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B Public Agendas Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories First Committee Meeting July 19, 2017 National Academies Keck Building 500 Fifth Street NW, Washington, DC 20001 AGENDA OPEN SESSION 1:00â1:15 p.m. Opening Remarks to Public Audience Jeffrey Botkin, Committee Chair 1:15â2:00 p.m. Presentation by Sponsors: Stephanie Devaney, National Institutes of Health Adam Berger, Food and Drug Administration Karen Dyer, Centers for Medicare & Medicaid Services 2:00â2:45 p.m. Sponsor Q&A with Committee Moderator: Jeffrey Botkin, Committee Chair 2:45 p.m. ADJOURN Open Session PREPUBLICATION COPY: UNCORRECTED PROOFS B-1
B-2 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Second Committee Meeting September 6â7, 2017 National Academy of Sciences Building 2101 Constitution Avenue NW, Washington, DC 20148 AGENDA OPEN SESSION Day 1: September 6, 2017 8:30â8:45 a.m. Welcome and Opening Remarks Jeffrey Botkin, Committee Chair 8:45â10:15 a.m. Session 1: Participant and Community Perspectives Moderator: Gregg Gonsalves, Committee Member Fran Visco, President, National Breast Cancer Coalition Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy Chioma Nnaji, Program Director, Multicultural AIDS Coalition 10:15â10:30 a.m. BREAK 10:30 a.m.â12:00 p.m.Session 2a: Perspectives of Researchers and Laboratorians Moderator: Debra Leonard, Committee Member Wendy Chung, Professor of Pediatrics and Medicine, Columbia University Carolyn Compton, Professor of Life Sciences, Arizona State University Jessica B. Langbaum, Principal Scientist, Banner Alzheimerâs Institute Lea C. Harty, BioBank Biological Materials Custodian, Pfizer Inc., Representative of The Industry Pharmacogenomics Working Gro 12:00â12:30 p.m. LUNCH 12:30â1:15 p.m. Session 2b: Successes and ChallengesâCSER and eMERGE Moderator: Steven Joffe, Committee Member (resigned from the committee on September 26, 2017) Rex Chisholm, Vice Dean for Scientific Affairs and Graduate Education, Adam and Richard T. Lind Professor of Medical Genetics, Feinberg School of Medicine, Northwestern University, eMERGE Gail Jarvik, Head, Division of Medical Genetics, University of Washington, CSER/eMERGE PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX B B-3 1:15â2:45 p.m. Session 2c: Experiences to Date of Returning Results from Different Health Care Institutions Moderator: Chester Brown, Committee Member Febe Wallace, Director of Primary Care, Cherokee Health Systems Ronald Przygodzki, Director, Genomic Medicine Implementation, Department of Veterans Affairs, Office of Research & Development Joanne Murabito, Research Center Director, Framingham Heart Study Adam Buchanan, Clinical Investigator I, Geisinger Health System 2:45â3:00 p.m. BREAK 3:00â4:30 p.m. Session 3: Laws and Regulations Governing the Return of Results Moderator: Jeffrey Botkin, Committee Chair Susan M. Wolf, McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; University of Minnesota Law School, Medical School, and Consortium on Law and Values in Health, Environment & the Life Sciences David J. Peloquin, Associate, Ropes & Gray LLP Sally Howard, Head of Regulatory Affairs and Policy and Chief Privacy Officer, Human Longevity, Inc. 4:30â6:00 p.m. Session 4: Institutional Management and Oversight Moderator: Rhonda Kost, Committee Member Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute Alexis Carter, Physician Informaticist, Childrenâs Healthcare of Atlanta, Representative from College of American Pathologists Mark Sobel, Executive Officer, American Society for Investigative Pathology Heather Pierce, Senior Director, Science Policy and Regulatory Counsel Association of American Medical Colleges 6:00 p.m. ADJOURN DAY 2: September 7, 2017 8:00â8:15 a.m. Welcome and Opening Remarks Jeffrey Botkin, Committee Chair 8:15â9:45 a.m. Session 5: Communicating Results to Meet User Needs Moderator: Consuelo Wilkins, Committee Member Sally Okun, Vice President for Policy and Ethics, PatientsLikeMe Julia Wynn, Senior Genetic Counselor and Clinical Research Manager, Columbia University Medical Center PREPUBLICATION COPY: UNCORRECTED PROOFS
B-4 RETURNING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS Sara Czaja, Leonard M. Miller Professor in the Departments of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine (participating via WebEx) John Wilbanks, Chief Commons Officer, Sage Bionetworks 9:45â10:00 a.m. BREAK 10:00â11:00 a.m. Session 6: A Discussion with Workshop Panelists Moderator: Jeffrey Botkin, Committee Chair Gail Javitt, Member of the Firm in the Health Care and Life Sciences Practice, Office of Epstein Becker Green (participating via WebEx) Leslie G. Biesecker, Chief, Medical Genomics and Metabolic Genetics Branch, National Institutes of Health, National Human Genome Research Institute Ellen Wagner, Board of Directors, Parent Project Muscular Dystrophy 11:00â11:30 a.m. Public Comment Moderator: Jeffrey Botkin, Committee Chair 11:30 a.m. ADJOURN Public Workshop Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Third Committee Meeting October 24, 2017 National Academies Keck Building 500 Fifth Street NW, Washington, DC 20001 AGENDA OPEN SESSION 1:00â2:30 p.m. Basic and Translational Researcher Panel (non-genetic genomics) Moderator: Suzanne Bakken, Committee Member Nicholas Newman, Department of Pediatrics, Cincinnati Childrenâs Hospital Medical Center Theresa Powell, University of Colorado Anschutz Medical Campus 4:30â5:30 p.m. Public Comment Session 5:30 p.m. ADJOURN Open Session PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX B B-5 Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Public Webinar December 7, 2017 90-Minute Webinar 2:00â3:30 p.m. Quality Standard for Regulated and Non-Regulated Biomedical Research Laboratories Moderator: Debra Leonard, Committee Member Rebecca Davies, University of Minnesota Randy Querry, American Association for Laboratory Accreditation Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Fourth Committee Meeting Community and Participant PerspectivesâPublic Webinar December 11, 2017 Arnold and Mabel Beckman Center 100 Academy Drive, Irvine, California 3:30â6:30 p.m. Community and Participant PerspectivesâPublic Webinar John Molina, Native Health, Phoenix Sonja Fuqua, JHS Participant and Community Health Advisor Crispin Goytia-Vaquez, Mount Sinai Matthew Rose, NMAC (National Minority AIDS Council) Lisa Schlager, FORCE (Facing Our Risk of Cancer Empowered) Stephen Mikita, ASPREE (ASPirin in Reducing Events in the Elderly) PREPUBLICATION COPY: UNCORRECTED PROOFS