Agenda and Videos

Cowles Auditorium, Hubert H. Humphrey Center, University of Minnesota
Thursday, November 6, 2014

8:30am   
Welcome and introductions  View video  Duration: 14 min
Moderator: Susan M. Wolf, JD (Co-PI), 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

  • Brian Herman, PhD, Vice President for Research, University of Minnesota

8:45am
Keynote:  Where do we stand on return of results & incidental findings in research & clinical care? Where does return to family fit in the puzzle?  View video  Duration: 39 min
Moderator: Susan M. Wolf, JD

  • Wylie Burke, MD, PhD, Professor, Dept. of Bioethics & Humanities, University of Washington School of Medicine

9:15am 
Offering results & incidental findings to family in genomic research: Project analysis & recommendations*
Moderator: Susan M. Wolf
, JD

  • Barbara Koenig, PhD, Professor, Dept. of Social & Behavioral Sciences, Institute for Health and Aging, University of California, San Francisco
  • Gloria Petersen, PhD, Professor, Dept. of Epidemiology, Mayo Clinic College of Medicine; Associate Director for Population Sciences, Mayo Clinic Cancer Center; Associate Dean for Research Informatics, Mayo Clinic (Co-PI)

*Video not available for this presentation. Recommendations can be found in the Fall, 2015 issue of the Journal of Law, Medicine & Ethics.

10:00am 
Do families desire unexpected genomic research results? A national survey of participants in a cancer biobank, their blood relatives, partners, and matched controls  
View video  Duration: 30 min

 Barbara Koenig, PhD (Co-PI), Professor, Dept. of Social & Behavioral Sciences, Institute for Health and Aging, University of California, San Francisco (Co-PI)
• Carmen Radecki Breitkopf, PhD (Co-PI), Associate Professor, Health Services Research, Mayo Clinic

10:30am 
Break

10:45am 
Panel: Reactions to recommendations  
View video  Duration: 1 hr, 26 min
Moderator: Susan M. Wolf, JD
Panelists:

  • Jean McEwen, JD, PhD, Program Director, Ethical, Legal, and Social Implications Program, National Human Genome Research Institute, National Institutes of Health
  • Scott Nelson, Patient Advocate
  • Jerry Menikoff, MD, JD, Director, Office for Human Research Protections (OHRP)
  • Ellen Wright Clayton, MD, JD, Craig-Weaver Professor of Pediatrics; Professor of Law; Founding Director, Center for Biomedical Ethics & Society, Vanderbilt University
  • Mark E. Robson, MD, Clinic Director and Associate Attending Physician, Clinical Genetics and Breast Cancer Medicine Services, Department of Medicine, Memorial Sloan Kettering Cancer Center; Chair-elect, Ethics Committee, American Society of Clinical Oncology

12:15pm 
Networking Lunch

1:00pm
Concurrent Session #1How should researchers, IRBs, and biobanks approach return of results & incidental findings to family, including after the participant’s death? What policies are appropriate?  View video  Duration: 52 min
Moderator: Jean McEwen, JD, PhD, Program Director, Ethical, Legal, and Social Implications Program, National Human Genome Research Institute, National Institutes of Health

  • Implications of penetrance differences in subpopulations — Prof. Robert C. Green, MD, MPH, Dept. of Genetics, Brigham and Women’s Hospital; Associate Director for Research, Partners Center for Personalized Genetic Medicine, Harvard Medical School
  • What are the implications of a family-centered approach to cancer genetics for return of research results to kin? — Prof. Mary Daly, MD, PhD, Chair, Dept. of Clinical Genetics, Fox Chase Cancer Center
  • What is the IRB’s role in the return of results? — Prof. P. Pearl O’Rourke, MD, Director, Human Research Affairs, Partners HealthCare; Prof. Laura Beskow, MPH, PhD, Institute for Genome Sciences & Policy, Duke University; Prof. Susan Berry, MD, Professor of Pediatrics & Genetics, University of Minnesota; Prof. Conrad Fernandez, MD, Dept. of Bioethics, Dalhousie University; Dept. Pediatric Hematology/Oncology, IWK Health Centre
  • How should biobanks & registries approach this? — Prof. Gloria Petersen, PhD; Prof. Brian Van Ness, PhD, Dept. of Genetics, Cell Biology & Development, University of Minnesota
  • What do the HIPAA Privacy Rule, state laws, and professional codes of ethics tell us about return of results to family, including after the participant's death? — Prof. Mark A. Rothstein, JD, Herbert F. Boehl Chair of Law & Medicine; Director, Institute for Bioethics, Health Policy & Law, University of Louisville School of Medicine

