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From page 69... ...
A major goal of the workshop will be to examine current regulatory provisions that may not adequately protect patients or may be hindering research, and to discuss potential strategies and actions to address those challenges. Participants will be invited to discuss topics that may include • Use of central Institutional Review Boards for multicenter cancer studies; • Use of materials and data (including genomic data)
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From page 70... ...
AGENDA February 24, 2014 7:30 am Registration 8:00 am Welcome from the IOM's National Cancer Policy Forum John Mendelsohn, MD Anderson Cancer Center Chair, National Cancer Policy Forum Overview of the Workshop Steven Piantadosi, Samuel Oschin Comprehensive Cancer Institute Angela Bradbury, Perelman School of Medicine at the University of Pennsylvania Planning Committee Cochairs 8:15 am The Current Landscape in Human Subjects Protections Holly Taylor, Associate Professor, Health Policy and Management, Johns Hopkins Bloomberg School of Public Health and Core Faculty, Johns Hopkins Berman Institute of Bioethics 8:45 am Session 1: The Revised HIPAA Privacy Rule and Researchers' Use of Data Moderator: Tom Kean, C-Change • Melissa Bianchi, Partner, Hogan Lovells • lice Leiter, Policy Counsel, Health Privacy Project, A Center for Democracy & Technology • rad Malin, Associate Professor of Biomedical B Informatics & Vice Chair for Research, School of Medicine, Vanderbilt University Group Discussion
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From page 71... ...
APPENDIX 71 10:15 am Break 10:30 am Session 2: Improving the Informed Consent Process Moderator: Laura Cleveland, Patient Advocate, CALGB/ Alliance and NCI CIRB The Patient Experience • Laura Cleveland, Patient Advocate, CALGB/Alliance and NCI CIRB NCI Common Consent Form • Mary McCabe, Director, Survivorship Program, Memorial Sloan Kettering Cancer Center Challenges and Opportunities to Improve the Informed Consent Process • Terrence Albrecht, Associate Center Director, Barbara Ann Karmanos Cancer Institute, Wayne State University • Laura Cleveland, Patient Advocate, CALGB/Alliance and NCI CIRB • Michael Paasche-Orlow, Associate Professor of Medicine, Boston University • effrey Botkin, Associate Vice President for Research J Integrity, University of Utah, and Chair, Secretary's Advisory Committee on Human Research Protections Group Discussion 12:45 pm Lunch Break 1:30 pm Session 3: Ethical Challenges of Genome-Based Cancer Research Moderator: Angela Bradbury, Perelman School of Medicine at University of Pennsylvania, and Planning Committee the Cochair
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From page 72... ...
72 PROTECTING PATIENTS IN CANCER RESEARCH • Overview: Angela Bradbury, Perelman School of Medicine at the University of Pennsylvania, and Planning Committee Cochair • Gail Jarvik, Head and Professor, Division of Medical Genetics, University of Washington School of Medicine • Ellen Wright Clayton, Craig Weaver Professor of Pediatrics and Professor of Law, Vanderbilt Center for Biomedical Ethics and Society • Angela Bradbury, Perelman School of Medicine, University of Pennsylvania • Jeffrey Peppercorn, Director, Duke Cancer Survivorship Center, Associate Professor of Medicine, Division of Medical Oncology, Duke University Medical Center Group Discussion 3:45 pm Break 4:00 pm Session 4: Patients' Perspectives on Human Subjects Protections in Cancer Research Moderator: Patricia A Ganz, University of California, Los Angeles • Sharon Terry, Genetic Alliance • Laura Cleveland, Patient Advocate, CALGB/Alliance and NCI CIRB • Deborah Collyar, Founder and President, Patient Advocates in Research Group Discussion
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From page 73... ...
APPENDIX 73 February 25, 2014 8:00 am Registration 8:30 am Session 5: Ethical Oversight of Clinical Effectiveness Assessments Moderator: Steven Joffe, University of Pennsylvania Risk-Based Oversight in a Learning Health Care System • Ruth Faden, Director, Johns Hopkins Berman Institute of Bioethics • Jerry Menikoff, Director, Office for Human Research Protections, Department of Health and Human Services Oversight of Pragmatic Randomized Trials • Susan S Ellenberg, Professor of Biostatistics, University of Pennsylvania School of Medicine Group Discussion 10:00 am Break 10:15 am Session 6: The Challenges and Successes of Review and Oversight of Multicenter Cancer Studies Moderator: Steven Piantadosi, Samuel Oschin Comprehensive Cancer Institute Part I: Perspectives of the Principal Investigator, Trial Sponsor, and Host Institution • Barbara Bierer, Senior Vice President of Research, Brigham and Women's Hospital, and Program Director, Harvard Catalyst Regulatory Knowledge and Support Program • Richard Schilsky, Chief Medical Officer, ASCO
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From page 74... ...
74 PROTECTING PATIENTS IN CANCER RESEARCH Part II: Perspectives of Local and Central Oversight Bodies • David Parda, System Chair, Cancer Institute, Radiation Oncology, IRB, Allegheny Health Network • Christopher Daugherty, Professor of Medicine, Chair, Biological Sciences Division Institutional Review Board, University of Chicago Group Discussion 12:15 pm Workshop Wrap-Up Angela Bradbury, Perelman School of Medicine at the University of Pennsylvania Planning Committee Cochair 12:30 pm Adjourn
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