May 10, 2016: This workshop focused on unique ethical and regulatory issues identified by the NIH Collaboratory Trials supported by the NIH Health Care Systems Research Collaboratory Program.
Agenda and Slides
Welcome and Introduction
Catherine Myers, MD
Wendy Weber, ND, PhD, MPH
Keynote: Addressing the Ethical and Regulatory Issues in Pragmatic Clinical Trials
Jeremy Sugarman, MD, MPH
Panel 1: Options for Altered Consent and the Importance of Minimal Risk Determination
Moderator: Kevin Weinfurt, PhD
Panel:
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- Laura Dember, MD
- Gregory Simon, MD, MPH
- John Lantos, MD
- Emma Meagher, MD
Panel 2: Oversight of Pragmatic Clinical Trials: Institutional Review Boards and Data and Safety Monitoring Boards
Moderator: Adrian Hernandez, MD, MHS
Panel:
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- Douglas F. Zatzick, MD
- P. Pearl O'Rourke, MD
- Susan S. Ellenberg, PhD
Panel 3: Privacy Issues for Pragmatic Clinical Trials
Moderator: Valerie Bonham, JD
Panel:
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- Sarah M. Greene, MPH
- Valery Gordon, PhD, MPH
- Miguel Bazquez, MD
Panel 4: Vulnerable Populations
Moderator: David Wendler, PhD
Panel:
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- Susan S. Huang, MD
- Mary Jane Welch, DNP, APRN, BC
Panel 5: Expert Panel Q&A
Moderator: Jeremy Sugarman, MD, MPH
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- Kevin Weinfurt, PhD
- Adrian Hernandez, MD, MHS
- Valerie Bonham, JD
- David Wendler, PhD
Summary and Concluding Remarks