Concurrent Session #2: How and when should return of results and incidental findings occur in research involving children and adolescents? What does that suggest more broadly for return to family outside of the pediatric context?  View video  Duration: 1 hour, 18 min
Moderator: Prof. Sharon Plon, MD, PhD, Professor of Molecular and Human Genetics; Professor of Pediatrics, Baylor College of Medicine; Director, Cancer Genetics Clinical Program and Cancer Genetics Research Program, Texas Children’s Hospital

  • Returning secondary findings from pediatric sequencing to families — Prof. Ben Wilfond, MD, Director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Hospital; Chief, Division of Bioethics, University of Washington; Prof. Conrad Fernandez, MD, Dept. of Bioethics, Dalhousie University; Dept. Pediatric Hematology/Oncology, IWK Health Centre; Prof. Robert C. Green, MD, MPH, Dept. of Genetics, Brigham and Women’s Hospital; Associate Director for Research, Partners Center for Personalized Genetic Medicine, Harvard Medical School
  • Return of results and incidental findings in research involving adolescents — Ellen Wright Clayton, JD, MD, Craig-Weaver Professor of Pediatrics; Professor Law; Director, Center for Biomedical Ethics & Society, Vanderbilt University
  • Return of results and incidental findings in research on dried blood spots from newborn screening — Michelle Huckaby Lewis, MD, JD, Research Scholar, Berman Institute of Bioethics, Johns Hopkins

2:30pm
Break

2:45pm 
Concurrent Session #3: Progressing to consideration of populations and specific subpopulations in the return of results debate  View video  Duration: 1 hour, 20 min
Moderator: E. Charlisse F. Caga-anan, JD, MA, Program Director, Health Sciences Specialist, Division of Cancer Control and Population Sciences, National Cancer Institute, NIH

  • How should policy on return to family address diversity among families? — Prof. Carmen Radecki Breitkopf, PhD, Health Services Research, Mayo Clinic
  • Engaging diverse communities on return of results: What about return to family? — Nanibaa’ A. Garrison, PhD, Assistant Professor of Pediatrics, Vanderbilt University Medical Center
  • Return of results in families with rare and ultra-rare variants — Prof. Sharon Plon, MD, PhD, Professor of Molecular and Human Genetics; Professor of Pediatrics, Baylor College of Medicine; Director, Cancer Genetics Clinical Program and Cancer Genetics Research Program, Texas Children’s Hospital
  • GENE-SCREEN: Decisions about return of results & incidental findings in the context of public health genomics — Prof. Gail Henderson, PhD, Professor & Chair, Dept. of Social Medicine, University of North Carolina at Chapel Hill

Concurrent Session # 4: The relationship of research to clinical care in return of results and incidental findings to family View video  Duration: 1 hr, 20 min
Moderator: Jerry Menikoff, MD, JD, Director, Office for Human Research Protections (OHRP)

  • What should the relationship be between return to family in clinical genetics and return of research results? — Prof. Barbara Koenig, PhD; Prof. Susan M. Wolf, JD; Prof. Wylie Burke, MD, PhD, Professor, Dept. of Bioethics & Humanities, University of Washington School of Medicine
  • What can return to family in the context of research learn from return in the context of clinical care? — Prof. Bonnie LeRoy, MS, Dept. of Genetics, Cell Biology & Development, University of Minnesota
  • Genomic sequencing for tumor profiling: From cancer research to cancer care — Mark E. Robson, MD, Clinic Director and Associate Attending Physician, Clinical Genetics and Breast Cancer Medicine Services, Department of Medicine, Memorial Sloan Kettering Cancer Center; Chair-elect, Ethics Committee, American Society of Clinical Oncology
  • Should return to family hinge on clinical actionability? How should that be specified — actionability in the care of family members themselves? What does “actionability” mean in this context? — Noralane (Laney) Lindor, MD, Dept. of Medical Genetics, Mayo Clinic Arizona
  • Returning results relating to reproductive health: Implications for women — Research Associate Rebecca Branum, JD, Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota; Prof. Susan M. Wolf, JD

4:30pm 
Reports from Concurrent Sessions and Next Steps 
View video  Duration: 41 min

5:00pm 
Adjourn