of Results and Incidental Findings” View Online

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