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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.
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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-

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.
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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
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.
×
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

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.
×
  • 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
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.
×

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
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.
×
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
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.
×
Page 69
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.
×
Page 70
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.
×
Page 71
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.
×
Page 72
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.
×
Page 73
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.
×
Page 74
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In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research.

Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.

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