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Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary (2014)

Chapter: Appendix: Workshop Statement of Task and Agenda

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Suggested Citation: "Appendix: Workshop Statement of Task and Agenda." Institute of Medicine. 2014. Contemporary Issues for Protecting Patients in Cancer Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18823.

Appendix

Workshop Statement of Task and Agenda

STATEMENT OF TASK

An ad hoc committee will plan and host a 1.5-day public workshop to examine current issues in human subjects protections in cancer research. The workshop will feature panel discussions and invited presentations from experts and advocates in clinical cancer research and oversight. 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) stored in biobanks for cancer research;
Informed consent and authorization forms;
Risk-based oversight of clinical effectiveness assessment in a learning health care system; and
Potential changes to the Common Rule delineated in the recent ANPRM.

An individually authored workshop summary will be prepared by a designated rapporteur based on the information gathered and the discus-

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sions held during the workshop in accordance with institutional policy and procedures. No committee will be used in the development of the workshop summary.

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 Alice Leiter, Policy Counsel, Health Privacy Project, Center for Democracy & Technology Brad Malin, Associate Professor of Biomedical Informatics & Vice Chair for Research, School of Medicine, Vanderbilt University
	Group Discussion

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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 Jeffrey Botkin, Associate Vice President for Research 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 the University of Pennsylvania, and Planning Committee Cochair

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	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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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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	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