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-
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 |
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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 |
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Group Discussion | |
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
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NCI Common Consent Form
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Challenges and Opportunities to Improve the Informed Consent Process
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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 |
Group Discussion |
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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 |
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Group Discussion |
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
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Oversight of Pragmatic Randomized Trials
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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
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Part II: Perspectives of Local and Central Oversight Bodies
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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 |